STORY FROM: Drugs & Medical Devices
FDA Sends Warning Letters to Silicone Breast Implant Makers Mentor, Sientra
March 20, 2019
WASHINGTON, D.C. — The Food and Drug Administration has issued warnings to two silicone gel-filled breast implant manufacturers for failure to conduct post-approval studies to assess the long-term safety and risks of their products.
According to a news release, the agency issued warning letters on March 19 to Mentor Worldwide LLC and Sientra Inc.
The letter to Mentor noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that it had failed to enroll the required number of patients in the study. The FDA also noted that Mentor had poor ...