ATDEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGIC HEALTH
GENERAL AND PLASTIC SURGERY DEVICES PANEL
OF THE MEDICAL DEVICES ADVISORY COMMITTEE
Tuesday, October 14, 2003
Gaithersburg Marriott Hotel
9751 Washingtonian Boulevard
Thomas V. Whalen, M.D., Acting Chair
David Krause, Ph.D., Executive Secretary
Brent A. Blumenstein, Ph.D.
Phyllis Chang, M.D.
Michael A. Choti, M.D.
Ann Marilyn Leitch, M.D.
Michael J. Miller, M.D.
Amy E. Newberger, M.D.
Alisa M. Gilbert
Debera M. Brown
TEMPORARY VOTING MEMBERS
Benjamin O. Anderson, M.D.
Dennis W. Boulware, M.D.
Emily F. Conant, M.D.
Nancy A. Dubler, LLB
Ruth A. Lawrence, M.D.
Stephen Li, Ph.D.
Ellice S. Lieberman, M.D., DR PH
Barbara R. Manno, Ph.D.
Mary H. McGrath, M.D., MPH
Michael J. Olding, M.D.
Celia Witten, Ph.D., M.D.
C O N T E N T S
Conflict of Interest and Opening Remarks:
David Krause, Ph.D. 7
Thomas V. Whalen, M.D. 10
CDR Stephen P. Rhodes 16
Dr. David Feigal 18
Open Public Comment
Introductory Remarks: Thomas V. Whalen, M.D. 20
Susan Scherr, National Coaltion
for Cancer Survivorship 23
Shery Henderson, Silicone Solutions Outreach 28
Carolyn Kittle 31
Elizabeth Anderson 34
Arlene Nicole Cummings 37
Michelle Colombo 40
Dr. Thomas Joiner 42
Susan Cunningham 45
Anne Stansell 49
Rosella Rust 51
Kathy Pate 54
Nancy Bruning 57
Jill Fallows 63
Elizabeth Santoro 65
Evon Peterson 69
Elizabeth Weber 72
Ed Brent 73
Dr. Bruce Cunningham 76
C O N T E N T S (Continued)
Open Public Comment (Continued)
Margaretha McGrail 78
Gail Hamilton 80
Audrey Moritz-Ciancutti 84
Cynthia Teague 87
Pamela Dowd 89
Lisa Bordelon 92
Jessica Forman 94
Diane Fjelstad 98
Dr. Frank Vasay 101
Marcy Gross 104
Dr. Marga Massey 109
Carolyn Wolf 113
Dr. Vicki Hofnagel, (by conference call) 117
Virginia Gallagher, (by conference call) 121
Dr. Mark Jewel 124
Mary Ann Richards 127
Lisa Bancarz 129
Eileen Wright 132
Lisa Lowenstein 134
Kathleen V.F. Nye 138
Betty Buikema 140
Dr. Caroline Glicksman 143
Dr. Edward Melmed 147
Dr. Paul H. Wooley 152
Nancy Gertner 157
C O N T E N T S (Continued)
Open Public Comment (Continued)
Dr. Eugene Goldberg 160
Mindy Tapscott 164
Kim Gandy, National Association for Women 168
Mary Ann Ward 175
Marlene Keeling, Chemically Associated
Neurological Disorders 180
Vanessa Rose Ferelli 183
Connie Wasserman 190
Dr. Sidney Wolfe, Public Citizen 193
Judy Norsigian, Our Bodies, Ourselves 203
Dr. Deborah Bash 208
Kathy Keithley Johnson, Toxic Discovery 212
Dr. Paul Weiss, National Endowment
for Plastic Surgery 218
Dr. Laurie Casas, American Society
for Aesthetic Plastic Surgery 223
Dr. Leroy Young, Aesthetic Surgery
and Research Foundation 229
Dr. Martha Burke, National Council
of Women's Organizations 233
Dr. Laurie Young, Older Women's League 237
Christine Lozier 241
Anne S. Kasper, Finding My Way 244
Dr. Shawna Willey, American College
of Surgeons 249
Margaret Volpe, Y-Me 252
Regulatory Overview of Silicone Gel-Filled
Cilia M. Witten, Ph.D.,
C O N T E N T S (Continued)
McGhan Silicone-Filled Breast Implants
Ronald J. Ehmsen, Sc.D. 264
Preclinical Studies Review:
Thomas E. Powell 267
JoAnn M. Kuhne, MSN, RAC 295
ODE and Office of Surveillance and Biometrics (OSB)
Introduction and Mechanical Testing:
CDR Samie Allen 393
Sam Arepalli, Ph.D. 399
David B. Berkowitz, Ph.D., VMD 405
Clinical Data Overview:
Sahar M. Dawisha, M.D. 413
Telba Z. Irony, Ph.D. 439
Medical Devices Surveillance and
S. Lori Brown, Ph.D., MPH 448
Postapproval Study and Labeling:
CDR Samie Allen 465
Open Panel Discussion 489
Open Panel Discussion and FDA Questions 551
P R O C E E D I N G S
Conflict of Interest and Opening Remarks
DR. KRAUSE: Good morning, everybody. We are ready to begin this, the 63rd meeting of the General and Plastic Surgery Devices Panel. My name is David Krause. I am the Executive Secretary of this panel and I am also a biologist and a reviewer in the Plastic and Reconstructive Surgery Devices Branch.
I would like to remind everyone that we request that you sign in on the attendance sheets which are just outside the door. You can also pick up an agenda, a panel-member roster and information about today's meeting out there on the table. The information includes how to find out about future meetings, future-meeting dates, through the advisory panel phone line and how to obtain meeting minutes or transcripts.
Before I turn the meeting over to Dr. Whalen, I am required to read two statements into the record. One is the deputization to temporary voting status and the other is the conflict-of-interest statement.
"Pursuant to the authority granted under the Medical Devices Advisory Committee Charter, dated October 27, 1990, and as amended August 18, 1999 I appoint Benjamin Anderson, Dennis Boulware, Emily Conant, Nancy Dubler, Ruth Lawrence, Stephen Li, Ellice Liberman, Barbara Manno, Mary McGrath and Michael Olding as deputized voting members of the General and Plastic Surgery Devices Panel for this meeting on October 14 and 15, 2003.
"In addition, I appoint Thomas Whalen to act as temporary chair for the duration of this meeting. For the record, these individuals are special government employees and consultants to this panel or other panels under the Medical Devices Advisory Committee. They have undergone the customary conflict-of-interest review and have reviewed the material to be considered at this meeting."
This is signed by Dr. David Feigal who is the Director of the Center for Devices and Radiological Health.
The conflict-of-interest statement is as follows. "The following announcement addresses conflict-of-interest issues associated with this meeting and is made a part of the record to preclude even the appearance of an impropriety. To determine of any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.
"The conflict-of-interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. However, the agency has determined that the participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved is in the best interest of the government.
"We would like to note for the record that the agency took into consideration certain matters regarding Dr. Miller. He reported his institution's past and current involvement with firms at issue. The agency has determined, therefore, that he may participate fully in the panel's deliberations.
"In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participants should excuse him- or herself from such involvement and the exclusion will be noted for the record.
"With respect to all other participants, we ask, in the interest of fairness, that all persons making statement or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon."
At this time, I would like to turn the meeting over to Dr. Whalen.
DR. WHALEN: Thank you, Dr. Krause.
Good morning. I am Dr. Thomas Whalen. I am Professor of Surgery and Pediatrics at Robert Wood Johnson Medical School. I would venture, based on my own experience this morning, there are others who are going to be at this meeting who are probably visibly aging waiting for the elevators to get down here because it takes so long, including some of our panel members. So we would hopefully tolerate some of them coming in a little bit later than we had anticipated.
Today, the panel will be making recommendations to the Food and Drug Administration on a premarket approval application. Our next item of business is to introduce the panel members who are giving of their time to help the FDA in these matters and the FDA staff who are here at this head table.
I would ask each person, starting at my left, to introduce themselves and for the panel members to specifically not only give the typical introductions with your names, institutions and titles, but to please give a very brief comment upon the area of expertise that you bring to this particular panel.
Starting to my left, then, from the FDA with Dr. Witten.
DR. WITTEN: I am Dr. Celia Witten, the Division Director at FDA of the Reviewing Division for these products.
DR. MILLER: I am Michael Miller. I am a professor of plastic surgery at the University of Texas M.D. Anderson Cancer Center and I have worked with breast reconstruction and breast surgery and these types of devices for many years.
DR. ANDERSON: My name is Ben Anderson. I am an associate professor of surgery at the University of Washington. I am a breast-cancer surgeon. I do not place implants but my patients do receive them and I am listening on their behalf.
DR. LI: My name is Dr. Steve Li. I am the President of Medical Device Testing Innovations. My areas of expertise are biomaterials, biomechanics and failure of medical devices.
PROF. DUBLER: I am Nancy Dubler. I am Director of the Division of Bioethics at Montefiore Medical Center and a professor of epidemiology and population health at the Albert Einstein College of Medicine. My expertise is in medical ethics.
DR. NEWBERGER: I am Amy Newberger. I am a dermatologist in private practice in Scarsdale, New York. I teach at St. Luke's Roosevelt Medical Hospital Consortium in New York City. My expertise is that I have along experience with various forms of silicone.
DR. BOULWARE: My name is Dennis Boulware. I am a professor of medicine at the University of Alabama at Birmingham. I am also a rheumatologist.
DR. McGRATH: I am Mary McGrath. I am a professor or surgery at the University of California, San Francisco, and I am a practicing plastic surgeon, have been working with implants for almost 25 years. My research interests are in wound healing and biomaterials.
DR. LEITCH: I am Marilyn Leitch. I am a professor of surgery at the University of Texas Southwestern Medical Center in Dallas. I am a surgical oncologist so I deal with patients having breast cancer and also breast-screening issues. That is the expertise I bring.
DR. CHANG: I am Phyllis Chang. I am an associate professor at the University of Iowa College of Medicine, Department of the Surgery in the Division of Plastic Surgery as well as in the Division of Hand and Microsurgery. My expertise is as a reconstructive plastic surgeon.
DR. CHOTI: My name is Michael Choti. I am an associate professor of surgical oncology at Johns Hopkins University and my interest is in clinical surgical oncology.
DR. BLUMENSTEIN: I am Brent Blumenstein, a biostatistician working independently.
DR. CONANT: I am Emily Conant. I am an associate professor of radiology and Chief of Breast Imaging at the University of Pennsylvania. My expertise is in detecting and diagnosing breast cancer with breast imaging.
DR. LAWRENCE: I am Ruth Lawrence from the University of Rochester School of Medicine and Dentistry, Professor of Pediatrics and OB-GYN. My particular area of interest and expertise is breast feeding and human lactation, its impact on both the mother and the baby, and the breast and its function and purpose.
DR. LIEBERMAN: My name is Ellice Lieberman. I am an associate professor of obstetrics and gynecology at Harvard Medical School and an associate professor of maternal and child health at the Harvard School of Public Health. I am also Director at Brigham and Women's Hospital of the Center for Perinatal Research and my expertise is in epidemiology.
DR. MANNO: I am Barbara Manno. I am from the Louisiana State University Medical Center in Shrevepoint, Louisiana. I am professor in the Department of Psychiatry. My specialty is toxicology. I have been trained as a general toxicologist. I have worked in poison-center activities from management down to answering the phones. So I come to you with quite a few years in medical-toxicology support and my subspecialty is forensic toxicology.
DR. OLDING: My name is Michael Olding. I am an associate professor of surgery at George Washington University in the Division of Plastic Surgery. I have had a long interest in plastic-surgery devices in general and, in particular, breast reconstruction. I bring that experience to this panel.
MS. BROWN: My name is Debera Brown. I am the Vice President of Regulatory Affairs for Broncus Technologies. I am the industry representative for the panel. I have worked in medical-device development for over twenty years.
MS. GILBERT: Good morning. My name is Alisa Gilbert. I am the co-founder of the Unbroken Circle and Director of Office of Native Cancer Survivorship and the consumer representative today. I am also a breast-cancer survivor of seven years and I have intimate experience with implants and this whole process. So I am delighted to be here.
DR. WHALEN: I would like to thank all the panel members for their introductions and also thank them for the time they are giving these two days to help out the FDA.
Also, because of the panel configuration going from Delaware to Virginia, you may need to not just raise your hand but speak into the microphone if you need get my attention at any time to ask questions or make comments, please.
I would like to note for the record that the voting members present to constitute a quorum as required by 21 CFR Part 14.
Next, I would like to introduce Commander Stephen Rhodes, the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch who will make some introductory remarks. Commander Rhodes?
CDR RHODES: Thank you, Dr. Whalen, and good morning. I am Stephen Rhodes, the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch here at the FDA. Welcome members of the panel, members of the public and manufacturers to this important two-day meeting of the General and Plastic Surgery Devices Panel, important because it is the first FDA panel meeting to make recommendations on the approvability of a silicone gel-filled breast implant since 1992. Tomorrow, you will make recommendations and vote on Inamed Corporation's premarket approval application.
Because of the high public interest in silicone-gel-filled breast implants, in addition to the regular public-comment periods for any PMA discussion, we have scheduled eight hours for public comment on general issues related to silicone-gel-filled breast implants.
After the public comment period this morning, Dr. Celia Witten, Director of the Division of General Restorative and Neurological Devices, will review the history of FDA's regulation of silicone-gel-filled breast implants. Following Dr. Witten's presentation, Inamed Corporation will present the data in their premarket approval application followed by FDA's review of the application.
While this afternoon's FDA presenters are in the Office of Device Evaluation and the Office of Surveillance and Biometrics, there are other offices in the Center for Devices and Radiological Health that are part of the FDA team and many are here today. These include: the Office of Compliance who have evaluated the sponsor's manufacturing facility and audited the clinical-study data; the Office of Health Industry Programs who provide assistance to consumers and review the program labeling; the Office of Science; and Technology and the Office of the Director.
Additionally, the FDA team consists of reviewers from the Division of Pediatric Drug Development and the Pregnancy Labeling team in the Office of New Drugs in the Center for Drug Evaluation and Research. I also want to acknowledge the valuable assistance provided by the Office of Women's Health in FDA Headquarters.
As a reminder, we will not be discussing saline-filled breast implants at this meeting and I request that panel members and the members of the public limit their comments and discussion to the products being evaluated, silicone-gel-filled breast implants.
Panel members, we appreciate your commitment. The representatives of 27 professional organizations and 92 members of the public who have requested time to address the panel, we appreciate your comments. And, PMA sponsor, we appreciate your participation in presenting the safety and effectiveness data you have collected to the panel and answering questions that the panel may have.
Thank you for your attention. I would now like to introduce Dr. David Feigal, the Director for the Center for Devices and Radiological Health.
DR. FEIGAL: Good morning. I would also like to extend my welcome here. I wanted to take a moment to actually address a problem which we are trying to deal with. We have heard for a number of years that it is very difficult for people who have medical devices to get notifications and information about these devices.
It has been suggested registries could be used for such a mechanism but registries track individuals by name, must keep track of their addresses. They are very labor intensive and beyond, really, the resources of the Center aside from any of the confidentiality issues and problems that that creates.
What we have done in breast implants is a new program which we hope to extend to other medical devices where we will actually provide, through e-mail contact, information about products of great concern to the public. There is a brochure that is out on the table that people can sign up and all that is needed is an e-mail name. If you would like to also give us your name, that is fine, but we are not in any way tracking individuals. This will be an opportunity where we can communicate with people who would like information about medical devices, about medical devices that they are using, about such products.
So, for example, the summary of this meeting, the web pages where the transcripts may be found, other kinds of information about these implants will be provided as a part of the updates that would be sent by e-mail. If there are organizations that would like us to load mailing lists and other lists of people who would like to participate in this and hear information from us, we can do that as well.
One of the things that we particularly appreciate is the publicness of this process. We realize that it is at some expense that people travel here. It is certainly a commitment of people's time. We value very much the perspectives that we hear from people who will put a face on the use of these products and we value, very much, your expertise in considering whether or not these products meet the standards for safe and effective products.
So, with that, let me conclude my welcome and wish you a successful two days.
DR. WHALEN: Thank you. We now will proceed with the open public hearing session of this meeting.
Open Public Comment
DR. WHALEN: All those who will be addressing the panel are asked to speak clearly into the microphone at the podium as the transcriptionist is dependent upon this means of providing an accurate record of the meeting.
I would specifically now like to have the attention of all those who are registered or who might be considering speaking to the panel today. You have each, if you have registered, been given a number corresponding to your order of appearance. We would ask that you come to the podium area in advance so that we are not spending a great deal of time in transitions from speaker to speaker due to the volume of individuals who will be speaking.
FDA staff will direct you to the appropriate podium. Please remain within your time constraints as we will have a timer going to help people remain on time and please be aware that you will receive a flashing light when 30 seconds remain in your allocated time. If you go beyond that, I will try to, as unobtrusively as possible, remind you that you need to come to conclusion.
Both the FDA and the public believe in a transparent process for information gathering and decision making. To ensure such transparency at the open public hearing session of the advisory committee meeting, FDA believes that it is important to understand the context of an individual's presentation.
For this reason, FDA encourages you, the open public hearing speaker, at the beginning of your written oral statement, to advise the committee of any financial relationship that you may have with the sponsor, its product and, if known, its direct competitors.
For example, this financial information might include the sponsor's payment of your travel, lodging or other expenses in connection with your attendance at the meeting. Likewise, FDA encourages but does not require you at the beginning of your statement to advise the committee if you do not have any such financial relationships.
If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking, which is a departure from the last time I chaired a meeting a couple of years ago.
We will start with those individuals who have notified FDA of their request to present in the open session. I would tell you in advance, for those of you who will be lining up in your assigned order, that, at a particular point in time in mid-morning, I will be interrupting to take a break and then I also will be interrupting at a later point in early afternoon when we will be breaking for 45 minutes for lunch.
If the first speaker would come to the podium, then, please.
MS. SCHERR: Good morning. My name is Susan Scherr and I am with the National Coalition for Cancer Survivorship. There is no conflict of interest. I have not received any funds. This is a statement letter on behalf of twelve different organizations.
To the members of the panel, the National Alliance of Breast Cancer Organizations, Y-Me National Breast Cancer Organization, the National Coalition for Cancer Survivorship and nine non-profit health and cancer organizations that share our concerns believe it is important that women requiring reconstructive surgery for because have silicone breast implants available as an option for reconstruction.
Please note that we offer no opinion or comment on the availability and use of silicone breast implants for cosmetic or other purposes. Consistent with the missions and expertise of our organizations, we are not endorsing products from any manufacturer and the following comments are limited to the availability of silicone breast implants for women with breast cancer, breast disease or other medical needs and by qualified clinicians.
All of the undersigned organizations support the right of each consumer and patient to consider options for selection and then receive individualized treatment and care that follows the approach she or he desires and believes is best. Furthermore, we encourage consumers to make healthcare decisions in consultation with an expert clinician after receiving and understanding in-depth information on the benefits, risks and unknowns and uncertainties of a range of state-of-the-art options for care.
Consistent with these rights, we believe that silicone breast implants should be available as an option for women requiring reconstruction. About 20 percent of patients with breast implants receive them because of a breast cancer diagnosis or other medical need. Current options for post-mastectomy reconstruction are limited and not all are suitable or possible for every woman.
For many women, an external prosthesis is impractical and saline-filled breast implants often cannot achieve acceptable symmetry, appearance or comfort. We emphasize that, because women differ by health status and by emotional, physical and personal needs, they require a similarly wide variety of post-mastectomy reconstruction options.
A further important distinction is that women with breast cancer who choose implants do so with a different risk/benefit analysis than those who choose implants for other reasons. After breast cancer, most women with an implant consider it is necessary, not optional, or even crucial, for their healing and recovery.
Despite the availability of implants over the past decade, in reality, it has been very difficult for women to get implants in controlled studies as many physicians are unaware of the studies or unable to offer them to their patients. After an extensive review of the science surrounding breast implants, the U.S. National Academy of Sciences' Institute of Medicine reported there is no causal relationship between systemic illness and breast implants as these illnesses occur with the same frequency in women with breast implants and women without breast implants.
The U.S. Federal Court's National Science Panel, the European Parliament's Scientific and Technology Options Assessment and the British Ministry of Health all reached the same conclusion. In its recent report to Congress, NIH reported that a large meta-analysis following the IOM review of the literature concluded that there was no evidence of an association of silicone-gel-filled breast implants with connective-tissue diseases or other autoimmune or rheumatic conditions.
Women should receive accurate information and give their informed consent regarding the risks and benefits of silicone breast implants. No breast-cancer or any medical procedure is without risk. Neither are medical devices which do not last forever. These treatments and devices are not completely predictable or completely understood. Silicone breast implants for reconstruction should not be held to a different, higher standard.
However, we feel strongly that women considering silicone-gel-filled or any type of breast implants must receive current detailed and accurate information about the device's risks, benefits and complications including incidence of capsular contracture and rates of rupture. In addition, we advocate ongoing data collection and reporting based on long-term follow up of all women who receive silicone implants for reconstruction.
Follow-up mechanisms such as privacy-protected recipient registries and close physician tracking will be needed to facilitate medical professional education training and disclosure data compilation and analysis, regulatory oversight and prompt communication of significant findings to consumers, panels and providers.
In conclusion, the undersigned twelve organizations recommend that the panel make silicone breast implants available for reconstruction use for women with breast cancer, breast disease or other medical needs.
Do I have time to read the organizations?
DR. WHALEN: No; I am afraid that is the end of your time.
MS. SCHERR: Okay. Thank you.
DR. WHALEN: Thank you for your comments. Just two technical notes before our next speaker. One is, apparently, the light does not flash at 30 seconds but simply turns yellow. So you can be aware of that. Or it will turn red at the end of your time.
The other technical note for the audience, if you are in possession of cell phones or pagers, I give you three choices; silent mode, off or outside. Thank you.
The next speaker?
MS. HENDERSON: Good morning. My name is Sherry Henderson and I am from Bossier City, Louisiana. I came here today at my own expense with no conflict of interest. I had fibrocystic breast disease and precancerous cells which resulted in a double mastectomy and reconstructive surgery with implants. During my first year of the implants, I had chest pain and headaches. Within the next three years, I had hair loss, muscle spasms, irritable bowel, reflux, chronic fatigue and rashes.
By the eleventh year, a sonogram verified a silent rupture I had and I had my third surgery with a tram-flap. That was a six-hour surgery and the medical cost was $41,000. I was fortunate to see a doctor who studied implanted women for over 20 years. I was diagnosed with several diseases including lupus likeness, rheumatoid arthritis, fibromyalgia, myositis, organic brain syndrome, high blood pressure and autoimmune diabetes. I am now on disability.
I would like to ask the FDA to have the implant makers to do at least ten years of study and research. They should be required to pay for a national implant registry and require all women in it to have yearly screening examinations for local and systemic complications. Let unbiased researchers do the screening.
The Inamed research shows very high complication rates and an increase in symptom-like fatigue in just the first two years after getting implants. But to know the real consequences, we must have longer research. Breast implants are not life-saving devices. If they are not safe, they should not be approved.
Like thousands of breast-implant women, I live in pain every day and I pray that my grandchildren and my nieces do not go through the pain that I have gone through. The higher rate of brain and lung cancer, more suicides and the study linking implants to fibromyalgia are warning signs that silicone gel should be made less available, not more available.
We are tired of all the suffering. There are young women becoming 100 percent disabled and the government is finally coming after the manufacturers. If the FDA refuses to approve this defective product, the implant makers should be better research and develop safe implants.
In the past, the FDA ignored hundreds of thousands of adverse reports reported to them dating back in the '70s. Breast-implant women have copies of these reports and would be glad to provide them for anyone to see. These reports document horrible health problems and unbelievable complications with these devices.
Please make the right decisions for the sake of women who trust your opinion and whose lives depend on your trust.
DR. WHALEN: Thank you. The first two speakers representing national organizations were each allotted five minutes, for audience knowledge. The next set of speakers for some time will be individuals and each will be allotted three minutes.
The next speaker, please.
MS. KITTLE: Good morning.
DR. WHALEN: You can take advantage of our setting it up and just go ahead and take a few extra seconds.
MS. KITTLE: What did you say?
DR. WHALEN: You can go ahead and start.
MS. KITTLE: Oh, I'm sorry. My name is Carolyn Kittle. I am from Shreveport, Louisiana. I came here at my own expenses. I have no conflicts of interest.
I am here today to testify about seeing a loved one experience pain from breast implants. I have two sisters that have had breast implants. My younger sister had breast implants for cosmetic reasons. After having two children, her breasts were sagging and her husband wanted her to have bigger breasts. She was only 22-years old.
She immediately starting having problems. They became hard. Five ruptured and she has had at least five breast surgeries. Her health has deteriorated. She has been diagnosed with chronic fatigue, fibromyalgia, muscle pain, MS and many strokes and white lesions on the brain. She is only 46-years old and cannot work due to her pain and the MS.
My other sister had fibrocystic disease and cancer cells, had to have a mastectomy with reconstructive surgery and implants. She soon was debilitated by headaches, muscle spasms, muscle pain, irritable-bowel syndrome and reflux. She had a silent rupture and three surgeries. I have seen her go from a vibrant wife, other and professional to a woman coping with lupus, fibromyalgia, thyroid disease and autoimmune diabetes. She has had three breast surgeries.
I grieve to see both my sisters go through what they have gone through as a result of a product that, even today, has never been tested for long-term safety. My sisters have to travel hours away from their home to be seen by a knowledgeable doctor to treat their medical problems.
Inamed's own research shows very high complication rates and they only studied women for two or three years. Just imagine what the data would have looked like if they followed the women for another few years.
I am asking the FDA to please make the manufacturers study women for at least a few more years before considering approval. If you approve the implants first and tell the company to continue to study afterwards, the FDA has no authority to make them complete the study and you see, from the company's study so far, they won't do more than required.
The European Union, on September 1, 2003, has reclassified all breast implants from a moderate risk category to the highest risk category for medical devices. Now is not the time to lower our standards here in the U.S. Scientists have found breast-implant women have higher rates of suicide and are more likely to die from brain cancer and lung cancer compared to plastic-surgery patients who smoke just as often as implant patients do.
The FDA's own study shows the risk of leaking implants and those leaking implants are difficult and very expensive to remove. I urge the FDA to reject approval until further research and long-term data are available. We need to know what implants do to the human body year after year. I ask the advisory panel to the FDA to listen to all the ill women, make manufacturers do better research before you consider approval.
Thank you and God bless.
DR. WHALEN: Thank you.
MS. ANDERSON: My name is Elizabeth Anderson and I come here from Florida at my own expense. I have no conflicts of interest.
Until last month, I was director of an on-line health hotline and I have spoken with hundreds of women who have had breast implants or who wanted to get them. They wanted to know if implants were safe and if implants could make them sick. Many wanted to have their implants removed but they either had no money for the surgery or needed to find a doctor who would take their problem seriously and who would treat them.
Many of the women I spoke with were sick with problems ranging from mild to devastating. While some got sick shortly after getting implants, most were fine for ten years after implantation and then they started getting sick at that point.
Women told me they were suffering from multiple illnesses and of doctors who were unresponsive to any suggestion that their problems could have been caused by their silicone implants. Their doctors sometimes told them that they were depressed and that was why they were so ill, but it seems more logical that, because they were so ill, they were depressed.
When you hear so many stories of ruined lives, you understand this. Some became so sick they could no longer work which, of course, meant the loss of income and health insurance. Can you imagine believing the medical device you have chosen is perfectly safe and thinking you are going to feel better about yourself only to become so sick that you lose everything, even your spouse.
I have spoken with numerous women who have gone through this and I know women in their 30s and 40s who are completely disabled from their breast implants. I believe that women who have had mastectomies should have a choice for reconstruction, but what kind of choice do implants offer?
There is no long-term reliable research proving the safety of breast implants, not the Mayo study, not the Harvard study, and not the IOM report that is based on them. Epidemiologists will tell you that these often quoted are seriously flawed because so many women in them had implants for only a few months or years. Diseases like scleroderma and MS take a few years to develop and to be diagnosed.
Breast-cancer patients have suffered enough but, according to Inamed's data, these women will have more complications from their breast implants than those who receive implants for augmentation. So not only does a woman have to worry about a recurrence of because but she has to worry if her breast implants are going to make her sick.
I am sure everyone here realizes the only thing most people need to hear about a medical product is that it is FDA approved. That is the seal of safety. People believe the FDA protects them from untested and unsafe products. To be approved, silicone-gel breast implants should be proven safe for long-term use by research on a large cohort over a long period of time, at the very least, ten years.
The FDA is mandated to make decisions based on science but using all long-term research that is available is a hollow statement when there is no solid long-term research available. Everyone knows that three years of research is not sufficient. Since all Inamed's silicone-gel breast implantees since 1998 should have been enrolled a study, we should have at least a four-year study by now. But, where is it?
The study that Inamed started in 1990 could have been an excellent study but they neglected to include more than a few cancer patients and then most of the augmentation patients were lost to follow up making the study useless.
DR. WHALEN: Can you conclude, please.
MS. ANDERSON: Yes. The FDA did not want to ban silicone-gel breast implants in 1992, allowed them to remain on the market to still be studied. I ask, where are the data from those women?
MS. CUMMINGS: Good morning. My name is Arlene Nicole Cummings. I came here at my own expense and will not be reimbursed.
At the age of 12, I had a benign breast tumor removed from my right breast. This left me with an asymmetry problem that only got worse as I got older and had my children. Fixing my breasts was something I had thought about for years. After I was done having my children, I felt the time was right.
I did a lot of research on line and found a great deal of information but nothing personal. This is what prompted me to start implantinfo.com back in 1998 after I had my own surgery. implantinfo is now the largest community website for breast-augmentation patients where women can read the pros and the cons about breast implants and go through photos and stories of thousands of other women.
I am here today primarily because I am a satisfied breast-augmentation patient. However, I never had the option of choosing silicone back in 1998. After talking to women and doing my own research, I would choose silicone now over saline if it was available to me.
On my website, I have corresponded with countless women who, for many reasons, probably should have had the silicone option but did not. They were denied silicone implants, had an unsatisfactory result with saline, and then had a second surgery to replace the saline implants with silicone. So they actually had to have two surgeries to get the result they wanted the first time.
I am also aware of the frustration that surgeons feel because they can't give a patient what they know, in some cases, will produce a better result for them. The risk of a second surgery, in my opinion, is far greater than the risk of silicone implants.
Ironically, breast-cancer patients already have compromised immune systems but, for the most part, receive silicone implants. Are they at less of a risk of the supposed risks of silicone implants? I believe silicone implants provide a far better result for reconstruction. If these patients get breast implants and get a better result with silicone, shouldn't they be available to all of us?
Women, along with their surgeons, should be allowed to choose silicone or saline. We are neither ignorant nor shallow and we are not seeking breast implants with informed consent. We have researched the procedure for years. The average age of a woman on my website is 34. Most of us are married with children and just want to get back what we lost after pregnancy and nursing.
I believe in informed consent and women should be told all the risks. But, in the end, after we receive that information, let us decide, along with our surgeons, silicone or saline.
I have passed out to a handful of testimonies from other women who, for many reasons, could not physically be here. There are thousands more on implantinfo.com and I encourage you to read about them and give us back the choice of saline and silicone.
I think you for your time.
MS. COLOMBO: Good morning. My name is Michele Colombo and I come here on my own behalf and I have no conflict of interests,
I am 34-years old and married. For many years, I have been dissatisfied with the size and appearance of my breasts. I am very self confident and I am an educated person but have always seriously considered improving my appearance by undergoing breast augmentation.
I have been researching breast augmentation for approximately five years including reading the FDA website as well as other resources on the Internet. In doing so, I have satisfied myself that silicone implants are a safe alternative for my breast augmentation.
Unfortunately, in the early 1990s, silicone breast implants were banned for sale to people like me in the United States. If I lived in Europe, I could get silicone breast implants. If I traveled to Europe, I could silicone breast implants and come back to the U.S. and live here with them even though they are unavailable here. If I had breast cancer, I could get silicone breast implants. What's more, if I were a man, I could get silicone testicular implants and if I required a shunt for medical reasons, it would also be silicone.
But, unfortunately, for me, I am just a woman seeking to undergo a cosmetic procedure. Moreover, what I seek is a procedure using a product which has been shown in numerous studies to have no more long-term heath risks than saline breast implants or other silicone devices.
