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

CONTEXT: 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.

OBJECTIVE: Our objective was to evaluate synthetic MUS safety outcomes at long term in adult women.

EVIDENCE ACQUISITION: 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.

EVIDENCE SYNTHESIS: 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.

CONCLUSIONS: The incidence rates of reoperations and complications are heterogeneous, and data beyond 5 yr are rare.

PATIENT SUMMARY: 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.