Aug. 25, 2003
Health and Advocacy Groups Call on U.S. FDA to Halt Breast Implant Approval Process
Statement from Kim Gandy, President, National Organization for Women and Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group
AUGUST 25: The National Organization for Women and Public Citizen call upon the U.S. Food and Drug Administration (FDA) to suspend its consideration of lifting restrictions on the sale of silicone gel breast implants. Reuters reported August 21st that an FDA advisory panel will review, on October 14th and 15th, Inamed’s application to resume sales of the devices.
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.
On May 8th, NOW convened a panel of scientists and clinicians to review the latest research on the safety and efficacy of silicone gel breast implants. The panel included representatives of the National Institutes of Health, the FDA and the Armed Forces Institute of Pathology. The panel concluded that long-term safety has not been adequately addressed in past research, specifically regarding the likelihood of leakage, rupture, and local and regional medical problems more than several years after implantation. The panel agreed that little regard has been given to the changing physical and chemical properties of the implant materials over time.
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.
NOW and Public Citizen will continue to fight against this flawed review process, caused by inadequate follow-up of women. NOW and Public Citizen will participate in the hearings on behalf of the hundreds of thousands of women who deserve to have ALL of the facts about silicone gel breast implants.