How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial

PROSPECT study group

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Abstract

Objective: To report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs. Design: Secondary analysis of the PROSPECT randomised controlled trial and cohort study. Setting: Thirty-five UK hospitals. Population: A total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair. Methods: Event rates were calculated for all complications. Analysis was by treatment received. Main outcome measures: IUGA/ICS classification of complications and validated patient reported outcome measures. Results: At 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. Conclusions: This 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 abstract: A prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.

Original languageEnglish
Pages (from-to)2180-2189
Number of pages10
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume128
Issue number13
Early online date27 Sept 2021
DOIs
Publication statusPublished - 1 Dec 2021

Bibliographical note

Funding

The project was funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 07/60/18). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.

Acknowledgements
The authors wish to thank the women who participated in the PROSPECT study. We also thank Margaret MacNeil for her secretarial support and data management, the programming team in CHaRT and the staff at the recruitment sites who facilitated the recruitment, treatment and follow up of study participants.

Data Availability Statement

Author elects to not share data.

Keywords

  • Cumberlege report
  • dyspareunia
  • IUGA/ICS complications classification
  • pain
  • polypropylene mesh
  • prolapse
  • surgery
  • surgical complications

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