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Medical Devices / Regulatory Affairs

FDA Warns Two Breast Implant Makers Over Post-Approval Studies

April 2, 2019
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The FDA served two breast implant manufacturers with warning letters after the agency found they failed to comply with post-approval study requirements.

The FDA found that the two silicone gel-filled breast implant makers — Johnson & Johnson’s Mentor Worldwide of Irvine, California and Sientra of Santa Barbara, California — violated the requirement that they conduct post-approval studies to assess the long-term safety and risks of their implants.

The agency found both companies were in violation of two of the seven post-approval study requirements which were set as part of their 2013 premarket approval applications.

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