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Policy

FDA Lifts Ban On Silicone Gel Breast Implants

Agency overturns 14-year moratorium

by Bette Hileman
November 27, 2006 | A version of this story appeared in Volume 84, Issue 48

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Credit: Mentor
Credit: Mentor

After a 14-year ban, the Food & Drug Administration on Nov. 17 approved silicone gel implants for cosmetic breast enhancement in people over 22 years old and for breast reconstruction with no age restriction. The decision provoked criticism from some health groups but praise from the companies—Mentor and Allergan—that manufacture the products. Since 1992, patients seeking breast augmentation have been limited to saline implants.

In announcing the decision, FDA issued some assurances and several warnings. "FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information, to determine the benefits and risks of these products," said Daniel Schultz, director of the agency's Center for Devices & Radiological Health. "However, we know that women who get these devices will probably need to have additional implant surgery at least once" because they may collapse or leak.

Rupture of an implant is most often "silent," which means neither the recipient nor the doctor is aware of the problem, FDA notes. To detect ruptures, recipients should get an MRI screening three years after the original operation and at two-year intervals after that.

Silicone gel implants were used in the U.S. between the 1960s and 1992, when a moratorium was placed on their use owing to reports of pain, deformity, and illness from leaking or ruptured devices. Thousands of lawsuits over the implants forced Dow Corning, which sold both silicone gel and the implants, into bankruptcy.

"Silicone gel breast implants are the most defective medical device ever approved by FDA," says Sidney Wolfe, director of Public Citizen's Health Research Group.

"FDA's decision to approve silicone gel breast implants is a triumph of corporate lobbying and hype over sound science and women's health," says Diana Zuckerman, president of the National Research Center for Women & Families.

FDA is requiring Mentor and Allergan to each conduct 10-year studies involving 40,000 women to monitor for possible adverse effects. "We are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options," says Mentor President Joshua H. Levine.

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