FDA Strengthens Its Breast Implant Safety Requirements

December 15, 2023

On December 15, 2023, the U.S. Food and Drug Administration (FDA) published (https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants) a public update about its work to strengthen safety requirements and consumer communication about risks surrounding breast implants. Through the following actions, FDA said it intended to support patient-provider discussions and shared decision-making for breast implants:

FDA update

The agency said it regularly updates information on the Post-Approval Studies (PAS) Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm) regarding breast implant manufacturers’ post-approval studies. FDA also took several actions (https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants) in October 2021 to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions, including restricting the sale and distribution of the following breast implants to help ensure that patients are provided with adequate risk information:

FDA Guidance on Breast Implants

The Breast Implants—Certain Labeling Recommendations to Improve Patient Communication (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication) supplement FDA’s Saline, Silicone Gel, and Alternative Breast Implants guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants), both issued in September 2020. The new labeling approved in October 2021 follows the labeling recommendations described in the September 2020 guidance. It contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants, including:

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