FDA Approves New Silicone Gel–filled Breast Implant

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FDAlogoThe FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

With this approval, there are now three FDA-approved silicone gel–filled breast implants in the United States, manufactured by Allergan, Mentor, and Sientra.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, MD, MPH, Deputy Director for Science in the FDA’s Center for Devices and Radiological Health.

‘Not Lifetime Devices’

“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.” said Dr. Maisel.

The FDA based its Sientra approval on 3 years of clinical data from 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. ■




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