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FDA Panel Recommends Approval of Silicone Implants

An independent advisory panel recommended that the Food and Drug Administration (FDA) end restrictions on silicone gel breast implants, with some conditions imposed on the manufacturers. Despite acknowledging that the implants have a tendency to rupture and that there are no long-term studies on the effects of silicone in the body, the panel voted 9 to 6 to put the implants back on the market, according to the Los Angeles Times. In fact, the panel based its recommendations on a two-year study conducted by an implant manufacturer, Inamed Corp. “The FDA is examining less than three years of clinical trial data, yet the FDA’s own researchers have previously noted in published studies that problems with breast implants dramatically increase at, on average, seven to 10 years post-implantation,” said Kim Gandy, president of the National Organization for Women (NOW).

NOW and other women’s health groups have been pushing for the FDA to delay a decision on the implants until long-term studies are conducted on silicone’s effects on women’s bodies. The implants were pulled from the market in 1992 after many women reported illnesses and pain from the implants, which often broke open, causing repeat surgery, pain, and disfigurement.

The FDA usually follows the lead of advisory panels, but it is not required to do so. In fact, FDA scientists told members of the advisory panel that they were still concerned about the long-term health impacts of silicone implants, the Times reports. The Feminist Majority Foundation joins NOW and other advocacy groups, including In the Know, Breast Cancer Action, Public Citizen, National Council of Women’s Organizations, the National Silicone Implant Foundation, and other groups in urging the FDA to continue testing the implants to make sure they won’t harm women’s health.

TAKE ACTION with NOW to tell the FDA to delay approval until silicone breast implant safety is proven

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Sources:

LA Times 10/16/03; NOW 10/10/03; Feminist Daily News Wire

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