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Updated: Sep 24, 2025
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Complications Reported to the Food and Drug Administration: A Cross-sectional Comparison of Urogynecologic Meshes
Amanda M Artsen1, Jessica C Sassani, Pamela A Moalli
1From the Division of Urogynecology, University of Pittsburgh Medical Center, Pittsburgh, PA.
Importance:
The 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.
Objective:
The aim of the study was to compare complications among available urogynecologic meshes reported to the Manufacturer and User Facility Device Experience database.
Study Design:
This 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.
Results:
The 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).
Conclusions:
Individual 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.
Insights
Urogynecologic mesh complications vary significantly by product. Different mesh properties correlate with specific adverse events like pain and erosion, impacting patient safety and device development.
Area of Science:
- Urogynecology
- Biomedical Engineering
- Medical Device Safety
Background:
- The U.S. Food and Drug Administration (FDA) utilizes the Manufacturer and User Facility Device Experience (MAUDE) database to monitor urogynecologic mesh safety.
- However, individual urogynecologic mesh device safety profiles and complication rates have not been systematically characterized.
Purpose of the Study:
- To compare the complication profiles of various urogynecologic meshes reported in the MAUDE database.
- To identify specific mesh characteristics associated with higher rates of reported adverse events.
Main Methods:
- A cross-sectional analysis of 34,485 urogynecologic mesh medical device reports (MDRs) from January 2004 to March 2019 was conducted.
- Data were extracted and analyzed using the Reed Tech Navigator, comparing the percentage of specific complaints for different mesh types (transvaginal, sacrocolpopexy, midurethral slings).
- Statistical comparisons (chi-squared tests with Dunn-Sidak correction) and correlations with mesh properties (time on market, weight, stiffness, porosity) were performed.
Main Results:
- Significant differences in reported complications, primarily pain and erosion, were observed among urogynecologic meshes.
- For transvaginal meshes, Prolift/Prolift+M had over 90% reports of pain/erosion, versus less than 10% for Uphold Lite.
- Gynemesh (sacrocolpopexy) showed higher erosion/pain reports (>90%) compared to other sacrocolpopexy meshes (<60%). Heavier and stiffer meshes, and those longer on the market, showed stronger correlations with reported complications.
Conclusions:
- Individual urogynecologic meshes possess distinct properties leading to varied complication profiles.
- Gynemesh demonstrated a higher frequency of pain and erosion reports compared to other devices.
- Findings underscore the need for mesh development informed by specific complication data and the establishment of comprehensive post-market surveillance registries.
