March 21, 2019

FDA issues warning letters to two breast implant manufacturers

By: Judy Mathias

Editor’s Note

The Food & Drug Administration (FDA) on March 19 issued warning letters to two breast implant manufacturers (Mentor Worldwide LLC of Irvine, California, and Sientra, Inc of Santa Barbara, California) for failing to comply with post-approval study requirements.

All manufacturers of approved silicone gel-filled implants are required to conduct post-approval studies to further evaluate safety and effectiveness of the implants and to answer additional scientific questions about the long-term safety and risks that their premarket clinical trials were not designed to answer.

The companies must respond to the FDA within 15 working days with details about how noted violations will be corrected, or the agency may pursue criminal and civil penalties.


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