New Silicone-Gel Breast Implant Wins Cautious FDA Approval

Disclosures

February 20, 2013

The US Food and Drug Administration (FDA) today approved a new silicone-gel breast implant. The approval comes with a requirement that the manufacturer conduct post-approval studies to assess the product's long-term safety and effectiveness and the risk for rare disease.

The requirement for continued surveillance reflects the history of complications with silicone-gel breast implants, which were subject to a limited moratorium in the United States from 1992 until 2006.

The newly approved implant is called the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Allergan). It is indicated for increasing breast size in women aged 22 years or older and rebuilding breast tissue in women of all ages. Natrelle 410 becomes the fourth FDA-approved silicone-gel breast implant available in the United States.

The last time the FDA approved a silicone-gel breast implant was in March 2012, when it gave market clearance to one from a company called Sientra.

"It's important to remember that breast implants are not lifetime devices," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a press release issued today. "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."

The FDA's approval of the Natrelle 410 implant is based on 7 years' worth of data from 941 women. "Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection," the FDA stated. Investigators also observed fissures in the gel of some implants that are unique to Natrelle 410.

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

More information about today's decision is available on the FDA Web site.

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