Myrl Jeffcoat myrlj@jps.net

1 mai, 2005 09:29

MS. GANDY: Good afternoon. My name is Kim Gandy, and I am President of the National Organization for Women. NOW is the oldest and largest women's rights activist organization in the United States, advocating for women's equal rights, economic and social well-being, and for women's health.

The National Organization for Women and myself represent only our own 501(c)(4) nonprofit organization. And my appearance today is underwritten by our 550,000 members and contributing supporters.

To be blunt, it's disappointing that we find ourselves here today. Just last year, the Food and Drug Administration made it clear that there was insufficient long-term safety data on silicone gel breast implants. And here you are again, and here we are again reviewing another petition for market approval, a little more than a year later, still without long-term safety data.

What sort of message is the Food and Drug Administration sending to the public and to industry petitioners when it backs down so quickly on its demands for patient safety? Inamed's less than four years of data is not sufficient to demonstrate long-term safety.

FDA reviewers agree that little can be learned about rupture and other aspects from studies of such short duration. And, indeed, the company's data that has been reviewed by the agency shows substantial evidence that these devices are not safe for women.

The agency reviewers estimate that between 74 percent and 93 percent of the implants under study will rupture within 10 years. Those projects and the absence of sufficient clinical data are solid reasons to recommend against allowing these implants to be marketed generally.

Aside from the prospect of frequent implant rupture, there is the equally serious problem of slow leakage. Silicone particles and chemicals from the implants can and do seep into the body. Inamed's own data submitted for the 2003 panel reported significant problems with silent rupture, local complications, connective tissue disorder signs and symptoms, and

reoperations. There are too few properly designed studies that have been conducted to determine exactly what effect silicone gel has on human physiology.

Especially troublesome to us is the lack of knowledge about the effect of the chemical constituents of silicone gel in pregnant women on the developing fetus and lack of information about the transmission of potentially harmful substances to breast?feeding infants through breast milk, all of which are items that we recommended last year for inclusion in

guidance to the industry for further study. Such studies should also include following children born to women with silicone gel implants to evaluate health or developmental problems resulting from exposure in utero or exposure through breast milk.

Another area of concern relates to the difficulties that these implants pose for accurate mammogram readings. According to a five-year evaluation of seven mammography centers involving thousands of mammograms, breast implants obscure and greatly reduce the accuracy of mammogram readings.

As reported in the Journal of the American Medical Association, 55 percent of breast cancers in this study went undetected in women with breast implants. That's 67 percent greater than the number that went undetected in women without implants.

Our national commitment to reduce the incidence of breast cancer could be undermined by the implant industry's media campaign to sell more implants. And the dramatically higher rate of implant rupture and complications experienced by post?mastectomy as compared to augmentation patients seems a cruel consequence for women who have survived a life?threatening battle with breast cancer.

This panel has already heard and will continue to hear the heartbreaking stories of women who became seriously debilitated after receiving breast implants. Many of these women can no longer work or take care of their families due to grave health problems.

Stories exactly like this from NOW members is what started our inquiry into this issue three years ago. I urge the panel members to consider how the availability of well?based long?term clinical data and an effective regulatory process could have changed these women's lives.

These women are asking the FDA to take responsibility for regulating an industry that cannot or will not regulate itself. In this specific instance, reneging on the reasonable requirements required last year in approving these implants could result in devastating health consequences.

Such a public health catastrophe is preventable, and women are counting on you to prevent it.

Thank you.

MEMBER MILLER: Dr. Choti?

CHAIRMAN CHOTI: A question. Dr. Miller?

MEMBER MILLER: May I ask a question, Ms. Gandy? I appreciate hearing from you today. I'm curious. You know, your organization is funded by gifts, I believe, charitable types of gifts. Do you have any idea what percent of the gifts that you receive are related to this issue on your annual giving?

I assume women are --

MS. GANDY: A fraction.

MEMBER MILLER: There are many people in the country who --

MS. GANDY: I think a fraction of a percent. We have a women's health project that occasionally gets dedicated gifts. I think the largest grant our women's health project has received in many years was about $300,000 for the work that we did on tobacco, tobacco use in women.

MEMBER MILLER: So do you have any way to determine the specific concerns of those who decide to support your organization in terms of whether they're concerned about one issue or this issue? Is there any way to determine that in how you organize yourself?

MS. GANDY: No. I mean, not in terms of our individual contributions. We are about a $5 million organization, and over 99 percent of our income comes from gifts from individual members, $5,000 and under.

They are average gift organizationally. If you add it all up and divide it by the total number of gifts, our average gift is about $42.

MEMBER MILLER: Okay. All right. Thank you.