FDA: Silicone breast implants have expiration date

June 22nd, 2011 by | Permalink

Photo: Flickr/Malingering

When it comes to silicone breast implants, women are unlikely to be able to “set them and forget them” according to a new report by the Food and Drug Administration.

The report states that women with silicone breast implants are “likely” to have to go back under the knife within ten years of receiving the implants to “address complications.”

According to Reuters, most complications arising from the implants include hardening of tissue around the implant and rupture or deflation. Women with silicone implants are also at risk of “implant wrinkling, asymmetry, scarring, pain, and infection at the incision site.”

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health was quoted as saying, “The key point is that breast implants are not lifetime devices. The longer you have the implant, the more likely you are to have complications.”

The data in the FDA report was derived from post-approval studies done by pharmaceutical companies Allergan and Johnson & Johnson’s Mentor division in part of an agreement to bring silicone implants back onto the market in 2006 after the FDA had banned their use in 1992.

The report also stated a possible correlation between the implants and several dozen cases of anaplastic large-cell lymphoma, which approximately 3,000 Americans are diagnosed with annually.

But Shuren was quick to point out the correlation does not equal causation, stating, “If there’s a true association between that cancer and implants, it’s very, very rare.”

However, Diane Zuckerman, the president of a women’s advocacy group, says the FDA’s study is “not accurate” because there was a large dropout rate among participants. Zuckerman added that it was “impossible” to put a number on the number of women who have needed additional surgery or have had complications years after receiving breast implants, and that “this raises questions about the FDA’s reliance on studies required after a product is approved.”

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