Following testimony by women last spring about problems caused by breast implants, the FDA will require new warning labels on the devices, and defines risks and problems with them. The public has 60 days to comment on the new regulations. Here’s how to comment and the FDA notice issued today:
The draft guidance, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling information for saline and silicone gel-filled breast implants, including:
- Boxed warning
- Patient decision checklist
- Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants
- Silicone gel-filled breast implant rupture screening recommendations
- Patient device card
When final, the recommendations in this guidance will supplement or, in some cases, replace recommendations in the FDA’s Saline, Silicone Gel, and Alternative Breast Implants guidance, issued November 17, 2006.
This draft guidance will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467.