National Organization for Women,
Before the General and Plastic Surgery Device Panel,
U.S. Food and Drug Administration,
Regarding the Pre-Marketing Application of Inamed Corporation,
Seeking Approval for the Sale of Silicone Gel-Filled Breast Implants
October 14, 2003
The National Organization for Women (NOW) is the oldest and largest feminist activist organization in the U.S., 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 represents our 501 (c) (4) incorporated entity and no other party. Our appearance here today is underwritten by our 500,000 contributing members and supporters. We have asked three researchers and clinicians who assisted at our May 8 scientific symposium and our July 21 press conference with Congressional briefing to present testimony at this hearing. They are Eugene Melmed, M.D., Medical City Hospital, Dallas, Texas; Paul Wooley, Ph.D., Wayne State University School of Medicine, Detroit, Michigan; and, Ernest Lykissa, Ph.D., Expertox Laboratories, Deer Park, Texas.
Thank you for the opportunity to present comments today on a matter of critical importance to the health of women who have silicone gel-filled breast implants and those considering getting implants in the future. With hundreds of thousands of womenfrom high schoolers to retireesseeking breast implants each year, and the number increasing each year, a dangerous product will affect the health and safety of enormous numbers of individual women.
And when substantial number of these women become ill and depend on government health care systems for medical care, the safety of their breast implants, a question you must address 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. Their stories are heart-breaking. Many report having lost not only their good health, but their husbands and partners, their jobs and even their life savings. They are in deep depression.
We have also heard of cases of suicide by these women, some of them mastectomy patients who became even more ill with their silicone breast implants than with breast cancer. These women have reported a wide variety of symptoms, ranging from fibromyalgia to lupus to rheumatoid arthritis and other serious conditions. Most cannot afford the $10,000 to 15,000 or more to have explantation surgery. They really do not know where to turn for relief from their pain and uncertainty.
Informed by the personal stories of these survivors, the assembled membership of NOW at two national conferences, 1997 and 1999, adopted resolutions urging independent research, long-term following of implant patients, and fully informed consent for all prospective breast implant patients.
This spring, on learning that the Food and Drug Administration had been asked to consider returning silicone gel-filled implants to the broad market, the National Organization for Women sponsored a symposium on May 8, convening it with more than a dozen dedicated researchers and government health officials to review recent findings about effects of silicone gel in the human body. You will be hearing from a number of the participants.
We did so 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 intimidated researchers and medical writersspending great sums of money in persuasive campaigns to mislead breast cancer patient advocacy groups and the public on breast implant safety.
Women deserve the truth. They deserve to trust what this agency tells them about the safety of products they put inside their bodies, and when the information is based on flawed and biased research, the result can be tragic.
We know that all breast implants leak, rupture and disintegrate in women's bodies over timebringing silicone gel into contact not only with tissue in the immediate vicinity, but to the lymph nodes and to distant organs like the lungs. This important research and others lay the groundwork for more advanced studieswhich many believe will conclusively demonstrate that silicone gel should never be introduced into the human body. This research must be given the opportunity to run its course before this body rushes to spread this devastation to millions more women over the next 5 years.
Findings by several of our symposium's presenters suggest that silicone gel acts as a potent adjuvant associated with specific immune responses over the long-term. These compelling data were presented by researchers Miller and O'Hanlon of the National Institutes of Environmental Health, Environmental Autoimmunity Group, where preliminary findings suggest that shared, antigen-driven T-cell responses may contribute to chronic inflammation in silicone capsules as well as at systemic sites of immune pathology. The NIEHS researchers are conducting clinical, immunogenetic and serologic studies of patients developing inflammatory muscle disease (myositis) following silicone implants. Preliminary data suggest that "Silicone may promote the development of atypical forms of systemic connective tissue disease." [Research Indicates Long-Term Risk to Women's Health Not Fully Addressed in FDA Clinical Trials: Conclusions from Symposium on the Safety and Effectiveness of Silicone Gel-Filled Breast Implants, National Organization for Women, July 21, 2003]
If these preliminary findings lead to more conclusive assessments about silicone-gel and immune system pathologies, then it will clear that silicone gel-filled breast implants are not safe over the long term.
For NOW's part, we accept Inamed's own declaration in a U.S. Patent that silicone gel is not bio-compatible with human tissue.
We have read a preliminary statement about the submissions from Inamed Corporationthough the lateness of the release of those documents makes it difficult to thoroughly review the materials. Frankly, we were shocked to see that complication rates from Inamed's own "core studies" are so high46% of reconstruction patients needing re-operation within three years, 21% re-operation rate for augmentation patients and a 33% re-operation rate for revision patientsand many of these women hadn't even been in the study for the full three years.
The poor follow-up with patients who agreed to participate in the adjunct study indicates that the quality of longer-term data is seriously lacking. These and other findings from the research submitted by Inamed Corporation lead us to urge that this application be denied. We implore the Food and Drug Administration to see that more extensive, well-designed research over a seven to 10 year period is conducted and made available to advocates and the public.
Our symposium researchers and clinicians have made numerous recommendations for further research and for improving the Food and Drug Administration's review process. These are included in a summary document that I wish to append to this statement. Thank you.
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