FDA Holds Hearings on Silicone Breast Implants

After making public documents written by health regulators on the dangers of silicone breast implants to women’s health, the Food and Drug Administration (FDA) is holding hearings this week to decide whether or not to allow silicone breast implants to return to the market. According to the New York Times, the FDA documents, which reviewed data provided by silicone breast implant manufacturers Inamed Corp. and Mentor Corp., state that as many as 74 percent of women will suffer implant failures within 10 years. Currently, only women needing breast reconstruction due to diseases such as breast cancer or from other disfigurement can obtain silicone breast implants, reports Reuters. The FDA estimates that the failure rate for women undergoing reconstructive surgery is 93 percent over 10 years. The FDA is allowing for 15 hours of public testimony today, and will then meet with expert advisors before announcing a decision by April 13.

Silicone breast implants were pulled from the market in 1992 after many women reported illnesses and pain from the implants, which often ruptured, allowing silicone to travel to other parts of the body and allegedly causing repeat surgery, pain, and disfigurement. After months of pressure by women’s health advocates, the Food and Drug Administration (FDA) denied approval in January 2004 of silicone breast implants, rejecting the advice of its expert advisory panel, which had recommended approving the implants despite questions about their safety and durability.

The National Organization for Women (NOW), one of the major women’s groups which has fought approval of the implants, 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 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 will not harm women’s health.

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New York Times 4/11/05, 4/7/05; Reuters 4/6/05; Associated Press 4/7/05; Village Voice 10/22/03; National Organization for Women website 6/1/04

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