The FDA has given a conditional nod to the Sientra® portfolio of Silimed®– brand silicone gel breast implants .
The new implant is approved for breast augmentation in women at least 22 years old and for breast reconstruction in women of all ages. There are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.
There were some caveats along with the approval. Sientra must conduct post-approval studies of the long-term safety and effectiveness of the implant. The FDA has required manufacturers of other silicone-filled breast implants to conduct post-marketing approval studies.
The approval is based on three years of clinical data from 1,788 participants. Complications in this study included capsular contracture, revision surgery, implant removal, asymmetry, and infection.
Sientra must also continue to follow these participants in their pre-market study for an additional 7 years. They must also conduct a 10-year study of 4,782 women with the implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes including rheumatoid arthritis and breast and lung cancer; and conduct five case-control studies on the association between the breast implant and rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma. Sientra Inc. is based in Santa Barbara, Calif.
"This is exciting information for patients because it offers another choice for women undergoing breast cancer reconstruction or cosmetic breast augmentation," says Alan Matarasso, MD, a plastic surgeon at Lenox Hill Hospital and Manhattan Ear Eye and Throat Hospital in New York City.