Sientra Silicone Implants Approved by FDA
Sientra’s gel-filled silicone breast implants have been FDA approved for both breast augmentation and reconstruction under the condition they begin a 3 year study of long-term safety, effectiveness, and possibilities of rare disease and risks.
The study must include the data of at least 1,788 participants. During the study, they will need to compare outcomes and complications with implants studies from the past. Complications include capsular contracture – a tightening around the implant, removal of the implant, re-operation rates, and infection and asymmetry.
The deputy director of science for the Food and Drug Agency recently stated in a recent FDA news release, “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 understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
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