Long-term Risk of Reoperation After Synthetic Mesh Midurethral Sling Surgery for Stress Urinary Incontinence

One in 3 women is affected by stress urinary incontinence (SUI) in their lifetimes. The criterion standard for treating SUI is considered to be the midurethral sling. Treated patients often experience a significant improvement in quality of life, with increased ability to exercise, laugh, and engage in sexual activity. Over the past decade, midurethral slings have largely replaced traditional, more invasive procedures, such as the autologous fascial sling and open retropubic urethropexy. A large number of studies have shown that midurethral slings are safe and effective in the short (<1 year) and mediumterm(1-5 years). Thus, for less than 5 years of follow-up, complication and failure rates are well characterized. Long-term evidence (>5 years) for safety (complications) and efficacy (success or failure) is limited. Complications that occur include pain, mesh exposure, and persistent or recurrent SUI. Despite the advantages of midurethral slings (minimally invasive approach, shorter operative and recovery times, and high efficacy rates), there have been increasing concerns from both patients and the medical community about mesh-related adverse events. The US Food and Drug Administration in 2011 published a safety communication addressing these concerns. Over the last 8 years, increased complaints by thousands of women treated with mesh products and a large number of lawsuits have questioned the efficacy and safety of using transvaginal mesh and subsequently led the US Food and Drug Administration to ban production and sale of mesh products on April 16, 2019. The aim of this retrospective cohort study was to measure the long-term (>5 years) reoperation risk for mesh revision or removal (safety) and recurrent SUI (efficacy) after midurethral sling surgery. Participants were women who underwent a synthetic midurethral sling surgery for SUI between 2005 and 2016 within a large managed care organization of 4.5 million members. The system-wide medical record was queried for Current Procedural Terminology and International Classification of Diseases (9th or 10th revision) codes to identify perioperative and demographic patient data. Implant registry coding assessed the sling type. The primary study outcome was overall reoperation rate after midurethral sling surgery. Secondary outcomes were specific reoperation rates for mesh revision or removal, and for recurrent SUI. The cumulative incidence of reoperation risk was calculated as a function of time: at least 1 year, at least 5 years, and at least 9 years. Demographics, characteristics, and reoperation of patients were compared using 2 x 2 for categorical variables and Wilcoxon rank sum for continuous variables. A Cox proportional hazards model was used to estimate the adjusted hazard ratio for reoperation. The cohort comprised 17,030 patients treated with primary midurethral slings. The all-cause reoperation rate was 2.1% (95% confidence interval [CI], 1.9%-2.4%) at 1 year, 4.5% (95% CI, 4.1%-4.8%) at 5 years, and 6.0% (95% CI, 5.5%-6.5%) at 9 years. Demographic or perioperative factors were not associated with risk of reoperation rate with the exception that this rate was lower in Asian or Pacific Islanders than white patients (P = 0.04). There was a small increased risk of reoperation for mesh revision or removal over time: 0.7% (95% CI, 0.6%-0.8%) at 1 year, 1.0% (95% CI, 0.8%-1.1%) at 5 years, and 1.1% (95% CI, 0.9%-1.3%) at 9 years. Among patients with recurrent SUI, risk of reoperation was 1.6% (95% CI, 1.4%-1.8%) at 1 year, 3.9% (95% CI, 3.5%-4.2%) at 5 years, and 5.2%(95% CI, 4.7%-5.7%) at 9 years. The type of sling used affected risk of reoperation for recurrent SUI; reoperation was significantly more common after single incision than with retropubic sling (adjusted hazard ratio, 1.5; 95% CI, 1.06-2.11; P = 0.03). These data show that the long-termrisk of reoperation formesh revision or removal and recurrent SUI is low after a primary midurethral sling. The findings add convincingly to evidence for the safety and efficacy of these slings for treatment ofwomen with SUI.