Abstract: There is disclosed an acellular dermal matrix (ADM) graft stored as a packaged ADM graft pocket product prepared by a process that includes providing a portion of ADM tissue having a thickness between 1 mm and 2 mm. The process includes scoring the portion of the ADM tissue into a pre-defined shape to form the domed shape ADM graft. The process includes verifying the thickness of the domed shape ADM graft; shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant. The process includes packaging the ADM graft pocket to form a packaged ADM graft pocket. The process includes irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the packaged ADM graft pocket product. Other embodiments are also disclosed.

Abstract: There is disclosed a tool having a set of features for forming a domed acellular dermal matrix (ADM) graft. An acellular dermal matrix (ADM) graft product includes an ADM graft derived from full-thickness skin, with a pre-formed domed shape having a mesh pattern formed therein. In an embodiment, the set of features include a shaping tool feature and a scoring tool feature. The shaping tool feature has a shaping portion configured to shape a dome shaped ADM graft. The scoring tool feature has a scoring portion configured to impart a desired mesh pattern into the domed shaped ADM graft. Other embodiments are also disclosed.

Abstract: An acellular dermal matrix (ADM) graft product includes an ADM graft derived from full-thickness skin, with a pre-formed shape having a mesh pattern formed therein. The ADM graft is disposed in a sterilization package and irradiated to provide a two year shelf-life for the ADM graft product, which is used in the time-saving, efficient, and effective surgical reconstruction of soft tissue defects. One manufacturing method involves providing a portion of full-thickness donor-derived skin, removing an epidermis and a fat layer form the portion of the skin, decellularizing the portion of the skin to form a portion of ADM graft material, pre-shaping and meshing the ADM graft material, verifying a thickness of the ADM graft material, and packaging the pre-shaped, meshed ADM graft material in a sterilizable package and irradiating for a two-year shelf-life to form the ADM graft product. Other embodiments are also disclosed.