Changes in management of stress urinary incontinence following the 2011 FDA Health Notification

Abstract

Purpose: We sought to assess for impact on management trends in new patients presenting to our institution with stress urinary incontinence (SUI) following the release of the FDA Health Notification in July 2011 for vaginal mesh. Materials and methods: Chart analysis was performed on patients assigned a primary International Classification of Diseases (ICD-9) diagnosis code of 625.6 for SUI at initial consultation by two providers at our institution between June 1, 2010 and November 30, 2014. Rates of treatment and types of procedures performed were analyzed: urethral bulking, mesh sling, or pubovaginal sling. Results: A total of 333 new patients were identified with an increasing trend over time. One hundred and twenty-three patients underwent 153 procedures for stress incontinence. The mean proportion that had a procedure per six-month period was 37%, with decreasing proportions over time. Initially all procedures were midurethral mesh slings, with a decline at the time of and after the notification, and a temporary increase in bulking procedures. Subsequently, there was a rise again in sling placement, namely with an increase in pubovaginal slings. Of the 20 pubovaginal slings placed, 13 were placed in patients who had a prior anti-incontinence surgery (eight for sling failure, vaginal mesh, or fixed urethra, and two in patients with mesh extrusion/erosion). Seven were performed in patients who had never had prior surgery (two for very high-grade incontinence, two with urethral diverticulectomy, and three in patients who expressed concern about mesh). Conclusions: Although there were an increasing number of patients seen for management of SUI over time, there was a progressive decrease in the proportion of patients having anti-incontinence procedures after release of the FDA notification. There was an overall decrease in the use of mesh slings and an increase in bulking, and more notably, placement of pubovaginal slings.