Presentation and management of major complications of midurethral slings: Are complications under-reported?
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Deng
Donna Y
DY
Department of Urology, University of California, San Francisco School of Medicine, San Francisco, California, USA.
Rutman
Matthew
M
Raz
Shlomo
S
Rodriguez
Larissa V
LV
D016208:Databases, Factual / Q000706:statistics & numerical data; D006801:Humans; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000401:mortality; D011183:Postoperative Complications / Q000401:mortality* / Q000601:surgery; D011475:Prosthesis Failure; D012086:Reoperation; D012189:Retrospective Studies; D053825:Suburethral Slings / Q000009:adverse effects* / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data; D014549:Urinary Incontinence / Q000401:mortality* / Q000601:surgery*