Press Announcements > FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

Press Announcements > FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements





FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. 

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to ...