Clinical Epidemiology (Dec 2021)
The Long-Term Impact of Vaginal Surgical Mesh Devices in UK Primary Care: A Cohort Study in the Clinical Practice Research Datalink
Abstract
Emily McFadden,1 Sarah Lay-Flurrie,1,2 Constantinos Koshiaris,1 Georgia C Richards,1,3 Carl Heneghan1,3 1Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; 2EMEA Real World Methods and Evidence Generation, IQVIA, London, UK; 3Global Centre on Healthcare and Urbanisation, Kellogg College, University of Oxford, Oxford, UKCorrespondence: Emily McFaddenCentre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UKTel +44 1865 617940Email [email protected]: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) may be treated with surgical mesh devices; evidence of their long-term complications is lacking.Patients and Methods: Rates of diagnoses of depression, anxiety or self-harm (composite measure) and sexual dysfunction, and rates of prescriptions for antibiotics and opioids were estimated in women with and without mesh surgery, with a diagnostic SUI/POP code, registered in the Clinical Practice Research Datalink (CPRD) gold database.Results: There were 220,544 women eligible for inclusion; 74% (n = 162,687) had SUI, 37% (n = 82,123) had POP, and 11% (n = 24,266) had both. Women undergoing mesh surgery for SUI or POP had about 1.1 times higher rates of antibiotic use. Women with no previous history of the outcome, who underwent mesh surgery had 2.43 (95% CI 2.19– 2.70) and 1.47 (95% CI 1.19– 1.81) times higher rates of depression, anxiety, or self-harm, 1.88 (95% CI 1.50– 2.36) and 1.64 (95% CI 1.02– 2.63) times higher rates of sexual dysfunction and 1.40 (95% CI 1.26– 1.56) and 1.23 (95% CI 1.01– 1.49) times higher opioid use for SUI and POP, respectively. Women with a history of depression, anxiety and self-harm had 0.3 times lower rates of these outcomes with SUI or POP mesh surgery (HR for SUI 0.70 (95% CI 0.67-0.73), HR for POP 0.72 (95% CI 0.65-0.79)). Women with a history of opioid use who had POP mesh surgery had about 0.09 times lower rates (HR 0.91 (95% CI 0.86– 0.96)) of prescriptions. Negative control outcome analyses showed no evidence of an association between asthma consultations and mesh surgery in women with POP, but the rate was 0.09 times lower (HR 0.91 (95% CI 0.87– 0.94)) in women with SUI mesh surgery, suggesting that study results are subject to some residual confounding.Conclusion: Mesh surgery was associated with poor mental and sexual health outcomes, alongside increased opioid and antibiotic use, in women with no history of these outcomes and improved mental health, and lower opioid use, in women with a previous history of these outcomes. Although our results suggest an influence of residual confounding, careful consideration of the benefits and risk of mesh surgery for women with SUI or POP on an individual basis is required.Keywords: urinary incontinence, epidemiology, mental health, sexual dysfunction, pain management
