The Long-Term Impact of Vaginal Surgical Mesh Devices in UK Primary Care: A Cohort Study in the Clinical Practice Research Datalink.

Georgia C Richards,Emily Mcfadden,Carl Heneghan,Sarah Lay-Flurrie,Constantinos Koshiaris

doi:10.2147/clep.s333775

Abstract

PurposeStress 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 MethodsRates 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.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 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.ConclusionMesh 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.

Highlights

Surgical mesh has been used in urogynaecological proce dures to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for the past 20 years
Women were eligible for inclusion if they had a diagnostic code for SUI or POP recorded in their primary care electronic medical record, and they met the following criteria: they were registered at an “up-to-standard” practice, their record was deemed “acceptable” for research based on Clinical Practice Research Datalink (CPRD) defined quality indicators,[12] and they were eligible for data linkage
For POP mesh surgery, the numbers needed to harm (NNH) at 5 years was similar for depression, anxiety and self-harm, where there was one extra episode for every 45.1 women and for opioid prescriptions, where there was one extra prescription for every 42.8 women

Summary

Introduction

Surgical mesh has been used in urogynaecological proce dures to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for the past 20 years. Previous research in the UK has used Hospital Episodes Statistics (HES) data to describe complications (mainly rates of reoperation) related to mesh surgery in the hospital setting.[5,11] There is a lack of evidence on longterm outcomes arising from mesh devices beyond readmission.[1] this study will use the Clinical Practice Research Datalink (CPRD) linked to HES data to examine long-term patient outcomes affecting comorbidity and quality of life, including depression, anxiety and selfharm, and sexual dysfunction, and numbers of prescrip tions for antibiotics and opioid pain relief, in patients with SUI and/or POP, both with and without surgical mesh implants

Methods

Results

Discussion

Conclusion