eprintid: 10135926 rev_number: 12 eprint_status: archive userid: 608 dir: disk0/10/13/59/26 datestamp: 2021-10-07 13:06:55 lastmod: 2021-10-07 13:06:55 status_changed: 2021-10-07 13:06:55 type: article metadata_visibility: show creators_name: Muller, P creators_name: Gurol-Urganci, I creators_name: Thakar, R creators_name: Ehrenstein, MR creators_name: Van Der Meulen, J creators_name: Jha, S title: Impact of a mid-urethral synthetic mesh sling on long-term risk of systemic conditions in women with stress urinary incontinence: a national cohort study ispublished: inpress divisions: UCL divisions: B02 divisions: C10 divisions: D17 divisions: G90 keywords: autoimmune disease, colposuspension, fascial sling, fibromyalgia, incontinence surgery, midurethral synthetic mesh sling insertion, myalgic encephalomyelitis, severe adverse events, stress urinary incontinence, systemic conditions, urogynaecology note: © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. abstract: OBJECTIVE: To compare the incidence of systemic conditions between women who had surgical treatment for stress incontinence with mesh and without mesh. DESIGN: National cohort study. SETTING: English National Health Service. POPULATION: Women with no previous record of systemic disease who had first-time urinary incontinence surgery between 1 January 2006 and 31 December 2013, followed up to the earliest of 10 years or 31 March 2019. METHODS: Competing-risks regression was used to estimate hazard ratios (HR), adjusted for patient characteristics, with HR > 1 indicating increased incidence following mesh surgery. MAIN OUTCOME MEASURES: First post-operative admission with a record of autoimmune disease, fibromyalgia or myalgic encephalomyelitis up to 10 years following the first incontinence procedure. Competing-risks regression was used to estimate hazard ratios (HR) of admission, adjusted for patient characteristics, with HR > 1 indicating increased incidence following mesh surgery. RESULTS: The cohort included 88 947 women who had mesh surgery and 3 389 women who had non-mesh surgery. Both treatment groups were similar with respect to age, socio-economic deprivation, comorbidity, and ethnicity. The 10-year cumulative incidence of autoimmune disease, fibromyalgia or myalgic encephalomyelitis was 8.1% (95% confidence interval 7.9% to 8.3%) in the mesh group and 9.0% (8.0% to 10.1%) in the non-mesh group (adjusted HR 0.89 [0.79 to 1.01]; p = 0.07). A sensitivity analysis including only autoimmune diseases as an outcome returned a similar result. CONCLUSIONS: These findings do not support claims that synthetic mesh slings cause systemic disease. date: 2021-09-15 date_type: published official_url: https://doi.org/10.1111/1471-0528.16917 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1890621 doi: 10.1111/1471-0528.16917 lyricists_name: Ehrenstein, Michael lyricists_id: MEHRE20 actors_name: Flynn, Bernadette actors_id: BFFLY94 actors_role: owner full_text_status: public publication: BJOG: An International Journal of Obstetrics and Gynaecology event_location: England citation: Muller, P; Gurol-Urganci, I; Thakar, R; Ehrenstein, MR; Van Der Meulen, J; Jha, S; (2021) Impact of a mid-urethral synthetic mesh sling on long-term risk of systemic conditions in women with stress urinary incontinence: a national cohort study. BJOG: An International Journal of Obstetrics and Gynaecology 10.1111/1471-0528.16917 <https://doi.org/10.1111/1471-0528.16917>. (In press). Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10135926/1/1471-0528.16917.pdf