FDA Safety Communication: Acellular Dermal Matrix Products Used in Implant-Based Breast Reconstruction

April 05, 2021—On March 31, 2021, the FDA issued a safety communication informing patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products have a higher chance of complication. In addition, a recent FDA analysis of patient-level data suggests that some ADMs have higher risk profiles than others.

Providers should be aware that ADM is still not approved for use in breast reconstruction. Off-label use remains acceptable but in light of this new communication, plastic surgeons who wish to employ ADM should be sure to have a complete discussion about risks, benefits, and alternatives with patients, preferably using a shared decision-making approach. As always, these discussions should be documented in the medical record.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

J12780 04/21