My problem, it seems, is that the FDA, up until now, has viewed people like me as unable to decide what it best for me. I could make that decision if I had cancer but simply because I want to improve my physical appearance, that is not enough to justify the risks, in someone else's opinion.
I think it is time to reevaluate the true motivations for the ban in silicone breast implants. The fact that breast-cancer patients may obtain them and cosmetic patients cannot exposes the true reason for the ban. What is at stake is a moral judgement rather than a medical one. If my breasts are completely deflated from breast feeding, weight loss or age, improving my appearance with breast implants is deemed unacceptable because it would be for vanity. If I had had a mastectomy, it would be acceptable because it could be justified as medically necessary. The difference is a moral one and not the a medical one.
I urge you to remove the ban on simply breast implants and let women make informed decisions about their bodies the way millions of people do every day with countless other devices and medicines that are approved by the FDA.
Thank you for your time.
DR. JOINER: Good morning. I am Dr. Thomas Joiner, the Bright-Burton Professor of Psychology at Florida State University. I have authored a peer-reviewed paper on the association between breast augmentation and suicide as well as six books and over 200 scientific articles on topics related to mental disorders including suicide.
I was awarded a Guggenheim fellowship for research on suicide and was given the Schneidman Award for Excellence in suicide research from the American Association of Suicidology. My travel expenses to this hearing were paid by the American Society for Aesthetic Plastic Surgery. I have no financial ties to any implant manufacturer and no involvement in a pending law suit related to breast implants.
I thank the panel for the opportunity to address the relation between breast augmentation and suicide. To date, there are four studies indicating that women who undergo breast augmentation have higher suicide rates than women in the general population. It is crucial to note that breast-augmentation patients are not representative of the general population and the ways in which they differ from the general population are very relevant to suicide risk.
The crucial point it this. Breast-augmentation patients should be at relatively high risk for suicide for reasons that have nothing to do with breast augmentation. Given the demographic and other characteristics of breast-augmentation patients, their suicide rate should be higher than that of the general population.
Consider race, for example; virtually 100 percent of breast-augmentation patients are white whereas the general population of women is, of course, more diverse. This is relevant because white people are more likely to die by suicide than non-white people. Breast-augmentation patients' risk for suicide is increased partly because of the simple fact that they come from a racial group with relatively high suicide rates.
This same exercise can be repeated with the same conclusions for each of the following factors; age, marital status, alcohol use, personality and symptoms of mood and other disorders. In each case, breast-augmentation patients appear to differ from the general population of women and, in each case, the difference is such that suicide risk is increased.
I calculated the expected suicide rate in breast-augmentation women given their demographic and other characteristics. A conservative calculation produces an expected suicide rate among breast-augmentation patients that exceeded the population rate by fourfold. For reasons having nothing to do with breast augmentation, the subgroup of women who undergo the procedure should have relatively high suicide rates because their demographic and other characteristics put them at high risk.
Given that expected rates are fourfold the population rate, and actual rates are lower in every study to date, the possibility arises that breast augmentation actually confers protection from suicide a possibility that squares with the finding that vast majority of breast-augmentation patients report high satisfaction with the procedure.
A safe conclusion appears to be that actual suicide rates are no higher than and may possibly be lower than expected suicide rates among women who undergo breast augmentation.
MS. CUNNINGHAM: Good morning. My name is Susan Cunningham. I came here at my own expense. My biggest concern is that these implants do rupture and there is still no medical information on how to recognize a rupture and what to do about it. It is a frightening experience to be so sick and not have a clue what is wrong with you.
Many women cannot afford an MRI to check and, even if they find out their implants are ruptured, they don't have the money needed for surgery. My own experience began after I had breast-fed both of my children. I decided on implants and arranged for a consultation with a highly respected plastic surgeon. I had concerns, but the surgeon said the implants would last a lifetime.
I was fairly pleased with the results, but it didn't last long. I began to experience loss of nipple sensation and numbness. Then I experienced capsular contracture in the right breast which is very painful. As the years went by, I was plagued with sinus and respiratory problems. My health continued to decline.
Finally, in 1993, I consulted my plastic surgeon. As he wrote in his notes, "I reassured her concerning this and advised her to leave her implants in place unless there are further difficulties because they look very good." My body was wracked with joint pain. I was diagnosed with Raynaud's and suffered from constant muscle spasms.
My breathing and chest pain were severely affected and I had been in the emergency room several times. Finally, tests indicated remarkable changes in my immunological system characterized by an unexplained decrease in the total CD4 or helper cells. I was getting sicker and experienced a fatigue so devastating that I would weep from the smallest effort.
My concentration was zilch and I started having huge gaps in my memory like pulling out of my driveway and then wondering where I was going or what I was doing in the car. It was frightening and it became worse. Finally, I was forced to quit a career that I loved. At this point, it became necessary to sell our family home.
I sought out Dr. Feng whose practice was 120 miles away. She informed me that at least one implant was ruptured. They were removed in 1995, both ruptured, and I promptly noted relief in the chest pain I had been experiencing for years. Within a few months, my bloodwork, which for many years had been abnormal, returned to normal except for IgE levels and a positive antihistone antibody which took an additional two years to return to normal.
My overall physical condition has taken a few years to improve. I still suffer from fibromyalgia-like symptoms although attacks are less frequent and of shorter duration. At the ripe old age of 61, my mind is much sharper and my body much stronger than it was just a few years ago.
Today, I live a far different life than I could have lived if it were not for ruptured implants and their devastating effects to my life. I am on disability which was granted on silicone rupture and related problems. It was a very black day for me to finally accept the fact that working is no longer an option for me.
I am not looking for pity because I have been blessed with many other things in my life. But, if there is anything I could do to help another woman to avoid these devastating effects of ruptured or leaking implants, then I must try. That is why I am asking you to not approve silicone-gel implants until the company provides long-term safety data proving that leaking silicone and immune diseases can be avoided.
The company's application for silicone-gel breast implants was rejected in 1991.
DR. WHALEN: Can you conclude please.
MS. CUNNINGHAM: Thank you. They had twelve years to collect data but they only collected three. They will only do better research if approval is denied until they do.
MS. STANSELL: My name is Anne Stansell. I came here from New Mexico at my own expense. I am a breast cancer survivor. I was diagnosed at age 39. The doctors said I needed a mastectomy, radiation therapy and breast implants. Implants were just part of the treatments. No discussion.
I trusted the doctors who I felt had just saved my life. I didn't know there was no safety study of breast-cancer survivors with implants. That had never been done. I was all right for the first few years. Then I became very ill. I was diagnosed with Graves' disease, fibromyalgia. My eyes were so dry that one of the retinas tore.
My implants were taken out about two years later. I had to fight with my insurance company to cover the removal. Half of one of my implants was gone. Where did the silicone go? I don't know. Even with silicone left inside of me, almost immediately, I began to feel better. My family really noticed a difference even before I did.
I am still recovering, but I can work some now. I thought of my own experience when I heard about the Inamed study of breast-cancer patients. I had many of the same local complications. I can't even remember how many surgeries I suffered. Silicone was found in my side where it migrated from a broken implant.
Inamed cancer patients also had an increase in some autoimmune symptoms during the first two years. I think my symptoms started at the third year or so so it is likely that those signs and symptoms will increase over time, just like mine did.
It doesn't do cancer patients any favor to give them the kind of choice I was given. The choice isn't a choice if it is not a safe choice. Informed consent isn't possible if the physicians think the FDA approval means a safe product. A recent NIH study shows a doubling risk of brain cancer and a tripling risk of lung cancer in breast-implanted women.
Health Canada has now started a study in 1996 to determine the cancer risk in 40,000 breast-implant women who were implanted from 1974 to 1989. This data should be available later this month. It is outrageous to continue to allow the marketing of a device that may increase the risk of cancer in women who are recovering from breast cancer. Your job is to look at the research, but I hope you will listen to the patients, too. We illustrate the data. We are the examples of what can and what has happened to tens of millions of women around the world.
MS. RUST: (Read by Beth Nichols.) My name is Beth Nichols and I am reading this on behalf of Rose Rust who is too ill to be here today. I have no conflict of interest.
"My name is Rose. I am 57-years old. After I remarried in 1990, I thought I needed to look younger so I opted to get silicone breast implants made by McGhan, now called Inamed. I had talked to a plastic surgeon and he told me they were safe and they would last my lifetime.
"Within four months of getting the implants, I noticed I was aching all over and had headaches. I went back to the surgeon and told him I thought they were making me sick. He told me I was listening too much to the media and he saw no reason to remove them. I believed him and left them in.
"I became more ill and the headaches became almost unbearable. I had so much pain that I had to quit my job. I had become so ill that I was put on Social Security disability. In the mid-'90s, my nasal passages started burning and my nose was swelling shut in addition to the horrible headaches. My GP sent me to a neurologist who did many tests and sent me to an ENT.
"I ended up having three sinus surgeries. The three different doctors all told me that something was inflaming my nasal passages. They told me that if I didn't find out what my body was reacting to, they couldn't help me. I went to an allergist and he found no allergies. We had our house checked for any toxins. My husband checked our vehicles. By now, I was feeling much worse, dizzy and nauseated.
"Over the next few years, I went to many doctors including the Mayo Clinic, but nobody could find out what was wrong with me. The last two or three years, I have become so ill I am almost bedridden. My nasal passages burn all the time and my headaches are constant. My legs and feet burn, swell and hurt so badly, I can hardly walk. I am dizzy and nauseated. I have lost much of my short-term memory.
"Over the last few years, I have become intolerant of all chemicals. When I am exposed accidentally, my nose swells shut, nausea and headaches worsen and my heart acts up. In June of this year, I finally decided I was going to die if I didn't do something. In August, I had my implants removed. My left implant was ruptured and the plastic surgeon said most of the silicone had leaked out, migrating into my chest and into my lymph nodes. She described it as 'a sticky mess.'
"She also removed the lymph nodes with silicone in them. At that time, she told me there was probably silicone in my liver, lungs and brain. The right implant was intact. I have no idea how long the left implant had been ruptured. I saw no difference in how I looked.
"Through the years, I have become unable to even take care of my home. Sometimes, I am not able to fix meals for my husband. I spend many days in bed. Long ago, I gave up on social events. My husband tells me I actually am much worse off than I realize. It is just a struggle to survive. If the doctors had not told me my illness was unrelated to my silicone implants, I would have had them out many years ago and perhaps avoided much of the silicone leakage.
"I think of how, in 1991, the FDA decided not to take silicone-gel implants off the market. It sent the clear message that silicone-gel implants are probably okay. I feel many of us have been the guinea pigs and I feel we have proven that silicone is not safe because the implants can leak throughout our bodies. It is too late to do much for women like me, but let's please save the next generation.
"It is your responsibility to protect us and hopefully you can restore my faith in our FDA.
MS. PATE: Hello. My name is Kathy Pate and I would like to thank the panel for the opportunity the speak today on behalf of silicone breast implants. I am a registered nurse in Albany, Georgia and I work in an operating room there. I have never had any financial relationship with any medical-device corporation or their competitors. I am here representing myself and I have paid my own way.
I have breast-augmentation surgery in December of 1983 because I had difficulty buying clothes to fit. As many other women have stated, after I breast-fed my baby, I didn't have very large breasts to start with and then, after that, the problem was even worse.
I became quite frustrated with this problem so I decided to have breast-augmentation surgery. At that time, the quality of saline implants was very poor. The possibility of deflation was very high. At that time, also, there was no discussion about the serious complications related to silicone implants when I had my surgery.
My plastic surgeon did tell me that there were possibilities of localized irritation if the gel ruptured. He also said there was a possibility of capsular contracture. I went ahead and chose the gel because they looked more natural and they were lighter.
When the media put out the information on silicone implants, and they were removed from the market in the early '90s, I wondered what should I do. Should I have them removed? What should I do? So I pondered the thought and decided that the best thing to do was see if anything developed. I have not developed any problem with silicone implants and really have no concerns about their safety.
I monitor my breasts with visual and physical exam and I have an annual mammogram. I stay in close contact with my plastic surgeon and we decide we would monitor for any changes in shape or consistency to detect an early rupture.
I realize there are risks associated with all types of surgery and especially with any implantable device. Although it has been twenty years since my surgery, and I am sure at some point I am going to have to have those replaced, I would definitely do the same procedure again and I will go back to silicone.
I believe firmly that women should have the option to choose saline or silicone and that they should have the risks and benefits outlined for each. The individual receiving the product needs to have confidence in the product, itself, and also in the surgeon who is performing the procedure.
I believe women who are well informed will make the decision that works best for them. Given all the research and investigation of these devices, I feel certain that the product has been vastly improved to resist rupture and prevent complications. Breast-implant surgery has allowed me to be comfortable buying clothes and not reduced to buying bras with heavy padding to fill out my clothes, and even bathing suits.
The real message I want to convey here is that I feel like the women need to have a choice and be informed of the risks and benefits and have the option to choose.
MS. BRUNING: Good morning. My name is Nancy Bruning and I have no conflicts of interest. I was told I had six minutes. Can I have six minutes, five minutes?
DR. WHALEN: You are here with Ms. Peterson?
MS. BRUNING: Bruning.
DR. WHALEN: I know your name is Bruning. You are listed as being here with Ms. Peterson. That is why the two of you together were given six minutes.
MS. BRUNING: I see. Well, I am wearing three hats, so--thank you.
I am wearing three hats. I am here today as a breast-cancer survivor. I am here as the author of a book about breast implants that is currently in its third edition. And I am here as a graduate student completing her Masters degree in public health.
I became interested in breast implants because of my own experience with breast cancer and its aftermath. You would probably never suspect it to look at me or to hear me, but I have had my chest cut open seven times, twice for breast cancer and five times to fix what the breast-cancer surgery wrought on my mind and body.
My most recent surgery was to remove the gel implant that had ruptured along with the entire scar capsule that surrounded it, and it was replaced with a saline implant. I am here to tell you that, although this could be dismissed by some as merely local complications, this surgery caused me more pain and disability than any of the other surgeries including the mastectomy.
I am here because, if I had to do it all over again, you would have to tell me that, based on the studies that exist including the new Inamed study, breast-cancer patients have a very high probability of these things happening including a 46 percent chance of reoperation in the first three years.
But can you tell me what the rate might be down the line? No; you cannot. I am here because, if I had to do it all over again, I would like you to tell me the odds that any silicone that escaped the scar capsule will cause systemic disease down the line. Can you do that? No; you cannot. Can you tell me the odds of that happening with the new Inamed implant? No; you cannot.
The subtitle of my book is Everything You Need To Know About Implants and one of the first things I tell my readers that they need to know is that we don't know everything. Far from it. This was true when I first wrote the book in 1993 and it is only a little less true now. And what we do know is not good.
During the process of writing and twice revising the book, I interviewed scores of plastic surgeons, breast-cancer survivors, implant patients, researchers and advocates. The one thing that is clear is that silicone breast implants were sold to almost 1 million women before any research on women was published in the peer-review journals.
Currently, over a quarter of a million American women have breast implants every year. This could be a disaster waiting to happen if silicone implants become available without proper long-term study.
We now know that silicone-gel implants break after about ten years, on the average. We now know that leaking silicone can migrate to the lymph nodes, lungs and all throughout the body. We know that, in several studies, women with breast implants were more likely to die from certain types of cancer.
And we know that, in three studies, women with silicone implants are three times as likely to commit suicide. In the Inamed study, quality of life, including social interactions and self esteem, actually declined within two years of getting their implants. This certainly raises questions about whether implants make women feel good about themselves as promised. Results amy be even worse than the studies indicated. Let's remember that most women do not like to admit mistakes or to criticize their doctors to their faces.
Regarding the research conducted by Inamed, in light of what we know already, I wonder why they thought two or three years of research was enough. Although the diagnosed rupture rate was low, 6 percent after three years reconstruction, we must assume that they are higher since three out of four ruptures are not apparent without an MRI.
If you share my concerns that only half the breast-cancer patients were followed for even three years, especially since Inamed has been selling gel implants to cancer patients since the late 1990s. Breast-cancer patients deserve better. I am the living proof that they are living long lives.
We deserve implants that don't result in additional surgery for 46 percent of us in the first three years. We deserve long-term studies that can provide accurate information about the risks of developing serious implant-related health problems. We deserve to have a choice. Unfortunately, we do. Most breast-cancer patients can now choose lumpectomy, saline implant, silicone-gel implants or autologous construction. Choice is good but we deserve to have safe choices. Silicone implants should only be approved if they are proven to be a safe choice for all women.
If there is a problem with the way studies are conducted and there is a problem with recruitment and compliance, then the answer is to fix that, not to make silicone-gel implants available.
Since I received my diagnosis of cancer over 23 years ago and experienced the first inklings that breast implants were not as safe as I was led to believe they were, I have been living with two kinds of uncertainties. One, will I get breast cancer again and, two, will my implant cause me harm? I have seen studies that address the first question. Where are the good studies that address the second? Inamed has not provided them for the women who currently have silicone-gel implants or for the millions more who would if the FDA approves them.
I have suffered more than enough and don't want other women to follow in my footsteps. We deserve to have better science than the implant companies have given us and it is your responsibility to use your power to make sure that they do just that before approval because it won't happen afterwards.
DR. WHALEN: Just to make it clear to the other speakers, to make sure that everything seems fair, the reason somebody would have six minutes as opposed to three is because two speakers who have preregistered with FDA have combined their time and one of those two individuals is addressing us. So, if you are wondering why you only have three and somebody has six, that is the reason.
MS. FALLOWS: Good morning. My name is Jill Fallows. I am a nurse as well as an attorney. I do not have any financial relationship to Inamed or any of its competitors and, as a note of levity, as a trial attorney, I rarely find myself speaking before a group of such receptive physicians. I am appreciative of the opportunity.
I will address the issue of choice this morning. It seems as though Inamed has framed its pro-silicone-breast-implant argument in terms of a woman's right to choose the device. But simply offering a woman the right to choose is a far reach from providing relevant, unbiased, sound medical information upon which a reasonable woman can make an informed choice.
It is irresponsible to argue that a woman is entitled to choose a medical product while simultaneously glossing over the relevant safety data in the device's promotion and labeling. We want women to have choices. But we have learned from the Dalkon Shield and DES that they are not safe products and should not be offered to women simply because we cherish the notion of an individual's right to choose.
This is particularly true at today's meeting because the silicone-gel breast implant does not purport to relieve the discomfort or pains commonly associated with diagnosed illnesses and conditions. Indeed, we don't want to offer women a choice of an implant knowing that it could rupture and leak silicone gel into their lymph nodes, lungs and other body parts where it cannot be removed.
We don't want it leaking into their breasts so that removal results in a mastectomy to remove silicone rather than cancer. We should be mindful that breast augmentation is a completely elective cosmetic procedure and the risks to the patient should be clearly outweighed by its benefits.
We need to empower women and their physicians with adequate, accurate, unbiased information broad enough to address the diversity among the 50 states informed-consent laws and yet specific enough to affirmatively warn women that they are buying a product with a litany of known serious risks.
We take, as a starting point, the notion that a doctor or a patient must be apprised of information upon which a reasonable person can rely and make an informed choice about the safety of the implant. It would not be reasonable to minimize or hide the risks from the physician or the patients. The manufacturer's product literature should especially make mention of the rate of risks of complications and a black-box warning would be minimally acceptable if it stated that the manufacturer has not adequately completed five-year safety studies.
I am most appreciative your time. Thank you.
MS. SANTORO: Good morning. I drove here on my own expense and have no conflicts of interest. My name is Elizabeth Santoro. I have been a nurse for three years and I recently received a Masters of Public Health from Johns Hopkins. I will be discussing problems with data quality.
A major area of debate is whether silicone breast implants cause autoimmune diseases such as scleroderma, lupus, rheumatoid arthritis and fibromyalgia. In 1999, the Institute of Medicine reviewed the 17 studies available at that time and found that most research found no significant link.
A year later, a meta-analysis of the same studies agreed with that if the largest study by Hennekins, et al., at Harvard was excluded. If the Hennekins study was included, there was a significant link between implants and these diseases.
I would like to highlight some of the flaws in the studies that were both in the IOM report and the meta-analysis. First, not all the studies were published in peer-review journals. Second, many of the studies were based on hospital records. This is problematic because a lot of people who suffer autoimmune diseases are not hospitalized for symptoms such as pain and fatigue. Therefore, data from hospital records will not identify them.
Medical records were also used as a primary source of information instead of a comprehensive medical exam. The absence of a medical exam creates the opportunity where valuable health indicators of adverse events can be missed. Often, vague and nonspecific symptoms can be present in the beginning of an autoimmune process. As a result, medical records may not be the best way to detect this class of disease.
Most of the studies also included women who had implants for a very short period of time. Autoimmune diseases can take at least five to ten years to develop. So, including women with implants for only a few months or years cannot accurately capture all of the autoimmune diseases that might develop.
I would also like to comment on the importance of sample size. Many of these studies had women with just a few hundred. That does not sound bad but a larger sample is needed when rare diseases such as scleroderma is being assessed. The research that has been conducted in the past and reviewed by the Institute of Medicine is not sufficient to draw conclusions about the safety of breast implants regarding autoimmune disease.
And, by the way, those studies did not look at morbidity and mortality from other causes or from disorders that were not diagnosed diseases and therefore are useless for drawing any conclusions at all regarding cancers and other disorders.
Also remember that the first Institute of Medicine on Agent Orange found no link to cancer. The first Institute of Medicine report on Gulf War veterans found no link to illness. Subsequent research found clear evidence of statistically significant increased risk of serious diseases that were not apparent to the IOM in their first analyses.
I would also like to note how the data that was made available by Inamed is suggestive of a connection between silicone implants and autoimmune disease. Upon reviewing these data, FDA scientists found an increase in muscle pain, joint pain, hair loss, rashes and fatigue within two years of patients getting implants. During this same two-year period, it was also found that many patients reported decreases in both physical and emotional health. These signs and symptoms are characteristic of several autoimmune diseases in their early stages.
In addition, FDA scientists noted previous studies found an excess of some cancers and leukemia among implant patients. These studies were published after the IOM report. The fact that implants may delay cancer detection via mammography is also troubling. Moreover, the FDA's own study found that silicone implants break within about ten years often with no warning signs and the clinicians and pathologists have reported numerous cases where silicone gel had migrated to the abdomen, groin, fingers and axillary lymph nodes.
These findings raise grave questions about the safety of silicone-gel implants. They provide evidence that Inamed's implants are associated with many serious complications and declines in both physical and emotional health status even within the first two years.
The data supplied by Inamed, combined with the limitations of the studies in the IOM report, show that there are many unanswered safety questions in regard to silicone-gel breast implants. As a result, they should not be approved by the FDA.
MS. PETERSON: (Read by Jennifer Brooks.) Good morning. My name is Jennifer Brooks. I am reading testimony for Evon Peterson who cannot be here today due to an illness. She has no conflicts of interest and neither do I.
"My name is Evon Peterson. Ten years ago, my silicone-gel implants were removed. I was an R.N. and had implants for reconstruction for following bilateral mastectomies. The doctors acted as if reconstruction was a given, something I should do. It wasn't presented as a choice.
"When I was explanted in 1993, the right implant was found to have ruptured and the left implant was severely leaking. Three additional surgeries in 1994, 1995 and 1996 followed to remove bilateral siliconomas.
"The first symptoms to appear after implants were the first to resolve or diminish when the implants were removed. A few weeks after reconstruction--what an oxymoron that is--the firmness and contractures began. The shape of my breasts became distorted and the surrounding tissue became inflamed. Lying on my right side or freely using my right arm was restricted. Searing pain invaded by back and neck.
"After that, more obvious systemic symptoms developed. By 1989, at age 45, I was totally disabled in my work and personal life. I experienced profound fatigue, insomnia, seizures, tingling and numbness of extremities, dizziness, nausea, skin discoloration and hardness, migrating joint pains, chemical sensitivities and balance disturbances. I felt like I was in a mental fog. I had contemplated suicide as an option to stopping the pain. I know if I had kept the implants in any longer, I would have committed suicide.
"One of the worst aspects of this experience has been in the continuing denial of manufacturers and the medical community. They fail to study implants and their related complications over a long period of time and then arrogantly claim that the products are safe for long-term use.
"Prior to explantation, I faced a paradox. I was too ill to have surgery and too ill not to have surgery. I am glad that, on the recommendation of three of my many physicians and also based on my increasing knowledge, I chose to improve the quality of my life by removing my implants.
"Despite living with multiple autoimmune processes and complications, my health has improved from about 10 percent functioning to 60 percent functioning. Considering that I have also aged ten years, I am delighted. I remain convinced that, had I not been explanted, I would have died within the year.
"I am unable to physically present today because of pneumonia. However, I petition you to require unbiased long-term studies before any decision is made about approval.
MS. WEBER: Good morning. My name is Elizabeth Weber. I live in Southern Maryland and I was not paid to come here today. The opposite is true. I asked to come today to share my story.
My mother had breast cancer and had a bilateral mastectomy. I, too, had a bilateral mastectomy in June of 1999. I was aware of the controversy of silicone breast implants and, therefore, opted for the saline implant. I am a very active person. I trained for the Olympic Games since age of nine in the equestrian sport.
Pain and perseverance is not new to me. The saline implants were very uncomfortable to me. Dr. Scott Spear did a wonderful job of my reconstruction and the outward appearance of the saline implants looked good, but I hated the way they felt inside. They were hard and hurt from the inside. I felt like I had a mass pushing against my chest.
I stopped doing the sports I used to do and it was hard to sleep at night. One year later, I went to Dr. Scott Spear and asked to have the saline implants changed and replace by silicone implants. After I woke up from my surgery, I could feel such a huge difference. After I healed from the surgery, I felt like myself, a whole, natural and complete woman.
The outward appearance was impressive and beautiful. But, even better, my breasts felt like mine from the inside. I now do everything I used to and more. I hope you give other women the same choice.
Thank you for your time.
ED BRENT: Good morning. My name is Ed Brent and I have received no funds nor do I have a sponsor that has helped me to fund this trip.
Three years ago, my wife stood before you and did her best to convince you, the FDA, not to allow saline breast implants on the market. My wife had double-lumen implants, my daughter, Catherine, leg braces, and that was because of the silicone implants, carried one of my wife's implants to your table showing the black fungus growing inside of it.
My wife was P.J. Brent. You may have seen her on CNN or other t.v. networks discussing breast implants. She was distraught after being here and learning that everything that she had said was anecdotal evidence and not to be considered by the panel. We were here March 1, 2000.
On May 29, 2000, my wife committed suicide. She left behind seven children and I am here on behalf of my wife and children to urge you not to allow silicone breast implants on the market.
There are three studies showing that women that breast implants are more likely to commit suicide compared to other women. Some experts think that these suicides mean that women with breast implants have lower self esteem before they got their implants as well as after. But the National Cancer Institute study, which compares implant patients to other plastic surgery patients, shows that the problem is more likely to be from the implants.
My wife was not a woman with low self esteem. She was a vibrant, loving wife and mother. P.J. loved the way she looked the first few years after the implants. Then she started to get sick. Her joints hurt. Her fingers would swell so she could not wear her rings. She did not know what was happening and sought medical help. She had lupus-like symptoms and was diagnosed with fibromyalgia.
She was explanted in 1992. P.J. breast-fed the two daughters she had after the implants. Catherine was born in 1985 and was diagnosed with chronic inflammatory demyelating polyneuropathy, CIDP, as well as esophageal-motility disorder. She spent years in leg braces to allow her to walk. Now, the braces are gone and have been replaced with a wheel chair and she has a special car with hand controls to help her drive.
Christine was born in 1986 and also had esophageal-motility disorder and signs of the neurological disorder. After P.J. committed suicide, an autopsy was performed from her. Samples were extracted. Large amounts of platinum were found in her body. This came from the silicone. The high platinum levels, a doctor at CDC saw them and said, "No wonder she committed suicide. She could not have been in her right mind."
Hair, nail and tissue samples were taken from our daughters who breast fed and it was found that they, too, had elevated platinum levels.
You have an awesome responsibility before you, a responsibility of conscience and doing what is right for the women and yet unborn children of these women who may be forever affected. Don't let this be a money issue, but a moral issue.
DR. CUNNINGHAM: Good morning. My name is Dr. Bruce Cunningham. I am Professor and Chair of Plastic Surgery at the University of Minnesota. I am speaking as an individual and have personally paid my way for the appearance today. I own no stock in any implant manufacturer and receive no compensation of any kind.
I have, however, received peer-reviewed research grants from implant manufacturers and I have served as a medical director of a PMA breast-implant submission. I do use implants in my clinical practice.
ASPS has recognized and acted on its responsibility to plastic surgeons and their patients. The American Society of Plastic Surgeons has already established a breast-implant registry within a larger outcomes data-collection activity. I worked on the development of TOPS, or Tracking Outcomes in Plastic Surgery, which collects plastic-surgery procedural data and clinical outcomes and can include collecting satisfaction data from patients, themselves.
A breast-implant registry is embedded within the Internet data-collection tool of TOPS and can track things such as the number of implants placed or removed, clinical indications and type of facility, anesthesia and short-term complications. NBIR, or the National Breast Implant Registry, was designed to allow physicians and their highly mobile patients to track implanted and explanted devices. NABIR was, in fact, so successful in its design that it attracted international interest. It has served as the template for IBIR, the International Breast Implant Registry, which is poised to become the standard for the European community, Australia and South America.
In the initial piloting phase of NBIR, this data-collection tool over the Internet, 9,000 surgeries were recorded including 14,912 implants and 2,084 explants. TOPS and NBIR, however, are hindered in their ability to provide benefit for patients and physicians by the stringent confidentiality constraints of HIPAA. They could be improved significantly to provide transparent tracking of devices, surgeon records and implant-related events.
To do this, however, the breast-implant registry that we have established requires public-health authority status as a part of a Governmental Health Operations Act. The management, government and composition of the leadership of the NBIR could be changed to reflect the involved stakeholders by including the FDA, the public and industry representative members.
Finally, TOPS could be enhanced to provide an interactive on-line patient-information and education process that could be linked, in turn, to verification and documentation of patient informed consent.
In conclusion, ASPS, the American Society of Plastic Surgeons, is dedicated to providing the gold standard of outcomes data to benefit patients, the public and the profession. We look forward to a partnership. TOPS and NBIR can become a valid method for a registry to trace implant-related data and outcomes.
Thank you for the opportunity to present.
MS. McGRAIL: Hi. My name is Margaretha McGrail and I am not being compensated or paid in any way to be here. I live locally.
Four years ago, I made a decision to have breast-augmentation. It was a personal choice. I didn't need the surgery. Years of running and age had caused my breasts to sag and shrink and it was affecting my self-esteem. Someone referred me to a local surgeon who specialized in breast reconstruction and I went in to speak with him about possibly having the procedure.
After talking with him, I decided the procedure was harmless and that it was worth going forward with. While discussing the procedure with my doctor, my doctor mentioned that there was a study taking place that I could participate in if I wished. It involved the opportunity to have silicone implants rather than the typical saline implants.
He explained that silicone implants were much more natural looking and feeling than the saline. Remembering vaguely that there had been some issues with silicone implants, I asked him about the hazards of silicone implants. We discussed the pros and cons of silicone and I was given a couple of articles about the topic.
My surgeon felt it was a very safe procedure. It was my understanding that silicone implants had significantly improved over the years, that leakage was no longer an issue and that the past problems had been due to leakage. The articles I had been given were very positive and the benefits of my taking place in a study seemed to outweigh any possible problems. The study provided for regular checkups, periodic MRIs and I thought that was a benefit.
I opted for the silicone implants. I can attest to the fact that silicone implants are, indeed, dramatically more natural looking and feeling than the saline implants. I have had no problems at all these past four years. I have been extremely happy about my decision to have breast-augmentation. I am very health conscious and take very good care of myself. I believe in a preventative and holistic approach toward my health, so the issue of possible problems with silicone implants is a concern of mine.
I would do nothing knowingly to jeopardize my health. I have only had the implants for four years, so I cannot address the potential for problems after ten or fifteen years.
MS. HAMILTON: (Read by Elizabeth Curtis Hamilton.) Good morning. My name is Elizabeth Curtis Smith and I am here of my own will and I am reading the testimony of Gail Hamilton who was too sick to be with us this morning.
