Elsevier

The Lancet

Volume 389, Issue 10069, 11–17 February 2017, Pages 629-640
The Lancet

Articles
Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997–2016: a population-based cohort study

https://doi.org/10.1016/S0140-6736(16)32572-7Get rights and content

Summary

Background

Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures.

Methods

We did a cohort study of women in Scotland aged 20 years or older undergoing a first, single incontinence procedure or prolapse procedure during 1997–98 to 2015–16 identified from a national hospital admission database. Primary outcomes were immediate postoperative complications and subsequent (within 5 years) readmissions for later postoperative complications, further incontinence surgery, or further prolapse surgery. Poisson regression models were used to compare outcomes after procedures carried out with and without mesh.

Findings

Between April 1, 1997, and March 31, 2016, 16 660 women underwent a first, single incontinence procedure, 13 133 (79%) of which used mesh. Compared with non-mesh open surgery (colposuspension), mesh procedures had a lower risk of immediate complications (adjusted relative risk [aRR] 0·44 [95% CI 0·36–0·55]) and subsequent prolapse surgery (adjusted incidence rate ratio [aIRR] 0·30 [0·24–0·39]), and a similar risk of further incontinence surgery (0·90 [0·73–1·11]) and later complications (1·12 [0·98–1·27]); all ratios are for retropubic mesh. During the same time period, 18 986 women underwent a first, single prolapse procedure, 1279 (7%) of which used mesh. Compared with non-mesh repair, mesh repair of anterior compartment prolapse was associated with a similar risk of immediate complications (aRR 0·93 [95% CI 0·49–1·79]); an increased risk of further incontinence (aIRR 3·20 [2·06–4·96]) and prolapse surgery (1·69 [1·29–2·20]); and a substantially increased risk of later complications (3·15 [2·46–4·04]). Compared with non-mesh repair, mesh repair of posterior compartment prolapse was associated with a similarly increased risk of repeat prolapse surgery and later complications. No difference in any outcome was observed between vaginal and, separately, abdominal mesh repair of vaginal vault prolapse compared with vaginal non-mesh repair.

Interpretation

Our results support the use of mesh procedures for incontinence, although further research on longer term outcomes would be beneficial. Mesh procedures for anterior and posterior compartment prolapse cannot be recommended for primary prolapse repair. Both vaginal and abdominal mesh procedures for vaginal vault prolapse repair are associated with similar effectiveness and complication rates to non-mesh vaginal repair. These results therefore do not clearly favour any particular vault repair procedure.

Funding

None.

Introduction

Female stress urinary incontinence (incontinence) and pelvic organ prolapse (prolapse) are common conditions causing substantial disability.1, 2 The lifetime risk (by age 80 years) of undergoing pelvic floor surgery for incontinence or prolapse for women has been estimated as one in eight in the UK3 and between one in nine4 and one in five5 in the USA. Surgical repair for incontinence and prolapse has traditionally been done using native tissue. However, over the past two decades, alternative procedures involving the transvaginal placement of synthetic mesh tapes (for incontinence) and implants (for prolapse) have been developed, because these procedures were believed to be potentially less invasive, safer, or more effective than traditional non-mesh repairs.

In the 1990s in the USA and in the 2000s in the UK, mesh tape procedures for incontinence were rapidly adopted6 because of the perceived equivalent efficacy to open surgical approaches and the benefit of a minimally-invasive approach and cost savings.7 Mesh tape procedures initially used a retropubic approach; transobturator approach procedures were subsequently developed in an attempt to reduce the risk of intraoperative bladder damage.8 Transvaginal mesh implant procedures for prolapse were developed to reduce the high risk of prolapse recurrence after native tissue repairs,9 and their use has gradually increased over the past decade.10

