From Local Oversight to National Frameworks: Twenty Years of Face Transplant Governance.

Abstract

Since the first facial vascularized composite allotransplantation (fVCA) performed in France in 2005, the procedural, ethical, and legal structures regarding donor procurement and institutions have significantly evolved. Initially developed by local institutions that were pioneering the procedure, the regulations progressively became more standardized with national oversight. This study reviews the global evolution of bodies governing face transplant regulation and procurement process, highlighting a shift toward more formalization and national standards through 3 distinct eras. A review of publicly available literature was conducted to identify all face transplant procedures performed worldwide from 2005 to 2023. Each documented procedure was classified based on the level of local, regional, and national institutions involvement. Information on the procedure approval, ethics approval, consent models, and fVCA procurement was analyzed. Forty-eight face transplants across 11 countries were identified. Pioneering procedures (2005-2008) were approved mostly by local or university committees. Between 2008 and 2014, although more and more national entities were participating in protocol approval and donor allocation, VCA-specific policies remained limited. Finally, since 2014, we noted the trend toward national standardization with an important shift marked by the United States, the country executing most face transplant procedures around the world, incorporating face transplantation within formal national frameworks. The evolution of fVCA governance from locally governed and experimental surgeries toward nationally standardized frameworks demonstrates the field's growth into a viable therapeutic option, which will continue to play a key role in promoting safety, patient education, and long-term success in fVCA.