The National Organization for Women and Public Citizen Call Upon the U.S. FDA to Suspend Breast Implant Approval Process
August 25, 2003 - The following statement is from Kim Gandy, President, National Organization for Women and Dr. Sidney Wolfe, Director, Public Citizen's Health Research Group:
The National Organization for Women and Public Citizen call upon the U.S. Food and Drug Administration to suspend its consideration of lifting restrictions on the sale of silicone gel breast implants.
Inamed filed its application last December, including data from only two years of clinical trials. The FDA is using this data for its review even though its own researchers have found that problems dramatically increase seven to ten years after implantation.(1)
Because silicone gel breast implants are widely available for augmentation and reconstruction under clinical trials, there is no reason to lift restrictions on their sale until we are sure they are safe and effective.
(1) Brown et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology, 2001; 28: 996-1003.
Source: National Organization for Women; Public Citizen's Health Research Group