Washington — The Food and Drug Administration has approved Sientra’s silicone gel-filled breast implant for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age.
As a condition of approval, the FDA is requiring Sientra to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
The FDA based its approval on three years of clinical data involving 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), reoperation, implant removal, an uneven appearance (asymmetry) and infection.
In an FDA news release, William Maisel, M.D., deputy director for science in the agency’s Center for Devices and Radiological Health, said, “Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness. It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
Sientra is based in Santa Barbara, Calif.
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