FDA Approves Third Silicone-Gel Breast Implant
(NEW YORK) — The U.S. Food and Drug Administration has conditionally approved a new silicone-gel breast implant, HealthDay reports.
The implant, manufactured by Santa Barbara-based Sientra, can be used for breast tissue reconstruction for women of any age and for breast augmentation in women 22 or older. Sientra is required to continue studies on the implant’s long-term safety, effectiveness and risks of rare diseases under the approval.
The approval resulted from three years of clinical studies on almost 1,800 patients. Tightening of the area around the implant, re-operation, implant removal, uneven appearance and infection were some of the complications experienced during the study.
The implant is the third to be approved in the United States.
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