Abstract

ObjectiveTo report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs.DesignSecondary analysis of the PROSPECT randomised controlled trial and cohort study.SettingThirty‐five UK hospitals.PopulationA total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair.MethodsEvent rates were calculated for all complications. Analysis was by treatment received.Main outcome measuresIUGA/ICS classification of complications and validated patient reported outcome measures.ResultsAt baseline, 8.4% of women had ‘generic’ pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re‐admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re‐admission were vaginal adhesions, urinary retention, infection and constipation.ConclusionsThis is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications.Tweetable abstractA prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.

Highlights

  • Transvaginal polypropylene mesh for pelvic organ prolapse (POP) and stress urinary incontinence has been the subjectPROSPECT study group members are presented in Appendix A.of much controversy with its use being suspended in some countries as the result of complications,[1] and several series including the management of such complications have been published.[2,3]The evidence collected during the Cumberlege inquiry in the UK4 has highlighted serious side effects of the use of a 2021 The Authors

  • BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd

  • Very few studies have compared the complications of POP surgery using polypropylene mesh or biological xenografts compared with native tissue surgery

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Summary

Introduction

Transvaginal polypropylene mesh for pelvic organ prolapse (POP) and stress urinary incontinence has been the subjectPROSPECT study group members are presented in Appendix A.of much controversy with its use being suspended in some countries as the result of complications,[1] and several series including the management of such complications have been published.[2,3]The evidence collected during the Cumberlege inquiry in the UK4 has highlighted serious side effects of the use of a 2021 The Authors. Transvaginal polypropylene mesh for pelvic organ prolapse (POP) and stress urinary incontinence has been the subject. PROSPECT study group members are presented in Appendix A. of much controversy with its use being suspended in some countries as the result of complications,[1] and several series including the management of such complications have been published.[2,3]. The evidence collected during the Cumberlege inquiry in the UK4 has highlighted serious side effects of the use of a 2021 The Authors. Mesh and short comings in medical practice. The report, First do no harm, states that there is a risk of harm from the primary surgical procedure and from subsequent mesh removal surgery. Very few studies have compared the complications of POP surgery using polypropylene mesh or biological xenografts compared with native tissue surgery

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