Presentation and management of major complications of midurethral slings: Are complications under‐reported?

TLDR

Midurethral slings are the primary treatment for stress urinary incontinence, but serious urethral and bladder perforations can be underdiagnosed and underreported. This study aimed to describe the presentation and management of major complications from midurethral slings and to expose a discrepancy between published literature and FDA MAUDE reports. The authors retrospectively reviewed 2001–2005 cases at UCLA, performed a literature review and queried the FDA MAUDE database, identified 26 patients with mesh in the urethra or bladder, and treated them with urethrolysis, graft reconstruction, and bladder excision, comparing outcomes to literature rates of <1%. MAUDE reported 161 major complications out of 928, a significantly higher rate than literature, indicating that major complications are more common than previously thought and most require reconstructive surgery.

Abstract

Midurethral slings have become the mainstay of stress urinary incontinence (SUI) treatment due to their efficacy and low complication rates. The purpose of this study was to report the presentation and treatment of major complications from these minimally invasive treatments presented to a tertiary referral practice and to highlight a discrepancy in major complications between literature and the food and drug administration (FDA) device failure database.From 2001 through 2005, we reviewed all cases of midurethral sling complications that presented to our institution. A literature review of all complications due to midurethral slings during the same time period was performed as was the FDA manufacturer and user facility device experience (MAUDE) database queried for self-reported complications.A total of 26 patients referred to UCLA with voiding dysfunction after sling placement was found to have mesh in the urethra or bladder. Treatments required a combination of urethrolysis with mesh removal, urethral reconstruction with graft, and bladder excision. These were compared to major complications reported in the world literature of <1%. The MAUDE database contained 161 major complications out of a total of 928 complications reported for suburethral slings. There was significantly more major complications reported in MAUDE than in published literature.Although rare, major complications of midurethral slings are more common than appear in literature. Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and thus are likely under-diagnosed and under-reported. Most of these cases need to be managed with additional reconstructive surgery.