"My name is Gail Hamilton. I got silicone implants when I was 24-years old. I had had two children and was very disappointed with my appearance after nursing. I was slim and healthy and was told by the plastic surgeon how wonderful these implants were and how they would improve my appearance and they would last a lifetime.
"Ten days after augmentation, the wounds opened up and there was no appreciable healing. The implants were removed along with very large blood clots. The implants were cleaned and reinserted. This time, the wounds healed. My body formed scar tissue around the implants causing them to feel like baseballs.
"Seven years after my initial surgery, the implants were removed. The troublesome scar tissue was taken out and the same implants were reinserted. By 1989, I was experiencing very uncomfortable pain in my right breast and visited the plastic surgeon again. He could find nothing wrong so I went home and tried to ignore the sore area under my right breast.
"In the summer of 1993, I started to feel a burning sensation behind the implants against my chest wall. It started with one side and the other one soon followed a couple of weeks later. The burning became worse and worse every day and I went back to the plastic surgeon again. I told him of the burning and how I was experiencing a shooting pain down my arms and legs and through my back.
"The surgeon told me that this pain could not possibly have anything to do with my implants but I would be able to have them removed if I wanted. I know this sounds dramatic and disgusting, but to try to explain the depth of this pain would say only that I felt like there was rotting inside my chest while I was still alive.
"The pain was so severe I felt I needed to have these things taken out of me. Nearly 20 years after I sat in the surgeon's office as a young, healthy woman, I was now desperately ill and in unimaginable pain. On November 16, 1993, I had another surgery and this time the implants were removed and not replaced.
"I had asked for the implants to be returned to me. Eventually, when I was able to look in the container, I found only one implant. The other one, the right implant, I was told was too ruptured and could not be returned to me. At home, I began having one crisis after another. I wasn't able to get out of bed myself or even sit up.
"I started asking questions. Why, after this surgery, had I been so ill? I had had numerous surgeries before and recovered in due time. Lying in bed, I wrote for the hospital records. I questioned my surgeon. One day, as I was lying there reading over the paper, something caught my eye. My surgery had begun at 1420 hours and was completed at 1443 hours. Those 20-year implants that I had been telling my surgeon had been giving me so much grief were removed, from start to finish, in a mere 23 minutes, less time than it takes for me to get a haircut.
"How could that be? More questions to the surgeon revealed that implants had ruptured and had been somewhat adhered to the chest wall. None of this was in the original OR reports and came out only after I continued to ask questions. Could some of that silicone have been left inside of me, I was so desperately ill?
"I owned a thriving hair salon and, no matter how hard I tried, I could not get rid of the terrible pain throughout my body. I eventually had to close my business, sell everything I had worked for my entire life. Life, as I knew it, was over. I was 43-years old.
"In February of 2002, a different plastic surgeon operated on the right breast and found a very large mass containing silicone. The pathology reports confirmed it was silicone within the scar tissue. Curiously, I asked about the size of it. Was it the size of a walnut? He said, no.
DR. WHALEN: Ms. Curtis Smith, if you could conclude, please.
MS. CURTIS SMITH: Thank you.
MS. MORITZ-CIANCUTTI: Good morning. My name is Audrey Moritz-Ciancutti. I have come here from Pittsburgh on my own and I have no conflicts of interest.
I had a bilateral mastectomy at Mayo Clinic due to fibrocystic disease with reconstruction with silicone-gel implants. My first rupture was two years later and both implants were replaced. Over the years, I started to become ill. I had a continuous burning in my chest and developed a very high sensitivity to any kind of heat and sun. Fourteen years after that rupture, and MRI revealed both implants were ruptured.
The surgeon that removed the implants left some residual tissue behind. I think he thought he was doing me a favor because I opted not to have an additional implant put in that I would have some sort of breasts.
My rheumatologist at Cleveland Clinic told me that, unfortunately, the surgeon didn't do me any favors, that in that tissue that was left behind were globules of silicone and there is silicone in my lymph nodes. She felt that this silicone has caused my condition. The silicone in my body explains why, immediately following the surgery, I began to have severe pain in my right arm and continuous swelling. I developed a cyst on my hand which had to be removed surgically and, after two biopsies, I was diagnosed with scleroderma.
I continued to suffer with extreme fatigue and depression and my immunologist diagnosed me with atypical-tissue disorder, arthritis, cognitive dysfunction as well as asthma and allergic rhinitis. I suffer from recurrent bacterial infections and I go through monthly treatments of I.V. gammaglobulin.
My body can no longer tolerate heat or sun and, two-and-a-half years ago, I had to leave Florida and move back to Pittsburgh because I could only tolerate a colder climate. Today, I am experiencing new scleroderma lesions on my chest, abdomen, my face and the top of my head and, once again, the chronic fatigue is reoccurring.
The bottom line is that I have silicone throughout my body because these implants ruptured and the doctor is sure this has caused my condition and this silicone cannot be removed. There have never been any studies of the health of women with leaking silicone implants except for the one study conducted by the FDA. That one study found painful disorders such as fibromyalgia among women with leaking breast implants compared with women with implants that didn't leak.
The results might have been even more dramatic if they had compared to women without implants but we don't know that because no such study has ever been done. If Inamed really wants to prove their implants are safe for women in the real world, they need to study the health of women with broken gel implants. Instead, they avoided that by studying women who only had implants for a very few years.
Thank you very much.
MS. TEAGUE: Ladies and gentlemen, my name is Cynthia Teague and I am a registered nurse from Baton Rouge, Louisiana. Inamed had sponsored my trip allowing me the opportunity to be here today. However, I am here because I am an individual recipient of silicone implants.
I would like to address the panel regarding the use of silicone implants and encourage you to allow women to make the choice between silicone and saline implants for themselves. I would like to offer my personal testimony as to the safety of silicone implants and to their importance in improving my quality of life.
I decided on breast-augmentation surgery due to the postpartal change in my body and after breast feeding my three children. I was feeling self-conscious, dissatisfied and eager for a change. My self confidence was suffering and my body image was low. I sought the consultation of a board-certified plastic surgeon and spoke with him at length about my concerns and desired outcome.
My physician was very forthcoming with the benefits and risks of this surgery. At this time, women had the choice between silicone and saline implants. Ladies and gentlemen, I freely chose silicone implants. That was over thirteen years ago and, since that time, I have had absolutely no complications or regrets about that decision.
My surgical results were excellent and I remain as healthy now as when I had my surgery. I attribute the remarkable improvement in my self esteem to the augmentation surgery. I attribute the remarkable surgical result largely, in part, to the use of silicone implants. In my consultation, I was able to handle both types of implants before making my final decision and I was also shown postoperative pictures of patients with both types of implants.
I chose silicone because of their more natural look and feel. My excellent surgical results further validated my decision to use the silicone implants. Having the ability to choose what type of implants were placed in my body, was very important to me. I felt that I was in control and in charge of my own destiny.
Not all women have that opportunity today. It is my belief that this choice should be extended to all women. Being able to make important decisions for oneself is crucial. Women in American have struggled for decades for this right. It is my request that the FDA reconsider its position on silicone implants and restore this choice to each individual.
MS. DOWD: Good morning, ladies and gentlemen of the panel. My name is Pamela Dowd and I have traveled from Boise, Idaho yesterday to come to you at my own expense because my family felt it was vital that the panel hear from a 28-year survivor of breast cancer. Today, I stand before you totally breastless and I am proud.
At the age of 27, I became a breast cancer statistic. I never had chemotherapy. I never had radiation. I was never sick before or after the mastectomy. But, in November, 1980, almost 22 years ago--23 years--I began the road through reconstruction hell with a bilateral breast reconstruction that included a failed latissimus dorsi flap and three ruptured silicone breast implants. The first replacement was within 90 days.
In June, 1987, when I experienced the third rupture, it sent me to the ER with a pain so excruciating, it felt as if thousands of needles were pulling and pushing through my body and I was literally pulling at my hair and screaming.
After getting breast implants, I developed a constant cough and, at times, I choked on my own saliva. I have peripheral neuropathy and burning in the spine. I have IBS and photosensitivity. I have been diagnosed with Sjogren's and Raynaud's and considered lupus suspect. I have MS-like symptoms that cause me to fall at the drop of a hat. The silicone in my chest and vascular system will never go away. My chest constantly itches and burns from the residual silicone. My bones still scream with pain.
In 1995, when I underwent explantation, my chest had to be scraped and cauterized to clean out the residue of the previous ruptured implants. The American taxpayer will, at some time, be responsible for the cost of my healthcare as they are now responsible for the healthcare of other victims of silicone-gel-filled breast implants.
We are being asked one more time to trust the manufacturers. Their story is based on 41 years of corporate lies and we have no reason to believe they are telling the truth now. The manufacturer-funded New York study in the early 1990s didn't ask if anyone developed breast cancer autoimmune disease after breast implants. It asked if participants had ever heard of anyone who did, proof of nothing more than do people listen to gossip.
In a federal depository in Birmingham, Alabama, lie 80 million documents of implant manufacturers, the ASPRS, FDA and others, telling the truth of this massive corporate coverup of the dangers of silicone-gel breast implants and I am a freelance researcher of those documents.
I have survived breast cancer for 28 years and do not believe I deserve to have a faulty toxic product foisted onto me by corporations without a conscience. The implant industry has taken away my health but they will not take away my hopes and dreams. This, too I will survive.
I ask you to please keep the ban on silicone-gel breast implants in place, not for my sake but the sake of generations of women to come who can and will become ill and disabled due to the toxins in the silicone gel.
Thank you for your time.
DR. WHALEN: If any of the speakers have handouts, could they bring them directly to Dr. Krause rather than to any other panel member. Thank you.
MS. BORDELON: Good morning, ladies and gentlemen of the panel. My name is Lisa Bordelon. I am a registered nurse and I have practiced in the field of plastic surgery for fourteen years. I have also been actively involved as a study coordinator with both McGhan, Inamed, and Mentor adjunct studies from the inception.
I have had silicone implants for some 20-plus years also. I am not here today because Inamed has sponsored my trip nor because of any business affiliation we may have but as an individual recipient of silicone implants. I am here to share my experience with and opinions of silicone implants.
My decision to have implants initially was not unlike many others. I simply wanted to be more proportionate for my body and to appear more feminine. After the birth of my first child, I began to explore the option of breast-augmentation surgery.
At the time of my initial consult in 1982, I was given a choice between silicone and saline implants. I chose silicone because of their more natural appearance and feel. The resulting surgery had a tremendous impact on my self esteem. I was more proportionate. My clothing fit better and I felt more feminine. Basically, I felt better about me.
Many patients today do not have the choice of silicone implants for their breast surgery unless they meet certain qualifying criteria. For those select few that do meet these criteria, they often choose saline because of the prohibitive cost of silicone and because of the negative publicity received in recent years.
As a plastic-surgery nurse, I see many patients with unacceptable results that may have been avoided by the use of silicone implants. Therefore, many patients are undergoing multiple procedures to achieve a result they may never reach with the use of saline implants.
I cannot say that my experience with silicone has been totally uneventful. I have experienced encapsulation that has required surgical intervention. But this is a condition associated with saline implants as well. This response cannot always be predicted beforehand and makes no difference as to what type of implant is used.
Great advances have been made in the manufacturing of silicone implants in recent years. I do not believe that the silicone implants are more dangerous than any other medical device but, like any other medical device, there are inherent risks involved. It then becomes the responsibility of the physician to inform their patients of these risks.
I believe the decision to choose silicone or saline implants should be left up to the individual patient based on physician recommendations as to which result in a better outcome. For me, the correct choice was to have silicone implants. I would make this same decision again today. I believe silicone implants offer a good safe option to those considering augmentation surgery and I hope you will see fit to, once again, give all women this option. Thank you.
MS. FORMAN: Good morning. I am Jessica Forman. I am a cancer survivor and I have no relation to any of the implant companies. I was here about ten years ago when FDA was holding its first round of hearings on silicone breast implants. I was then a breast-cancer patient scheduling surgery to replace the tissue expanders for permanent implants. I participated in that lobbying effort to persuade members of Congress and the FDA panel that silicone implants should remain on the market. I feel very differently today.
I had my first mastectomy in 1990. I opted for immediate reconstruction and was actually in the hospital for surgery to equalize the normal remaining breast. It all came to a screeching halt because my oncologist re-read the latest mammogram and found another suspicious spot. Two weeks later, I had the second mastectomy and still wanted immediate reconstruction.
Together, those two surgeries were a horror story, the first, for emotional storms, the second for physical problems. I had so many bad side effects that my doctor said to me, are you sure you are not an M.D.? This is only supposed to happen to M.D.s. Well, I am not. But all those setbacks explain why, two years later, I was still scheduling surgery.
Ten years ago, I didn't care about the future. I wanted to look and feel as if I had never had breast cancer. I wanted to wear a bathing suit, wear sleeveless tops. I wanted to shop at Loehmann's in a group dressing room and not have anyone stare at my scars. And I wanted it right away.
It didn't happen. It could not happen. Some days, I look in the mirror and I hate my scars. Other days, they are all right. I can't wear some clothing styles. They are simply too revealing. Sometimes, I can't lift my arms over my head. And I still can't find a bra to fit both parts of me.
I know that the company testifying today provided data showing women with silicone or saline breast implants have a higher rate of complication than augmentation patients and I am upset to hear about that. I have an older sister who also had bilateral breast cancer. She got silicone-gel implants. She is suffering so badly from these connective-tissue immune diseases that she almost cannot work. She sacrificed everything to be able to work five hours a day.
We don't know. Is this from her cancer or is this from the silicone implant. There is no way to find out. For myself, I know it takes longer to heal. I know I hurt a lot more and the fatigue factor has gone up tremendously. I can't get in to work like everyone else in my office. If I commute downtown for two or three days, I am exhausted. I am too tired to cook dinner, remember anything, can't solve problems, don't know what I am talking about. It is a lot easier if I can do this at home and cut out a two-hour commute.
Hindsight is always twenty-twenty. If I had cancer today, I wouldn't opt for immediate reconstruction. I am not sure that I would have reconstruction at all. I would, however, take a long time to investigate my choices. There may be a better way than implants. There are tissue-flat reconstructions. They are not always appropriate. Given my weight and medical health, my doctor refused to do them. More power to him. I think it would have caused more problems.
Recommendation; I think we need a big caution flag waved. There is a lot of information we don't have about cancer, the immune system and the safety of breast implants. I would like to see much more long-term research on silicone before your restrictions are lifted. I would like to make sure that they are long-term safe, not two years, not five years, but ten, fifteen, twenty years.
I am not actually sure that gel implants need to be available since saline is. But, if they are available, I would ask you to restrict them and to insist on truly informed consent.
MS. FJELSTAD: (Read by Kathy Sachs.) Good morning. I am Kathy Sachs and I reading the story of Diane Fjelstad who is too sick to be here today.
"In 1978, I was encouraged by a team of doctors, including an obstetrician, a plastic surgeon and radiologist to have bilateral mastectomies to prevent breast cancer. I believed these doctors when they told me that the implants were perfectly safe, would last as lifetime and I would go to the grave looking better than most women.
"Although I had early warning signs, I didn't suspect the implants. There were unexplained blood disorders, a strange rubbery substance oozed through the skin of my foot, and a rash of new allergies developed which did not respond to treatment. I could not understand my continual fatigue in the late '80s and '90s. I was unable to drive to the next town, only fifteen miles away, without having to stop for a nap.
"This was very foreign to me as I had been a competitive athlete. My skin began to hurt. Worst of all, I feared I couldn't continue to work as a high-school teacher due to my memory lapses, fatigue and continual illnesses. In '95, I noticed a dyslexia-like problem with words and numbers. Finally, I noticed that the left implant had seriously shifted and was pressing against my lungs. Breathing became difficult.
"I attended a conference on silicone exposure and discovered that many of my symptoms were classic; chronic inflammation, myofascial-pain syndrome, swollen glands, numbness and tingling, and, later, severe pain, early signs of Sjogren's syndrome, chronic-fatigue syndrome, muscle atrophy, low-grade fever, severe headaches, chronic sinus infections, lung problems and gastrointestinal problems.
"My condition deteriorated very quickly in the fall of '95. I was explanted in late January, '96. The explanting surgeon was furious that I had been allowed to get so sick and that the doctors had not picked up on my symptoms and treated them earlier.
"The simple explanting surgery turned out to take over five hours with black substances and school-bus yellow oil running all over the operating table onto the floor. What a stinking mess. The implants were filled with fungus and no sign of silicone gel remained in the ruptured shells.
"Since that time, I had a routine bunionectomy and asked the operating physician to do a biopsy testing for silicone. He was totally shocked to discover that there were, indeed, silicate crystals in the bunion. I also know that I have lesions on the brain from the silicone as revealed in an MRI. Who knows where else the silicone has settled since the body has few ways to rid itself of it naturally.
"My life has been disastrously impacted by silicone-gel implants. I have no breasts. I was no longer able to work as a high-school teacher. I had to go on disability. My husband of 40 years divorced me. My financial income has been reduced to one-fourth of what it was. My health has been compromised in many ways as I have mentioned.
"You will hear from some women who insist on being given a choice. Don't do us any favors by giving us the choice of an implant whose safety is unknown after just a few years.
DR. VASAY: (Read by Dr. Diana Zuckerman.) Hello. I am Dr. Diana Zuckerman. I am going to be testifying on behalf of myself tomorrow. Today, I am just reading the testimony of Dr. Frank Vasay who asked me to briefly describe his research. Dr. Vasay is Director of the Division of Rheumatology at the University of South Florida College of Medicine.
Dr. Vasay did provide some testimony ahead of time. I hope you have it. He has personally evaluated approximately 2,000 symptomatic women, most of whom have silicone-gel-filled breast implants. He has been doing this work for over twenty years.
He wants me to say for him that he has been satisfied that some women's immune system does not tolerate silicone breast implants. The syndrome remains undefined but recent information suggests that 10 to 25 percent of women are so ill approximately thirteen years after getting implants and that recent epidemiologic studies show statistically increased symptoms in women with breast implants compared to control groups.
He has done some research and he asked me to describe it for him. This is published in various places. I had hoped his coauthor could do this for him, but she works at the National Cancer Institute and I guess that is a conflict of interest.
He studied approximately 100 women who had rheumatologic symptoms as diagnosed by rheumatologists and who had silicone breast implants. Approximately half of them chose to have their implants taken out as was suggested to them and the other half, although it was suggested to them, and the other half, although it was suggested, decided to keep their implants. So that was his study group, obviously not randomly controlled.
He followed them up for an average of 18 months. What he found was a remarkable number of women who had their implants taken out and not replaced showed slow steady improvement. The symptoms that they had were similar to fibromyalgia; muscle pain, chronic fatigue with multiple trigger points. He points out that, unlike classic fibromyalgia, exercise aggravated the muscle pain. So that was different from what one would normally see in fibromyalgia.
He also found that some women got better and some did not, not surprisingly, but that most of the women who had their implants taken out did get better and most of the women who did not have their implants out got worse. By "most," that was over 90 percent.
There was a way to at least predict who would get better and who would not. Women who tended to have a bad prognosis and ruptured implants with silicone debris in their chest wall so that the silicone had not been entirely removed and could not be removed. He also found that women who had delayed removal where their implant had ruptured some years before but they hadn't gotten it out for quite a while also had a poor prognosis.
He also found that the women who didn't do so well after getting their implants taken out tended to have an onset of problems very soon after getting their breast implants, usually within two years.
He has, as I said, published some of this work and it will be made available to the panel.
MS. GROSS: Good morning. My name is Marcy Gross. I have six minutes having combined time with another potential participant. I am a health-policy consultant and a member of the State of Maryland's Women's Health Promotion Council. I retired in November of last year after 25 years at HHS most recently as the Senior Advisor for Women's Health at the Agency for Healthcare Research and Quality.
During part of my tenure at HHS, I also participated in the Secretary's ad hoc working group on silicone breast implants. I give you this brief resume just to establish my familiarity with the issues you are considering today but I am here as a private citizen and I base my remarks on my personal views and on information available to the general public. I am not paid.
One legacy of my six-year tenure at ARC is a good appreciation of the need for women and policy makers to have a strong evidence base for making decisions on healthcare issues. My concern today is that an adequate evidence base for the premarket approval of silicone-gel-filled breast prostheses does not exist and that the short-term assurances drawn from the applicant's study will override continuing gaps in the research on long-term risks.
I can see from the information posted on the panel's website for the hearing that the FDA has done exhaustive background work including literature reviews, assessments of toxicology and chemical testing and extensive consideration of the clinical data. All this and more will come to you over the next two days.
But some facts are simple and have not varied in the twelve years since silicone breast implants were pulled from the market. The studies available on the health aspects of silicone-gel implants are short-term analyses often involving mere handfuls of mice studied over the course of a few weeks in the case of toxicology and chemical testing and over a two-to-three-year period in the case of Inamed's core study being cited in this proceeding in support of a case for reintroducing silicone breast implants for unrestricted use.
Yet, even these short-term assessments indicate that the rate of ruptures and other complications which lead to a reoperation remains unacceptably high, 20 percent plus for patients using implants to augment their figure and 45 percent plus for reconstruction patients.
Thanks to our longer life spans, breast implants will stay in a woman's body for the rest of her life which can be 50 years or more. A two- or three-year study simply doesn't offer the kind of assurance of safety needed. It is a setup for future medical problems for women who have this type of device implanted, especially when retrospective studies show that, by ten years, most women with silicone-gel implants will experience at least one broken implant. At least these women know they have a problem and have further surgery. Silent ruptures are also a documented and recurring problem.
Sometime in the next few days, I feel certain you will hear someone say that none of the several important studies of the possible risks of implants have shown that they cause long-term health problems. You may even hear it said that, well, we use silicone in other implanted devices such as heart valves, knee joints, hip replacements, so why should silicone from breast implants be different.
My response is that having bubbles or globules of migrating gel floating through a human body into and around organ is, on its face, a health risk. As for silicone and other implanted devices, one doesn't expect bits of a heart valve to break off and migrate to the brain, liver, other organs.
Further, patients who get hip or knee joint replacements are routinely warned that a small number of patients will have an immune-system reaction to the silicone fragments shed by newly implanted joints. How is it that orthopedic surgeons know this problem but the breast-implant community continues to doubt.
There is no health imperative behind the push to reintroduce silicone breast implants. On the contrary, they are used in elective cosmetic procedures that often cause serious health complications associated with ruptures and the surgery, itself. Although there are other options available to breast-cancer patients that carry fewer risks, for some, silicone-gel implants is felt as important to their recovery.
We know that this choice will make them more vulnerable to future illnesses and complications and will obscure future cancer screening procedures. But, again, we lack the kind of long-term studies that would allow their choice to be fully informed.
This FDA panel will be making a decision that affects the lives and pocketbooks of women quite substantially. There are emotional issues involved in the decision and results. Implants are an expensive procedure especially when the cost of care for complications, reoperations, infections and other medical side effects are added in.
About 250,000 new procedures were done last year at a cost estimated at approximately 5,000 each on average for a total cost of $1.2 billion to the healthcare system. While much of this is paid for by the patient, the cost for reconstructive procedures that many cancer patients elect to have is most often covered by insurance and, of course, follow-up care also would be covered most insurance.
What is the policy recommendation here? The FDA found the middle ground twelve years ago. While I would still prefer to not have seen the fourfold increase in implants that has since occurred, at least the current policy sends a strong cautionary signal to women with choices. This should not change until we have more confidence that these implants are safe for long-term use and that will take time and more research, the kind of research that should have been initiated ten years ago. Let's not miss another opportunity.
I thank you for your time and attention this morning. I see that you have an agenda which runs well into this evening so I wish you luck and stamina. Thank you very much.
DR. MASSEY: Good morning. I am Dr. Marga Massey. I am an assistant professor of surgery and the Director of Basic and Clinical Science Research in the Division of Plastic Surgery at the University of Utah Hospitals and Clinics in Salt Lake City, Utah. I have no affiliations or conflicts of interest with any implant device manufacturer and have paid my own travel expenses to testify at the hearings today.
I use breast implants in performing both cosmetic breast-augmentation and breast-reconstructive surgery. I am on a fixed salary as a University of Utah paid employee and receive no financial gain whether I perform breast-augmentation or reconstruction procedures utilizing breast implants.
As an academic plastic surgeon involved in basic science research which occupies greater than 50 percent of my current time, I have restricted the majority of my clinical-practice interest to breast patients, both cosmetic and reconstructive. I have been impressed that cosmetic patients are very informed about their current surgical options to enhance the physical appearance of their breasts. This level of knowledge likely reflects the current availability of information regarding cosmetic breast augmentation on the Internet and through the mass-media coverage of this topic.
Breast-cancer patients additionally master a very complicated variety of breast reconstructive options to include but not limited to tissue expansion with delayed breast-implant placement, immediate breast-implant placement in the setting of skin-sparing mastectomy and the use of autologous muscle flaps which may be augmented by the placement of the incorporation of a breast implant in order to restore the appearance of a natural breast after a mastectomy.
Many speakers today will provide testimony regarding the safety of silicone-gel-filled breast implants. My personal review of the published information to date regarding the safety and efficacy of silicone-gel-filled breast implants supports their availability to cosmetic patients for breast enhancement. This availability would mirror that which is currently acceptable for breast-reconstruction patients.
As a plastic surgeon practicing in an academic setting, along with my colleagues here today, we eagerly await review of this most recent evidenced-based investigation. We wish to continue collaborative scientific clinical investigations with the FDA and the device manufacturers to ensure patient satisfaction and safety.
When the final review of this most recent evidence-based investigation becomes publicly available, I believe women will be empowered to make informed choices regarding the use of silicone-gel-filled breast implants.
In conclusion, breast-implant device availability in clinical use should be based on sound scientific investigation. Public education should be based on sound scientific investigation. Implant-device availability and public education based on sound scientific investigation will ensure patient safety and will allow patients to make informed personal decisions regarding the use of silicone-gel-filled breast implants for cosmetic enhancement and for reconstructive restoration after mastectomy.
I greatly appreciate the panel's time and consideration. Thank you.
DR. WHALEN: Dr. Massey, would you entertain just one question? I appreciate your full discloser at the beginning.
DR. MASSEY: Yes, sir.
DR. WHALEN: But is it your contention, in your academic environment, that there is absolutely no relationship between any volume of procedures you do and present and future income?
DR. MASSEY: I beg your pardon?
DR. WHALEN: I am in an academic setting, as you are.
DR. MASSEY: Yes, sir.
DR. WHALEN: And certainly the number of procedures that I do will impact, at a divisional and departmental level, a revenue structure that does impact upon the income of I and my fellow faculty members. You said you are on a fixed income.
DR. MASSEY: I am on an absolute fixed income that has no reflection on the number of surgical procedures that I perform.
DR. WHALEN: So your department is able to remunerate you even if you do zero procedures or you do 200?
DR. MASSEY: That's correct, sir.
DR. WHALEN: Thank you.
DR. MASSEY: Thank you.
MS. WOLF: My name is Carolyn Wolf. I live in Virginia. I came here at my own expense. I have no conflicts of interest.
In 1971, I had a double mastectomy and was reconstructed with what were then considered new and improved silicone implants. That was the time when breast implants were much thicker than they are today and were a rarity. Few women have had implants as long as I did. There are no published studies focused on women with implants for longer than 25 years because so few implantees have lived so long.
I would like tell you what happened to me. At first, I had no health problems and, even when they started, I had no idea they were related to the implants. But, after nine or ten years, I developed dozens of hard, burning blister-like growths on my neck and boils on my forehead. I have pain and numbness in my left shoulder, arm, hand and foot.
By 1993, my family had noticed a distinct change of personality and I noticed cognitive changes. I am diagnosed with rheumatoid arthritis, Raynaud's, irritable-bowel syndrome, silicone-induced MS-like syndrome with neuropathy of the extremities. I have neurological damage to the left eye. My silicone level is double normal. This is two years after explantation.
My brain MRI reveals more than 20 lesions. In March, 2000, a batch of silicone moved from my left breast into my armpit leaving an elongated swelling in its path with excruciating pain. On April 13, 2000, I lost vision in my left eye for 45 minutes. I had constant pain in that eye for six weeks but, after a long, thin greasy glob came out of it, the pain lessened.
I have had two similar strings come out of my left ear in the last year. That is 30 years after implantation. Although I did not smoke, I was coughing up hard gold-colored globs and a lung X-ray showed chronic obstructive-pulmonary disease. Although the type of silicone implants that I had were thicker than those of today, MRI showed both implants ruptured. I went to three different plastic surgeons but they only wanted to install replacements.
When my implants were removed three years ago, both implants were extensively ruptured, both much smaller than when they were implanted. The scar capsule surrounding the implants had cysts filled with chronic inflammation and foam cells containing silicone materials.
Chest X-rays show that I still have silicone in the breast area. I am still exuding silicone from the nipples and have deposits of silicone in both armpits. Researchers at the National Cancer Institute have conducted the only studies of women who had implants for at least eight years. They found that women with implants were more likely to die from certain cancers and suicide.
The FDA conducted the only study of women with ruptured silicone implants and they found they were more likely to have fibromyalgia. If implants are so safe, make sure that the implant makers prove it. The studies you will hear about today do not do that. Please remember that, whatever you do, if implants are approved by the FDA, you cannot control the advice given by plastic surgeons many of whom are still claiming that breast implants are perfectly safe and continue to insist that broken implants should be replaced.
We beg you, please protect the younger generation. Thank you.
DR. WHALEN: Thank you very much. I think that is an appropriate time that we will break for about thirteen minutes until 10:30. I need to remind the panel members, as difficult as it is, that any discussions upon the topic at hand need to be public, in front of the microphone, so refrain, outside of this panel room, from discussing anything at hand.
DR. KRAUSE: Let's continue, please. Thank you.
DR. WHALEN: To try to keep on time, we are going to resume. Actually, the next public presenter is going to be via a conference call from the Hofnagel Group. They will have five minutes. Probably there will be people filtering back in because apparently the rest rooms were engineered by the same people who did the elevators. So we will have to have some forbearance for that.
So the microphone is already rigged towards the speakerphone and we will initiate with the Hofnagel Group's discussion.
DR. HOFNAGEL: Hello. We are speaking to the committee. We had difficulty hearing before. My name is Dr. Vicki Hofnagel. I have a group called the Hofnagel Institute. We came before the FDA previously on multiple issues. In 1994, I presented documents to the FDA showing that saline silicone breast implants still had migratory silicone into the chest wall of women.
At that point of the purpose of that discussion and conference was to discuss the fact that surgeons who were removing implants were replacing implants and not taking tissue to study it from migratory silicone.
At this time, we supported the decision by David Kessler because he was looking at life-long chronic complications not life-threatening complications. The implants that are being presented have not changed in their design, the manner in which the protocol for placement or the protocol for follow up has occurred.
In this hearing, the availability to give public testimony is wonderful as it is in all hearings. However, that public testimony is usually not taken into consideration whatsoever as seen in the May, 2000 uterine-artery-embolization discussion before the FDA.
We will be petitioning to the FDA to request that all FDA hearings will now be made public with public-television and also on the Internet. It is extremely important that this meeting be made known to women across the nation and throughout the world.
The things that prompted the Dow Corning case are still existing today. I still see women every day with silicone breast complications. Virginia Gallagher will be speaking to that, the crystallization of silicone causing glass to cut into the chest wall, the implantation of migratory silicone onto the nerves, and things that have not been made public such as the common condition of chest-wall deformity from all breast implants being used today and that this chest-wall deformity is the cause of many of the complaints of pain, itching and heat discomfort that women have.
This has not been known to the public. You can take chest X-rays and see the actual rib deformations in all of these women. Yet it is not a baseline study.
There is much to be done. We need a national registry that will actually take in all of the complaints and look at them from the past if not looking on to the future. C-reactive protein, ANA, LE prep, complement fix, all of the routine studies still are not part of a strong protocol.
We need to move forward and we should have seen a new design. We have technology to increase tensile strength. We have technology to encapsulate even a silicone gel. But the technology has not been shown in the new implants. Instead, we are given an implant now with a two-year shelf life. That two-year shelf life and the aspect of the life of an implant is still not given to patients. Informed consent and complete disclosure is absolutely a sham still today. We need a much better educational program for women.
If we are going to move forward and reallow silicone to be used, then we need to change the design of the implant, make sure that it has radiopaque material to see when it leaks because so many women have no idea that they have leaks, by they have symptomatology and they are basically told, honey, go home. It is a little ache and pain. You are crazy in the head. And then, when we operate on them, we find that their entire chest wall has been destroyed.
