Myrl Jeffcoat myrlj@jps.net

1 mai, 2005 09:29

MS. JAMES: Good afternoon. My name is Diane James. And I am here today on behalf of the Jacobs Institute of Women's Health. We are not supported by anyone with a inancial interest in this matter.

The Jacobs mission is to promote excellence in women's health by studying the nteraction of medical and social systems, facilitating informed dialogue and awareness mong consumer and health providers and promoting problem resolution and information dissemination of key issues. It is from this perspective that the questions surrounding availability of silicone breast implants are important to the institute.

The regulation history of breast implants is long and complex. Following decisions made in the 1990s, use of silicone gel implants has only been permitted among women who have been part of adjunct studies. The limitation on use of these implants has been the result of numerous unanswered questions; in particular, questions regarding long-term safety. These questions mandate carefully executed studies to acquire the data needed for approval.

Now in 2005, this distinguished panel has been assembled to determine once again whether questions related to the safety and effectiveness of silicone gel implants from Inamed and Mentor have been adequately investigated and if the accumulated data answer the safety questions sufficiently.

The panel must determine whether the current data available for review are sufficient to provide practicing physicians with the information they need in order to recommend these breast implants and have confidence that their use will not cause harm to their patients.

Physicians and other health care providers must know that the benefits far outweigh the risks for an elective procedure requested by women who often are young and in good physical health. The data must also be sufficient to provide women contemplating breast implants with the information they need in order to make a truly informed decision.

What are the key questions for which a physician must have answers? These have been outlined in the guidance document issued by FDA on January 13th, 2004. But clearly of prime importance is the question regarding complication rates. Has the longstanding issue of implant rupture during the lifetime of these devices been adequately addressed in the core study?

Preliminary estimates from reviewers released to the public late last week suggest that the rate of rupture of silicone implants within 10 years for women having reconstructive surgery may be as high as 93 percent. Among women undergoing breast implant surgery for other cosmetic reasons, the rate may be as high as 74 percent.

This ten-year estimate obviously includes women whose implants will rupture long before ten years and raises questions about appropriate ongoing surveillance and diagnostic testing that will be required at regular intervals.

It also raises questions about who will pay for this surveillance. What percentage of women will be able to afford appropriate diagnostic tests and even further surgeries should health care coverage be unavailable for what is generally categorized as an elective cosmetic procedure.

Imbedded in this critical safety issue is the persistent question of what happens to the silicone when the silicone implants from Inamed and Mentor rupture. Are there adverse health effects from the ruptures, either local or systemic?

While an IOM committee in 1999 determined that there was little evidence that silicone implants caused connective tissue disease, we must keep in mind that this conclusion was based largely on retrospective data from the nurses' health study and from a case-controlled database from the Mayo Clinic.

Because of the study limitations related to the size and types of studies used, the true risk of these conditions cannot be precisely estimated. There may still be a small but significant increased risk of some forms of connective tissue disease associated with the silicone implants under review.

>From the patient's perspective, it will be vital for physicians to have these answers in order to openly and honestly discuss the risks and benefits of this procedure.

Women must be informed regarding the expected incidence of rupture and what rupture may mean in terms of the need for repeat surgeries. They need to know about the process for removing gel-filled implants following rupture, discomfort they may experience, and the potential long-term health consequences should silicone gel leak. Women must also have this information presented to them in a clear and concise fashion that is part of the informed consent process itself.

The Jacobs Institute is concerned about the existing process and urges the Committee to consider this in their deliberations. These concerns arise from examining current saline breast implant patient brochures provided by industry.

Subjected to a Fry analysis used by reading experts and those committed to following clear health communication principles, as advocated by the Surgeon General and the DHHS, this written information cannot be easily understood by the majority of audiences in the United States.

According to the Fry analysis, the 42-page brochure reviewed is clearly written for college-level individuals. This means women who are not able to read health information at the college level will not be able to fully comprehend the information provided.

We urge the Committee and the FDA to be certain that educational materials describing risks and benefits are written at a level that most women will understand.

In closing, we urge you, the Committee, to consider carefully the safety and effectiveness requirement that Congress has mandated to the FDA in determining whether devices should be permitted on the market.

Thank you for this opportunity.