Complications Reported to the Food and Drug Administration: A Cross-sectional Comparison of Urogynecologic Meshes

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 χ2 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.

Acellular Dermal Matrices as an New Alternative for Treatment in Reproductive Organ Static Disorders: A Pilot Study

“…Among transvaginal implants, <10% of Uphold Lite (Boston Scientific, Marlborough, MA, USA) reports contained pain or erosion vs. >90% of Prolift/Prolift+M (Ethicon, Raritan, NJ, USA; p < 0.001). Researchers emphasized the different properties and side effect profiles of individual meshes and signaled the need to maintain comprehensive registers of such reports [ 13 ].…”

The Risk of Stress Urinary Incontinence After Hysterectomy for Uterine Fibroids

“…The most common surgical procedure for SUI involves the insertion of a midurethral sling via a transobturator or retropubic approach. However, this surgery carries risks of complications, including pelvic hematoma, bladder perforation, urinary retention, pain, erosion, and infection [ 10 ].…”

“…Furthermore, the impact of prior hysterectomy for benign reasons on the need for subsequent SUI surgery has seldom been examined [ 8 ], and to our knowledge, there is only one dataset available on this topic. This issue is particularly significant given the high prevalence of SUI, its association with poor hygiene and diminished quality of life [ 1 , 9 ], and the fact that the most common surgical treatment for SUI, the midurethral sling using mesh, may lead to complications such as pain, erosion, and infection [ 10 ].…”

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

“…From 336 articles, 21 that downloaded MAUDE data files were set aside for further analysis 11–31 . Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 .…”