Dear FDA Commissioner Mark McClellan
I am writing to express my concern about the new Inamed silicone gel breast implant that the FDA is considering approving. I am extremely concerned about the safety and effectiveness of this new silicone implant. Women have had serious health problem with silicone gel implants in the past. And many of the problems that women have had with silicone implants do not appear until six, seven or even more years after implantation. Finally, the long-term health effects of silicone gel in the body have not been adequately studied.
It is my understanding that Inamed will not be required to provide long-term safety data on this new implant. Silicone gel breast implants were pulled from the market in 1992 due to a lack of long-term safety data, and we still do not have that much needed information. Why rush to approve a device that may pose serious health risks without long-term safety data.
I urge the FDA to require Inamed or any company seeking approval of a silicone gel breast implant to conduct studies on the long-term health effects of any new silicone gel breast implants before approving them. So many women have been hurt by silicone gel implants in the past. The FDA has the power to act now to prevent a new generation of women from experiencing the same harm.
cc: David Feigal, Director Center for Devices and Radiological Health, David Feigal
cc: Susan Wood, Director Office of Women's Health Susan Wood