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.