Myrl Jeffcoat myrlj@jps.net

29 mars, 2005 09:03

Dr. Martha Burke Testimony - FDA Panel Hearings - October 2003

(Sharyn Noakes testimony included)

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.