FDA approves new breast implants by Allergan, requires post-approval studies

February 20, 2013 by Arezu Sarvestani

Aesthetic products maker Allergan lands FDA approval for a new silicon gel-filled breast implant, on the condition that the company conduct post-approval studies to keep an eye on the long-term safety and effectiveness of the device.

breast exam image

Aesthetic medical device giant Allergan (NYSE:AGN) won FDA approval this week for a new generation of its Natrelle silicon gel-filled breast implants.

The new Natrelle 410 features a more anatomical shape that imitates the slope of the breast, providing an alternative from traditional round gel implants, the company noted. It's also filled with a "highly cohesive silicone gel," which Allergan says will hold its shape over time while remaining soft to the touch.

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The approval marks the 4th silicon breast implant approved for the U.S. market, alongside previous Allergan implants and those made by Johnson & Johnson (NYSE:JNJ) subsidiary Mentor and Sientra, which in March 2012 became the 3rd company with permission to sell breast implants in the U.S.