Conflicts of Interest in Studies Related to Mesh Use in Ventral Hernia Repair and Abdominal Wall Reconstruction

Abstract

Objective: To examine the accuracy of the reporting of conflicts of interest (COI) among studies related to mesh use in ventral hernia repair and abdominal wall reconstruction. Summary Background Data: Accurate declaration of COI is integral to ensuring transparency of study results. Multiple studies have demonstrated undeclared COI are prevalent in surgical literature. Methods: Studies with at least 1 American author accepted between 2014 and 2018 in 12 major, peer-reviewed general surgery and plastic surgery journals were included. Declared COI were compared with payments listed in the “Open Payments” database [maintained by the Centers for Medicare & Medicaid Services (CMS)] during the year of acceptance and 1 year prior. Studies and authors were considered to have a COI if they received payments from any of 8 major mesh companies totaling >$100.00 from each company. Risk factors for undeclared COI were determined at the study and author levels. Results: One hundred twenty-six studies (553 authors) were included. One hundred two studies (81.0%) had one or more authors who received payments from industry and inaccurately declared their COI. Two hundred forty-eight authors (44.8%) did not declare their COI accurately. On multivariate analysis, last authors were found to be at highest risk for undeclared payments (OR 3.59, 95%CI 2.02–6.20), whereas middle authors were at significantly higher risk for undeclared payments than first authors (OR 1.64, 95%CI 1.04-2.56). Conclusions: The majority of studies investigating the use of mesh in ventral hernia repairs and abdominal wall reconstructions did not accurately declare COI. Last authors are at highest risk of undisclosed payments. Current policies on disclosing COI seem to be insufficient to ensure transparency of publications.

The undisclosed disclosures: The dollar-outcome relationship in resuscitative endovascular balloon occlusion of the aorta

“…Some journals allow corresponding authors to submit the COI forms on behalf of all authors, whereas some journals require each co-author to report their COI independently. Sekigami et al 25 suggested that authors check the OPD before they report their COI to verify the accuracy. United States–based journals may include adding a step to the journal submission process by providing a link that directs to the OPD so that the corresponding author can report COI accurately.…”

Extent, transparency and impact of industry funding for pelvic mesh research: a review of the literature

“…Univariate analyses were used to determine the presence of study characteristics that aligned with discrepancy between declared and undeclared COI. Guided by previous research on COI of authors studying hernia mesh [ 20 ] we included impact factor (continuous), follow-up time (continuous), author’s role (e.g. first author, contributing author, senior author – categorical), and recommendations of mesh safety and effectiveness (categorical – yes/no).…”

“…First, despite many accounts of the value of mesh for hernia repair, none has reported on women, specifically, or considered that women’s greater immune response to foreign materials might predispose to disproportionate harm from insertion of the product [ 12 , 19 ]. Second, Sekigami and colleagues [ 20 ] determined that the majority of studies of mesh used for hernia repairs did not accurately report COI.…”

Impact of the ventral hernia working group’s publication: a bibliometric analysis

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have been explored [4][5][6], a knowledge gap persists regarding whether industry relationships have affected the broader hernia research agenda with respect to the types of research questions that are studied or the assumptions on which most studies are based. It is possible to investigate the effect of certain publications on the future scientific evaluation of key terms utilized in these sponsored publications by utilizing bibliometric analysis.

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