Feb. 21, 2013 -- The FDA has approved a new silicone-gel breast implant from Allergan called Natrelle 410. It will be used to increase breast size in women 22 and older, and to rebuild breast tissue in women of all ages.
The implant is designed to mimic the slope of the breast. The gel is intended to help the implant hold its shape over time while remaining soft to the touch, according to a prepared statement from Allergan.
The approval comes with a requirement that the manufacturer do further studies to determine the product's long-term safety, effectiveness, and the risk of rare disease. That requirement reflects the history of complications with silicone-gel breast implants, which were subject to a limited ban in the United States from 1992 until 2006.
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. Natrelle 410 becomes the fourth FDA-approved silicone-gel breast implant available in the U.S.
“It’s important to remember that breast implants are not lifetime devices," says Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. "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 seven years' worth of data from 941 women. Most complications were similar to those from studies of other implants, including tightening of the area around the implant, re-operation, removing the implant, an uneven appearance, and infection, according to the FDA. 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,” says Shuren. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”