New Silicone Breast Implant ApprovedLast Updated: March 09, 2012.
FRIDAY, March 9 (HealthDay News) -- Sientra Inc.'s silicone gel-filled breast implant has been approved by the U.S. Food and Drug Administration for breast reconstruction or augmentation in women aged 22 or older, the agency said Friday in a news release.
Similar products made by two other manufacturers -- Allergan and Mentor -- were approved previously by the FDA.
Breast reconstruction includes replacing tissue removed due to cancer or injury, while augmentation generally is used to increase breast size.
Approval of the Sientra product followed clinical testing involving 1,788 people. Adverse reactions included tightening of the area surrounding the implant, implant removal, uneven appearance and infection.
As a condition of approval, Sientra will be required to follow clinical participants for seven additional years, and to conduct a 10-year study of nearly 5,000 women to see if the implants are associated with diseases including rheumatoid arthritis and breast cancer.
Sientra is based in Santa Barbara, Calif.
The FDA has more about breast implants.