Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse Surgery: A Meta-analysis of 161 536 Patients

Júlia Ács; Anett Szabó; Péter Fehérvári; Andrea Harnos; Benjamin Skribek; Martin Tenke; Tibor Szarvas; Péter Nyirády; Nándor Ács; Péter Hegyi; Attila Majoros

doi:10.1016/j.euf.2023.11.001

Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse Surgery: A Meta-analysis of 161 536 Patients

Eur Urol Focus. 2023 Nov 13:S2405-4569(23)00243-2. doi: 10.1016/j.euf.2023.11.001. Online ahead of print.

Authors

Affiliations

¹ Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Urology, Semmelweis University, Budapest, Hungary.
² Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Biostatistics, University of Veterinary Medicine Budapest, Budapest, Hungary.
³ Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
⁴ Department of Urology, Semmelweis University, Budapest, Hungary; Department of Urology, University of Duisburg-Essen and German Cancer Consortium, Essen, Germany.
⁵ Department of Urology, Semmelweis University, Budapest, Hungary.
⁶ Department of Obstetrics and Gynecology, Semmelweis University, Budapest, Hungary.
⁷ Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary; Institute for Translational Medicine, University of Pécs Medical School, Pécs, Hungary.
⁸ Department of Urology, Semmelweis University, Budapest, Hungary. Electronic address: majoros.attila@med.semmelweis-univ.hu.

PMID: 37968187
DOI: 10.1016/j.euf.2023.11.001

Abstract

Context: Among the many surgical treatments for pelvic organ prolapse (POP), better results can be achieved with the use of vaginal implants. However, owing to perceived complications, vaginal implant surgeries have been restricted or banned in many countries.

Objective: To assess the real value of vaginal implants in POP surgery and compare the safety and efficacy of operations with and without implants.

Evidence acquisition: A systematic search was performed in three medical databases. Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes.

Evidence synthesis: We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20-3.87), vaginal erosion (OR 14.05, 95% CI 9.07-21.77), vaginal bleeding (OR 1.67, 95% CI 1.25-2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18-1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06-5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36-0.85) were superior in the implant group.

Conclusions: POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. Therefore, the complete prohibition of implants for POP surgeries should be reconsidered.

Patient summary: We compared vaginal surgery with and without implants for repair of pelvic organ prolapse. Despite higher complication rates, vaginal implants provide better long-term results overall than surgery without implants.

Keywords: Pelvic floor reconstruction; Prolapse repair; Reconstructive surgery; Vaginal mesh; Vaginal sling; Vaginal tape; Vaginal wall repair.

Publication types

Review