Testimony of Audrey Sheppard at the FDA on Silicone Gel Implants

Audrey Sheppard, April 2005

I have no financial conflicts.

For four years, 1996 through ’99, I directed the FDA Office of Women’s Health. As a result of my professional involvement with silicone breast implants, I regard sharing my perspective an ongoing responsibility. I hold the agency and you in high regard and am optimistic about your making scientifically sound judgments.

My role at OWH, nearly a decade ago, requested by and partnering with the Center for Device Leaders, was to champion and obtain full funding to conduct what became the critically important FDA rupture study. Its findings have resulted in a better understanding of the frequency of these devices rupturing over time.

You will be briefed — and there has been reference to it already — on the results. Suffice it to say that over time more than 65 percent of women in the study were found to have at least one ruptured implant and over 21 percent had silicone gel outside the capsule in one or both breasts. The latter finding is particularly concerning since the effect of silicone on the tissues and in development or progression of disease remains unknown.

After leaving the agency five years ago, I have advised and assisted women’s health and other women’s nonprofits and projects and from this vantage point will share three requests. One, follow the science.

Even the company’s data, which you know will put on the best face, will not dispute a significant rupture rate nor other consequences of having these devices for years. These are not lifetime devices and, as such, without regular and too frequent resurgeries are not safe and effective, as intended.

Two, pay close attention to FDA’s own documents and data. A number of documents on the CDRH Web site, including — and I have the names, but you can find them. These themselves are damning information that is based on scientific research, decades of experience, tens of thousands of adverse event reports. And it also includes disconcerting photographs.

Please don’t discount this body of material with the argument that the devices are much improved today. Make certain there is data to prove it.

And, number three, please believe your own eyes and ears when you see the dozens of sincere women whose health has been compromised standing before you. Of course, you will also hear from those who are highly satisfied. Their experience does not provide reason enough to open implants to wide use for augmentation, even by teenage girls.

To summarize, the health and well-being of some of America’s women and girls will be affected, even if they won’t know it for years to come, by your decisions.