Statement by Sybil Niden Goldrich, Command Trust Network on FDA Panel Tentatively Set for Silicone Gel Breast Implants in April 2005

Business Wire, Dec 6, 2004

LOS ANGELES -- Goldrich is responding to announcements today by the Mentor and Inamed Corporations that the FDA has tentatively set a panel date to review silicone gel breast implants. Inamed also announced that it had submitted its documentation for approval of a new type of cohesive gel silicone breast implant.

I am personally appalled that the FDA would announce that it was taking this controversial device to panel in the midst of the Vioxx scare. Broken breast implants have mutilated many tens of thousands of women specifically because the review process at the FDA better accommodates industry than patient health. Breast implants are, quite simply, the Vioxx of medical device industry.

Last year, the agency had an attack of good sense and called for stringent additional research to examine the high product failure problems with breast implants. Yet we have not heard one word about any new research, or about new standards for research. If the FDA goes to panel in April, it will be reviewing a product without having set the standards for that review - clearly, once again putting the cart before the horse and the needs of industry before the health needs of American women.

The Inamed submission for consideration of a new cohesive silicone gel implant further underscores this cozy industry relationship. This device has been in clinical trials for barely two years. We know from FDA's own research that the latency period for harm from silicone breast implants is seven to ten years. Yet the manufacturers seem to believe the agency will take their submission seriously based on just a few years of clinical trial data.