FDA Safety Communication – Acellular Dermal Matrix Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates

The FDA is informing patients, caregivers, and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.

The FDA has not cleared or approved ADM or mesh for use in breast reconstruction. The FDA is informing the public of our recent analysis, and requesting prompt reporting of adverse events to help us better understand the risks. 

The safety communication provides important information about the use of ADM in breast reconstruction, including:

• Differences in major complications among certain ADM products used in implant-based breast reconstruction
• Recommendations for patients, caregivers, and health care providers
• Instructions on how to report problems with these devices.  

Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).