The off-label use of Acellular Dermal Matrix (ADM) products in implant-based breast reconstruction can result in post surgical complications and problems for patients up to two years after the surgery according to a recent analysis by the FDA.
Off-label use not approved by FDA
Accellular Dermal Matrix is a type of surgical mesh that is developed from human or animal skin. It has been approved by the FDA for specific use such as hernia surgery and more recently many surgeons specializing in breast reconstruction after a mastectomy have been using the product off-label. The off-label use of ADM for breast reconstruction has never been approved by the FDA and a recent analysis found that some patients suffered complications up to two years after the surgery.