Myrl Jeffcoat myrlj@jps.net

29 mars, 2005 09:05

Kim Gandy Testimony - FDA Panel Hearings - October 2003

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.

We believe-

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.

Thank you.

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.