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FDA Approves Allergan’s Silicone-Gel Breast Implant

Update Date: Feb 21, 2013 06:28 AM EST

Allergan's silicone gel-filled implant is approved for breast augmentation surgeries in women, the U.S. Food and Drug Administration announced Wednesday.

The agency said that the new Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant can be used to increase breast size of women over 22 years and to reconstruct breast tissue of women of any age. The FDA, however, warned about the risks associated with breast implants.

"It's important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, in a news release from FDA.

Safety of the product was assessed based on test results from 941 women, FDA said. Adverse effects of the surgery included infection, tissue tightening, uneven breast appearance, etc., which the agency said are common side-effects of any surgery involving implants.

"The data we reviewed showed a reasonable assurance of safety and effectiveness. We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness," said Shuren.

"The Natrelle® 410 shaped gel implant is designed to mimic the slope of the breast and is filled with a highly cohesive silicone gel, which is intended to enable the implant to hold its shape over time while remaining soft to the touch," Allergan said in a statement.

According to latest data from the American Society of Plastic Surgeons (ASPS), there were nearly 89,000 breast lifts and breast augmentation surgeries in the U.S. in 2012, which is 2 percent lower than the surgery rates in 2011.

FDA added that Allergan would require a series of tests post-approval to assess the long-term impact of these implants.

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