Background: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair.
Materials and methods: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI.
Results: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results.
Conclusions: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.
Keywords: 510K process; Conflict of interest; Hernia; Medical device; Mesh.
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