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Mentor Worldwide LLC in Irvine is one of two breast implant makers that received a U.S. Food and Drug Administration warning letter for failure to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.
The other company is Santa Barbara-based breast implant maker Sientra Inc.
“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 answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer,” according to a statement from the agency.
The FDA’s warning letter to Mentor said the manufacturer had failed to enroll the required number of patients in its post-approval study for MemoryShape breast implant, first approved in 2013.
Mentor, a Johnson & Johnson (NYSE: JNJ) company, makes aesthetics surgical products.