Does Industry Influence Persist? Financial Conflicts and ADM Outcomes After the 2021 FDA Safety Alert
Melih K. Sifil, David M. KahnBackground:
Financial conflicts of interest may be associated with outcome reporting in surgery. In March 2021, the FDA issued a safety communication highlighting complications associated with acellular dermal matrices (ADM) in breast reconstruction. This study assessed whether the association between industry payments and favorable ADM reporting persisted after this regulatory intervention.
Methods:
We analyzed clinical ADM studies published from 2020 to 2025 in the four plastic surgery journals used in the prior benchmark study. Conclusions were coded as positive, neutral, or negative. Open Payments data were queried for first and senior authors. Logistic regression and receiver operating characteristic (ROC) analysis determined the association between payments and favorability. Findings were compared with a historical pre-warning cohort (2014-2019).
Results:
Of 46 studies, 23.9% reported positive conclusions, down from 43.6% in the pre-warning era. Despite this decline, financial ties remained associated with favorable reporting. Authors of positive studies received significantly higher median payments than authors of neutral or negative studies ($8,792 vs. $0; p < 0.001). Regression demonstrated an association between higher payments and favorable reporting (OR 1.37; p < 0.001). The financial threshold associated with positive conclusions rose five-fold, from $376 pre-warning to $1,921.
Conclusions:
Although the FDA warning coincided with fewer positive studies, financial relationships remained associated with favorable reporting. These findings are associative and do not establish that payments caused individual study conclusions. Reviewers, journals, and readers should consider both the presence and magnitude of industry relationships when interpreting ADM studies.