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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
Open accessAbstract
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.
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Although the rate of severe complications may be low, due to high surgery rates, a substantial number of women will suffer after POP surgery worldwide.
“Although the rate of severe complications may be low [90], due to high surgery rates, a substantial number of women will suffer after POP surgery worldwide [92].”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [90]
The Conclusion says some women experience severe pain, dyspareunia and other life-changing morbidity after prolapse surgery, supporting the claim that women can suffer after POP surgery. The paper does not establish high surgery rates or a substantial number of affected women worldwide; its findings come from the PROSPECT cohort. (LLM, conf=0.83)
Experimental — accuracy not yet measuredSurgery for prolapse can be associated with various adverse events and potentially poorer quality of life than the original condition.
“Furthermore, the recurrence rate following traditional surgery for POP is approximately 30% [88, 89], and surgery for prolapse can be associated with various adverse events and potentially poorer quality of life than the original condition [90, 91].”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [90]
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Cites
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Flagged first, then by citations
Research works printed but not linked: 2
- NHS Improvement and NHS England, 2018, Vaginal Mesh: High Vigilance Restriction Period: Immediate Action Required, All Cases Should be Postponed If it is Clinically Safe to Do So
- First Do No Harm, 2020, The Report of the Independent Medicines and Medical Devices Safety Review
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Bø, K., Anglès-Acedo, S., Batra, A., Brækken, I. H., Chan, Y. L., Jorge, C. H., Kruger, J., Yadav, M., & Dumoulin, C. (2022) · International Urogynecology Journal · doi:10.1007/s00192-022-05324-0 · Cited by 64
“” Although the rate of severe complications may be low [90], due to high surgery rates, a substantial number of women will suffer after POP surgery worldwide [92].”
BackgroundPROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse
Reid, F. M., Aucott, L., Glazener, C. M. A., Elders, A., Hemming, C., Cooper, K. G., Freeman, R. M., Smith, A. R. B., Hagen, S., Kilonzo, M., et al. (2023) · International Urogynecology Journal · doi:10.1007/s00192-022-05308-0 · Cited by 18
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Metadata
- Authors
- Reid, F., Elders, A., Breeman, S., Freeman, R., & the PROSPECT study group
- Affiliations
- The Warrell Unit Saint Mary’s Hospital Manchester University NHS Foundation Trust Manchester Academic Health Science Centre Manchester UK
- Glasgow Caledonian University (GB)
- University of Aberdeen (GB)
- Plymouth Hospital (GB)
- Venue
- BJOG: An International Journal of Obstetrics & Gynaecology
- Publisher
- Wiley
- Published
- 2021-09-27
- Volume
- 128
- Issue
- 13
- Pages
- 2180-2189
- ISSN
- 0306-5456 (ISSN-L)
- 1470-0328
- 1471-0528
- PMC
- PMC9292877
- OpenAlex
- W3196675518
- Cited by
- 20
- References
- 17
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 5 · 2023: 5 · 2022: 4 · 2021: 1
- FWCI
- 2.82
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BJOG An International Journal of Obstetrics & Gynaecology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ResearchOnline (Glasgow Caledonian University) (acceptedVersion, cc-by)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion, other-oa)
- Funders
- National Institute for Health and Care Research (07/60/18)
- University of Aberdeen
- Chief Scientist Office, Scottish Government Health and Social Care Directorate
- Health Technology Assessment Programme
- Topics
- Health Sciences › Medicine › Urology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Surgery › Hernia repair and management
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Keywords
- pelvic organ prolapse, vaginal mesh repair, polypropylene mesh, native tissue repair, surgical complications, dyspareunia, postoperative pain, vaginal adhesions, urinary retention, PROSPECT trial
- MeSH terms
- Adult, Collagen, Female, Humans, Middle Aged, Polypropylenes, Postoperative Complications, Prospective Studies, Gynecologic Surgical Procedures, Surgical Mesh, Uterine Prolapse, Cohort Studies, Treatment Outcome, Patient Satisfaction, Plastic Surgery Procedures, Pelvic Organ Prolapse, Heterografts
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