Related Experiment Video
Updated: Jul 26, 2025
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Transvaginal Mesh Placement and the Instructions for Use: A Survey of North American Urologists
Gina Kirkpatrick1, Kenneth D Faber2, Debra L Fromer1,3
1Florida Hospital Physician Group, Tampa, Florida.
Introduction:
Since the issue of the FDA (Food and Drug Administration) Public Health Notification in 2008 regarding complications associated with the use of transvaginal surgical mesh for pelvic organ prolapse and stress urinary incontinence, multimillion dollar litigation has been brought against the companies that have manufactured these products. One component of the litigation has focused on risk information provided in the Instructions for Use document provided with each mesh kit. In this study we evaluated the types of urologists using transvaginal mesh kits and their use of the Instructions for Use provided with each mesh kit.
Methods:
A 14-question survey was e-mailed to all urologists registered with 7 of the 8 geographic sections of the American Urological Association in 2016. The survey inquired about the use of transvaginal mesh kits for prolapse and incontinence as well as how often, if ever, the urologist had read the Instructions for Use.
Results:
Overall there were 314 respondents. The majority (79.3%) identified as general urologists and 12.7% identified as Female Pelvic Medicine and Reconstructive Surgery trained urologists. Of the respondents who reported having placed mid urethral slings and/or a mesh prolapse repair kit, 36.9% and 23.1%, respectively, had never read the Instructions for Use. Of those providers who had read the Instructions for Use the most common frequency was once before the first placement.
Conclusions:
The pertinent role of the Instructions for Use in mesh related litigation stands in contrast to our finding that many surgeons who use these kits read the Instructions for Use infrequently, if ever.
