D70. Suspicious or Safe? A Systematic Review on the Impact of FDA Guidance on Reporting of Fat Necrosis in Autologous Fat Grafting of the Breast

Abstract

PURPOSE: Autologous fat grafting (AFG), increasingly popular in breast reconstruction and augmentation, often causes fat necrosis. In late-2014, the FDA draft guidance recommended cessation of all AFG. In late-2017, the final guidance was updated to allow AFG with restrictions. The landscape of clinically relevant fat necrosis reporting remains undescribed in the context of these changing guidelines. METHODS: PubMed, Embase, Cochrane, Web of Science, and Scopus were queried for studies mentioning fat necrosis and fat grafting in breast reconstruction or augmentation from inception to August 11, 2022. Of the 1359 articles identified, 62 met inclusion criteria. Studies were temporally stratified according to released FDA guidelines. RESULTS: 7 of 22 (31.8%) studies pre-2014 FDA draft guidance used clear fat necrosis definitions. There is an absence of defining fat necrosis in the 13 studies between 2015 and the late-2017 FDA guidance (p=0.023). After the 2017 guidance, only 3 of 27 (11.1%) studies clearly followed FDA recommendations to define fat necrosis. Among the 10 studies defining fat necrosis, none used identical definitions. 52 (83.9%) of all studies did not define what constituted fat necrosis. CONCLUSION: Clear fat necrosis definitions are not consistently utilized in literature describing autologous fat transfer of the breast, despite FDA recommendations. Given the rise of non-PRS-performed fat grafting procedures, we call on the PRS community to commit to uniformly reporting clinically distinct fat necrosis complications.