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BJOG An International Journal of Obstetrics & Gynaecology
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How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial

Authors: Reid, FM; Elders, A; Breeman, S; Freeman, RM; Glazener, CMA; Hemming, C; Cooper, KG; +9 Authors

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

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.

Keywords

Heterografts/transplantation, patient satisfaction, Reconstructive Surgical Procedures/methods, polypropylenes/therapeutic use, R Medicine (General), surgery, Cohort Studies, Gynecologic Surgical Procedures, Postoperative Complications, cohort studies, Uterine Prolapse, middle aged, Obstetrics and Gynaecology, pain, surgical mesh, Prospective Studies, humans, Research Articles, Uterine Prolapse/surgery, reconstructive surgical procedures/methods, adult, collagen/therapeutic use, Middle Aged, surgical complications, Takes and figures, IUGA/ICS complications classification, female, Treatment Outcome, Patient Satisfaction, Cumberlege report, Heterografts, Female, Collagen, Cumberlege Report, 07/60/18, Adult, heterografts/transplantation, Supplementary Information, pelvic organ prolapse/surgery, Polypropylenes/therapeutic use, 610, Polypropylenes, Pelvic Organ Prolapse, Pelvic Organ Prolapse/surgery, Collagen/therapeutic use, postoperative complications, Humans, gynecologic surgical procedures/methods, National Institute for Health Research (NIHR), dyspareunia, Plastic Surgery Procedures, Surgical Mesh, R1, prolapse, polypropylene mesh, prospective studies, uterine prolapse/surgery, treatment outcome, Gynecologic Surgical Procedures/methods

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    popularity
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    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
18
Top 10%
Average
Top 10%
Green
hybrid