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. 2021 Dec;128(13):2180-2189.
doi: 10.1111/1471-0528.16897. Epub 2021 Sep 27.

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

F M Reid  1   2 , A Elders  3 , S Breeman  4 , R M Freeman  5 ; PROSPECT study group
Collaborators, Affiliations

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

F M Reid et al. BJOG. 2021 Dec.

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.

Keywords: Cumberlege report; IUGA/ICS complications classification; dyspareunia; pain; polypropylene mesh; prolapse; surgery; surgical complications.

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References

    1. NHS Improvement and NHS England . Vaginal Mesh: High Vigilance Restriction Period: Immediate Action Required, All Cases Should be Postponed If it is Clinically Safe to Do So. London, UK: NHS Improvement and NHS England; 2018. [https://i.emlfiles4.com/cmpdoc/9/7/2/8/1/1/files/47633_mesh‐letter‐to‐ac...]. Accessed 5 August 2020.
    1. Firoozi F, Ingber MS, Moore CK, Vasavada SP, Rackley RR, Goldman HB. Purely transvaginal/perineal management of complications from commercial prolapse kits using a new prostheses/grafts complication classification system. J Urol 2012;187:1674–9. - PubMed
    1. Miklos JR, Chinthakanan O, Moore RD, Mitchell GK, Favors S, Karp DR, et al. The IUGA/ICS classification of synthetic mesh complications in female pelvic floor reconstructive surgery: a multicenter study. Int Urogynecol J 2016;27:933–8. - PubMed
    1. First Do No Harm . The Report of the Independent Medicines and Medical Devices Safety Review. UK: APS Group; 2020. [https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf]. Accessed 5 August 2020.
    1. Glazener C, Breeman S, Elders A, Hemming C, Cooper K, Freeman R, et al. Clinical effectiveness and cost‐effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: Two randomised controlled trials within a comprehensive cohort study ‐ results from the PROSPECT study. Health Technol Assess 2016;20:1–452. - PMC - PubMed