I am going to move on to Virginia Gallagher who is going to speak. We had two other women who wanted to speak. Those women are young and beautiful and, when they went to their physicians complaining of itching and burning and other difficulties, they were patted on the head because their breasts looked great. They looked great. These women were attractive. They were scared to death to have their implants removed because of chest-wall deformity.
Our institute notified the FDA in 1994 and we have continued. We now have developed a plasma-state surgery using argon beam and liquids to actually prevent chest-wall deformity and the public is unaware of this.
In the panel and committee, you should also have psychotherapists because of the reasons that women have implants and the reasons they do not present afterwards such as the two young women within our group and we will be forwarding documents.
I conclude because of the time limitations. We will be sending a formal document because we cannot put all the data in such a brief discussion--and move on to Virginia Gallagher. We will close with Denise Bennett who is the attorney and counsel for the Hofnagel Institute on illegal issues.
MS. GALLAGHER: Hello. My name is Virginia. I can't tell you in this short time the multiple problems that I developed, but I suffered many health problems and, within two to three days of surgery of having the implants put in, my back and chest area was completely erupted with red sores that left multiple scars all over and remain to this day.
My implants became hard and lumpy, not only painful but socially embarrassing. Can you imagine what it is like to meet an old friend at your alumni and have them give you a hug, jerk back and look at you in shock at your chest because they have just hit a rock wall. That happened to me enough times so that I began to withdraw. It was embarrassing and humiliating.
My lymph glands were very sore and felt like they burning. Within one or two months of the time my implants were put in, it was almost impossible--well, was impossible--to maintain totally normal range of motion with my arms. It was impossible, also, to find a comfortable
DR. KRAUSE: Excuse me. Could you wrap up, please. We need to go on.
MS. GALLAGHER: It was uncomfortable to find a position to sleep in. I asked the surgeon to remove them. He said, no, I would be psychologically damaged and that it would be an irreversible depression. The social situations were humiliating but the pain was terrible. My left breast grew to protrude from my body several inches more than the right breast and was inflamed and red.
I was told by another surgeon that the implants didn't need removal, although they could be replaced with new ones. At the time of my removal, the burning lymph glands were free of pain when I came out from under anesthetic for the first time in 26 years.
I am outraged that doctors have no concern for our health, that they deny the health problems that results, that insurance doesn't cover the removal of the implants and for teaching--(operator interruption)--is inorganic. It is not natural unless it is already there normally.
I was told that these implants--I was not told that they were not a lifetime procedure, that they would need to be replaced at any time in the future. When I got them.
MS. BENNETT: This is Denise Bennett wrapping up. For a long time, manufacturers and regulatory--
DR. WHALEN: I am afraid that we need to move on because you are so far beyond the allocated time and I apologize for cutting you off.
Let me just say to the rest of the people in the room as well, we try very hard to balance between the number of people who wish to speak to us and to try to allocate the time appropriately. So we are not trying to efface--ignoring what people are saying by cutting people off but, rather, trying to balance that with justice towards everybody who wishes to be heard. Indeed, there are many people who do wish to be heard.
On the contrary, I have to interject at this point to what I have heard now at least twice this morning. Having chaired the panel where we looked at saline breast implants, I can totally assure you that I, and our panel members, do not ignore what the public is saying. We very acutely listen to what the public is saying and we take that into account.
The next speaker, please.
DR. JEWEL: Thank you. My name is Dr. Mark Jewel. I am a board-certified plastic surgeon with over 25 years of experience with breast-implant surgery. I have no financial ties to industry or health-professional societies. I have been a clinical investigator for Inamed's core gel study and an investigator for Inamed in Mentor's cohesive studies.
I am Vice President of the American Society for Aesthetic Plastic Surgery which will reimburse my expenses for travel and hotel. Today, I am speaking as an individual. I thank the panel for this opportunity to address the topic of patient informed consent and the management of expectations.
I have a particular interest in this subject having researched and written the Patient Consultation Resource Book which is used by more than 40 percent of all board-certified plastic surgeons.
With the Internet patients who see more information today than at any time in the past regarding breast-implant surgery, many arrive at the physician's office with a great deal of information including pictures of results from the websites, yet have an incomplete understanding of what will actually be their personal result of after breast-implant surgery.
I believe we need to move beyond traditional approaches of informed consent to empower our patients to be actively involved in all aspects of the clinical decisions which precede breast-implant surgery. We must effectively educate patients regarding potential problems that may occur subsequently. In this way, the patient can better understand surgical risk, expected outcome, potential dissatisfaction and financial responsibilities of breast-implant surgery.
Because the patient takes an active role in the entire process, she and whoever else she chooses to involve in her decision, are invested with a degree of responsibility and control over the outcome. Physicians have discovered that, even though patients may sign a consent form, that does not necessarily mean they will in the future remember being informed about potential complications or the possibility of dissatisfaction with results.
Research into effective methods of achieving informed consent is ongoing and plastic surgeons have funded such research to help determine the extent of informed consent in breast-augmentation procedures. Informed consent means that the patient must be educated as to surgical alternatives and the probability of any unwanted outcome. Risk must be quantified in ways that patients understand and communicating risk effectively is a complex task.
Patients must understand the limitations of surgery and the process involved with recovery. Patients need to understand this involves the potential for complications of the surgical procedure, itself, inherent risk of implanted devices and additional advisory information pertinent to the use of breast implants.
It is essential for patients to understand that breast implants may need to be replaced over time. I have been involved in developing materials for breast-implant patients that I believe successfully meet all the criteria that I have discussed today. The FDA's ongoing regulatory process will ensure that sound science will determine what choices may be available for women going forward.
Plastic surgeons welcome the current hearings which will determine whether silicone-gel breast implants can be available for general use.
MS. RICHARDS: Dr. Krause, and members of the panel. My name is Mary Ann Richards. My transportation costs and hotel accommodations have been paid for by Inamed. I have not been offered, nor would I accept, compensation for the time I have taken from my employment to present with you today.
I am a four-year cancer survivor who chose to have a silicone implant after a mastectomy. Between the time it was determined I would need a mastectomy and actual surgery, itself, I did considerable research on the various types of breast construction available to me. After extensive research, I felt an implant would be my best option.
The initial expander was put into place following my surgery on January 25, 2000, by Dr. Caroline Glicksman, an excellent board-certified plastic surgeon. It was a saline expander and, as it was filled with the saline solution, I found it extremely hard and uncomfortable, a constant reminder of my disease and loss.
As part of a cancer support group, I knew several other women who had opted for the saline implants and they, too, found them hard, uncomfortable and disappointing. When I mentioned this to Dr. Glicksman, she said that I might be a candidate for a silicone implant. She gave me some literature and I did extensive research. After I did my homework, I felt that the silicone implant was the way I wished to proceed.
I discussed this at great length with Dr. Glicksman and she gave me additional literature with both the advantages and disadvantages of silicone implants. I decided to proceed and, on May 26, 2000, I had a McGhan silicone breast implant inserted.
Losing a breast because of cancer is not easy, but facing daily the reality that the cancer might reoccur was, for me, far more difficult. With my silicone implant, I am not constantly reminded of that possibility. My silicone implant is comfortable, soft, and feels very natural, unlike my original saline expander.
I feel I am a responsible, informed consumer. I see Dr. Glicksman yearly. I am aware that silicone implant have a limited life expectancy, much as a pacemaker or artificial knee or hip and will need to be replaced in the future, much as they would.
I have never, for one minute, regretted my decision with regard to my silicone implant and feel very strongly that other women who have to face the horror of breast cancer and the mastectomy should have the same options available to them that I have had. It is for this reason that I am willing to present before your committee about this very personal matter.
Thank you for the opportunity to speak before you.
MS. BANCARZ: Good morning. I'm Lisa Bancarz, a 1982 graduate from Pacific Union College and resident of California who had silicone-gel-implant surgery in 1987. Following two pregnancies and breast-feeding both of my children, I found my breasts were asymmetrical. I was not happy with this change in my appearance.
I decided to have breast-augmentation surgery and scheduled an appointment with a board-certified plastic surgeon. My surgeon discussed at length the pros and cons of the surgery. I spoke to several of my friends and acquaintances who already had this surgery. Some mentioned they were slightly more firm because of capsular contracture but they were happy and did not want them removed.
I decided to proceed with the surgery and have never regretted it. I remember several articles and media programs regarding the issue of silicone and breast implants from the early 1990s. I spoke to my surgeon and he talked to me at great length regarding the silicone issues. He explained that, since I was not having problems with the implants, I should follow the recommendation of the American Society of Plastic and Reconstructive Surgeons and not have them removed.
I obtained more information from articles given to me by my physician and what I personally read in the newspaper and magazines. It became evident, through my readings, that silicone had been, and still is being, used successfully for other types of implant procedures. I am offended that a woman's option to choose a silicone-gel implant was taken away.
I feel comfortable with my decision to have silicone-gel implants and have never regretted it. Because of the controversy surrounding the silicone implants, I have attempted to keep up the studies and their results. Again, I feel I made the correct decision.
I have several friends who have had the surgery. After seeing their results with saline implants, I am thrilled to have my silicone-gel implants. My breasts are soft and feel like natural breast tissue. I am extremely satisfied with the surgery and would not hesitate to have the procedure again.
I would strongly recommend silicone-gel implants to friends and, yes, even my daughter if she expressed an interest at an acceptable age. I am very appreciative and glad that I was given the opportunity to choose silicone-gel implants. It is my strong belief that every woman, after consultation with her physician, should be able to determine which type of breast implants are best for her. Silicone-gel implants should be an option.
MS. WRIGHT: Good morning. My name is Eileen Wright and I want to thank the panel for allowing me to comment on my nearly 20-year experience with silicone breast implants. I currently work as a nurse manager within the Johns Hopkins Health System. I do not have any financial interest in the manufacturer or its competitors.
I am a breast-cancer survivor. After my diagnosis and subsequent mastectomy, I chose to have breast-implant surgery. At that time, I was under the mistaken impression that my implants would last forever. I lost touch with the surgeon who performed my implant surgery very shortly after the procedure as he left the area to practice in another state. I truly felt any further follow up by a surgeon would be unnecessary.
It was not until nearly 16 years later that I noticed, one, my implants had appeared to rupture; two, I discovered implants were not designed or meant to last forever. It was only through a conversation I had with a colleague who also had silicone implants that I learned implants, like any other medical device, may need to be replaced periodically.
Needless to say, when I visited a local plastic surgeon in 2000, he advised me that the implants I had for 16 years needed to come out. He also told me about the various surgical options available to me after the implants were removed. As I look back on this process, it is clear to me that the science, along with the patient-education process, has evolved considerably since my first implant surgery in 1984.
My plastic surgeon took the time to explain the range of reconstruction options available to me. He noted that I did not need to replace my implants with silicone-gel implants if I did not want to. He showed me, and allowed me, to handle examples of both saline and silicone implants and he detailed an exhaustive list of potential complications associated with the devices.
When I expressed an interest in having the old gel implants replaced with new ones, he explained that rupture could occur again. He also confirmed that I understood that the implants might still need to be replaced at some point in the future. Until the time of the implants' rupture, I had been very satisfied with the outcome of my initial surgery. Thus, I felt very comfortable replacing the old implants with new ones.
It has been three years since my most recent implant surgery. I am very satisfied with the result and now consider myself a well-informed patient. It does not make sense to me that silicone-gel implants are only available to women for breast reconstruction.
I think it is important that all women have the option of silicone implants available to them. I believe they provide a look and feel that is most natural.
Thank you for your time.
MS. LOWENSTEIN: Good morning. I am Lisa Lowenstein from Fremont, California. Inamed paid for my travel and accommodation to attend today's meeting.
After breast-feeding and raising four children, I was not happy with the way my breasts looked and the way my clothes fit. I decided that I wanted to have breast augmentation to restore the look and the feel of my breasts. In 1997, I researched all the implants that were available to me. In August of that year, I met with my plastic surgeon and he informed me that my only choice was saline-filled implants.
I was not happy with that choice due to a number of reported rupture incidents and an unnatural look that it had a history of. My next step was to have a mammogram done before the procedure. Within 30 minutes of having the mammogram done, I received a call from my doctor stating that he wanted me to retake the mammogram and that he wanted me to see him at his office.
During that appointment, my doctor explained to me that what he and the X-ray technician found were decalcified starburst spots on both of my breasts. Considering the fact that my mother died from breast cancer, this was alarming to both me and my doctor.
After discussing my options and the procedures, we decided it would be best to do a bilateral subcutaneous mastectomy, something that is rarely performed these days. The surgery took place in September of 1997. I was so scared of the possibility of having cancer. My doctor was quite pleased when the surgery was over and the tissue expanders were put in for healing time. The biopsy report came back negative. What a relief.
My doctor knew that the silicone-gel implants would be out for testing and maybe in time for me to have them. He explained to me that if I was his wife, that he would want her to have the silicone-gel implants in this situation because they were, in his opinion, much more natural, softer, tier-drop shaped like real breasts, and feel like real breasts.
He believed that there was less chance of leaking or rupturing and I trusted his opinion. In May of 1998, after qualifying to be a case study, I underwent my final surgery to insert the silicone-gel implants. My doctor informed me that these would be so much nicer than the tissue expanders and that, in time, would soften and drop into position like real breasts.
I was ecstatic when the surgery was over. I hardly had any pain and my breasts looked beautiful. They were perfectly shaped, soft to touch and looked great in clothes. I never had any side effects or problems of any kinds with these implants and, as time went by, they softened even more and looked more natural than my girlfriends who had saline implants.
Even though I had all my breast tissue removed, my implants looked much more natural with no wrinkles and no hardness. I am a very athletic women and work out at a health club very strenuously. I wanted to make sure that these implants could keep up with and not limit me in any way.
Nothing limits me in my life by having these implants. I forget that I have implants most of the time and no one knows that these are not my own breasts and I never give my secret away. The best part for me is that I am healthy and these implants look great. I love being able to find clothes now that I fill out the top perfectly and evenly. It is important to me that I am proportional.
The worry about breast cancer is erased from my mind. I would make exactly the same decision today if I had to. I wouldn't change one thing about my experience.
In the dental field, which is my background, we let the patients choose what kind of filling to put in their mouth, whether it is a lesser material, veenamalgam*, one-color silver, unnatural, or higher-quality materials such as a tooth-colored composite that is more natural and unnoticeable. Based upon my experiences, patients that care about their appearance will choose the higher-quality composite because it is more natural and aesthetically nicer.
The key word here is choice. Women should have a choice of what kind of implant they want in their body from a list of all products deemed safe and effective.
DR. WHALEN: Can you conclude, please, Ms. Lowenstein.
MS. LOWENSTEIN: At the end of the day, I don't consider these an implant but part of my body. Thank you for your consideration.
MS. NYE: Good morning. My name is Kathleen V.F. Nye. I rode in from Pennsylvania with friends and I have conflict of interest.
I know from experience that silicone-gel implants will adversely affect the lives of many people if they are approved based on just a few years of safety data. Not only are the women who are implanted at risk but, also, there is a trickle-down effect affecting the whole family.
Inamed says that their new and improved silicone breast implants are safe. I would like to relate my story of new and improved silicone breast implants. My first experience was in 1968. I was 22-years old and had a bilateral mastectomy. These new devices started to get hard in about six months. I also started having fatigue and joint pain and, in '76, I found a doctor who would remove them. The new ones also hardened and were removed in '81.
At this time, the doctor told me there was a new and improved version and they would not get hard. I had the new and improved inserted in '81. This new and improved silicone implant started to harden again in about six months. After three years of much pain, I went to a plastic surgeon and told him just to remove the implants. I did not want another set.
But, again, I was told about a new and improved silicone breast implant. Again, the new and improved implant started to get hard in about six months. I started to feel lumps around the edge of the implant. There were three masses. The cancer was sandwiched between two masses of foreign material with giant cells.
This started me on the road of more implant disasters. I had a total of 13 implants including devices made by McGhan, a company now called Inamed. In the early '90s, the implant came through the skin and popped out on its own. I have a photo that I included in my presentation.
I am sure you understand my concern when I heard the manufacturers are now trying to promote a new and improved silicone breast implant. Talk is cheap. It is easy to call an implant new and improved, but you won't know if it is really better until it has been inside a woman's body for five, ten or fifteen years.
I urge you not to be as naive as I was when I was told that they are better than the old ones. Please do not put these new and improved implants, silicone-gel implants, back on the market unless they have been tested for a long enough time to really prove they are safe.
MS. BUIKEMA: (Read by Kirstin Hoskison.) Hi. My name is Kirstin Hoskison and I am reading for Betty Buikema. "Every day has been a silicone day in my life for the last ten years. In 1993, I became a support-group leader with two other special women, Kay Dlugopolski and Peggy Pardo. We had the same thing in common, silicone breast implants. One was for reconstruction after cancer, one to keep from having cancer because of recurring cysts, and one for cosmetic reasons.
"We each became ill, have problems with the implants, had to have them removed and be reconstructed with our own tissue. Our medical records and history are similar to those we have heard over and over from so many women. Because we believed in the cause of fighting what happened to us, we began, at our own expense, to inform and educate ourselves and as many women as possible.
"We have had the opportunity to meet and talk to hundred, perhaps thousands, of women across America and the world. What we all had in common were silicone breast implants and the illness caused by them. That many women couldn't be a coincidence.
"When I heard that there are now three studies showing that women with breast implants are three times as likely to commit suicide compared to other women, I wasn't surprised. We knew women who have committed suicide, something I, myself, had considered when the pain was unbearable, when it doesn't seem like the pain will ever go away, and doesn't seem like you ever get better and, when you have mutilated breasts and you are broke, in addition to the pain, it can be hard to feel that life is worth living.
"The cost of having implants inserted is nothing compared to the cost of having them removed, not just in dollars but in health. This has cost me all of my savings for retirement. At a time when I should be enjoying life, all I can do is pay for pain-killing medications to survive. "My own story started when I was 40 and had a double mastectomy because of chronic cystic mastitis and reconstruction with silicone implants. I immediately had a hematoma. A year and a half later, I had a small tumor near my rib cage which was removed a few months later. By 1990, my left breast was deformed, probably due to rupture. My implants were removed in 1992, but I was diagnosed with Sjogren's syndrome and later with atypical connective-tissue disease.
"Are Inamed's current silicone breast implants substantially different from implants I had. Will they leak or rupture, cause contractures? Will some women be allergic to silicone? Can you guarantee they will be safe this time? Are women going to be guinea pigs again? You know that silicone implants leak as they age. Why would anybody think a two- or three-year study is long enough when everyone knows that most women's health problems don't begin until seven to ten years after they get implants.
"I am not here to tell you what to do. I am here to beg you to base your decision on whether you would want your 17- or 18-year-old daughter to get these poorly tested implants. Remember that if silicone-gel implants are approved, teenagers will be first to line up.
"Thank you for listening to the women, but listen with an open mind and be sure they are safe before restrictions are lifted. You owe this to the women who are depending on your judgment."
DR. GLICKSMAN: Distinguished panel members, I have no financial affiliation to any corporation. I have come to testify before you today as both a plastic and reconstructive surgeon and as a woman, wife and mother.
I began my experience with breast implants in the late 1980s where, at Memorial Sloan Kettering, I performed close to 350 breast reconstructions and augmentations using both saline and silicone implants. In 1992, I began using only saline implants for augmentation and reconstruction and was an investigator in the McGhan saline study for five years.
For seven years, I limited my patients to only saline implants while I, like my colleagues, followed the national and international studies on silicone and systemic illness. When, in 1998, the European nations declared silicone implants safe, I became an investigator in the FDA adjunct silicone study with Inamed.
To date, I have implanted 130 women with over 300 silicone implants. I have followed these patients for close to five years with no reported systemic illness and a capsular-contracture rate of less than 1 percent. You have before you the data, the science, but I would like to talk to you as a physician and a woman.
I, like many of my patients, am a 40-something-year-old mother of four small children. We have all heard the arguments of the National Organization of Women. Women should feel good about themselves. Women don't need to diet and exercise. Women don't need to feel attractive to men. Well, I'm sorry, but NOW does not represent me or the thousands of my patients whom I have treated over the last twelve years.
We know the early detection of breast cancer and mastectomy saves women's lives. If we are to encourage women to undergo such procedures, we must be able to provide them with an aesthetically natural, soft and comfortable breast reconstruction.
The majority of my patients seeking breast augmentation are in a similar position to myself, in their 30s and late 40s, have had several children and desire the fullness they have lost to pregnancies and breast feeding. They are not looking for the Baywatch look. They are well informed, educated, mature, American women who are seeking to restore their self esteem and improve their self image with a soft, comfortable breast implant.
If you, as a panel, carefully review the last ten years of rigorous epidemiologic peer-reviewed studies, you will see no proven connection between silicone and systemic illness. Therefore, the final decision as to which implant to use should be made between the well-informed patient and her physician.
No medical device can guarantee a lifetime of safety. Capsules, often tender and uncomfortable, form around neurostimulators, pacemakers and heart valves, and total joints do not last a lifetime. When I sit with my patients, we weigh the risks and benefits of any surgical procedure. Total joints may increase mobility and relieve pain and heart valves may prolong life, but both procedures carry considerable morbidity and mortality rates.
But what are the benefits of breast implants? Who determines that the benefits of breast implants are not valid? Is self esteem and improved quality of life only reserved for men on Viagra? Are we protecting women in America or denying them the free choice that women in the rest of the world already have.
I urge you to let the science of medicine speak, not emotions, hysteria, money or politics.
DR. WHALEN: Excuse me, Doctor. I don't believe you stated your name. If you could, please?
DR. GLICKSMAN: Dr. Caroline Glicksman.
DR. WHALEN: Thank you.
MS. GILBERT: Dr. Glicksman, I have a question. Can you tell me how you followed these patients?
DR. GLICKSMAN: I follow my patients at six-month intervals. I bring all my patients in, whether the study guidelines are at six months or a year or the three years and five years. I follow all my patients every six months. I bring all my patients back on an annual basis regardless of the study guidelines.
MS. GILBERT: Is this done through MRI or is it physical examination?
DR. GLICKSMAN: Physical examinations, mammography, annual mammography for those patients who are appropriate, unless there are problems, then ultrasounds and MRIs. But I have not had any problems that required those testings as of yet.
PROF. DUBLER: Dr. Whalen, since the panel is arranged so that we can't see who is talking, could you ask panel members to who ask questions to please state their names.
DR. WHALEN: And who were you? (Laughter)
DR. EDWARD MELMED: I am Edward Melmed. I have no financial payment made to me but my trip was supported by NOW. I am a board-certified general surgeon and plastic surgeon. I am board-certified in England, South Africa and the United States. I came to the United States in 1973 as assistant professor of plastic surgery at the Southwestern Medical School in Dallas and I am currently in private practice.
I did an enormous number of breast implants. I actually started in plastic surgery doing implants before there were implants. We used to use buttocks. I have seen the evolution of implants and I wrote extensively about it. In 1992, I changed and I started seeing women with problems. And now, when I counsel women and I want to tell you I have now done over 600 explantations, and if you include the miserable Pep implants, probably about 650 because every one of those ruptured.
When I meet with women I tell them there are three problems with implants. The first is they rupture. Now, when you see an implant that is three-years old and you take out an implant that is three-years old, you are going to see a perfectly good gel implant that is not sticky. It does not cause any problems. The likelihood of capsular formation is minimal.
When you get to four-and-a-half years, and these are implants that I have explanted fairly recently--when you get to four-and-a-half years--I beg your pardon. I don't do that quite as roughly when I explant. (Laughter) I will get to it eventually. I apologize--the implant is now starting to get sticky and if I wasn't wearing gloves, I'll have a residue on my hands. Implants are porous. They have silicone bleed from the Day 1. But when they get to four-and-a-half years, we started to get significant tackiness to implant.
A few months ago, I explanted a lady who I had implanted who had implants that I had put in seven years ago. What came out was the typical explanted mess. Now I have seen this hundreds of times and I am worried. I am very worried because we have an implantable surgical device. When I hear the last speaker make an analogy to a hip joint, a hip replacement, we are talking about a 70-year old who has got pain. We are talking about 17-year-old girls who are faced with a lifetime.
One of my colleagues in Dallas said, This is a matter of informed consent. I, he says, put the silicone implants into my own 17-year-old daughter. I have lots of comments I could make on that.
DR. WHALEN: Doctor, you need to conclude, please.
DR. MELMED: I was granted six minutes, sir, because of another speaker. So, my first question to you, as a physician in practice, is tell me what is an acceptable failure rate of an implant. We accept that hip implants break. That is one thing. But here we are talking about putting an implantable device into a young person, and I, in practice, would like you to guide me and tell me what you consider an acceptable failure rate.
We know it is upwards of 70 percent after a given time. And time is the factor that we are talking about in implants.
The second problem that implants have is they form tremendous scar tissue and, perhaps, it is relevant to show a specimen of what it looks like at 15 years--I am too efficient for the airport. I apologize again. This is a capsule that I took out after 15 years. This you could probably put on the soles of your shoes and wear for a while, it is so thick. It is full of silicone inside. This horrible tissue is in a human.
Now, if you extrapolate that you are going to put implants into 17-year-old girls, at the age of 35, you are going to have these problems. So my next question to you is what do you consider a time element at which you consider implants must be replaced. Surely, you are going to replace them or you are going to just say, you can have this inside of you; we don't care.
As my FDA, I want you to advise me what you consider a time element, first in terms of product safety and failure and, secondly, time in terms of scar contracture and its resultant problems.
The third issue I don't want to dwell on because you have heard about it, but when it comes to symptomatology, I see an enormous lot of women with problems. Undoubtedly, a lot of psychological overlay. Undoubtedly, there are a lot of who real disease. The truth probably lies somewhere in the middle. I think our legal profession probably muddied the water by going after established connective-tissue diseases. We know it is not that. The Institute of Medicine is 100 percent correct. This is not a problem that is classical.
DR. WHALEN: Doctor, conclude, please.
DR. MELMED: My last question for you is, then, if you are going to reintroduce this product, please tell me that it is safe. What do I tell me patients? Do you accept 1 percent, 2 percent? That is for 100,000 women.
I think you, sirs.
DR. WHALEN: Doctor, which of the other speakers yielded the time, just for our list?
DR. MELMED: I beg your pardon, sir?
DR. WHALEN: Can you just tell me which other speaker yielded to you for our list?
DR. MELMED: I don't even know. I was sponsored by the National Organization of Women and they said that somebody had given up their time for me to talk.
DR. WHALEN: Thank you.
DR. WOOLEY: Hi. I'm Dr. Wooley. I am also sponsored for travel arrangements by the National Organization of Women and I also have six minutes due to a donation from a breast-cancer survivor.
I am a professor of orthopedic surgery, immunology and biomedical engineering at Wayne State University. One of the studies that I am going to describe to you was sponsored by Lifomatrix*, the manufacturers of Trilucent.*
I am going to take the first minute to describe the findings of the scientific panel convened by the National Organization of Women in July of this year. This is a collection of scientists including those from the FDA, the NIH and academia.
We are not anti-manufacturer and we are not anti-implant. However, our review of the literature and recent findings including some not published reveal three concerns to this group. The first, as you have heard, is device failure. It appears that elastomer shells are still experiencing a high rate of failure with recent studies suggesting about 17 percent rate of detectable leaks within five years of implantation.
The second concern is local tissue reactions, capsular contracture, which you have just seen a sort of dramatic demonstration of, and tissue inflammation due to silicone exposure remain a viable concern.
The third issue which I am going to speak to scientifically is latency issues. The study suggests that long-term exposure to silicone may result in an increase in both immunological and autoimmune connective-tissue disease problems, albeit not classic. That had been implicated during short-term testing. However, the consideration of the two years of clinical data, it is the panel's opinion, is woefully inadequate.
I am going to move on to preclinical or animal testing and I would like to acknowledge the FDA for publishing, if not the whole technical report, summaries on their website. I would like to quote from Study 7. "While a significant increase in total spleen activity was observed in high-dose animals implanted with the shell test article, the increase appears to be related to a low response of the sham control animals."
I have heard far better explanations from recalcitrant graduate students trying to explain away data. This is a fairly reasonable explanation of what we believe is the adjuvant effect of silicone, something that the manufacturers are quite well aware of.
If the panel would like to look at the handout that I provided them, I am going to contrast two studies, the first of which was done about ten years ago and looked at the implantation of silicone within an experimental model of autoimmune arthritis.
Our finding in our first short-term was there were no adverse effects of silicone implantation of either the elastomer or gel on the incidence of this model Type-2 collagen-induced arthritis. There was no adverse influence of the elastomer or gel on the severity of the disease. However, immunological findings did reveal that a variety of proteins which had adhered to the elastomers were observed and autoantibodies unique to this type of implantation were detected. But I want to emphasize again, these autoimmune findings did not influence the disease. This is published in the leading journal of the American College of Rheumatology.
A follow-up study to look at long-term effects was quite different. Long-term silicone elastomer--by long-term in a mouse, I mean a year which is a considerable portion of a mouse's life-span--significantly increased the incidence of arthritis in the mice and long-term silicone elastomer implantation significantly increased the severity in the immunized mice.
So what I am afraid of is that the panel, by looking at only two-year data or short-term data is going to make the same misconclusion that we did with our initial look at short-term implantation and that long-term implantation must be considered. These autoantibodies that we see included anticollagen antibodies, particularly Type I. That is a protein that is inevitably going to bind to any elastomer.
What is the significance of animal findings? Well, extrapolation of animal findings to the human situation is controversial, but this is an essential part of drug and device development and it is the panel's responsibility, of course, to consider that.
The findings suggest that the implantation of silicone could exacerbate autoimmunity in susceptible individuals resulting in the development of autoimmune connective-tissue disease. We do, of course, predict that there are many other contributing factors particularly genetics which will influence the response to silicone in patients.
I would like to thank the panel for their time.
DR. WHALEN: Thank you. Before the next speaker, we apparently are going to take a brief unscheduled break of just five minutes. So, please, don't stray too far. Five minutes. A reminder to the panel, just talk about how the Red Sox are going to beat the Yankees today.
DR. WHALEN: We would like to resume. It may have been obvious to anybody who witnessed what just transpired, but, for future speakers, please, if anybody has any specimens that have potential as having biologic properties, please don't bring them to the podium or else we are going to be suspending activities once again. If we have to do that again, we may need to cut some speakers off and we certainly don't want to do that.
MS. GERTNER: Good morning. My name is Nancy Gertner. I want to thank the panel for hearing my testimony today regarding my experience with silicone implants. I am a retired attorney, a general surgeon's wife, and a five-year survivor of breast cancer. I am here representing myself. I have paid my own travel expenses to be here and I do not have any financial interest in Inamed or its competitors.
When cancer was found in my right breast in a routine mammogram in 1998, I elected to have a double mastectomy. My choice to have what I thought was a prophylactic mastectomy on my left breast proved to be a prudent one as the surgery revealed cancer was also present in that breast.
Before my surgery, I discussed various reconstruction options with my husband and my plastic surgeon. I knew I wanted to have immediate reconstruction following my mastectomy surgery and we discussed the options available including saline implants, silicone-gel implants and tram-flat reconstruction.
My plastic surgeon reviewed the benefits and potential complications of each procedure with me. He showed me both pictures and actual implant samples. We discussed the advantages, disadvantages and likelihood of problems or complications with each option and I chose silicone-gel-filled implants because I felt they offered the look and feel most like my own natural breast tissue.
I also knew other women who were satisfied with their silicone-gel-filled implants. I decided to have tissue expanders inserted at the time of the mastectomy surgery in November, 1998, with subsequent expansion. The silicone implants were inserted in February of 1999. I was immediately pleased and continue to be happy with the result. Because silicone implants were a viable option to me at the time I was diagnosed with cancer, I was much more able to cope with the loss of my breasts.
As a woman, it was also important for me to have a choice and be able to make an informed decision. While every woman is different, gel implants were the best alternative for me and I am grateful my doctor was able to present them to me as an option. I felt then, and continue to feel, that reconstruction with silicone implants provided me with the best possible aesthetic result with a reasonable post-op recovery time.
Having options and being explained my choices made me feel empowered as a woman and made me feel like I was not doomed to a single situation. I am happy with my reconstruction. I think it looks and feels beautiful and I have never experienced any personal or professional limitations as a result of my implants.
