FDA Rejects Approval for Silicone Breast Implants

After months of pressure by women’s health advocates, the Food and Drug Administration (FDA) today announced its decision not to approve silicone gel breast implants at this time. The FDA’s decision rejected the decision of its expert advisory panel, which had recommended approving the implants despite questions about their safety and durability. The FDA will issue guidelines later Thursday for implant manufacturers such as Inamed outlining what scientific issues must be settled if the implants are to return to the market, the Associated Press reports.

Kim Gandy, the president of the National Organization for Women (NOW), one of the major women’s groups rallying against approval of the implants, said, “I found it astonishing that, with less than three years of data presented by Inamed, the [advisory] panel went ahead and recommended approving silicone implants. I am relieved to hear that the full FDA is taking the health of women more seriously.” 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 Feminist Majority Foundation joined 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, in urging the FDA to continue testing the implants to make sure they won’t harm women’s health.

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NOW press statement 1/8/04; Associated Press 1/8/04; Feminist Daily News

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