The U.S. Food & Drug Administration has approved Sientra Inc.’s silicone gel-filled breast implant for breast reconstruction or augmentation in women aged 22 or older, the agency said news release dated March 9th.
Similar silicone breast implants made by two other manufacturers (Allergan and Mentor) have been on the market after receiving FDA approval in 2006.
Approval of the Sientra silicone breast implant followed rigorous clinical testing involving 1,788 patients. Adverse reactions included tightening of the skin and soft tissue surrounding the implant (capsular contracture), asymmetry and infection.
As a condition of approval, Sientra will be required to follow patients for seven additional years, and to conduct a 10-year study of nearly 5,000 breast augmentation and breast reconstruction patients to see if the implants are associated with diseases including rheumatoid arthritis and breast cancer.
Look for Sientra silicone breast implants to become available for breast augmentation in Dallas, Plano, Frisco and the surrounding communities in the upcoming months ahead.