I am frequently asked and glad to show other women my reconstruction and describe my experiences hoping to allay their fears when they, too, are diagnosed with breast cancer. I feel this because I was given many reconstruction options including gel implants. Breast cancer ended up being a small problem in my life rather than a big one that my body would have been a constant reminder of.
I sincerely appreciate your time and appreciate the opportunity to share my experience. Thank you.
DR. GOLDBERG: I am Eugene Goldberg. I am a professor at the University of Florida. I am going to try to provide some scientific information pertinent to this discussion. I have no financial interest. I have paid my own way here. I have worked in the past as a consulting expert in litigation on behalf of both defendants and, as well as defendants, plaintiffs. I want you to understand that clearly.
I have some charts up there which about a half a mile down there you are not likely to see. But they are in a handout so that may help.
My concern for this discussion will be--and if my voice breaks up, it is not because of puberty, it is because of bronchitis. So please forgive me. My concern is with the risk/benefit issues and, listed here, are some of the safety risks that are associated and are well known from fibrous capsule contracture, pain, disfigurement and I am going to refer primarily to the question of shell failure and additional surgeries because that is really the substance of much of what we have done research on at Florida.
I should mention parenthetically that several of the papers that we have published in Applied Biomaterials and in the Annals of Plastic Surgery are not discussed in your PMA nor is our failure analysis discussed in the PMA. The 1992 moratorium on silicone-gel breast implants was imposed due to inadequate safety data. The question is, do you have more safety data now in a relatively short two- to three-year period of evaluation, than you had at that time.
Sound engineering-design criteria for gel implants and the mechanical and biochemical properties have not been available and no peer-reviewed large cohort prospective or retrospective clinical studies have been reported by manufacturers today, even though gel implants have been on the market for 40-ish years.
The only peer-reviewed large cohort failure and safety analysis paper to date is from our laboratory and not discussed in the PMA. This analysis shows a statistically significant result for almost 10,000 explanted devices from 42 separate studies. Some people have considered, in the literature and in private discussion, that this may be a biased study. If it is biased, it is biased in favor of having a large, the largest, cohort available from 42 studies and, therefore, represents a very wide range of different implants from different time periods, all of them gel implants, for which we have significant data in the literature.
The results of that study can be represented qualitatively by some of the things you have just heard from Dr. Melmed where I show some examples from our laboratory examinations ranging from six-and-a-half years which are intact to 13-and-a-half years which is obliterated, literally, hardly there anymore.
The high prevalence of shell rupture and the frequency of additional surgeries is something that we have tried to emphasize beginning around 1995, first in a letter to the New England Journal and subsequently in considerable research in our laboratory. We observed, as you will see on the failure analysis curve that goes up next, a shell failure prevalence at five years of 30 percent, at ten years, 50 percent and 70 percent at about 17 years.
This explant meta-analysis, not discussed in the PMA, substantially is confirmed by a noninvasive MRI study that has been provided to you by Dr. Brown and coworkers and essentially indicates that this curve is a reasonable representation of even what has been termed silent ruptures.
If you look at two years, at the beginning of that curve, you find that it is extremely difficult to make any sense, whatsoever, out of rupture rates and reoperations. Our data from this study indicate that the reoperative frequency is of the order of one woman in three within six years and sometimes as many as two or three or four surgeries within the time frame.
Two other points, quickly, I would like to make. One is that this is a new shell. This is not the old dimethylsiloxane shell. It is a phenyl shell and the phenylsiloxanes are associated with carcinogenic behavior as indicated in the PMA and there is also indicated the PMA a higher prevalence of both pulmonary and brain cancer which has been glossed over.
DR. WHALEN: Dr. Goldberg, you need to conclude, please, sir.
DR. GOLDBERG: I will conclude. To conclude, therefore, it seems to us that there is a need for much more scientific information before this new implant should be approved.
DR. WHALEN: As the next speaker is coming up, just for planning purposes of the speakers who are representing societies, it looks like we will probably be having some of you going after lunch. We will breaking for lunch at 12:30 for 45 minutes. If there is anyone towards the tail-end of the society speakers to whom that would impose difficulty, if AnneMarie Williams would raise your hand--you probably already know her if you are speaking, in the back of the room--please see her now so that some juggling of the speakers can be done.
MS. TAPSCOTT: My name is Mindy Tapscott. I am 42-years old and I am a bilateral breast-cancer survivor. I would like to thank the panel for taking into consideration my experience with silicone breast implants. I also want it to be known that I am receiving no compensation from any group in any shape for form for my testimony.
I was first diagnosed with breast cancer in 1989 and I knew I would be seeking reconstruction of my left breast following mastectomy surgery. After discussions with my surgeon, I elected to have reconstruction with a silicone gel-filled breast implant. I felt this option looked more natural than the other reconstruction options that were available to me.
My surgeon provided and asked me to review and consider the insert that the manufacturer included with each implant. In addition, she reviewed with me the potential complications associated with silicone implants including capsular contracture and rupture. She informed me that some women are more prone to complications than others and that should could not reproduce what God gave me. I, nonetheless, felt comfortable with my decision.
At my initial post-surgical follow-up visit, my surgeon advised me that massaging my breasts would help reduce the risk of capsular contracture but, I must confess, I did not follow through with that recommendation and, after about one year of my first implant surgery, I experienced significant capsular contracture in my left breast.
I decided not to do anything about the encapsulation until ten years later, in 1999, when my implant was replaced. I requested that it be replaced due to the increased size of my right breast resulting from two pregnancies. After the procedure, my plastic surgeon specifically told me that the first implant was intact.
One year later, the new implant also became encapsulated and, in the same year, I received a diagnosis of breast cancer in my right breast. Despite the complications I had experienced with my first implant, I also elected to have a silicone-gel-filled implant inserted after my second mastectomy.
This, too, became encapsulated shortly thereafter. In January of this year, I decided to have both implants replaced once again. The latest procedure produced a terrific outcome and I have had no trouble at all since that time. Despite my history with local complications and the number of reoperations I have had, I still consider silicone breast implants the option of choice for me following my breast cancer.
When you are diagnosed with breast cancer, you feel a loss of control because you don't know what you did to get the disease. Having choices made me feel like I got some control back. The many operations I have had do not bother me one bit. It was all worth it. Silicone implants have simplified my life. I am a mother of three small children and I can barely remember my purse when I leave the house, let alone my breast prosthesis.
I don't have to worry if my breast is in before I answer to door or if my daughter has a friend sleep over. I never have to worry about my prosthesis falling out or coming out of position. The silicone-gel implants look and feel most like me and allow me to get on with the business of living.
I am a carrier of the Bracca 1 mutated gene. The odds are great that I have passed this gene on to at least one of three of my daughters and I would want them to have the same choices.
I thank you for your time today.
MS. GANDY: Good morning. I am not Marlene Keeling. I just traded places with her. My name is Kim Gandy. I am President of the National Organization for Women.
The National Organization for Women is the oldest and largest feminist activist organization in the United States advocating not only for women's equal rights, their economic and social well being but, also, for women's health. The National Organization for Women and myself represent only our own 501-C4 nonprofit corporation and no other party. My appearance today is underwritten by our 500,000 contributing members across the country.
We have also asked three researchers and clinicians who participated in our May 8 symposium and our July 21 press conference to present testimony at this hearing as well.
Thank you for the opportunity to present NOW's comments today on this very important issue. With hundreds of thousands of women from high school to retirees seeking breast implants each year and the number continuing to increase, a dangerous product will affect the health and safety of enormous numbers of women, individual women as well as their families.
When a substantial number of these women fall ill, and depend on government healthcare systems for their medical care, the safety of their breast implants, a question you must determine here, will have become an important public-health question.
But it is a personal health question for hundreds of thousands of women who need complete information in order to make informed choices about their medical care. Our organization has been contacted over the years by many women with silicone breast implants who are suffering from serious illnesses and disease that they associate with those implants.
Their stories are heartbreaking. Many report having lost not only their good health but their husbands and partners, their jobs and even their life savings. We have also heard cases of suicide by these women, some of them mastectomy patients who became even more ill from their breast implants than they did from breast cancer.
These women have reported a wide range of symptoms similar to fibromyalgia and lupus all the way to rheumatoid arthritis and other serious conditions. Most of them cannot afford the $10,000 to $15,000 and more that it costs to have their implants removed and they don't know where to turn for relief of their pain and uncertainty.
Informed by the personal stories of these survivors, the assembled membership of NOW at two national conferences have adopted resolutions urging both independent research and long-term following of implant patients in addition to fully informed consent for all prospective patients.
This spring, on learning that the FDA had been asked to consider returning silicone-gel-filled implants to the broad market, NOW sponsored a symposium on May 8 inviting more than a dozen researchers and government health officials from the Armed Services, from the National Institutes of Health, from the FDA and from private research institutes and universities to review their own findings and their own research with regard to the effect of silicone gel in the human body. Of course, you have heard already from some of those participants and will hear from more.
We did this out of a conviction that government reliance on industry-supplied data, when special interests are involved, may have a result that is good for the industry but bad for the consumer. In reaching out to potential participants, we also learned that breast-implant manufacturers and plastic surgeons have made researchers and medical writers feel intimidated by spending great sums of money in persuasive campaigns to mislead breast-cancer-patient advocacy groups and the public regarding breast-implant safety.
Women deserve the truth. They deserve to trust that what this agency tells them is a safe product to put in their bodies is, in fact, a safe product. When the information they are given is based on flawed or biased research, the result can be tragic.
We know the breast implants leak and rupture and disintegrate in the body over time. We know that this causes a variety of problems, not the least of which is the promotion of systemic connective-tissue disease. I will refer you there to the research report which I have brought many copies of but particularly the research by Miller and O'Hanlon of the National Institute of Environmental Health, part of the National Institutes of Health, the Environmental Autoimmunity Group which drew direct connections between silicone gel and systemic connective-tissue disease over the long term.
Our symposium of researchers and clinicians have made numerous recommendations for future research and for improving the FDA's review process. These are included in the summary document which I would like to append to my comments for your review.
If these preliminary findings do, indeed, lead to more conclusive assessments about silicone gel and immune-system pathologies, then we believe it will be clear that silicone-gel implants are not safe over the long term.
DR. WHALEN: Can you conclude, please, ma'am?
MS. GANDY: Yes--that if it is in the interest of this industry to develop and promote a safe silicone-gel-filled implant that they would have done so by now. It is clearly not in their interest to do that. The only thing we believe that will result in a truly safe implant for women to choose is if the FDA requires that it be safe.
If you permit them to continue to market unsafe implants to women, then they will have no motivation to make a safe implant for ourselves and our daughters.
DR. ANDERSON: Dr. Whalen, may I ask the speaker a question?
DR. WHALEN: Yes.
DR. ANDERSON: Ma'am, you spoke of the symposium on May 8. When NOW put this together--we are hearing two different viewpoints. Was NOW trying to present a discussion that included both sides or was the purpose of this to collect data that supported the view that implants are unsafe?
MS. GANDY: We were trying to find out what was going on because we were getting very mixed messages. We heard from groups of survivors, groups that represent survivors, that they were told by doctors that these were safe and that there was no problem and that we would be doing a disservice to women by not allowing them.
Then we had heard from so many groups of survivors and individual survivors that had terrible, terrible problems. The Co-Chair of our National Advisory Committee is a medical doctor and the dean of a medical school. And we knew that there was some unclarity over the long-term impact. So we thought it was important to reach out to people who were actually doing the work, who actually were doing the studies, themselves, who were looking at the women and who were engaged in the scientific part of it as opposed to the advocacy part of it.
DR. ANDERSON: Did you have speakers that advocated for implants as well as speakers that had had these bad experiences?
MS. GANDY: The speakers didn't advocate one way or the other. There actually was not a single speaker that advocated for or against the implants. That was a conclusion that was drawn from all of the research. What they did say was, and you will see the conclusions there--they found that there were severe painful and debilitating local complications from the breast implants, capsular contracture, the kinds of things that you already know, that there was a very high failure rate and that, over twenty years or so, it approached 100 percent and that there was substantial indication over a variety of the reports of the silicone gel, in particular, leaking into the human body had potential long-term consequences.
They approached this from a variety of different directions, not making--you are accustomed to dealing with doctors and researchers more than I, but what they did was they said, here are my findings and I have concluded that this seems to do this and we need to look at a longer sample, we need more information. That was the primary message that came from every doctor, from every researcher that testified, was this bit of information that we have leads me to think that there is a real problem here. But we don't really know until we have this much information.
Every one of those doctors came to the same conclusion. As a result, we came to that conclusion, that this body should not be making any decisions on silicone gel until we had this much information and not this much information.
DR. ANDERSON: Thank you.
MS. GANDY: Thank you.
MS. WARD: Good afternoon. My name is Mary Ann Ward and I am from Coco Beach, Florida. I am here representing myself and I have paid my own travel expenses to be here, have no financial interest in the manufacturers or its competitors.
I appreciate the opportunity to speak with you today about my experiences as a breast-augmentation patient with silicone-gel-filled implants. I made a decision in 1978, when I was 29-years old, to have breast-augmentation surgery. I always knew my implants would need to be replaced at some point. My plastic surgeon was completely clear with me regarding that.
Last year, that time came. The decision to have the implants replaced was solely my own. I was not suffering from any complications. I was not suffering from any disease or condition. I just thought, after 24 years, I should have them replaced.
After making the decision to have my implants replaced and have additional surgery, I consulted an experienced board-certified plastic surgeon and we reviewed different options including the type of implants available, the advantages and disadvantages of each option and I received a significant amount of medical information that I was able to apply in examining not only my health issues but my particular lifestyle and personal expectations.
I am very proactive regarding my health as I believe most American women are, and I did research on my own. The two studies which were particularly helpful to me were the Mayo Clinic Study which was published in the New England Journal of Medicine in 1994 and the Nurses Health Study of 1995. Both studies found no association between breast implants and systemic diseases.
My physician encouraged me in my personal education and discussed with me every piece of research I found. For me, having options was critically important not only from a health perspective but the implants needed to fit my lifestyle. You see, I am a 54-year-old woman who races sailboats competitively in the national and world arena. I race in bathing suits. I have to pull lines. I must be strong.
It was important to me that my strength and ability to continue my sport would not be compromised. While there are no guarantees in life, my physician made sure that my education on the issues was thorough and that I was making a well-informed decision.
Since my surgery, my physician has stayed close in contact with me requesting feedback on both process and results. I have been thrilled with the look and feel of my breasts. The gel implants have allowed me to have a natural appearance for a woman of my age while not interfering negatively or impacting my lifestyle. I continue to race sailboats. I work out. I play with my grandchildren and I do much more.
I believe all women should have the choice I had. Given the science and research today, it is illogical to me that silicone implants are only available to women for reconstruction surgery. You have heard many compelling stories today, many of them very sad. My story is no less compelling because it is a happy one.
Thank you for your time.
DR. CHOTI: May I ask a question?
DR. WHALEN: Sure.
DR. CHOTI: What was your thought process or thinking as to why, after 24 years without a problem, you would get them replaced? Why not at ten? Why not at 15?
MS. WARD: I actually was having no problems whatsoever. So I think I just kept putting it off. Finally, I had changed--at the time that the tests were done regarding hormone-replacement therapy, because I had been through menopause and I am on hormone-replacement therapy, when all of that came up and I started having in-depth discussions with my doctor about that, I actually changed doctors at that time.
The new doctor that I went to said, you know, Mary Ann, it has been 24 years. You should have this looked at more thoroughly than your normal breast exams, than, you know, your annual mammograms, than examining yourself. It has just been that long. I think you ought to have somebody take a look at them. So I did.
DR. CHOTI: But, at 15 years, you had the same thinking and decided, at that point, no need to replace them?
MS. WARD: I really didn't. As I said, I am very proactive about my health so I was attentive to my breasts, most assuredly. But only really when I changed doctors and it was a new--my new general physician said, I think you ought to at least go see a plastic surgeon and talk to him about it.
When I saw my plastic surgeon, she was quite honest with me and said, you know, we see no real reason to replace them unless you just want to, which I made that decision because, when I had them put in in the first place, they said, these will not last you forever, Mary Ann.
DR. CHOTI: And when they were removed, there were no leaks or ruptures?
MS. WARD: They were fine. I was fine. I continue to be fine. Thank you.
DR. WHALEN: A reminder to panel members of Dr. Dubler's appropriate request that we start off questions identifying ourselves.
MS. KEELING: My name is Marlene Keeling. I paid my own way here and I have no conflicts of interest.
I chose to get double-lumen breast implants in 1978 after my plastic surgeon assured me only 2 percent of his patients ever had problems and he could fix anything that happened.
My health problems did not start until about seven years after my surgery. I developed weakness, fatigue, periodic swollen lymph nodes in my neck, depression, memory loss, peripheral and demyelating neuropathy. Since removing my implants, my ruptured implants, in 1994, all of my symptoms have slowly improved. However, the last time I had my natural killer cells counted, they were low. This is consistent with a finding of the Institute of Medicine report that states, "Consistent with animal toxicology studies, it appears that natural killer cells might be affected by exposure to silicone gel."
Inamed data has revealed the loss of natural killer activity in their immunotoxicity research. How can this panel approve a device for breast-cancer survivors that compromises the immune system by lowering natural killer cells which are the cornerstone of the immune system, are responsible for controlling tumor-cell growth and are involved in control of infection?
In networking with other silicone-implanted women, I realize that many were being diagnosed with chronic inflammatory demyelating polyneuropathy and had memory problems or depression. In 1996, I became a founding director of Chemically Associated Neurological Disorders which is dedicated to information and research.
German research by Flasseck et al., published 2003, found higher platinum levels in the fat tissue of breast-implanted patients when compared to control patients without implants. The same researchers report the data of this work clearly show that the use of elemental silicon as an indicator of migration from breast implants to the surrounding tissue is not appropriate.
This becomes important because the Dow-funded Semple, et al., study on breast milk from implanted women used the inappropriate measurement of elemental silicon in an attempt to imply that breast feeding by implanted mothers is safe. In an e-mail, I asked the German researchers, could you comment on whether you believe that elemental silicon is an appropriate measurement for breast milk from implanted women to determine safety. Their response was, of course not.
How can this panel vote to approve devices for augmentation and revision of young women of childbearing age without a properly designed breast-milk study for safety of children born after implantation.
I have one final point. Two years ago, McGhan Medical, now Inamed, filed a patent which makes the statement, "Silicone oil is not biocompatible with other human tissues. Therefore, the use of silicone-based filler material has been discontinued in the industry."
How can this panel approve a device that harms human tissue, leaks silicone and heavy metals through the shell, ruptures at an underascertained rate, and the rupture may be silent. There is no way to remove all of the toxic and hypersensitizing chemicals once they leak into the tissues.
Women with breast implants have not had informed consent. I say, loud and clear, you are the scientists in charge who must stop this experimentation on women and our future generations and must say no to corporate greed. I don't have a Ph.D. in suicide risk, but I can tell you, in networking with thousands of breast-implanted women, many do not have the money to have their ruptured and leaking implants removed.
Many have constant pain. Many have declining health. Many have lost their health insurance or have been denied coverage. Many have children born after implantation with similar health problems and suffer guilt. Many are now no longer able to take care of their families and do not want to be a burden.
MS. FERELLI: Hello. My name is Vanessa Rose Ferelli. I have not been given any financial assistance from anyone related to this testimony.
I am 29-years old and I was implanted on August 7, 2000, as part of a study from Port Jefferson in New York. I was misled about the truth of what the study really was about when I received the implants and I have been informed now that I wasn't even eligible to receive the implants at the time.
Over the year and a half that I had the silicone implants, I was hospitalized many times. I was examined by a cardiologist, rheumatologist, my gynecologist and not once did anyone ever tell me that I could be sick or having some kind of a reaction to my implants.
I experienced abnormally heavy periods that lasted several months at a time, fatigue so bad that I slept 16 or more hours a day, numbness and pain in my arms and my hands. I couldn't even hold a glass in the morning. I also had severe breathing problems. I lost my hair--facial sores and a lot more.
On December 1, I called my plastic surgeon from the hospital--I was in the heart hospital having heart problems--and asked them again, was there any possible way that this could be related to my implants. And he told me absolutely not.
Finally, I met with a rheumatologist in New York that told me the truth about what was going on and he suggested I remove the implants as soon as possible. He said I was having something similar to an allergic reaction to them.
On May 5, my implants were removed and they were sent to Inamed. The right one was totally ruptured and the report showed granulomous inflammation from the specimen sent to the lab. I didn't get a letter back from Inamed who received the implants right away until October 11. I didn't feel that they were really concerned about what had happened or studying anything since now I found out I was part of a study.
Immediately after the implants were removed, I felt much better but I was still having breathing problems that were severe. I ended up going to another plastic surgeon who removed all my natural breast tissue, the surrounding tissue that was contaminated and that also had silicone in it.
It has been about two-and-a-half years since this has gone on and I am much better now. I haven't had any of those symptoms again. The tachycardia and problems with my heart and the breathing problems are all pretty much gone. I still have some minor symptoms but nothing like what was going on before and it cost me about $45,000 for the surgeries, the ordeal after the fact between the scans of my chest that never showed or revealed any kind of a rupture and I feel that I am lucky now to be okay, but I couldn't have imagined what would have happened if I didn't have the financial means to be able to take care of having them removed because a lot of things weren't covered under my insurance.
I just ask that you please make sure that the implants are safe before they are approved. That's it. Thank you.
MS. GILBERT: Ms. Ferelli, my name is Alisa Gilbert. I just have a question for you. You said you were part of a study. Did the study cover any of your expense when you had to go get the implants removed?
MS. FERELLI: The only thing that they offered to me--I called them when I talked to the rheumatologist and realized why I was sick. And I called them right away because I wanted a list of maybe chemicals that were now in my body, possibly. I was nervous about that.
And they said that they would send me some information. All they sent me was a packet and a claim form and they said I could get my money back for the implants which I think were, like, $1500. That's it. But as far as money--and my insurance company wouldn't cover--even if I wanted to go see if there was a rupture to get the--I think it is a C-scan or something when you go to scan. Do you know what I am talking about? I'm sorry,
MS. GILBERT: An MRI? Are you talking about an MRI?
MS. FERELLI: Yeah, something like an MRI but there is a special one that supposedly they could really tell to see if there was a rupture and they had me going into all of these different types of scans, but nothing revealed any kind of a rupture. But I had a lot of pain on my right side and burning. And I kept complaining about the right side and the burning.
Then we didn't know until they removed it that the right one was totally ruptured. Thank you.
PROF. DUBLER: Dr. Whalen, question. Could you come back to the podium for one minute.
MS. FERELLI: Oh, I'm sorry.
PROF. DUBLER: I am Nancy Dubler.
MS. FERELLI: Hi.
PROF. DUBLER: Before your first implant, in your discussions with the surgeon, what did he--he did not tell you it was a research protocol, involving a research protocol?
MS. FERELLI: Actually, I went to two different plastic surgeons because I had saline implants first and they were ten-years old. And I wanted to have them changed because I was told that, in ten years, you should. Both of the doctors said to me that they just brought the silicone implants back on the market, that they did all these studies and tests and they have proven that they are 100 percent safe and that all the stories that you heard of people getting sick wasn't true. So I believed the doctors.
PROF. DUBLER: You never signed a document that was labeled "informed consent?"
MS. FERELLI: What I got--
PROF. DUBLER: What did you sign before your first surgery?
MS. FERELLI: What I got from the--which I found out now, all of my records and stuff, what I signed was one general release that I read that talked about anesthesia and stuff and another one, one page, that just said--when they told me that they brought them back on the market, he said that I just have to promise to show up for several visits so that they can document and study my progress because they just brought them back on the market. So I said, okay.
They never told me that you could get sick from them. If I did, I would have known a year and a half before--when I had symptoms, I would have first realized that I could be having a reaction, but I went a year and a half of having these symptoms and nobody told me, not only the plastic surgeon that put them in. I was at St. Francis Heart Hospital in New York. I was at many different hospitals and I saw top doctors, cardiologists and nobody ever said that it could possibly be from that.
Now that I know what happened to me, I have gotten--
PROF. DUBLER: Just a brief follow-up question. So the only research element you were aware of was your obligation to return--
MS. FERELLI: Right.
PROF. DUBLER: --for examinations following the implant.
MS. FERELLI: Absolutely. That is why I called him from the hospital on December 1 to tell him that I couldn't make my appointment, because I had promised him I would be there. On the phone, he told me that this could have nothing to do with that and I have given documentation, and he also wrote up a letter and sent that to the study that said that I called from the hospital, I asked them if any of this could have anything to do with the implants, and he said, absolutely not.
So he has even put in writing on two different occasions that absolutely no way could this have anything to do with the implants. So I believed him.
PROF. DUBLER: Thank you.
MS. FERELLI: Thank you.
MS. WASSERMAN: My name is Connie Wasserman. I am a New York certified social worker. I am here on behalf of my niece, Vanessa Rose Ferelli, who I will refer to as Rose. I am not receiving any financial reimbursement of any kind for my testimony here today.
My niece has been experiencing ill health since the end of 2000. She was experiencing heavy menstrual bleeding that left her body anemic and exhausted. Her gynecologist placed her on the pill hoping to regulate her cycle. She developed other symptoms such as hoarseness in her voice, paleness in her color, difficulty breathing and a chemical taste in her mouth.
She would have episodes of passing out and was becoming progressively worse. I honestly did not know what to think. Doctors were attributing all these symptoms to extreme stress from the loss of her brother. I will never forget the terror in Rose's voice when she called me at 4:00 a.m. to tell me that she had figured out what her problem was. She was having a reaction to her breast implants.
Was this all stress related? Something in her voice convinced me that this was real and she was very sick. I immediately contacted my physician for help when he told me that there was no evidence that linked breast implants with disease or illness. This was the same statement that we had heard from each of the other doctors.
I indicated to him that I had heard this disclaimer from the other physicians, however, I wanted to know what he would do if this were his daughter. He then referred us to a prominent plastic surgeon who suggested removal.
The doctor took X-rays and examined my niece. The X-rays did not show any leakage. The doctor blamed her chest pain and burning on the size of the implants and then recommended they be removed. He explained the details of the surgery with us indicating that there was a strong possibility she would not feel any better after the implants were removed.
I counseled my niece by helping her to make a well-thought decision and not one in haste. I was concerned that if the implants were removed and she continued to feel sick, she might become depressed because of the scarring that could occur. She was adamant that, after being so sick for so long, she just wanted the implants removed and she did not care how she looked.
Unlike many young women, Rose could afford to pay the doctor to remove the implants. Surgery proved what the X-rays did not show. One of the implants had ruptured. After the surgery, Rose began the slow road to recovery. Today, she is experiencing better health and more energy as well as elevated mood in spite of everything she has gone through.
She is just grateful to be alive and feeling better. When I asked my niece what made her decide to get implants in the beginning, she told me that she was self conscious about her body and the doctor told her it was completely safe. My niece, along with many women who get breast implants, believe their doctors.
In order to remove the implants, doctors had to carve out the scar tissue that formed around them. Many argue that it is important for some women who have poor body image and low self esteem. I cried when I saw the scarring that she was left with after the implants were removed.
What about body image and self esteem now? Please, don't let this happen to other women. Please make sure breast implants are completely safe before they are approved.
DR. WOLFE: I am Dr. Sidney Wolfe. I do not get any money from Inamed, McGhan or any of the other companies and I drove out in my car today.
Both the FDA approval standard for medical devices, "reasonable assurance of safety," and the validity of informed consent, informed choice, are legitimate only if studies are long enough in duration and comprehensive enough to answer existing questions about safety.
Instead of reasonable assurance of safety, there is now, more accurately, reasonable assurance of ignorance and, therefore, reasonable concern about safety. If the decision is to approve now, women will not get the information they need for truly informed consent before deciding whether to undergo silicone-gel breast-implant surgery.
It is ironic that the clear evidence of certain danger such as local and regional complications, often from rupture, and remaining questions about other risks that led to the more-than-eleven-year-old moratorium on silicone-gel breast implantation, except for post-mastectomy patients, were based on much longer exposures of those women than now exists for the implants being seriously considered.
Despite these deficiencies in the duration of the data being considered by the FDA, only the first three years of a planned ten-year study, there are many red-flag warning signals within the thousands of pages of documents put up on the Internet last week, more than enough to justify a decision to wait at least five more years to collect more information on the thousands of women who already have had implants rather than precipitously approving these unsafe devices for marketing to hundreds of thousands of women a year who will, once they are told by the government that devices have "reasonable assurance of safety," opt for the surgery to insert them and, thereby, participate in a massive experiment.
I think Dr. Krause gave you copies of my testimony because there are some charts which I just want to go through briefly. The first chart shows that the complication rates for the three-year data in the 1990 Inamed study and the current core study are quite similar examining only the data on those implants in 1990 which Inamed is now seeking approval for. For example, for reoperation, it was 19.9 percent in the three-year 1990 and it is 20.6 percent in the three-year core.
The next chart, though, shows the data from three years with that of five years in the 1990 study and shows the striking increase in the risk of various complications occurring just in the two years between Years 3 and 5. For example, the risk of removal/replacement increased from 6.3 percent to 11.5 percent in two years, capsular contracture went from 9.5 to 14.9 percent. The cumulative risk of breast pain which wasn't provided at three years in these data was already 25.8 percent and loss of nipple sensation was 17.2 percent at five years.
Since the five-year follow up in the 1990 study was not as great as it could have been, it is not unreasonable to hypothesize that, in the current core study, when--not if; when--the five-year data are collected prior to approval, hopefully, the risks will be as high or even higher than those found in the 1990 study.
If you flip, now, to the third page, there are just four charts here that show, within the 1990 study, the effect of time on the increased risk of various complications, and this is in the face of having lost a number of people to follow up by the fifth year in that 1990 study. Breast pain goes from 14 percent at one year to 25.8 percent at five years, loss of nipple sensation from 11.8 percent to 17.2 percent, asymmetrical breasts increased from 5.9 percent in one year to 15.3 percent at five years and the effect of the implant duration on whether the implant is actually palpable or visible, sort of contrary to the idea of a cosmetic operation, goes from 12.5 percent to 23.3 percent at five years.
Moving on to the next two charts, these are derived from the unpublished data from the SEER study funded by Inamed and Mentor using the NCI, National Cancer Institute, surveillance data. The most striking finding is that the Kaplan-Meier risk of implant removal--this is projecting out on what you know, what is likely to happen--was 21 percent at five years risk of removal in these women who had had post-mastectomy implants.
But it has risen to 50.5 percent by ten years, more than doubling for those women with breast cancer who had a silicone-gel breast implant. In other words, by ten years, more than half of the women had their implants removed. This compares to 40.7 percent of those women getting saline implants. This is the only population-based study that we have on this topic with the advantages of better ascertainment to examine the problem of implant removal. It is noteworthy that, of the 6,563 women with breast cancer in the geographic areas covered by the study, which are Iowa and Seattle, only 1, 159, or 17.7 percent of all those women had implants. The rest chose, I believe wisely, in most cases if not all, not to.
There are in the study details for 1,012 of these; in other words, we have 87 percent ascertainment excellent follow up, much better than any of these studies. What it shows is, as I mentioned, it rises from 21 percent at five years, 27.4 percent at seven and 50.5 percent at ten years. I mentioned that rate was relatively, 20 percent, lower in the women getting saline implants.
In addition to the primary deficiency of only having three years of data in the ten-year core study, according to the FDA, "in the reconstruction study, only 59 percent of patients have reached the three-year follow-up visit. Worse, the follow up in the adjunct reconstruction group was only 53 percent at one year and 27 percent follow up at three years.
Other problems noted by FDA reviewers were that, in addition to 92 protocol violations in the core study, many involving a lack of informed consent as Vanessa Ferelli just mentioned, the adjunct study had even more egregious violations including 211 patients in whom informed consent was not obtained before surgery, 86 patients implanted in a facility without ethical review-board approval, and 25 patients implanted by non-authorized investigators.
According to another FDA medical officer who I think will present data this afternoon, Dr. Dawisha was very concerned about the lack of ascertainment of asymptomatic rupture since only a small fraction of these core patients had MRIs to detect rupture. This is particularly of concern because the FDA's own study, Dr. Brown's study, which she will talk about, based on 344 randomly chosen women who had had silicone-gel breast implants, found that 68 percent of the women had at least one ruptured implant using MRI. The median age of implant rupture was 10.8 years; in other words, half of them had ruptures after 10.8 year. 21 percent had silicone gel outside the capsule in at least one breast.
