Long-term Safety of Synthetic Midurethral Sling Implantation for the Treatment of Stress Urinary Incontinence in Adult Women: A Systematic Review

There is an urgent need to improve safety monitoring of suburethral slings. Available safety data at 5 yr and beyond are heterogeneous and of insufficient quality to guide the decision. There is a lack of randomized controlled trial data and heterogeneity outcomes. Recommendations on standardized reporting of complications are therefore necessary. National healthcare databases for research, constitution of large national observatories, or mandatory postmarketing surveillance are key opportunities to greatly enhance the long-term assessment of the safety of suburethral slings. Midurethral slings (MUSs) are the most used therapy for the treatment of stress urinary incontinence (SUI). While warning signals about potential complications have been raised worldwide, there is a lack of safety data especially in the long term. Our objective was to evaluate synthetic MUS safety outcomes at long term in adult women. We included all studies evaluating MUSs in adult women with SUI. All synthetic MUSs have been considered: tension-free vaginal tape (TVT), transobturator tape (TOT), and mini-slings. The primary outcome was the reoperation rate at 5 yr. Of 5586 references screened after duplicate removal, 44 studies (8218 patients) were included. Among these, nine were randomized controlled trials and 35 were cohort studies. The overall reoperation rates at 5 yr varied between 0% and 19% for TOT (11 studies), 0% and 13% for TVT (17 studies), and 0% and 19% for mini-slings (two studies). The overall reoperation rates at 10 yr varied between 5% and 15% for TOT (four studies) and between 2% and 17% for TVT (four studies). There were few safety data beyond 5 yr: 22.7% of the articles reported a follow-up at ≥10 yr and 2.3% at ≥15 yr. The incidence rates of reoperations and complications are heterogeneous, and data beyond 5 yr are rare. There is an urgent need to improve safety monitoring of mesh as our review highlights that available safety data are heterogeneous and of insufficient quality to guide the decision.