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)

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, 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 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.

(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

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