Despite the concern about implant rupture and spread of silicone around the body, FDA stated that, "Inamed provided no discussion of the significance of implant rupture," which includes published cases of lymph nodes, abdomen, groin and so forth.
The final irony can be found in the section entitled Preclinical Shelf Life in one of the FDA documents. The document states, "Based on all shelf-life data provided, Inamed supported a 2.5-year expiration date on their package label. The tests included gel cohesion--obviously if it migrates to the body, the gel isn't terribly cohesive--shell ultimate break force, shell tensile set and shell elongation. That is from the FDA document.
Even though so many women are led to believe these implants will last at least ten years if not a lifetime, this 2.5-year "expiration date" is a further insult.
The apparent unwillingness of the FDA to require silicone breast-implant manufacturers to provide longer-term data as a prerequisite to approval raises serious questions about whether the agency is enforcing the 1976 Medical Device Law to protect patients.
The major precipitating event leading to the passage of that law was the disaster concerning the Dalkon Shield intrauterine device. Seventeen women died and thousands of women were rendered sterile because of the increased uterine infections caused by this device.
Requiring adequate preapproval testing for permanently implantable devices such as breast implants was a major principle underlying the passage of the 1976 law. The agency appears poised to negate this principle as they consider the approval of breast implants.
This year marks Sybil Goldrich, who generously gave me some of her time, twentieth anniversary since her battle with breast cancer. But that was only the beginning of her fight on behalf of women. After undergoing a bilateral mastectomy in 1983, she received breast implants. She, over the next couple of years, underwent seven operations, two mastectomies.
During this time, she experienced excessive pain, capsular contracture, migration of gel to her uterus, ovary and liver, extrusion necrosis and rupture. Finally, she chose to have a tram-flap procedure. In 1998, Sybil cofounded Command Trust Network. I met her fifteen years ago when we originally got involved in silicone-gel breast implants, a national clearing house dedicated to providing thorough and unbiased information about breast implants.
Since then, she has worked tirelessly to ensure government and corporate accountability with regard to breast implants. Her goal is to ensure a safe implant is available to all women. She does not think that the short-term data submitted for FDA approval begins to approach such a goal.
Thank you. With three seconds to go.
DR. WHALEN: Are there any panel questions of Dr. Wolfe? Seeing none, I would like to thank everyone who has testified this morning. We are going to break for lunch and resume activities precisely at 1:20 p.m. when other society testimony will be heard.
[Whereupon, at 12:35 p.m., the proceedings were recessed to be resumed at 1:20 p.m.]
A F T E R N O O N P R O C E E D I N G S
DR. WHALEN: We are approximately 40 to 45 minute behind. I would urge everyone to try to keep within the time constraints as have been promulgated. As soon as the first speaker can come to the podium or is allowed to get at the podium, please feel free to begin.
MS. NORSIGIAN: Thank you. My name is Judy Norsigian. I am Executive Director of Our Bodies, Ourselves and coauthor of the landmark book about women's health and sexuality, also titled, Our Bodies, Ourselves. Since the early 1970s, over 4 million copies in 18 languages have appeared around the world and we include a section on breast implants which will be updated in our upcoming eighth edition. My organization has no conflict of interest with regard to this issue.
Our interest in breast implants goes back to the mid-1980s when Ester Rome, my coworker, began to work with hundreds of women, both locally and nationally, who believed that breast implants caused them serious problems. Some of her interviews with women are reflected in the chapter that she wrote about breast implants in, Sacrificing Ourselves for Love, the book she coauthored just before her death from metastatic breast cancer.
We still continue to hear from women, some of whom were initially very happy with their implants, that many of them have developed debilitating conditions after five or ten or fifteen years. Everyone knows that silicone-gel implants are more likely to break as they age, so it is essential that the FDA be concerned about what happens to women who have had their implants for at least five or ten or fifteen years.
Inamed's own data show that, even in the first two or three years, there are substantial problems especially for breast cancer patients. I won't repeat them here, but I do want to underscore the fact that most of the 6 percent diagnosed with rupture had silent rupture and, therefore, leaking can continue for years without notice, as you have already heard today.
Inamed also reported an alarming increase in many symptoms associated with autoimmune diseases for all implant patients including joint pain, fatigue, hair loss and muscle pain. If this is what is happening at two or three years using the best plastic surgeons that the company could find to participate in their study, what will happen to women across the country using less experienced doctors and with implants for ten or 20 or 30 years.
One of the more disturbing aspects of the ongoing public debate about the risks of silicone implants has been the largely absent voices of physicians who have examined women with breast implants, those doctors who have looked more closely at the joint aches, fatigue, dry mouth and eyes and the masses of silicone that have hardened in up to 70 percent of the women's chests over time.
To repeat Dr. Gary Solomon who has served as Associate Director of Rheumatology at New York University's Hospital for Joint Diseases Orthopedic Institute, "Any physician who has seen a dozen of these women knows there are illnesses caused by implants."
Unfortunately, as you have already heard, their symptoms and problems have not resulted in a clear clinical diagnosis. This difficulty with nomenclature has made it easier to discredit the women who have been suffering as well as their physicians who are trying to help them. Many experts agree that studies on silicone implants should include only women who have had implants in at least eight to ten years, since most leakage or rupture occurs after that period of time.
Studies by the FDA's Dr. Lori Brown and her colleagues look at such a targeted patient population and show an increase in fibromyalgia among women with leaking silicone-gel breast implants. You will hear about that later.
Let us also recall that three years ago more than 190,000 problems from breast implants had been officially reported to the FDA including 123 deaths. These complaints represented potentially more than 10 percent of the estimated 1.5 million women who then had breast implants.
We should also recall what happened in 1991 and '92 when the breast-implant industry and the American Society of Plastic and Reconstructive surgeons spent approximately $4 million in a PR campaign to try to downplay the potential risks of silicone breast implants and to block regulatory action by the FDA that might restrict access to these implants.
A well-funded publicity effort underscored the greed of trial lawyers involved in breast-implant litigation referred to the medical literature indicating problems as junk science and urged women to phone and write the FDA to protest any regulation of the use of silicone implants. Rhetoric about giving women a choice was heavily employed and paid advertising spots featured women who wanted their right to choose breast implants.
In the entire media flurry, what was often overlooked was the fact that breast-implant safety had never been demonstrated in over 30 years of use despite the repeated pleas of women's health advocates and scientists at the FDA. In a climate where cosmetic surgery and breast-implant procedures are heavily advertised and promoted, it is not surprising that augmentation is on the rise despite the mounting evidence of harm.
Many young girls are now given breast jobs as a high-school-graduation gift. With such a backdrop to these deliberations, it is especially important that FDA exercise extreme caution in the matter of approving a product that could have such long-term negative impact on so many otherwise healthy women.
The FDA, which is charged to protect the public's health should deny approval of any breast implants until better data are available to resolve the ongoing debates about safety. Choices are great, but we need safe choice. What kind of choice is it to approve a product with very high complication rates and unknown health risks over time.
I also want to give to you a letter from almost a dozen breast-cancer advocacy organizations who expressed similar views. They include the Mass Breast Cancer Coalition, other groups around the country.
I just want to add a small footnote that, as a lapsed member of NOW, and I have not been following everything that NOW does, I can tell you that the representation of NOW as espousing a view that women ought not to care about their appearance is just pure hogwash.
DR. BASH: My name is Dr. Deborah Bash and I am a plastic surgeon at Mayo Clinic in Scottsdale, Arizona. I am here today representing myself. I have no financial interest in the manufacturer or any of their competitors. My travel expenses are reimbursed by Mayo Clinic for my travel today. I perform both reconstructive and cosmetic breast surgery with breast implants. I am paid on a fixed salary which is independent of the type and amount of surgery that I perform.
I appreciate the panel providing me the opportunity to testify today. This is an important issue and I believe I have a unique perspective to offer for consideration. As a woman who has had a breast-augmentation surgery and a board-certified plastic surgeon, I can speak to both the clinical side and the patient side of these issues.
I decided to have a breast augmentation in 1985 when I was a third-year medical student. At that time, of course, silicone-gel-filled implants were the most common device used for the procedure and that is what I had. As a medical student interested in plastic surgeon, I was a particularly well-informed patient.
I knew what to expect and I was very comfortable with the decision that I made. I believe now, as I did then, that silicone-gel-filled implants are a safe option for women considering breast augmentation. I have not had any problems with my breast implants and, in fact, in 1999, I chose to have the original implants replaced.
I knew when I had my first procedure that the implants would not last a lifetime, just as any medical device will eventually need a replacement. After 14 years, I chose to have my implants replaced with new silicone-gel implants rather than saline-filled implants because I had that choice. And, as a patient and a board-certified plastic surgeon, I knew silicone-gel implants would give me a better cosmetic result.
Since my surgery in 1999, I continue to be a very satisfied patient. My experience as both a surgeon and a patient puts me in a uniquely credible position to discuss breast reconstruction and breast augmentation with my patients. I share with every one of my patients my history of breast implants and, in fact, my mother has also had a mastectomy and has silicone-gel implants at my recommendation.
While my experience allows me to relate to patients at the different level, I am concerned because they do not have the same access and choices that I had. I believe it is important that patients understand the difference between silicone and saline implants. As part of the informed-consent process I use with all of my patients, I ask patients to touch and feel both types of implants.
I explain the history of the implants and I tell my augmentation patients that, unfortunately, they do not have a choice for saline-gel implants. In my experience, it is rare that a primary augmentation patient prefers a saline implant after holding and touching both devices.
It has also been my experience that, when I operate on women with aging silicone implants who desire replacement, that they chose to have a saline implant when they have a choice of silicone or saline. I believe they make this decision based on positive personal experience and informed consent.
It has been my professional and personal experience that breast-augmentation patients should have the same options available that reconstructive patients have.
Thank you very much for your time and consideration.
MS. GILBERT: Doctor, this is Alisa Gilbert. Just out of curiosity, do you do any special protocol yourself in follow up or--how do you do your own follow up? I mean, are you getting MRI, or you haven't had any problem whatsoever.
DR. BASH: I have regular--my annual breast exams and my mammograms, just like any women would for routine breast care. I am also on the Mentor silicone-gel adjunct study and I have done my follow up at my one-year, three-years, and then I have my five-years coming up.
MS. GILBERT: Thank you.
MS. KEITHLEY JOHNSTON: Good afternoon. My name is Kathy Keithley Johnson and I am the Executive Director of Toxic Discovery, a national consumer-advocacy organization whose primary goals are education and emotional support for individuals who have sustained injuries from silicone and saline breast implants.
Toxic Discovery presently maintains a database of over 25,000 injured consumers with over 10,000 of those with breast implants. My expenses of my staff to attend this hearing were paid by private donations from our members and from the injured consumers. I also would like to submit to you today a collection of individual stories from the women called, We are the Evidence.
My personal journey has well prepared me for my present position as Director of Toxic Delivery. I am a registered nurse. I am a former surgical nurse and I am former Director of Hematology Oncology. But, more important than my nursing background, I am yet another injured consumer.
I am also one of the nurses in the Harvard Women's Study. I was implanted free of charge in Midland, Texas and was approached to become a spokesperson or poster child for the manufacturers. I so elected not to take part.
During these hearings, the FDA will be determining once again whether or not to lift current restrictions on the use of silicone implants. We ask you, the committee, what restrictions have the FDA truly enforced? The breast-implant manufacturers and plastic surgeons of this nation would like to consumer to believe that silicone implants have been restricted over the years. We say there has never been a true restriction or protection.
I ask you, who is minding the breast-implant store? The experts here today are not you, this learned committee member, nor are the experts the breast-implant manufacturers. The experts here today are not even the plaintiff attorneys or the defense teams. The experts here today and remain the injured who have suffered in the name of corporate greed.
Mark McClellan, the FDA Commissioner, wrote a white paper a few years ago entitled, Protecting the Public Health; FDA Pursues an Aggressive Enforcement Strategy. In Mr. McClellan's paper, and I quote, "The agency is committed to pursuing Food, Drug and Cosmetic Act violations." Toxic Discovery believes that violations are being committed daily via the route of the silicone breast prosthesis.
In view of the supporting evidence and facts, silicone breast implants have never been approved safe. lifting restrictions would appear purely motivated by special-interest groups and organizations of plastic surgeons and of the breast-implant manufacturers. Lifting the restriction will allow the unchecked violations to continue.
It was Abraham Lincoln from my sister state of Illinois that said, "Sin by silence when they should protest make cowards of men." The breast-implant women of this world should no longer suffer in silence. The women and children of this continued medical experimentation will remain the evidence with or without the FDA's so-called approval.
No committee including this one can change those facts. In Missouri, we were fortunate in January 2000 to pass a law concerning informed consent directly related to breast implants. The only other state that has such a law is the one I am visiting today, the Great State of Maryland.
I stand before you as injured consumer but one that knows the truth of product failure and corporate lies. I hear you speak of research and yet you turn away from the truth. We, the injured consumers, continue to be your research. We, the injured consumers, are your evidence and we will remain just that, evidence that not medical device is totally safe but especially the new PMA application that Inamed would lead you to believe that is new and improved.
Informed consent should being with informed individuals. Freedom of choice versus informed consent implies that women are aware of the consequences of their actions. But the women requesting breast implants are not provided the truth and continue to be the victims of social pressure and medical fraud.
The right to choose is meaningless without the right to know. The poor unsuspecting cancer patient has received a double insult to injury. They have, in a large majority of cases, survived cancer to only learn in the years to follow that the very device that they believed would make them whole again would later cause further mutilation.
Let us also not forget that the largest contributors to the majority of cancer organizations are the breast-implant manufacturers and corporations. As a former director of oncology, I know this very up-front and personal. Do you really want to hand over a legacy of a new generation of a breast implant to the--
DR. WHALEN: Can you conclude, ma'am?
MS. KEITHLEY JOHNSTON: --to the consumers who were so irresponsible to thousands? May I say that I gave up five minutes for Allen Keithley this morning who was unable to attend.
DR. WHALEN: Ma'am, you have five minutes and you are 52 seconds beyond that now. If you could conclude, please.
MS. KEITHLEY JOHNSTON: Women historically have been the cash cows of the medical profession. Women continue to be spoon-fed from the cradle to the grave how they should look by a media-funded, manufacturer-driven, silicone cartel. It is beyond time that we, the consumers, demand a safe breast implant.
We, the breast-implant women, demand from the FDA that you do not approve Inamed's application and we ask you to defer approval until only a safe implant can be offered. The injured masses call on you, the committee, to save the next generation and the second generation of women that breast-fed their children. Do not allow the silicone holocaust to continue.
MS. GILBERT: Ms. Keithley, I have a question for you. Alisa Gilbert.
MS. KEITHLEY JOHNSTON: Yes, ma'am.
MS. GILBERT: How many of the you said 25,000 patients or consumers that you--
MS. KEITHLEY JOHNSTON: We have 25,000 members.
MS. GILBERT: How many of those are breast-cancer survivors?
MS. KEITHLEY JOHNSTON: Out of that statistic, I would say only probably 25 percent since I am an oncology nurse, or was a former oncology nurse. Most of that is known and we do open our doors. That is our first love is the cancer patient.
MS. GILBERT: So you provide your main--the support that you provide to the participants that you represent is specifically support or--
MS. KEITHLEY JOHNSTON: We are the only organization that I know of in the United States for breast-implant survivors and cancer survivors that had breast implants that failed that you actually get to speak to one of our people. All of our registered nurses that answer the calls all had breast implants, they all failed and they all had them removed. I have never received one nickel from the breast-implant manufacturer in any litigation nor, also, do I take a check from Toxic Discovery. I do this from a passion.
DR. PAUL WEISS: Good afternoon. My name is Dr. Paul Weiss and I am a practicing plastic surgeon in New York City. I am here representing the National Endowment for Plastic Surgery and thank you for the opportunity to present today. I have no financial affiliations with the manufacturer, its product or its direct competitors.
As part of my practice of plastic surgery, I perform breast-implant surgery both for reconstructive and aesthetic indications. I, therefore, derive a portion of my income from this type of surgery. The American Society of Plastic Surgeons is paying my travel expenses.
The National Endowment for Plastic Surgery was established in 1994 to provide an ongoing secure funding source for specialty-based research projects. The Endowment was established by and is maintained by the Plastic Surgery Education Foundation, the research, education, domestic and international service arm of the American Society of Plastic Surgeons. The Endowment represents an unprecedented specialtywide cooperative effort and is funded solely through voluntary contributions of plastic surgeons and grateful patients.
The National Endowment is very important to organized plastic surgery and was created to support initiatives that are relevant to the immediate day-to-day clinical practice of plastic surgery. In 1991 and 1992, the manufacturers faced the FDA's call for the PMAs for silicone-gel-filled breast implants. The impact of this request created a crisis for implant recipients. From that experience came the realization that, as a specialty, we needed to be much more proactive in our research efforts.
With a commitment to our patients, sound science and quality research data, organized plastic surgery established the Endowment as a perpetual source of research funding for the specialty. Its mission includes supporting research directed toward defining the efficacy and safety of established plastic-surgical procedures, investigating innovative technology and plastic surgery, sponsoring research scholarships and fellowships and charitable programs in plastic surgery.
The review process used by the endowment for awarding research grants is rigorous. The process and the application form are modeled after those of the National Institutes of Health. The grant awards are selected by an expert panel of clinical and scientific researchers, many of whom have served on NIH review panels or are recipients of NIH grants.
While the Endowment is in the early years of awarding research grants, I would like to share with you information on the implant research funded to date. In 2001 and 2002, the National Endowment provided funding to establish and conduct research at the Center for Implant Retrieval and Analysis at Washington University in St. Louis, Missouri, and Bioaesthetic Plastic Surgery Center, also in St. Louis.
The emphasis of this study was to determine the modes, causes and rates of implant failure. The study determined and demonstrated the types of scientific analyses needed for each type of implantable device used by plastic and reconstructive surgeons. The analyses were macroscopic, microscopic, mechanical, chemical and physical.
A significant outcome of this research is that a standardized protocol has been developed which gives surgeons a clear approach for management of explanted breast implants.
Another research project funded by the Endowment is a two-year study that measured the analysis of physical benefits of breast-reduction surgery. Plastic surgeons and our patients have faced numerous challenges in recent years. As a specialty, we are at the forefront of both reconstructive plastic surgery and aesthetic plastic surgery. Perhaps, most importantly, we are more strongly committed than ever to facilitating and conduction good research and being more responsive as advocates for our patients.
In conclusion, the studies funded through the National Endowment for Plastic Surgery will provide information that will help determine best practices and deliver safe and effective care to plastic-surgery patients. We are confident that the FDA will review the scientific data on silicone-gel-filled breast implants and make its decisions based on the best interests of patients.
Plastic surgeons want safe products for their patients and fully support the FDA's ongoing regulatory process for breast implants. Plastic surgeons want good quality research data to drive the clinical decision-making.
DR. McGRATH: May I ask you a question, Dr. Weiss?
DR. WEISS: Yes.
DR. McGRATH: You said that you founded the Endowment in 1994. Ms. Kim Gandy, this morning, from NOW, made the comment or the statement that--I believe she said large sums of money have been spent by plastic surgeons to convince patients that implants can be used safely.
Could you tell us how you have used Endowment moneys, plastic-surgery moneys, for that purpose, please.
DR. WEISS: All of the Endowment funds are used to fund research projects and nothing more. There is no advertising or media money spent by the Endowment.
DR. MANNO: Barbara Manno. Doctor, have these studies been published in peer-reviewed journals, any of the data?
DR. WEISS: The one study on the effects of Betadine in breast implants has been published but mostly the work that has been done regarding breast implants has been to establish protocols for their study rather than reaching conclusions at this time.
DR. CASAS: Good morning. My name is Dr. Laurie Casas. Before I begin, I would like to let the panel know that the relevant statistics for my testimony can be found stapled to the copies of my testimony.
I am Dr. Laurie Casas. I have no financial ties to any implant manufacturer. I am neither a witness nor a party in an impending law suit. I am Communications Commissioner for the American Society for Aesthetic Plastic Surgery, also called ASAPS. My travel expenses to this hearing were paid for by ASAPS.
I am an associate professor of surgery at Northwestern University Feinberg School of Medicine. I have published extensively on breast-surgery topics. I am currently participating in an IRB-approved multi-site prospective outcome study on patient satisfaction following cosmetic procedures. In addition, I am a board-certified plastic surgeon in clinical practice for more than 13 years. Therefore, a portion of my income is derived from breast-implant surgery.
Plastic surgeons continue to fully support the FDA's ongoing regulatory process regarding breast implants. The FDA, the medical literature, plastic surgeons and their patients have raised valid concerns about these devices and, for the first time, we have data to respond to these specific concerns.
The results of two surveys of more than 5,000 women with or considering breast implants will be published in the Aesthetic Surgery Journal, ASAPS' peer-reviewed clinical publication. In these two retrospective outcome studies, these 5,000 women were anonymously surveyed in two separate questionnaires.
The first study surveyed 2,129 women with implants of which 13 percent had silicone gel and 1,625 who were considering implants. They were asked questions related to their demographics, compliance with follow-up appointments, body image, motivation, reoperation and quality of life.
The second study surveyed 1,359 women with breast implants of which 13 percent had silicone gel. They were asked questions regarding why women may not return for follow-up visit, the adequacy of informed consent, their ability to get health insurance, and overall satisfaction with breast augmentation.
The research was funded by the nonprofit Aesthetic Surgery Education and Research Foundation, ASERF. Each survey was posted on the independent website implantinfo.com over a period of months. The on-line surveys were implemented by professional research firms with protection in place to ensure respondents anonymity and to prevent multiple survey submissions. Neither ASAPS, ASERF nor implantinfo.com had access to the data before it was analyzed. The margin of error is plus-or-minus 3 percent at a 95 percent confidence interval.
Both surveys showed that women's motivation for having their breasts enlarged primarily relates to their sense of self. In the first survey, the top reasons for choosing breast augmentation for 79 percent or more of the respondents were; to look better in clothes, to feel better about themselves, to feel more confident and to feel less self-conscious. Pleasing others was one of their lowest priorities.
Results of both surveys showed that women's expectations were met by the procedure. 92 percent said they were happy about their decision to get breast implants. 89 percent said the augmentation completely or mostly met their expectations and 94 percent said they would recommend breast augmentation to their friends or family. And if they choose, based on what they know today, would women with implants in this survey choose to get them again? 84 percent said they would very likely do so and 82 percent reported an improvement in self-confidence.
The outcomes research also shows that women considering augmentation were not impulsive about their decision. 77 percent considered augmentation for at least a year before undergoing surgery and more than half thought about it for three or more years.
The demographics from this data was very interesting. It showed that the median age of the respondents was 34. 75 percent are either married or in long-term relationships. 84 percent had at least some college education and 45 percent at least had a Bachelor's degree. And the respondents came from every state as well as Puerto Rico and the Virgin Islands
The 2,800 members and candidates of the American Society for Aesthetic Plastic Surgery fully support the FDA's ongoing review of implant safety and efficacy and rely upon the agency's evaluation of the current science regarding silicone products.
MS. GILBERT: Excuse me. I have a question. Alisa Gilbert. So you had 5,000 women in the study.
DR. CASAS: Yes.
MS. GILBERT: Where were they on this scale? A year after their surgery? I know that you said that some of them were considering surgery and some of them weren't. Do you have any kind of--
DR. CASAS: We have women from the '80s to 2002 that were augmented.
MS. GILBERT: Okay. How do these numbers reflect that? I mean, so 91 percent wanted to look better in clothes or 92 percent said they were happy about the decision to get breast implants, but I guess what I want to know is how many of them were their first year out, their second year out, from implant surgery.
DR. CASAS: We don't have the data broken up that way. We have it--Dr. Leroy Young will complete the data for you and then, if he can speak to that, he will.
MS. GILBERT: Okay. Thank you.
MS. BROWN: This is Debbie Brown. I had a follow-up question. Of the questionnaires that you sent out, what was your percent respondents?
DR. CASAS: It wasn't a send-out questionnaire. It was an on-line survey.
MS. BROWN: And so did everybody respond or what was your percent respondents?
DR. CASAS: Well, you mean the people that started the survey, did they finish the survey?
MS. BROWN: Yes.
DR. CASAS: Because once you sign on, then you complete the survey. I don't have that information.
DR. YOUNG: Approximately 85 percent of people that started the survey finished the complete survey.
MS. BROWN: Thank you.
DR. YOUNG: I am Dr. Leroy Young. I have no financial ties to any implant manufacturer and am neither a witness nor a party in a pending law suit. I am testifying for the Aesthetic Surgery Education and Research Foundation, also known as ASERF. My travel expenses were paid by ASERF. The Foundation funded the research that I will be telling you about concerning two surveys of more than 5,000 women with or considering breast implants.
I am a board-certified plastic surgeon and a portion of my income is derived from breast-implant surgery. In the past, I have received research funding from McGhan, now Inamed, and have served as a consult to breast-implant manufacturers. I am Chairman of the National and Co-Chair of the International Breast Implant Registries. I am currently Co-Chair of the Breast Surgery Committee of the American Society for Aesthetic Plastic Surgery also known as ASAPS. Results of my research will be published in ASAPS' peer-reviewed clinical publication.
Plastic surgeons have shared the FDA's concerns about certain issues raised in previous breast-implant hearings which is why I undertook the two surveys I will be speaking about today. One of the most important issues raised previously was whether breast-augmentation patients have been adequately informed about risk associated with breast implants.
In the second survey, of 1,350 breast-augmentation patients, more than 90 percent of women remembered being provided with important information such as what to expect after surgery, specific complications, breast-implant deflation or rupture, and that breast implants do not last forever. 88 percent reported being actively involved in the decision about the size of their implants.
We also explored the issue of reoperation. In the first survey of more than 2,000 women with implants, only 13 percent reported a revision and nearly all of them chose implant replacement, not permanent removal. Most of the reasons for revisional surgery were cosmetic in nature such as the desire for larger implants.
Many women experienced breast pain associated with their menstrual cycles, nursing or other reasons. Surprisingly, a larger percentage of women without implants reported breast pain than women with implants. We also learned that 93 percent of breast-augmentation patients had all of their children before undergoing to procedure so nursing was not an issue. Of the small percentage who had children and nursed them after augmentation, there was essentially no difference in the rate of reported problems.
There have been concerns about whether women with breast implants are being denied health insurance. The survey results indicate that more than 90 percent of women with implants have insurance. Of those who applied for insurance after receiving breast implants, 91 percent were able to obtain insurance. A small number of women were charged at a premium and a number of others had a two-year exclusion on their policy for breast-related problems. The margin of error of the surveys I am talking about is a plus-or-minus 3 percent at a 95 percent confidence interval.
In the first survey, we have data covering the past ten years of patients' experience with breast-augmentation. There were more than 2,000 patients with saline and more than 250 with gel implants. This is an expected distribution given that silicone was not on the general market.
We have some preliminary data on comparisons between the devices regarding patient outcomes. For some findings, there are no statistically significant differences: fulfillment of expectations, whether patients would recommend the procedure, breast pain severity and frequency, asymmetry, skin wrinkling, hematoma and infection.
Other data indicate statistically significant differences between saline and gel regarding patient outcomes. Examples are natural feel of the breast, capsular contracture and reoperation. We plan to make this data available to the FDA as soon as analysis is complete.
Plastic surgeons are concerned that a small percentage of women say that breast augmentation does not meet their goals. We are gratified that these results demonstrate an overwhelming number of women report satisfaction with the procedure and we are constantly striving to make women's experience with breast implants meet their expectations.
We fully support the FDA's ongoing scientific review of implant data and I thank you for the opportunity to present.
DR. BURKE: I am Dr. Martha Burke. I am Chair of the National Council of Women's Organizations. We are the nation's oldest and largest coalition of women's groups representing 170 organizations and 10 million women collectively. I have been paid by no one to appear today. I am here representing the American women from all socioeconomic, ethnic and income groups that my groups represent.
We work on a wide variety of issues and, until now, we have never testified before the FDA. But, after hearing the stories of women who have been harmed by breast implants, we are here to show our concern for them and for women across the country who might be considering the implants.
Some argue that breast implants have already been studied more than any medical device. If that is true, perhaps there is a good reason. More than $2 billion in legal settlements might influence the need for research and the incentive for companies to fund such research. Unfortunately, even $2 billion cannot guarantee good-quality research.
I am here to let you know as panelists that American women who depend on the FDA to safeguard their health and safety are watching. We are not here to pressure you to vote a certain way but we are here to urge you to carefully scrutinize the safety of this product and answer these two key questions.
If a product with high complication rates is approved, will the company that makes that product have an incentive to improve it? And if a company provides inadequate long-term safety data and the product is improved anyway, will the company have an incentive to improve their research?
I would like to tell you about one of the many women who wanted to testify here today but could not come, one being Sharyn Noakes who is 55 years of age and she is too ill to be here. She had two sets of silicone-gel implants. The first was removed after only eight months due to extreme capsular contracture. When the surgeon opened her up, the implants were both ruptured. They were replaced with new implants that she kept for 24 years. And this is what she had to say.
"I had the implants removed when the pain and deformity became too much for me. The surgery that should have taken 90 minutes took over three-and-one-half hours. The implants had ruptured. The silicone and scar tissue had calcified and embedded into my chest. I was rushed to the hospital next door." This was apparently even outpatient surgery.
"I did not have cancer but I had to undergo surgery similar to a double mastectomy because of the silicone. I am forced to live deformed and I am very ill with several autoimmune disease. I believe there are many women like myself who will suffer when ruptured implants stay in their bodies.
"We are not like an automobile having our oil changed. Surgery is expensive and many women won't have enough money to have the implants removed. I am now on 13 different medications. Fortunately, my husband is retired military and I am able to get my medication free. Otherwise, it would cost me $1,500 a month to stay alive.
"Would you like to see what your wife, daughter, mother or girlfriend could look like after having the implants for 24 years? Please look at my picture."
Sharyn's story reminds me that the Center for Medicare and Medicaid Services is suing several breast-implant manufacturers to recover millions of dollars that Medicare had paid out in healthcare for older women harmed by breast implants. It doesn't make sense for one government agency to sue for healthcare costs while a different agency makes the same product even more available.
I hope some of you will ask Medicare how they made this decision to sue. Do they know something that this panel needs to know? Women should have many options in their lives including safe medical products. Unfortunately, Inamed did not study the health risk or the cosmetic risk involved in this product. As Sharyn Noakes' testimony shows, the cosmetic and health effects can be devastating.
In closing, I remind you, if the FDA improves silicone-gel implants, they can't require informed consent because the FDA cannot enforce that. The FDA can't restrict the gel implants to cancer patients or to women over 18 because the FDA cannot enforce that.
The FDA can only make meaningful restrictions on access if this panel decides that the company has not proven that the implants are safe. As you listen to testimony today, vote for approval only if you are confident that these implants are safe for long-term use.
DR. YOUNG: Good afternoon. I am Dr. Laurie Young, not to be confused with Dr. Leroy Young who preceded me.
I should first clarify that I am not paid by anyone who is involved in any kind of litigation or involved in the promotion of anything related to silicone gel breast implants.
I am the executive director of the Older Women's League. The voice of midlife and older women is the only national grass-roots membership organization focused solely on issues affecting midlife and older women.
As you know, the risk of breast cancer increases with age and since our mission is to improve the lives of women over the age of 40, we are very concerned about the safety of silicone gel breast implants.
We know that women with breast cancer want to have choices. Fortunately, however, these women have more options than ever before. Most will not need a mastectomy and if they choose to have one, saline breast implants and other reconstruction surgeries offer alternatives to silicone gel breast implants, so the standard for approval should be are these that are being considered by a panel today safe for women to use.
We know that many women with breast cancer who were happy with their implants at first, have problems that arise and are entirely consistent with the high rate of complications that Inamed will be reporting to you today, such as 46 percent need additional surgery within two to three years, 25 percent have had their implants removed, 6 percent had a ruptured implant, 6 percent had moderate to severe breast pain, and 6 percent had necrosis which means that the skin or breast tissue around them died.
Everyone knows that silicone gel implants are more likely to break as they age. When silicone gel implants break, the silicone can leak into the lymph nodes and other organs and unfortunately, Inamed did not study the health risks involved.
If there are so many complications in the first two or three years, what will happen to women with implants for 10 years or more? Most women in their 40s or 50s, we know now will live another 25 to 40 years.
