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212 posters, 10 topics, 5 sessions, 754 authors, 237 institutions

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The AAPS 101st Annual Meeting

29 April – 2 May, 2023 | Chicago, IL

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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

Part of Topic

Breast Reconstruction

The Use of Consistent Language in Reporting Fat Necrosis in Autologous Fat Grafting of the Breast: A Systematic Review

Introduction:

•Autologous fat grafting (AFG) is a widely adopted approach to optimize outcomes in breast reconstruction and augmentation.
•Although fat necrosis is a well-known consequence of AFG, it remains poorly and inconsistently defined in the literature. 
•In late 2014, FDA  released draft guidance to avoid future AFG – a statement that was permissively modified with restrictions in late 2017. 
•The language and descriptions of fat necrosis are inconsistent in the literature. 

Methods: 
•Five databases were queried for studies reporting fat necrosis following AFG for breast reconstruction or augmentation from inception to August 11, 2022. 
•Studies were temporally stratified according to released FDA guidelines: pre-2015, 2015-2017, and 2018-2022.

Results:
•61 articles met inclusion criteria. 
•Pre-2015, 6 of 21 studies (28.6%) offered clear definitions of fat necrosis.
• In contrast, 2015-2017 lacked clear fat necrosis definitions (0 of 13 studies, p=0.03). 
•2018-2022 period in annual publications compared with the pre-2015 period (5.4 vs. 1.9, p= 0.04) was not matched by a rise in clear fat necrosis reporting (14.8% studies, p=0.45). 
•Across all periods, 16.4% of articles offered clear definitions, which exhibited wide heterogeneity.

Conclusions:
•The number of studies clearly defining fat necrosis following AFG of the breast have fluctuated in the context of changes in FDA guidance.
• Despite increasing popularity of AFG, fat necrosis remains inconsistently defined.
•Failure to use consistent definitions of fat necrosis limits the ability to compare surgical outcomes across studies.
 
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