The PSF Receives FDA Approval to Conduct Multicenter Study of ADM and Surgical Mesh Used in Breast Reconstruction
The Plastic Surgery Foundation (PSF) received approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application and will now proceed as sponsor of a prospective, multicenter observational trial studying the impact of acellular dermal matrix (ADM) and surgical mesh in implant-based breast reconstruction.