I would like to tell you about one of the many women who wanted to testify here today, but were unable to come. Susan Nicewonger lives in St. Louis. She received implants more than 20 years ago for augmentation. This is what she says:
"Over time, my breasts looked and felt as if I had two croquet balls for breasts. I will always remember how humiliated I felt when my gynecologist performed my annual breast exam. Her facial expression revealed disgust at having to examine my breasts. I actually had to request that procedure from her each year. Clearly, she wanted to avoid it.
"Sleeping on my abdomen was not an option, too painful. Soreness was a way of life. Anything that required air movement, hence, breast movement, was painful. It was when I began to notice a sound similar to scrunching cellophane when my right breast moved that I knew something was terribly wrong.
"A trip to the doctor and a subsequent MRI confirmed that I had a ruptured silicone implant and surgery would be necessary. My implants were removed this past May. Because of the leakage, breast tissue had to be removed from the right breast which has left me disfigured and unable to wear most bathing suits or any neckline that would reveal the sunken half of my right breast.
"I am, however, extremely grateful that those foreign, hard, painful objects have been removed from my body. I can't be certain of the path that migrating silicone has taken inside my body or how it will eventually manifest, but it is on my mind every single day of my life."
I want to echo the comments expressed by Dr. Burke who said that the CMS, Medicaid and Medicare are now exploring legal methods to recover funds for the surgeries and medical treatments that women have had to experience as a result of these implants.
Again, I ask you today to be concerned and serious, and not to make judgments based on inadequate or studies that are not complete. Women deserve complete information, if we are to be truly informed, it can't be on half-baked information.
MS. LOZIER: (Read by Nancy Nealand.) Good afternoon. My name is Nancy Nealand and I am here reading for Christine Lozier from Hackensack, New Jersey.
"My name is Christine Lozier and I am from New Jersey. I have no conflicts of interest. I got my first set of silicone gel breast implants in the 1980s, but my breasts hardened soon afterwards and I had to have them replaced two years later.
"Cosmetically, the results of the second implantation were very good, but then, five years later, I developed autoimmune symptoms and other health problems I had never had before, like asthma, Raynaud's syndrome, and fibromyalgia.
"After living with my debilitating health problems for over a decade, I decided three years ago to have an MRI. It detected that the left implant had ruptured and was leaking. When I went to a doctor to get both implants removed, it was discovered that my right implant was also leaking. As a result of the leak, I had to have a partial mastectomy in my right breast to remove silicone, not cancer.
"I bled severely and had drains for two weeks. Four months later, I underwent reconstructive surgery and had saline implants put in. The right one deflated two months afterwards. I had it replaced and two months later developed an infection and a rash on my left side.
"Because of the rash, I had to have both saline implants removed and replaced with new ones. It was during this surgery that my doctors discovered silicone that had escaped my left implant during my very first explantation and was still in my body.
"Since my first explantation, I have undergone a total of six surgeries, and each time I have needed to have drains put in because of severe bleeding and infection. It has been one year since my last surgery, and I still have pain in my left side from the silicone under my skin that cannot be removed.
"Each one of my reconstructions was paid for out of pocket and overall I have spent $60,000 trying to get my body back to normal. Each time I have needed to be out of work for two weeks at a time and even though the silicone has caused severe health problems for me, I am stigmatized by my co-workers because I had implants and people have no sympathy for my condition.
"None of my doctors ever warned me of the possible effect silicone implants could have on my body and now that I am sick, they deny that silicone had anything to do with my illnesses. I feel betrayed and lied to and I am telling my story because I don't want future women to have to go through what I have been through.
"Please, don't allow silicone gel breast implants to go back on the market unless they are proven to never leak. If you require real proof of safety, I have no doubt that implant makers will develop a safer implant. If you don't, they will continue to sell the kinds of implants that have harmed so many of us.
DR. KASPER: My name is Dr. Anne Kasper and I came here at my own expense. I have no conflicts of interest.
I am a partner in Finding My Way, a support service for breast cancer patients that is in Bethesda, Maryland. I am also the senior editor and an author of the book Breast Cancer: Society, Shapes, and Epidemic.
Breast cancer patients have more choices than ever before and while it is important to have choices, and tell this to all the women in our practice, when a woman is diagnosed with breast cancer, the choices are often very difficult to make.
The good news today is that three out of four women newly diagnosed with breast cancer can choose to have a lumpectomy with radiation instead of a mastectomy, and if a woman needs to wants a mastectomy, she can choose saline breast implants, silicone gel implants, or autologous tissue transfer procedures.
How important is it that silicone gel breast implants be widely available to cancer patients? Under the current restrictions, the vast majority of women who want silicone gel implants for reconstruction are able to get them, but breast cancer patients are cautious, they want to live long lives and they have faced a life-threatening disease.
They also, however, are concerned about cosmesis and how they will look after cancer treatment. Many will choose lumpectomy which allows them to keep their breasts, preserving their appearance and the sensory feelings of the breasts, but what women tell us--and this is the take-home message from my talking with you today--is that they only want silicone gel implants if they can be assured that they are safe.
Women are often encouraged to choose implants and sometimes a rosy picture is painted about the benefits of implant reconstruction. In our practice, women are often disappointed to have reconstructed breasts that have none of the sensory, sexual, and maternal capacities of a normal breast and that often have complications.
Many reconstruction patients who choose silicone gel implants are happy with their implants at first, but unfortunately, many then experience the kinds of complications that you have heard today and that Inamed has found, which include 46 percent will need additional surgery, 25 percent will have their implants removed, 6 percent will have a ruptured implant, 6 percent will have moderate to severe breast pain, and 6 will suffer from necrosis.
In the Inamed core study of breast cancer patients, only 6 percent of the implants broke during the first two or three years, but over time we know that that percentage increases dramatically, and it is, of course, much more serious than when a saline implant breaks.
As you know, when silicone gel implants break, silicone can leak into the lungs, the lymph nodes, and other organs.
To determine the safety of silicone gel implants, Inamed should have studied the health of women whose implants broke especially since cancer patients may have compromised immune systems, unfortunately, they did not.
Another shortcoming of the Inamed research is that it only included African-American breast cancer patients in the core study and only five Asian-American women. Obviously, this is not sufficient data on which FDA would make safety decisions for all American women.
Both of those groups have approximately the same rates of cancer as white women, and African-American women are especially susceptible to autoimmune disease. All of these groups of women must be studied adequately to determine if implants are safe for them.
The bottom line, though, is that the complication rates for breast cancer patients are very high in just the first two or three years. What is ahead for these women in five years, 10 years, or even 20 years? Most breast cancer patients are living longer lives today and many choose mastectomy as a way to put the cancer behind them.
With implant reoperation rates of 46 percent in the first two or three years alone, and higher rupture rates in the years to come, many women will not consider implants a satisfactory and safe choice at all.
It is unusual to ask for more than two years of safety data for a new product, but silicone gel implants are not new. Inamed is asking for approval for an implant that has not changed much, if at all, in more than a dozen years.
If FDA had strictly enforced restrictions on breast implants established in 1992, we would now have 10- year data rather than two or three years.
If FDA approves silicone gel implants based on the data that has been provided, it sends the message they are not as concerned as women have a right to expect about the health and safety of breast cancer patients and especially women of color.
If FDA allows silicone gel implants to remain on the market, but only as part of clinical trials, and this time requires a third party to monitor the studies, then perhaps breast cancer patients will finally get the information they need to make a meaningful choice.
DR. ANDERSON: I have a question. You have made the statement that cancer patients have these options and that silicone implants are widely available. I work in the Seattle community and actually I don't know of the availability of silicone implants.
It would be an unusual plastic surgeon that would offer it as part of reconstruction, so I am curious what the basis of your statement that the silicone is easily available.
DR. KASPER: Well, the ones that we see here in the Washington, D.C. area have been able to get the silicone gel implants when they wanted them. I am basing my testimony on our practice.
DR. ANDERSON: Thank you.
DR. WILLEY: Members of the General and Plastic Surgery Devices Panel, I am Shawna Willey. I am a medical doctor and a Fellow of the American College of Surgeons. I practice in Washington, D.C., general surgery with an emphasis on breast surgery. I am an Assistant Professor at Georgetown University.
I am proud to represent the 64,000 fellows at the American College of Surgeons and thank you for the opportunity to offer a general surgeon's perspective on the issue of silicone gel-filled breast prosthesis for patients who are considering breast reconstruction or augmentation procedures.
I have no financial relationship with any medical device manufacturers.
Today, I would like to focus my comments on breast reconstruction and augmentation as procedures that improve the quality of life for our patients. Reconstruction of a breast that has been removed due to cancer is one of the most valuable surgical procedures available today. New medical techniques and devices have made it possible for surgeons to create a breast that can come close in form and appearance to matching a natural breast.
Frequently, reconstruction is possible immediately following breast removal or mastectomy, so the patient wakes up with a breast already in place having been spared the experience of seeing herself with no breast at all.
The availability of breast reconstruction gives the woman an option over which she has some control at a very emotional time. Both breast reconstruction and augmentation provide enormous benefits to women including an improved self-image and a sense of normalcy, but as is true with any operation, a patient must think carefully about her expectations and discuss them with her surgeon.
The American College of Surgeons has a long-standing commitment to improving the quality of surgical patient care and to enhancing patient safety. Therefore, we are eager to hear more about the data collected by the manufacturer on the safety of silicone gel-filled breast implants and we welcome the FDA's review of these safety data.
If these devices prove to be unsafe, we, of course, would not support their use in patients. Patient is always, and will always be, the primary concern of the College, but we also feel strongly that decisions that effectively limit patient options must be made on the basis of solid scientific evidence.
We are concerned that procedures with benefits that are life-enhancing rather than life-saving are occasionally viewed by society as somehow less important. Breast implants should be regarded as any other medical device that is being considered by this panel. Further, distinction should not be made between the use for reconstruction or augmentation purposes. If the device is safe in one group, it should be safe in the other.
Following more than 10 years of clinical studies and trials, if conclusive data are not found showing that these devices pose a significant risk to patients, we believe the choice to use them should be made by consenting patients.
The College also agrees that it is vital for any woman considering a breast implant procedure to be well informed of all possible risks associated with the procedure, as well as with the device being used.
Women must be informed, for example, that breast implants do not last forever, that complications can occur, and that additional operations may be necessary. Consequently, we support this panel's continuing efforts to ensure that breast implant patients have access to comprehensive and comprehensible material that can be used by patients to make informed decisions about these procedures.
To conclude, let me reiterate that all surgeons are obliged to be scrupulous in ensuring their patients are provided with the information they need to give truly informed consent for any operation. We are certainly hopeful that the information collected by the manufacturer of these devices will contribute significantly to these efforts and help resolve the continuing uncertainty about the safety of these devices.
Thank you again for the opportunity to speak today.
MS. VOLPE: Thank you for allowing me to present this statement. I am Margaret Volpe, a breast cancer survivor with a silicone breast implant. I have no financial ties to manufacturers or health care providers and am not being reimbursed for my appearance here.
I am a volunteer representing Y-ME National Breast Cancer Organization. Y-ME has received a minuscule amount of funding from manufacturers, but none in the past 18 months. Y-ME is committed to providing support and accurate information to empower individuals touched by breast cancer so they can select the most appropriate options in conjunction with their health care provider.
W-ME's comments concern silicone implants for breast reconstruction or other medical need. We have no opinion on silicone implants for cosmetic purposes. We are not endorsing a product or manufacturer, but feel strongly that silicone breast implants should be more widely available as an option for women requiring reconstruction.
When I was diagnosed with breast cancer in 1995, I faced fears and anxiety common to those diagnosed with a life-threatening illness. It was important to have reconstruction, to feel whole again, to not be constantly reminded of my breast cancer and to get on with my life.
I have had no problems or complications with my implant since my reconstructive surgery in February 1996. Options for reconstruction are limited. There is tram flap reconstruction, major abdominal surgery with a painful recovery period, leaving us without our abdominal muscles. Women who are too thin do not have this option.
If a woman has a tram reconstruction on one breast, she is unable to have a second tram at a later date. The latissimus dorsi reconstruction usually requires an implant. Saline implants are available, but for many they are unsatisfactory. A silicone implant gives a more natural look and feel.
Y-ME emphasizes the need for a range of treatment options, so that each woman can choose what best fulfills her needs.
The availability of silicone implants is important to women with breast cancer. It was difficult to get my implant because of FDA restrictions. I signed a lengthy and detailed informed consent. Even though a breast cancer patient theoretically can obtain silicone implants through a clinical trial, it is difficult for many women to enroll in a trial if the surgeon is unaware of or unable to participate in a trial.
Please adhere to the science when evaluating silicone breast implants. The Institute of Medicine's exhaustive and definitive review of existing research found no evidence that silicone breast implants cause cancer or disease and no convincing evidence that silicone produces a immunologic response.
The report states such diseases or conditions are no more common in women with breast implants than in women without them. U.S. Court's National Science Panel and several European Government Scientific Panels issued similar findings.
NIH recently reported to Congress that a large meta-analysis published in the New England Journal of Medicine concluded there was no evidence of an association of silicone gel-filled breast implants with connective tissue diseases or other autoimmune or rheumatic conditions.
Y-ME urges women to fully understand the risks and benefits of any medical or surgical choice. Women should understand that no medical device lasts forever. Shunts, pacemakers, and artificial knees and joints have an expected life span and possible complications including capsular contracture.
Women must be aware of such side effects as capsular contractions, potential rupture, and the need for replacement. Doctors must provide accurate information about the risks and benefits of silicone implants because informed consent is key.
As stated in the letter from several cancer and nonprofit health organizations, there should be long-term follow-up and data collected. Privacy-protected patient registries and physician tracking are vital along with timely communication of significant findings to consumers, patients and providers.
In an effort to resume their life after a devastating disease, breast cancer survivors must be assured the right to select appropriate and effective medical therapies or devices.
Y-ME urges you to consider the plight of these women, but in the end, to act based on the science alone.
Thank you very much.
DR. WHALEN: Thank you and on behalf of the panel, I would like to thank everyone who testified today for either their societies, organizations, or a individuals for taking time out of their schedules to talk with us. There will be further public testimony as we initiate our activities tomorrow morning.
Before I go on to Dr. Witten, just briefly, there will be a slight change in schedule due to our lagging behind somewhat. Dr. Witten will be giving a presentation on Regulatory Overview of Silicone Gel-Filled Breast Implants and we will then take the afternoon break following which the sponsor will make their presentation.
Dr. Witten is the director of the Division of General and Restorative Devices.
Regulatory Overview of Silicone Gel-Filled
DR. WITTEN: Thank you for the introduction.
Good afternoon. I would like to welcome everyone to this meeting of the General and Plastic Surgery Devices Panel. I am Dr. Celia Witten, Division Director of the Division of General, Restorative, and Neurological Devices in the Office of Device Evaluation at FDA.
I will talk about why we convened this meeting, what we are asking you, our distinguished panel, to do and provide the regulatory background for silicone gel-filled breast implants.
We have convened this panel meeting to obtain your recommendations on whether there is a reasonable assurance of safety and effectiveness for the Inamed silicone gel-filled breast implant. We ask that you base your recommendations on the valid scientific evidence contained in the premarket approval or PMA application for this device and on your scientific and clinical experience.
The FDA will listen to your deliberations and recommendations and all the evidence presented here today. After the panel meeting, FDA will continue to review the information contained in this PMA and we will consider the recommendations of this distinguished panel.
Ultimately, FDA will make a decision on the approvability of this medical device.
Now, I will move on to talk about the regulatory background for these devices. At the time of the medical device amendments in 1976, silicone gel-filled breast implants were already being marketed. FDA classified these implants as Class III in 1988, which means that they would require premarket approval in order to be sold.
However, like other devices that were grandfathered under the 1976 Medical Device law, they were allowed to remain on the market until FDA issued a rule calling for safety and effectiveness information. This occurred in April 1991.
At that point, manufacturers had 90 days to submit PMAs with data demonstrating the safety and effectiveness of their implants. Several PMAs for silicone gel-filled breast implants were submitted.
In November 1991, an advisory panel meeting was held to discuss the silicone gel-filled breast implant PMAs. A voluntary moratorium was issued after that panel meeting, requesting that it cease marketing of silicone gel-filled breast implants while FDA reviewed the safety and effectiveness information that was submitted.
In February 1992, a second advisory panel meeting was held to discuss that new information. In April 1992, FDA announced its decision that no sponsor had submitted adequate safety and effectiveness data to support approval of their silicone gel-filled breast implant.
Accordingly, silicone gel-filled breast implants became investigational devices at this point, however, FDA determined that there was a public health need for breast implants for reconstruction and revision patients.
To address this public health need, FDA approved adjunct studies designed to allow for continued access of silicone gel-filled breast implants for reconstruction and revision patients.
Inamed, in 1998, and Mentor in 1992, submitted protocols for an adjunct study and received approval. These studies currently remain active.
At the current time, FDA has not approved any PMAs for silicone gel-filled breast implants. They remain investigational devices, which means that today, a patient must be enrolled in an adjunct study or an IDE study in order to receive one of these implants.
I should add that in 1999, FDA issued a final rule calling for saline-filled breast implant PMAs, and in May 2000, two of these saline-filled breast implant PMAs were approved.
FDA has provided guidance to manufacturers both in written form and direct discussions to assist them in developing the data needed to support a PMA. The FDA's guidance document provides manufacturers with information in several important areas.
The Chemistry Section describes how to analyze the device, the Mechanical Section recommends bench testing, and the Toxicology Section includes a description of the types of biocompatibility information. All this preclinical testing is designed for evaluating a long-term implant.
The Clinical Section details information regarding study design, data presentation, and information on presentation of literature review.
So much for a brief summary of where we are with silicone gel-filled breast implants. Now for the task at hand.
Inamed has submitted a PMA to the FDA for its silicone gel-filled breast implant, and that PMA will be the focus of our discussion over the next few days. This is the first PMA submitted for a silicone gel-filled breast implant since 1992.
We are asking this panel to evaluate the information in Inamed's PMA and advise us as to whether there are sufficient information to provide a reasonable assurance of safety and effectiveness.
Each panel member has been provided a list of questions to consider as he or she reviews the data. We have heard this morning a number of comments from the public and there will be an additional open public comment session tomorrow.
FDA appreciates the effort our stakeholders have gone to, to provide us with input, and I want to assure everyone here that we will take these comments seriously as whether or not to approve this product.
What follows after the break will be presentations from Inamed and FDA on this application. Following that, we will solicit the advice of the panel on what action we should take with respect to the application before us.
The FDA very much appreciates your giving of your time and expertise to accomplish this important task.
I will now turn it back over to you, Dr. Whalen.
DR. WHALEN: Thank you, Dr. Witten.
Are there any panel member questions for Dr. Witten in regard to her presentation?
DR. ANDERSON: I have a question. Does FDA offer guidance as to what defines safety and efficacy?
DR. WITTEN: There is a definition of safety and effectiveness which is in our law, which we will read during the voting process. It is something--I can't tell you the exact wording--but it is something like it is safe if there is a reasonable assurance that the benefits outweigh the risks in the target population for its intended use.
DR. WHALEN: It is footnoted in your booklet. I can't tell you the exact page right now, but each of those definitions are in two continuous pages in the information that was provided us.
DR. WITTEN: Actually, it is cited in the panel question, because the panel questions that you have, have the definition in there, because we wanted you to keep it in mind as you answered our questions about safety.
DR. WHALEN: No other questions? Seeing none, we will take a 10-minute break. I would ask the sponsor to be ready to start at 10 minutes to 3:00 their presentation.
McGhan Silicone-Filled Breast Implants
DR. EHMSEN: Members of the Advisory Panel, FDA staff, interested guests, I am Ron Ehmsen, Senior Vice President in charge of Clinical and Regulatory Affairs for Inamed Corporation. As such, I do have a financial interest in the company.
My colleagues and I are very happy to be here today to have the opportunity to present a summary of the clinical and preclinical data that we believe supports our premarket approval application for McGhan silicone gel-filled breast implants.
We are also joined by a number of consultants and experts in their various fields: Professor Donald Berry from the University of Texas and M.D. Anderson Cancer Center; Dr. James Brenner, who is our central MRI reviewer, he is a radiologist in private practice in Santa Monica, California; Professor Michael Brook, Professor of Chemistry and McMaster University; Dr. James Lamb, who is a toxicologist with the firm of BDL Associates in Virginia; Joseph McLaughlin, Dr. McLaughlin is President of the International Epidemiology Institute here in Maryland; Professor Kathleen Rodgers from the University of Southern California; Professor David Sarwer from the University of Pennsylvania; Dr. Howard Smith from Cleveland Clinic; and Dr. Scott Spear, who is Professor and Chairman of the Division of Plastic Surgery at Georgetown University Medical Center in Washington, D.C. Dr. Spear also serves as our principal medical consultant on the clinical studies that will be reported here today.
For clarification purposes, Inamed Aesthetics, which is a business entity of Inamed Corporation, was formerly known as McGhan Medical Corporation, hence, the reference to the trademark McGhan in reference to our breast implants.
Our PMA was submitted in December of 2002 for breast augmentation in women over 18 years of age, for breast reconstruction, and for breast implant revision, which includes removal and replacement of previous breast implants.
This PMA covers seven device styles as shown in this slide, four smooth round, two textured round, and one textured shaped implant. The photographs on the righthand side of the slide show the smooth round, the upper photo, and the textured shaped in the lower photo.
Today, we will discuss the preclinical and clinical findings that were submitted in support of our PMA, as well as review the peer-reviewed research that we believe adds a great deal of credibility.
First, our key findings.
Our data demonstrates that McGhan silicone-filled breast implants are safe and effective. Eighty-nine percent of the patients in the revision cohort, 93 percent in the augmentation cohort, and 96 percent of the patients are satisfied at two years follow-up.
Lower rates were found for most complications in Inamed's Silicone-Filled Breast Implants compared to Inamed's saline-filled breast implants which were approved by FDA in 2000.
The peer-reviewed research demonstrates that there is no increased risk of breast cancer, no increased risk of rheumatic or autoimmune disease, and no negative effect on children of women with breast implants.
Tom Powell, our Director of Technologies, will now discuss the results of our preclinical studies. He will be followed by JoAnn Kuhne, our Senior Director of Regulatory and Clinical Affairs, who will discuss the results of our clinical studies.
Let's begin with the preclinical. Mr. Powell.
Preclinical Studies Review
MR. POWELL: Thank you, Dr. Ehmsen. Good afternoon. I am Tom Powell, Director Technology at Inamed, and I have a financial interest in the company.
I am presenting the preclinical data from evaluations performed by Inamed.
The key preclinical findings are: Silicone materials employed in Inamed's gel-filled breast implant demonstrate biocompatibility and support the Institute of Medicine's report where the committee concludes that a review of the toxicology studies of silicones and other substances known to be in breast implants does not provide a basis for health concerns, and that silicone materials meet the physical property specifications for breast implants.
Inamed's preclinical studies included toxicological evaluations, chemical evaluations, and the mechanical evaluations, meeting the requirements contained in the guidance for saline, silicone gel, and alternative breast implants, guidance for industry and FDA.
For the purposes of this presentation, the findings are summarized. Complete documented results have been submitted to the agency.
Toxicity evaluations demonstrated material biocompatibility as described in the FDA's guidance document for breast implants included pharmacokinetics studies, in vivo and in vitro standardized toxicity testing, and studies investigating special toxicological concerns of immunotoxicity, reproductive, and developmental toxicity, mutagenicity, chronic toxicity, and carcinogenicity.
Inamed's pharmacokinetics evaluation was a scientific study tracking the movement of silicone gel implanted without an elastomer shell subcutaneously in rats. As shown in this gel study, the silicone gel is encapsulated and remains localized at the site of implantation with minimal distant movement.
This result agrees with the IOM report which had similar findings where studies showed that deposit of gel, whether free or in implants, remained almost entirely where injected or implanted.
Additionally, the submitted review of silicone distribution studies from literature further supported the IOM conclusion that, "There do not appear to be long-term systemic toxic effects from silicone gel implants or from unsuspected compounds in the gels or elastomers detected by animal experiments.
A battery of standard toxicological testing was performed on silicone elastomers and silicone gel. This battery investigated a variety of biocompatibility parameters including cytotoxicity where the silicones of breast implants were found non-cytotoxic, hemocompatibility demonstrating that silicones are non-hemolytic, pyrogenicity showing the silicones are non-pyrogenic, acute systemic toxicity demonstrating the implant materials are non-toxic, intracutaneous irritation finding that silicones are non-irritant, intramuscular implantation where silicones of breast implants are found non-toxic, and dermal sensitization where the silicones were found to be non-sensitizing. All testing demonstrated the biocompatibilities of these breast implants silicone materials.
Additional toxicological studies were undertaken to evaluate areas described as special considerations in the breast implants guidance document.
The immunotoxicity studies evaluating the test animals' immune response to silicone elastomers and silicone gel were performed using National Toxicological Program methodologies.
These assays investigated various immunologic parameters including antibody response to antigen, T cell, T cell subset, and B cell enumeration, mixed leukocyte response, and natural killer cell assay.
In all testing, no adverse immunologic effects of silicone materials was found.
The reproductive and developmental toxicity assessment included fertility/teratology and reproductive toxicity studies. The results from these studies sponsored by Inamed demonstrate that silicone materials used in breast implants are neither reproductive nor developmental toxins as there was no effect on parental, fetal, or offspring parameters.
Additionally, the submitted review of silicone reproductive and developmental toxicity studies from literature further supported these results.
A series of standardized mutagenicity assays designed to investigate the potential for genetic damage was performed on silicone elastomers and silicone gel. The studies used both bacterial and mammalian cell cultures and included Ames assay, forward mutation assay, mouse lymphoma assay, unscheduled DNA synthesis assay, cell transformation assay, and in vitro cytogenic/chromosomal aberration assay.
In all testing, no evidence of mutagenic activity was found.
Subchronic toxicity studies demonstrated that breast implant silicones again were non-toxic. Studies investigating potential for long-term organ or tissue damage and possible cancer development from exposure to silicone elastomers and silicone gel of breast implants were performed using the two-year chronic carcinogenicity tests in rats.
The carcinogenicity testing demonstrated that incidents of carcinomas were similar to controls except for the expected occurrence of solid-state tumors. Rodent models for this testing are particularly prone to develop solid-state tumors at the site of implantation of foreign bodies. This well-known rodent response to implanted materials is not a physiologic reaction observed in humans.
In this two-year chronic testing, the recognized gold standard to evaluate long-term toxic effects, no evidence of systemic toxicity or cancer other than rodent solid-state was observed in association with silicone materials.
Overall, the extent of amount of toxicity testing performed has demonstrated that the silicone elastomers and silicone gel used in Inamed's breast implants are biocompatible and do not compromise the body's physiologic system.
Looking at preclinical data, the preclinical chemical data characterizing silicone materials in breast implants support the findings of biocompatibility. The chemical evaluations focused on the silicone materials extent of crosslinking, extractable compounds, and heavy metals content characterization.
The physical strength and elasticity of the silicone implant shell and patch materials are a result of the extent of crosslinking achieved during the vulcanization process. Physical property testing of elongation and tensile strength demonstrates the consistency across elastomer lots and that materials conformed to pre-established specifications
Validation testing ensured that the process that is used by Inamed to produce implant shells are adequate to achieve a crosslink density that assures for every lot the strength and elasticity to meet the American Society of Testing and Materials Standard F703, Specification for Breast Implants.
Every lot and every batch of silicone gel is tested to ensure the crosslink density conforms to predetermined specification using penetrometer testing prior to being released for use in the manufacturing of breast implants.
MS. GILBERT: Excuse me. Can I ask a question here real quick?
MR. POWELL: Certainly.
MS. GILBERT: How do you measure the strength of an implant? Can you just give us an example of how you tell, I mean do you run a car over it, how do you measure it?
MR. POWELL: There are number of physical tests that are run on the materials. Some are standard physical property testing of elongation and tensile strength run on a testing piece of equipment known as a tensile tester Enstron. They have various brand names.
We actually will talk about, in the Mechanical Section, additional testing that is run on the devices themselves.
MS. GILBERT: Thank you.
MR. POWELL: Finished, sterilized devices were analyzed using techniques to detect extractable components including solvent extraction followed by gas chromatography using a mass spectrometer, ionization detector, and analysis by gel permeation chromatography.
Levels of extractable silicone materials were determined and results of the toxicological testing of the implant materials demonstrated their biocompatibility and non-toxicity and support the IOM report where the committee concluded that a review of the toxicology studies of silicones known to be used in breast implants does not provide a basis for concern at expected exposures.
Heavy metal analyses were performed with separate chemical analysis on the shell, patch, and gel. Metal concentrations were found comparable to approved saline-filled breast implants. Specific analysis with respect to catalyst platinum and tin were performed.
Material toxicity testing demonstrated the biocompatibility of gel-filled breast implant materials and supported the IOM Committee conclusion that evidence is lacking for an association between platinum in silicone breast implants and local or systemic health effects in women who have these implants.
Addressing the preclinical mechanical data, it demonstrates that the materials meet physical property specifications for breast implants.
The mechanical preclinical evaluations included fatigue testing, gel bleed testing, and gel cohesiveness evaluations.
Fatigue testing assesses the number of cycles at specific applied loads that a device can endure without the rupture of the shell. Smaller sizes of smooth and textured devices, representative of Inamed's gel-filled implants were compressively test.
The testing was performed on individual worse case devices, those with a minimum acceptable thickness using load control equipment. For this testing, implants were tested at applied load levels of 20, 30, 40, and 55 pounds until either device failure was observed or 6 1/2 million cycles was reached.
In addition to cyclic testing, a test assessing the force to rupture from a single compression of an implant was performed. The minimum average force for this single compressive failure was 1,245 pounds force. This force is significantly greater than what would be normally experienced in vivo, such as the maximum 55 pounds force exerted by mammography equipment.
Fatigue values from the applied load test cycles and the single compressive tests were used to generate applied force per number of cycle graphs and a threshold force, the force below which an implant can undergo an unlimited number of cycles without rupture failure was determined.
The minimum threshold value was determined to be 30 pounds force which calculates to a safety factor of 8.1 compared to the expected maximum in vivo cyclic load of 3.7 pounds force. This means that implants can withstand more than 8 times the maximum expected cyclic load it would experience implanted in the body.
PROF. DUBLER: Excuse me, I have a question.
MR. POWELL: Yes.
PROF. DUBLER: If that is the case--and perhaps you will deal with this later on in your presentation--and if the rupture rate is as reported, then, does the company have theories about what would undergird the rupture rate, if it's not a matter of force? You seem to be comfortable in all of the data that you are producing about the strength of the elastomer.
MR. POWELL: The fatigue test is an in vitro test. There is a number of factors that are involved in the specific design of the fatigue test that may not be really predictive of an in vivo model.
PROF. DUBLER: And is that true for other of the tests that you are now presenting the findings from?
MR. POWELL: Yes, the gel bleed testing would be another in vitro assessment that really has no direct clinical correlation.
Talking about the gel bleed testing, gel bleed testing assess the diffusion rates of silicone gel components through the implant shell and is a PMA requirement.
The study design was consistent with ASTM F703 method and involved the use of a silicone disk technique and results have no direct clinical correlation.
The calculated normalized diffusion rate value did not exceed 0.0019 g/cm2/week.
DR. WHALEN: Mr. Powell, this is Dr. Whalen with a question on that. When you assert that there is no clinical correlation to that, how would you then counter someone looking at that--and I am engineering challenged, I will admit--who wanted a sound byte to say, well, we have shown that it leaks, but it leaks slowly?
To me, that would have enormous clinical import, but you say that doesn't have clinical implications?
MR. POWELL: The silicone materials are really not readily soluble in an aqueous solution. This test methodology represents the worst case test method that can be assessed with some type of reliability in terms of a result.
DR. WHALEN: Well, to follow up, I would assume that that standard is incorporated into the requirements for a device like this because of in-vitro concerns about leakage. If not, why else would it be done?
MR. POWELL: This was a test method involved in the ASTM Specification F703 to get an assessment technique, so that different designs of gel implants could be assessed for different rates of gel bleed diffusion, more to be used as a comparative for different designs.
Gel cohesiveness testing assesses the cohesion characteristics of silicone gel. Finished device gel testing was performed as per ASTM F703 methodology for gel cohesion.
