Andy
Senior Member (Voting rights)
Full 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
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.
Paywall, https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.16917
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.
Paywall, https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.16917
