FDA Issues Landmark Recommendations for Implant Manufacturers

Hot off the press – FDA is listening to women’s voices on breast implants. Today, FDA issued a recommendation to implant manufacturers that include many of the items that Breast Implant Safety Alliance and others have been pushing for:

  • a black box warning to clearly identify risks (this is the most serious warning labeling the FDA has in its toolkit)
  • a checklist to guide the patient-provider discussion
  • new screening guidelines for possible ruptures
  • clear ingredient information

This is about full disclose of a woman’s reconstructive options (this MUST include flat closure) as well as full information about the risks associated with each of those options. We applaud FDA for taking this important step and we extend our sincere gratitude to the explant advocates who have worked tirelessly at their own expense to be a voice for women on this issue.


Original version published on NPOAS’ Facebook page on October 23, 2019

Published by Not Putting on a Shirt

Founder of Not Putting on a Shirt, a mastectomy patients' rights organization that advocates for optimal surgical outcomes for patients going flat.

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