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# FDA Breast Implant Safety Actions
- URL: https://www.fdaweb.com/fda-breast-implant-safety-actions/
- Published: 2021-10-27T12:00:00.000Z
- Updated: 2026-09-14T17:20:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150458

FDA says it has taken several new actions to strengthen breast implant risk communications and help those who are considering breast implants to make informed decisions. An agency [notice](https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants?ref=fdaweb.com) says it: 

- issued orders restricting the sale and distribution of breast implants to help ensure that patients considering implants are provided with adequate risk information;
- approved new labeling for all legally marketed breast implants that includes a Boxed Warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device, and a patient device card; and
- released updated information on the status of breast implant manufacturer post-approval studies.