FDA Issues ‘Approvable’ Letter for Silicone Breast Implants

Despite safety concerns, the Food and Drug Administration (FDA) has preliminarily approved the sale of silicone breast implants made by Mentor Corporation. Due to widespread reports of women experiencing illnesses and pain from ruptured and leaky implants, in 1992 the FDA banned the use of silicone implants except in cases of reconstructive surgery. According to Sybil Goldrich, Executive Director of the Command Trust Network: National Breast Implant Information Clearinghouse, nearly all silicone breast implants eventually rupture and spread to other parts of the body, with half of implants failing in 10 years and three-quarters in 20 years.

The FDA’s approvable letter to Mentor Corporation calls for the company to meet certain conditions, including the stipulation that the company continue long-term studies on the implants’ safety and the requirement that the company undergo an independent annual review of its safety data. However, as women’s health organizations point out, the FDA not only lacks the power to ensure compliance with these conditions but studies conducted after approval will provide little in the way of assurance or protection to women who get the implants upon FDA approval.

Last Thursday, Senators Dianne Feinstein (D-CA) and Olympia Snowe (R-ME), along with seven other women Senators sent a letter to newly confirmed FDA Commissioner Lester Crawford expressing serious concerns about the implants’ safety. The joint letter urges the FDA to put women’s health first and argues that “post-marketing conditions” are not enough to protect women’s health – “such conditions have proven to be ineffective or unenforceable and thus cannot serve as a substitute for long-term clinical data.”

The Senate Health, Education, Labor and Pensions committee is conducting an investigation into whether a conflict of interest influenced the panel’s decision, as a plastic surgeon who voted on Mentor’s application was found to have accepted money from one of the companies seeking silicone implant approval and an FDA expert on implants was not given the opportunity to testify, reports the Boston Globe.


Boston Globe 8/3/05; The New York Times 7/29/05; Letter from Women Senators 7/28/05; Feminist Daily Newswire 4/11/05; Command Trust Network 7/28/05; NOW 7/28/05; National Research Center for Women & Families 7/28/05

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