Sientra Gets FDA OK on Breast Implant PMA

The FDA granted PMA approval March 9 to Santa Barbara, Calif.-based Sientra’s Silimed silicone breast implants, adding a third option to a long-standing duopoly of the U.S. silicone breast implant market. Allergan and Mentor, the only other manufacturers of silicone breast implants, have dominated the market for two decades. However, both offer only round implants, whereas Sientra’s portfolio includes alternate shapes.
Devices & Diagnostics Letter