Cohesion result values were well below the accepted 4.5 cm maximum value identified in the ASTM standard for gel-filled breast implants. The results ranged from zero to 1.1 cm.
DR. CONANT: A quick question. In terms of the cohesive testing, does silicone tenacity change at different temperatures? I assume these are done at room temperature versus body temperature?
MR. POWELL: The testing is done at room temperature, that is correct.
DR. CONANT: But how does the--
MR. POWELL: The crosslinking of the silicone is very thermally stable, so once it is crosslinked, it is not going to change with temperature.
DR. MANNO: Excuse me, I have a question also.
This gel bleed that you mentioned, was that the method that was presented in the material using the filter?
MR. POWELL: The earlier drafts of the gel bleed was using filter paper and now we use silicone disk as the absorbent media.
DR. MANNO: You are using a silicone disk to check for silicone gel leakage or bleed?
MR. POWELL: We used an extracted silicone elastomer disk that is more absorbent to the silicone materials coming through the silicone implant shell than filter paper would be, so it's the worst case technology.
DR. MANNO: How are you getting from to get to your amount of bleed from there?
MR. POWELL: Over an eight-week course of study, weekly measurements are taken of the weight gain of the silicone disk that the implants are placed on and then replaced in exactly the same location.
DR. MANNO: Okay.
DR. MILLER: Dr. Whalen, could I ask a question? I think that you said something which caught a lot of our attention, that I just think we need to clarify.
You said that the tests you are using have no clinical correlation or something like that, and I think that from the engineering point of view, what you are trying to say is that there are no comparable events in the body that are similar to the contrived test you are doing in a materials engineering sort of way, but the results you are getting have clinical implications because they are telling you something about the nature of the materials in the implants. Is that accurate?
MR. POWELL: I would say that would be accurate if you wanted to compare between two devices, if you had similar experimental data between two different designs, then, you could make somewhat of an assessment in terms of a clinical outcome, but until you have a correlation between both the physical mechanical testing and the clinical outcome, it may not be directly related.
DR. MILLER: There is a limitation--I mean I just want to make sure I understand you--when you do the tests, you get results. The results tell you something about the materials. How you move from those results to what is going to happen in a clinical situation is subject to some limitations.
MR. POWELL: It would be correlated with the clinical studies, yes, sir.
PROF. DUBLER: Dr. Whalen, I don't understand. I don't understand what you would like us to do with the data that you have just presented in terms of the sorts of deliberations that we are required to have.
Can you tell us how you would like us to view the data that you have just presented?
MR. POWELL: Let me refer to my colleague, Dr. Brook, maybe could better answer that question.
DR. BROOK: My name is Michael Brook. I am a Professor of Chemistry at McMaster University in Hamilton, Canada, and I am a paid consultant to Inamed.
I can understand the sense of confusion on the part of the committee and perhaps I can try and clarify the situation.
When one is trying to do a materials test, you want reliable and reproducible tests that allows you to understand just how easily material is going to bleed, is going to leak out through this implant.
We all know silicones are typically used for waterproofing materials. If you want to put shoe polish on that contains silicones, so that the water beads up, and if one was to try and design perhaps more clinically relevant tests, for example, into water, the problem is that the measurements are almost impossible to do. You don't get reliable data because so little goes into water or saline or other artificial materials that you can't get reliable data.
So, the ASTM test is designed kind of like Kleenex in water. We all know that the water wicks up into the Kleenex. If you choose silicone, which is the material in which silicones will dissolve, you kind of get the worst case scenario. You learn how bad it could possible be under the worst possible case.
You are essentially allowing it to go into a sponge that has exactly the same kind of properties. So, this allows you to develop a test in which you have reliable data, measurable data, quantifiable data, so you have good certainty, good numbers, and it counts as a worst case scenario. The problem is that you can't do that same kind of test into water, which is what you might like to do in order to make the clinical correlation. It is just so little that goes in, you can't use it as a reliable test.
DR. CHOTI: Just a question. Do these preclinical tests, any differences between the smooth and textured, or the double lumen and single lumen?
MR. POWELL: All these tests were done on both smooth and textured devices.
DR. CHOTI: Are there differences in bleed in mechanical properties?
MR. POWELL: Yes, there are differences in what I tried to describe here are the worst case scenarios.
DR. CHOTI: If so, one useful correlate would be whether there are differences when you talk about the clinical data between leak, rupture, and so forth, between smooth and textured, for example.
Does the textured have less of the stronger mechanical properties, for example, than the smooth?
MR. POWELL: Actually, it has weaker, some of the break force values, however, in the fatigue test it was stronger, so it is not strictly a direct relationship with the testing that has been done.
DR. CHOTI: And is the patch a weaker area or a stronger area?
MR. POWELL: The patch is definitely the strongest area on the implant, and it is the same for both.
DR. BOULWARE: Dr. Whalen, I would like to ask a question.
Am I interpreting your gel bleed data correctly, 0.0012 gram/square centimeter/week, so if I extrapolate that out for 52 weeks, about 0.1 gram/square centimeter, and assuming that it's about 6 inches across, two-sided, I just did it quickly here, about 150 centimeters, that is 15 grams per year bleed?
MR. POWELL: In the smallest case, the calculated value in a year would be 14 grams of gel. We have never had any implant come back from a returned device analysis that has ever had that much.
DR. BOULWARE: One more question. The permeability to water for the envelope, is it permeable at all to water?
MR. POWELL: It is permeable to water vapor, but permeable to water, I don't believe that is measurable. Dr. Brook?
DR. BROOK: No.
DR. MANNO: On these numbers you are giving as normalized diffusion rates, I have noticed that you have given a single number, but should you not have associated something like a standard deviation in there someplace or a standard error, or a range of responses? This is normally how it is done in the biological community rather than the straight chemical community.
Secondly, I would go along with the earlier question concerning having tested this, it's fine to test it at 25, but if you really want to see how it is going to work and you don't want to have to stand there and make a reference, that there is no clinical relevance here with this or correlation, then, it should have been done, I would think, at 37 degrees, which would be body temperature.
MR. POWELL: Thank you. Again, this is following the ASTM methodology, which is fairly precise in the way they want it calculated.
DR. MANNO: I would suggest that when you are looking at guidelines in developing a device and you are looking at safety, when guidelines should be considered to be a minimum requirement for testing, and anything else, while it may be costly and you may not think much of it, it is certainly icing on the cake to give us more to work with safetywise.
MS. BROWN: That leads to a question that I had. Were you following or what was your understanding of the guidance that you were supposed to be using for the testing, is it the breast implant guidance?
MR. POWELL: Yes, it was the FDA guidance that we were following.
MS. BROWN: Okay.
DR. OLDING: Michael Olding. I just want to back up for a second. You said this is the worst case scenario, and backing up to the mechanical evaluations, one would be surprised, given that information, that there would ever be a ruptured implant, but those values are really on just implanted implants, if you can relate them clinically, is that correct?
They were obviously not in vivo, but they could have been removed after they had been in at a year or two and tested, so that it would have been more clinically relevant?
MR. POWELL: Yes. We have accelerated shelf life studies that compare implants right after sterilization to those that would be on the shelf for five years, and find that the physical properties are not at all compromised in those particular comparisons.
Then, in the initial retrieval analysis, looking at in vivo testing that we are doing, we find also that at this point, with the sampling that we have, that the physical shell strength requirements also have not diminished with the samples that we have tested in the retrieval program.
DR. OLDING: How far out is that?
MR. POWELL: The retrieval program has tested samples up to 11 years, but it right now is a small distribution.
DR. OLDING: Thank you.
DR. LEITCH: Could I use more clarification about the bleed? It sounds like on your retrieval studies, you have verified that the bleed rate has not ever been to this extent, the 14 grams per year?
MR. POWELL: Correct.
DR. LEITCH: So, what is it?
MR. POWELL: What we evaluate when we have a returned product that comes back, we will look at the weight of the implant, we will weigh it and we will see if it's within the specifications for that implant, which is within 5 grams of the specified volume.
To my knowledge, we have never had an implant--
DR. LEITCH: So, you have never had one that has been more than 5 grams difference?
MR. POWELL: No, ma'am.
DR. LEITCH: Like how many would that be that you have looked at?
MR. POWELL: In the report that we submitted, we had 339 returned implants back.
DR. CONANT: Another quick question about gel bleed or the reverse, the solubility or the entry of things into the implant, how do you explain, with aging implants, the change of the internal contents, the opacifications, sometimes on imaging we may see water droplets or presumably serum within--suggesting that things are also getting in as things are getting out?
Have you noticed that in your retrieval program, they look different? I think we saw images this morning also of it.
MR. POWELL: There is a tendency, I believe--and, Dr. Brook, maybe you can help me with the potential for colorization of the implants?
DR. BROOK: When one exposes any material to a complicated environment, everything is going to be soluble to different degrees, so, for example, alcohol in water are infinitely soluble in water, whereas, sand in water, sand doesn't dissolve very well in the water.
So, those are the kinds of things that we also see with implants. Essentially, this outer layer is a membrane, and it's acting to prohibit some transport at some level, so that the rule of thumb is that things which are similar chemically, typically dissolve in one another.
So, for example, lipids might be anticipated to dissolve to a better degree in the silicone than would water, for example. So, I don't know the answer specifically with Inamed, is it like that some lipids cross that membrane that go into the gel, yes, the answer is that there is going to be a higher solubility of lipids.
Similarly, I should come back to this question of water. Absolutes are very dangerous. Small amounts of water are likely to go into the inside of the implant. The converse, the solubility of silicones in water is about 12 parts per million. It will be sort of comparable the other way around - small amounts can transform either in the gaseous form or in the liquid form.
So, this is a membrane that is trying to keep the two parts of the body and the gel apart, but it doesn't work perfectly. It is extremely difficult to design a barrier that is a true barrier for everything, so there will be some transport in both directions.
DR. MILLER: Could I ask one question, too? Do you have any theoretical calculation that could tell us, in the in vivo environment, what the bleed rate would be based upon the numbers that you get in your tests?
MR. POWELL: No, I do not.
DR. MILLER: Is it something that is possible to do, to make a theoretical calculation like that, or is that something that you just can't do?
DR. BROOK: I don't think so. I mean first of all, this is my personal opinion, essentially, everybody is slightly different, what is the exact local environment, could you come up with a dummy solution that would be a very good mimic.
DR. MILLER: Well, a physiologic solution of some kind, just an idealized solution, could you just put the numbers in a chemical, you know, some kind of equation for analysis and calculate what the bleed rate would be based upon these worst case scenario bleed rates?
DR. BROOK: My opinion is that it would be very difficult to try and do that. Among other things, the environment around the implant is changing with time as you start to build up a capsule, and so at which point do you want to try and mimic the local environment.
I guess by doing these tests into silicone itself, you know what the upper limit is, if you did it into saline, you probably would be able to measure, if you could, what the lower limit is, and it will be somewhere in the middle in vivo. But I don't know of any way to calculate that.
I guess since we are out 40 years and people have been worried about this for a long period of time, I am not the only one who has been unable to come up with a reliable test to get at that number in vivo.
MR. POWELL: So, just in summary, the preclinical evaluations performed in accordance to the FDA's guidance document demonstrates that the silicone gel-filled implant materials meet the physical property specifications for breast implants and the biocompatibility of silicone breast implants.
I will now turn the presentation over to Ms. JoAnn Kuhne for the clinical discussion.
DR. WHALEN: During that transition, let me just say to the panel members without any regard to where we stand on our schedule, I would like to strongly encourage the greatest possible scrutiny over both this presentation and FDA's. I don't want to restrict it in the least.
However, I think it might make sense from a flow point of view that we let Ms. Kuhne and then each of the FDA presenters, or whoever is representing Ms. Kuhne, do their entire presentation, make notations of what questions you want to ask, and at the conclusion, at their own respective conclusions, we will take breaks and then ask some questions.
MS. KUHNE: Good afternoon. I am JoAnn Kuhne, Senior Director of Regulatory and Clinical Affairs, and I do have a financial interest in the company.
First, I would like to address the key clinical findings from our ongoing clinical trials. From my presentation, you will note that Inamed's clinical data demonstrate safety and effectiveness of McGhan silicone gel- filled breast implants.
General patient satisfaction ranged from 89 percent in the revision cohort to 96 percent in the augmentation cohort with revision patient satisfaction falling within this range at 93 percent.
There were lower rates for most complications for Inamed's silicone-filled breast implants as compared to Inamed's FDA-approved saline-filled breast implants.
Now, let me briefly introduce what I will be discussing for the next 40 minutes. My remarks will encompass the scope of our clinical studies, the safety results obtained, the effectiveness results, comparison of the complication rates between the silicone gel-filled implants that are the subject of this PMA and our saline breast implants that have been FDA-approved for over three years.
In addition, some highlights from published peer-reviewed clinical research, and finally, the conclusions from our prospective clinical trials.
Now, for a brief overview of the three main studies Inamed has conducted on silicone gel-filled breast implants, which I may also refer to throughout the presentation as gel implants.
All three studies were prospective, multi-center trials, but the most comprehensive clinical trial, and the one that will be the primary focus of my presentation here today, is the core study. The core study provided the primary data for this PMA submission.
The study allows for evaluation of both safety and effectiveness of the gel implants. Our results include complete two-year follow-up data, as well as partial three-year data for those patients who have already returned for their three-year visit.
The study includes women in three cohorts or groups with approximately 50 percent in the augmentation group, 25 percent in reconstruction, and 25 percent in the revision group.
The adjunct study is a large ongoing safety study that also includes both reconstruction and select revision patients with a current enrollment of over 25,000 patients.
The AR90 was a five-year study which included a small sample size of both augmentation and reconstruction patients.
For a quick look at the scope of the three studies, we can see that the core study was initiated in 1999 and enrolled 940 patients. Patients are currently being seen for their three- and four-year follow-up visits.
The core study protocol is designed to provide for 10 years of clinical follow-up.
The adjunct study began in 1997 and continues to enroll new patients.
The AR90 study began in 1990 and was completed after five years of follow-up.
Our long-term post-approval studies for our core clinical study patients, should we receive PMA approval, consists of two phases. The first phase involves continuing to collect patient data via direct physician evaluation through five years post-implantation.
This phase also includes obtaining MRIs through five years on the patients enrolled in the serial MRI portion of the study.
Phase II of our proposed post-approval plan involves continuing to follow up on these patients through 10 years via mailed surveys. We have many measures in place to assure high compliance in mailed survey studies, such as premailings and follow-up reminder letters, as well as phone calls.
Now, for more detail regarding the core study, which again is a prospective, multi-center clinical trial involving 940 patients enrolled at over 50 sites nationwide.
Patients enrolled into the core clinical study with three different indications - augmentation, reconstruction, and revision.
Augmentation patients are those patients who seek breast implantation, reconstruction, and revision. Augmentation patients are those patients who seek breast implantation to enhance the size and/or shape of their breasts.
Reconstruction patients are women in whom one or both breasts are reconstructed after illness or injury. The majority of reconstruction patients choose to have breast implants placed after a mastectomy to treat breast cancer.
Revision patients are patients who receive breast implants in a previous augmentation or reconstruction surgery and are having them replaced either due to cosmetic or complication reasons.
The following slide show results of the augmentation and reconstruction procedures.
This slide shows the before and after results of a cosmetic augmentation with McGhan style 45 silicone-filled breast implants. The patient was unsatisfied with the appearance of her breasts and opted for breast implants to enhance their shape and size.
This slide shows the staged reconstruction results of a patient with McGhan style 10 silicone-filled breast implants. The patient previously underwent a bilateral mastectomy and desired to regain her shape.
The picture in the top left shows this patient pre-mastectomy. Moving directly to the right, we see the patient post-mastectomy after placement of tissue expanders.
The bottom left slide shows the patient after placement of breast implants, and immediately to the right, we see this patient approximately one year postoperatively.
Again, the revision indication refers to those patients who have had previous augmentation or reconstruction breast implant surgery and have their implants removed and replaced either due to choice or complications.
Now, for a description of the patient population. We see that the median age for augmentation patients is 34 years with those patients in the reconstruction and revision groups being somewhat older.
Most of the women in this study are Caucasian and approximately half or more in each group are married.
For augmentation patients, over 90 percent of the implants used were round with a smooth surface somewhat more common than textured. In reconstruction patients, 65 percent of the devices used were the textured shaped implants. Round implants were more common in revision patients with 71 percent choosing round devices fairly evenly split between smooth and textured surfaces.
High compliance rates have been maintained throughout the study with 90 percent of augmentation patients returning for their two-year follow-up visit, 95 percent of reconstruction patients, and 87 percent of revision patients.
Compliance rates are similar for our partial three-year data.
Turning to the safety results.
The complications we collected include reoperation, implant removal also referred to as explant or explantation with or without implant placement, rupture, capsular contracture, infection, and a number of others which we will discuss in greater detail shortly.
The data are based on physical assessment of the patient through a physical exam. The method used to analyze these complications at three years was a cumulative risk analysis based on the Kaplan-Meier product limit method. This is the same method that was used for the analysis and presentation of our data for Inamed's FDA-approved saline-filled breast implants.
Our protocol was designed to collect data on more than 30 different complications, all of which can be grouped into the following three categories: general breast surgery complications, breast implant related, cosmetic complications, and breast implant related, non-cosmetic complications.
General breast surgery complications are defined as complications which are related to breast surgery in general regardless of whether the surgery involves breast implants. This category includes surgery-related complications, such as breast pain, swelling, infection, and tissue or skin necrosis.
In the general breast surgery category, breast pain and swelling each occurred 7 percent or less in all cohorts. All other complications occurred at less than 5 percent. As you can see, infection ranged from 0.2 percent to 2.3 percent in the three cohorts, and tissue, skin necrosis ranged from 0.2 percent in the augmentation group to 4.3 percent in the reconstruction group with the revision rate falling in between.
Breast implant related cosmetic complications are defined as complications resulting from the breast implant surgery which are strictly related to the cosmetic appearance of the breast.
This category contains the following cosmetic complications: Asymmetry, implant palpability, visibility, implant malposition, and wrinkling.
In the cosmetic category, asymmetry is 2.8 percent for augmentation, 15 percent for reconstruction, and 5 percent for revision. Asymmetry could be expected to be higher in the reconstruction group because 37 percent of this group underwent only unilateral implantation.
All other complications are 5 percent or less in all groups with wrinkling ranging from 0.7 percent to 5 percent, and implant malposition ranging from 3 percent to 5 percent. Implant palpability is 2 percent or less in all groups.
Breast implant related non-cosmetic complications are defined as complications occurring as a result of the breast implant surgery which are not considered strictly cosmetic in nature. This category includes the following non-cosmetic complications: capsular contracture, implant rupture, capsule calcification, and implant extrusion.
For the non-cosmetic complications, capsular contracture is 8 percent for augmentation, 16 percent for reconstruction, and 9.8 percent for revision. Rupture is 1 percent for augmentation, 6 percent for reconstruction, and 3.6 percent for revision.
Both capsule calcification and implant extrusion are less than 1 percent in all cohorts.
Regarding other complications in the core clinical study, silent rupture, meaning patients who may have experienced a ruptured implant, but have no physical symptoms of a rupture, was studies via a subgroup of 351 patients who are undergoing postoperative serial magnetic resonance imaging or MRI.
These patients underwent routine MRI every two years. Of the 597 implants, 317 patients that have undergone at least 1 MRI in the serial MRI portion of the study with 170 implants having undergone 2 MRIs, 15 implants have been classified as having a silent rupture.
The calculated Kaplan-Meier risk of silent rupture is 2.7 percent at three years. The risk of 2.7 percent includes 2 out of the 15 implants that have been classified as indeterminate for implant rupture meaning it has not been confirmed that these two implants are actually ruptured.
It is important to note that because the patients are not experiencing any symptoms or adverse events related to the implant, some physicians do not recommend removing the implants that may have ruptured silently.
Now, we will be presenting the reoperation findings from the core clinical study. It is important to note that reoperation is not synonymous with implant removal or explantation. Instead, reoperation means any surgery that occurs after implantation.
As you can see on this slide, the three-year risk of reoperation was 20.6 percent in the augmentation group, 45.9 percent in reconstruction, and 33.4 percent for revision. Many different types of procedures are formed during reoperations as will be seen in the next slide.
Presented here are some examples of the types of procedures performed during reoperation, such as aspiration, biopsy, capsule procedures, flap or pocket revision, mastopexy, and nipple procedure.
As shown next in this list, removal/replacement of an implant is just one of the many types of procedures performed during a reoperation. Reposition implant and scar revision, wound repair are some of the last examples of possible procedures performed during a reoperation.
Of all these procedures listed for reoperations, the most common were capsule procedures. A capsule procedure involves removal, suturing, or position manipulation of the capsule that forms around the implant.
Within the augmentation group, 19 percent or 94 of the 494 patients underwent a reoperation. Of the 94 patients who had a reoperation, 32 had an implant removed for a total of 60 explants.
As seen in the pie chart on the left, of the 60 implants that were removed in the augmentation group, many were removed to treat capsular contracture; 18 were due to patient choice for a different size or style implant, and another 11 implants were removed for cosmetic complications, such as asymmetry or implant malposition.
The pie chart on the right shows that the majority of explants, 39 out of 60, were replaced with another silicone gel-filled implant, and only 9 or 15 percent were not replaced. Twelve explants were replaced with other breast implants that are not part of this study, for example, with gel-filled implants that are part of another study or with saline-filled breast implants.
Another significant finding was that upon explantation of these devices, there were no findings of extracapsular gel. These means that during the removal of these 60 breast implants, none of the physicians found that gel had migrated outside the capsule. This is consistent with feedback we received from plastic surgeons in general who indicate that it is not common to find extracapsular gel when removing an implant.
Forty-two percent or 92 of the 221 reconstruction patients had a reoperation. Of the 92 patients who had a reoperation, 46 patients had an implant removed for a total of 56 explants.
As shown in the pie chart on the left, of the 56 implants that were removed in the reconstruction group, 4 were due to patient choice for a different style or size implant, while 27 were removed to treat an unsatisfactory cosmetic result, such as asymmetry.
The pie chart on the right shows the majority, 45 explants were replaced with another gel implant, and only 9 percent or 5 explants were not replaced.
Furthermore, there were no findings of extracapsular gel during any of the explant procedures. This means that during the removal of these 56 devices, none of the physicians found that gel had migrated outside the capsule. This is also consistent with our augmentation group. You will see in the next slides that our revision cohort did not experience any extracapsular gel either.
Thirty-one percent or 70 out of the 225 patients in the revision group underwent a reoperation. Of the 70 patients who had a reoperation, 29 had an implant removed for a total of 46 explants.
Of the 46 explants that were removed in 29 patients in the revision group, many were due to patient choice for replacement with a different size or style implant or for an unsatisfactory cosmetic result, such as malposition, ptosis, or scarring.
The chart on the right shows that 29 implants or 63 percent were replaced with another gel implant. Again, there were no findings of extracapsular gel at the time of explantation of the 46 devices.
To reiterate, in this large controlled clinical trial, we see that none of the 162 implants removed showed gel outside the capsule formation upon implant removal. Plastic surgeons have shared with us that extracapsular gel is not a common event and is usually associated with a traumatic injury, such as a car accident or closed capsulotomy, which is a procedure that is not as common today as it used to be.
However, it is important to note that if the surgeon had observed extracapsular gel, it is expected that the gel would have remained at the site as demonstrated in our preclinical experiments where free gel was injected into experimental rats and stayed at the site of injection.
Moving on to other evaluations of safety - breast cancer, connective tissue disease, autoimmune disease, lactation, and reproduction.
In the augmentation group, there was one report of breast cancer post-implantation. Reconstruction had 5 reports and revision had zero reports. It is important to note that all the reconstruction patients with post-implant breast cancer also had pre-implant breast cancer with 2 of these patients experiencing recurrent breast cancer in the same breast.
Of the 494 augmentation patients, there was one diagnosis of rheumatoid arthritis at 11 months postoperatively. Of the 221 reconstruction patients, there was one diagnosis of systemic sclerosis/scleroderma at four months postoperatively. Of the 225 revision patients, there was one diagnosis of fibromyalgia at 11 months postoperatively.
These connective tissue diseases occurred in less than one-half of 1 percent of all patients in the study.
In the augmentation group, there were 5 reports of lactation problems primarily mastitis and inadequate milk production, and 8 reports of reproductive problems primarily spontaneous abortions. One of these 8 patients had a planned abortion to treat a medical problem pre-implant and experienced a miscarriage post-implant.
Reconstruction had no lactation problems and 2 reported reproductive problems. One patient experienced a miscarriage pre-implant and no menses post-implant.
Revision had 4 lactation problems, the majority of which were inadequate milk production postoperatively, and 6 reproductive problems mainly spontaneous abortions and infertility. Two of these 6 patients experienced infertility both pre- and post-implant.
For the effectiveness results.
Now, I will review the various components of our effectiveness results. Besides the endpoint related to increasing the breast mound, we examined three different measures: patient motivation, patient satisfaction, and psychosocial changes.
Within our satisfaction measures, we captured general patient satisfaction at follow-up and patient satisfaction with the size and shape of the breast pre- and post-implantation.
Within our psychosocial measures, we captured information pre- and post-implantation to assess any change in women's expectations of their breast implant surgery, self-esteem, and quality of life.
One of the areas we explored was patient motivation for implant surgery. Therefore, we asked patients to rate their motivations prior to implantation. As the side shows, the vast majority of women were motivated to improve the way they felt about themselves or make them feel better about their physical appearance.
It is interesting to note that motivations regarding partners and/or sex life were not a strong motivating factor for most of these patients.
Patient satisfaction was extremely high with one year rates at 96 percent for augmentation, 94 percent for reconstruction, and 87 percent for revision. Satisfaction was 96 percent, 93 percent, and 89 percent respectively two years after implantation.
When measuring patient satisfaction with breast size and shape at baseline and at the two-year follow-up, a significant positive change was observed in all three cohorts or groups.
In terms of patient's psychosocial changes, a questionnaire was developed by Dr. Julia Roland, the director of the National Cancer Institute's Office of Cancer Survivorship. This questionnaire was used to observe the pre-implant versus two years post-implant changes in general psychosocial concepts.
This graph shows that self-image increased significantly in the augmentation and revision cohorts postoperatively while it remained constant in the reconstruction cohort.
On the improved social relations subscale, there was a positive increase in all three groups.
For the Tennessee Self-Concept Scale, scores for all patients started high and despite any postoperative complications that may have occurred, remained high. The scores show no change in the augmentation and reconstruction groups pre- versus two years postoperatively.
We observed a statistically significant decrease at two years post-implantation in the way revision patients scored on this measure. This measure included aspects of how patients viewed their bodies and state of health, skills, their attitude about appearance, and sexuality.
Similarly, the scores were high both preoperatively and two years postoperatively for the Rosenberg Self-Esteem Scale. The scale provides for a maximum score of 40.
The scores obtained revealed a statistically significant decrease two years post-implantation in self-esteem for revision patients, whereas, no significant self-esteem changes were found in the other groups.
Additional information was collected using the Body Esteem Scale. This scale measures body image based on three subscales. These subscales are sexual attractiveness, weight concern, and physical condition.
The bar charts show the changes observed in the total score in the sexual attractiveness subscale. The bar charts on the left show that the total score does not change significantly in any of the groups, and the bar chart on the right shows significant increase in the sexual attractiveness scale in the augmentation cohort.
Various SF-36 scales were measured. In all cases, the quality of life scores remained well above those of the general U.S. female population both at baseline and at two years. Although scores started high and there were no major changes overall, some of the individual measures decreased postoperatively.
This may be attributed to ceiling effects seen at baseline, for example, 65 percent of the patients in the augmentation cohort scored 100 preoperatively, which is the maximum score indicating best possible quality of life at baseline for the role limitations due to physical health problems measure.
Therefore, this 65 percent of the patients could not have had any increase postoperatively because they were already at maximum score preoperatively.
In the next few slides, I will discuss the comparison of our current three-year core study complication rates to the three-year complication rates reported for Inamed's FDA-approved saline-filled breast implants which have been commercially marketed since May 2000.
The protocol for the saline study was very similar to the current core gel study with similar endpoints collected and similar follow-up intervals. In addition, many of the investigational sites in the saline study are also enrolled in the core gel study.
You will note that the complication rates for the silicone gel-filled breast implants that are the subject of this current PMA we are discussing today are comparable and, in many cases, lower than those same complications for our already PMA-approved saline-filled breast implants.
For the augmentation groups, all complications with risks greater than or equal to 5 percent in either the current gel-filled breast implants or Inamed's previously FDA-approved saline-filled breast implants are listed.
All the complications that showed gel-filled breast implants with a lower complication rate than those found in the saline study are noted in yellow. Almost two-thirds of the risks shown associated with breast implant surgery are considerably lower for gel-filled breast implants versus saline-filled implants.
For instance, we see that wrinkling in our gel patients occurs at 0.7 percent at 3 years, which is less than one-tenth of the risk of wrinkling in our patients with FDA-approved saline-filled devices.
Furthermore, implant palpability, visibility showed less than 1 percent risk with our gel-filled devices, while the risk of this complication was 9 percent with our saline-filled devices.
It is also important to note that the complication of implant malposition presented in our saline augmentation group where the risk of 8 percent is more than twice as high as the same complication in our gel-filled devices with the risk of only 3 percent.
Gel rupture is one-fifth the risk of saline deflation with gel rupture occurring at a risk of only 1.2 percent in the augmentation group.
Now, with a similar list of complication rates for the reconstruction group, we see that asymmetry at 15.3 percent with gel-filled implants is half the risk seen with saline-filled implants.
With the saline-filled implant, wrinkling and implant palpability each give a risk in the 20 percent range, while with our gel-filled devices, these two complications are dramatically lower.
Implant palpability in the gel-filled implants is only 0.5 percent. The complications of loss of nipple sensation and skin paresthesia further the evidence supporting the gel-filled breast implant safety.
In the saline-filled implant study, we saw that these risks were 12 percent and 5.6 percent respectively, but the rates for these complications in the core gel study were zero.
For the revision group, we see three complications that are displayed in yellow, indicating significant differences. All three are significantly lower with our gel-filled implants versus our saline-filled FDA-approved implants. Again, implant palpability shows a dramatically lower risk in the revision group. This complication was reduced significantly across all groups - augmentation, reconstruction, and revision.
Asymmetry and wrinkling are also significantly decreased with the use of gel-filled breast implants versus saline-filled breast implants. While the risk with saline-filled implants are over 15 percent for each of these complications, gel-filled implants provide one-third the risk at 5 percent each.
It is of interest that asymmetry and wrinkling were also significantly reduced in the augmentation and reconstruction groups showing that the gel-filled implants consistently reduced the concerns regarding asymmetry and wrinkling.
To summarize the comparison of complication rates of silicone gel-filled breast implants to Inamed's FDA-approved saline-filled breast implants, the complication safety profile for silicone gel-filled breast implants meets or exceeds the complication safety profile for saline-filled breast implants.
DR. ANDERSON: May I ask a very quick clarification question? I didn't hear you say what the follow-up time for the saline group was. We know for the gel, it is two years, but are these really comparable groups?
MS. KUHNE: These are three years to three years. This is our three-year gel data, as well as our three-year saline data.
Comparing our core study results to results reported in the medical literature, we find that with the exception of reoperation, all of the core study results fall at the low end of the rates found in other published studies with various lengths of follow-up.
To summarize, the core study, conforming to FDA guidelines, demonstrates safety and efficacy of McGhan silicone gel-filled breast implants. We see that 89 to 96 percent of all patients were satisfied at two years follow-up. Lastly, we see lower rates for most complications for Inamed's gel-filled breast implants compared to Inamed's FDA-approved saline-filled breast implants.
Examining the findings of peer-reviewed research, we have chosen to present findings from many independent reviews of published research by prestigious organizations rather than selectively citing individual published articles as you will see on the following slides.
Although these studies are not specific to Inamed's silicone gel-filled breast implants, they are representative of the body of knowledge that currently exists on silicone gel-filled breast implants relative to systemic diseases.
As a result of concerns raised in the early 1990s regarding the safety of silicone gel-filled breast implants, many government-funded agencies critically reviewed the available scientific literature concerning implants and disease.
These agencies have been consistent in finding no evidence that silicone gel-filled breast implants are a significant health risk. Without exception, they have found that silicone gel-filled breast implants do not increase the risk of breast cancer or autoimmune disease, nor do they affect the health of children born to mothers with breast implants.