ArticleFemale pelvic medicine & reconstructive surgery2022
Complications Reported to the Food and Drug Administration: A Cross-sectional Comparison of Urogynecologic Meshes.
Article in Female pelvic medicine & reconstructive surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- L-Ascorbic Acid 2-Phosphate-Releasing Poly(trimethylene carbonate) Increases Cell Proliferation and Collagen Production: A Novel Material for Pelvic Organ Prolapse Tissue Engineering.Tissue engineering and regenerative medicine · 2026Article
- Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.Scientific reports · 2026Article
- Scoping review on regulation, implementation and postmarket surveillance of medical devices.PloS one · 2025Article
- Review
- Acellular Dermal Matrices as an New Alternative for Treatment in Reproductive Organ Static Disorders: A Pilot Study.Journal of clinical medicine · 2024Article
- Article
- The Risk of Stress Urinary Incontinence After Hysterectomy for Uterine Fibroids.International neurourology journal · 2023Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
importanceThe U.S. Food and Drug Administration uses the Manufacturer and User Facility Device Experience database to evaluate the safety of urogynecologic meshes; however, reports on individual meshes have not been characterized.
objectiveThe aim of the study was to compare complications among available urogynecologic meshes reported to the Manufacturer and User Facility Device Experience database. STUDY
designThis study is a cross-sectional analysis of medical device reports (MDRs) of urogynecologic mesh from January 2004 to March 2019, using the Reed Tech Navigator (LexisNexis), which codes MDRs. The percentage of reports containing specific complaints (not an adverse event rate) were compared with χ 2 tests with Dunn-Sidak correction. Correlations with time on market, mesh weight, stiffness, and porosity were determined.
resultsThe 34,485 reports examined included 6 transvaginal meshes, 4 sacrocolpopexy meshes, and 10 midurethral slings. Most reported events were pain, erosion, and infection. For transvaginal prolapse, less than 10% of Uphold Lite (Boston Scientific) reports contained pain or erosion versus greater than 90% of Prolift/Prolift+M (Ethicon, P < 0.001). For sacrocolpopexy mesh, greater than 90% of Gynemesh (Ethicon; Prolift in vaginal form) reports included erosion and pain versus less than 60% for Artisyn (Ethicon), Restorelle (Colpoplast), and Upsylon (Boston Scientific, P < 0.0001). For slings, Gynecare TVT Obturator had the highest proportion of erosion and pain complaints. Heavier sling meshes had more reports. When Ascend (Caldera Medical), an outlier with only 5 reports, was excluded, transvaginal mesh stiffness correlated strongly with number of reports. For transvaginal meshes, number of reports correlated with time on market (ρ = 0.8, P = 0.04).
conclusionsIndividual meshes have different properties with different complication profiles, which should inform mesh development and use. Gynemesh MDRs included pain and erosion more frequently than others. Comprehensive registries are needed.
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