LAUSR

As a biologic product derived from human tissue, acellular dermal matrices (ADMs) did not require pre-market approval for their initial use as a soft tissue support product. Since their first utilization in breast surgery, ADMs have allowed for numerous advances in breast reconstruction. ADMs quickly gained popularity in breast surgery and are frequently utilized in various applications. During an investigation into potential factors leading to breast implant-associated anaplastic large cell lymphoma, the United States Food and Drug Administration (FDA) made an official statement that ADMs were not approved for use in breast reconstruction and that using ADMs in breast surgery was considered off-label. This special topic article details the history of ADMs in breast surgery and describes the ongoing evolution of the relationship between the FDA and ADMs.