The long-term impact of vaginal surgical mesh devices in UK primary care: a cohort study in the CPRD
McFadden E., Lay-Flurrie S., Koshiaris C., Richards GC., Heneghan C.
AbstractObjectiveStress 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.DesignLongitudinal open cohort study from April 01 2006 to November 30 2018SettingThe 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.ParticipantsWomen aged ≥18 years with a diagnostic SUI/POP code.ExposureMesh surgery coded in HES or CPRD data, compared to no mesh surgery.Main Outcomes measuresRates 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.ResultsThere 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).ConclusionsMesh 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.What is known on this topicThere are well publicised concerns about high complication rates and harms associated with surgical mesh, a treatment that has been used in urogynaecological procedures to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for the past 20 years. Yet, there is a consistent lack of long-term evidence over the use of surgical mesh beyond surgical readmission, with NICE, Cochrane, and the FDA all reporting a lack of long-term outcome data. This study reports long-term complications in women with stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP), with and without surgical mesh implants.What this study addsIn this cohort of 162,687 women with SUI and 82,123 women with POP, rates of depression, anxiety, self-harm, sexual dysfunction and opioid prescriptions were higher in women with mesh-surgery who had a previous history of these outcomes. Lower rates of depression, anxiety and self-harm were seen in women with a history of these outcomes and SUI or POP mesh surgery. Opioid prescribing were lower in women with a previous history of prescriptions and POP mesh surgery. Careful consideration of the benefits and risk of mesh surgery for women with SUI or POP on an individual basis is required.