The long-term impact of vaginal surgical mesh devices in UK primary care: a cohort study in the CPRD

Abstract

Objective: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are treated with surgical mesh devices; evidence of their long-term complications is lacking. To examine long-term complications in women with SUI and/or POP, with and without surgical mesh implants. Design: Longitudinal open cohort study from April 01 2006 to November 30 2018 Setting: The Clinical Practice Research Datalink (CPRD) Gold database, linked to Hospital Episodes Statistics (HES) inpatient data, Office for National Statistics mortality data, and Index of Multiple Deprivation socioeconomic status data. Participants: Women aged [≥]18 years with a diagnostic SUI/POP code. Exposure: Mesh surgery coded in HES or CPRD data, compared to no mesh surgery. Main Outcomes measures: Rates of diagnoses of depression, anxiety or self-harm (composite measure) and sexual dysfunction, using Cox proportional hazards regression, and rates of prescriptions for antibiotics and opioids, using negative binomial regression. 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 higher rates of antibiotic use (SUI: IRR 1.15 (95% CI 1.13 to 1.18; p<0.001); POP: IRR 1.09 (95% CI 1.04 to 1.14; p<0.001)). Women with no previous history of the outcome, who underwent mesh surgery for SUI or POP, had higher rates of depression, anxiety, or self-harm (SUI: HR 2.43 (95% CI 2.19 to 2.70; p<0.001; POP: HR 1.47 (95% CI 1.19 to 1.81; p<0.001)), sexual dysfunction (SUI: HR 1.88 (1.50 to 2.36; p<0.001); POP: HR 1.64 (95% CI 1.02 to 2.63; p=0.04)) and opioid use (SUI: IRR 1.40 (95% CI 1.26 to 1.56, p<0.001); POP: IRR 1.23 (95% CI 1.01 to 1.49; p=0.04)). Women with a history of depression, anxiety and self-harm had lower rates of these outcomes with SUI or POP mesh surgery (SUI: HR 0.70 (95% CI 0.67 to 0.73; p<0.001), POP: HR 0.72 (95% CI 0.65 to 0.79; p<0.001). Women with a history of opioid use who had POP mesh surgery had lower rates of prescriptions (IRR 0.91 95% CI (0.86 to 0.96); p=0.001). Conclusions: 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. Careful consideration of the benefits and risk of mesh surgery for women with SUI or POP on an individual basis is required.