Despite a number of randomised controlled trials investigating the use of mesh in female incontinence and prolapse surgery, evidence on outcomes in routine practice, particularly long term outcomes are scarce.7, 11, 12 Transvaginal mesh surgery, particularly for prolapse, is considered controversial. Patient advocacy groups have raised concerns about poor long-term outcomes. Litigation brought by women who have experienced serious complications after mesh surgery is underway in many countries, which involves claims settled for over US$1 billion and has forced some manufacturers to withdraw mesh products or close down.13, 14, 15 Enquiries into mesh surgery by the Scottish Government16 and by National Health Service (NHS) England17 are ongoing. Several organisations have expressed reservations about transvaginal mesh surgery, in particular for prolapse,18, 19, 20, 21 although mesh surgery continues to be provided in many settings.22 Procedures involving the transabdominal placement of mesh for uterine or vaginal vault prolapse have been available for many years and are less controversial than newer transvaginal mesh prolapse procedures.

Research in context

Evidence before this study

We searched the Cochrane Database, Database of Abstracts of Reviews of Effectiveness, and Health Technology Assessment database for systematic reviews of the surgical management of stress urinary incontinence (incontinence) and pelvic organ prolapse (prolapse) in women. We searched MEDLINE for observational studies of outcomes after surgical management of incontinence and prolapse published in English from 2000 onwards with search terms urinary incontinence, stress [surgery], prolapse [surgery], or pelvic organ prolapse [surgery] and treatment outcome, intraoperative complications, or postoperative complications. Finally, we searched for relevant guidance from professional bodies, health-care regulators, and UK governmental committees. Searches were conducted over 2015 and updated in April, 2016.

Existing trials on the surgical management of prolapse are small and of low or moderate quality. Evidence on long-term effectiveness and complications after surgical treatment of both incontinence and prolapse is scarce, and high-quality evidence from observational studies is limited.

Added value of this study

We report the first large-scale robust observational study of outcomes after surgical management of both incontinence and prolapse to our knowledge. We use high-quality administrative data with complete population coverage to examine long-term (up to 5 years) effectiveness and complications after specific mesh and comparable non-mesh procedures.

Implications of all the available evidence

Our data support the use of mesh procedures for incontinence, although further research on longer term outcomes would be beneficial. Mesh procedures for anterior and posterior compartment prolapse (when done as an isolated, first repair) cannot be recommended for primary prolapse repair. Our data do not clearly favour any particular vault repair procedure. New trials of mesh surgery for prolapse (PROSPECT) and incontinence (SIMS) are underway and will add to the available evidence, as will longer term follow-up of existing trial cohorts and ongoing judicious analysis of routinely available health-care data to monitor outcomes of routine clinical practice.

We aimed to compare long-term effectiveness and complication rates after procedures with and without mesh for all first, single incontinence and prolapse operations carried out in Scotland, UK, between 1997 and 2016, using a national health-care use database with complete population coverage.

Section snippets

Study design and participants

We did a population-based cohort study using data extracted from the Scottish hospital discharge dataset (SMR01) held by the Information Services Division (ISD) of NHS National Services Scotland. We extracted data for all women aged 20 years or older who underwent incontinence and prolapse procedures between April 1, 1997, and March 31, 2016 in Scotland, UK.

Ethical approvals were obtained from the local Caldicott Guardian and the Scottish Privacy Advisory Committee.

Index procedures

We restricted index

Results

16 660 (62·0%) of 26 885 incontinence procedures and 18 986 (24·5%) of 77 537 prolapse procedures carried out in Scotland between April 1, 1997, and March 31, 2016, were first, single procedures included in our main analysis (figure 1). Characteristics of women undergoing first, single included procedures are shown in Table 1, Table 2. Characteristics of women undergoing first combined procedures (excluded from our main analysis) are shown for comparison in the appendix (p 8). One (<1%) of

Discussion

In this paper, we report the first large-scale robust observational study of outcomes after surgical management of both incontinence and prolapse. We used high-quality administrative data with complete population coverage to examine long-term (up to 5 years) effectiveness and complications after specific mesh and comparable non-mesh procedures.

For stress urinary incontinence, we found that in routine clinical practice mesh surgery was associated with a lower risk of immediate complications and

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