NIHR DC Discover

NIHR Signal Using mesh does not improve results in vaginal prolapse surgery

Published on 15 August 2017

doi: 10.3310/signal-000464

Using a synthetic mesh or biological tissue graft is no better than standard surgical repair, without the use of these materials, in women with vaginal wall prolapse. Some women had problems from the mesh.

This large pragmatic study looked at over 3000 women with vaginal prolapse. Half of these were randomised; the rest contributed data but were not part of the main evaluation. The study separately compared mesh and biological grafts to a repair without these additions. It also took account of whether it was women’s first or subsequent repair operation.

There was no difference in prolapse symptoms or quality of life at two years in women who had surgery that used mesh or biological graft and those who had standard surgery. About 12% of women overall had minor or major complications from the mesh. 

Due to the lack of effect on quality of life and the possibility of minor or major mesh complications, neither option was assessed to be a good use of NHS resources (value for money).   

NICE currently recommends that meshes should be used only in a research context, due to uncertainty about long-term effects and the risk of complications. These findings showing lack of benefit do not support the use of mesh in routine NHS practice.  

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Why was this study needed?

The organs within a woman’s pelvis are normally held in place by ligaments and muscles. When these support structures become stretched, for example by childbirth, pelvic organs can slip and bulge (prolapse) into the front or back wall of the vagina. This study considers both types of prolapse, which can affect the bladder or bowel respectively.

Conservative management can help many women with vaginal prolapse, but 10% require surgery. Traditional surgical repair uses the woman’s own (native) tissue. However, these repairs fail for around a third of women, who then need further surgery.

The additional use of a synthetic mesh or a biological tissue graft could better hold the prolapsed organs in place and so potentially improve cure rates and reduce NHS costs. However, there have been concerns about the possible lack of long-term benefits and the adverse effects of using these materials.  

What did this study do?

The PROSPECT study (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials) comprised randomised controlled comparisons and cohorts totalling 3089 women having surgery for vaginal prolapse at 35 UK hospitals.

In randomised women having a first (‘primary’) prolapse repair, native repair was compared to mesh in 865, and to biological graft in 735. In randomised women having a repeat (‘secondary’) repair, the totals were 107 and 71 respectively. The other women or their surgeons had a strong preference for one technique, so they were not randomised and did not contribute to the main analysis.

The main outcomes were prolapse symptoms one year after surgery (measured using the Pelvic Organ Prolapse Symptom Score, POP-SS), quality of life and cost.

What did it find?

  • One year after primary surgery, prolapse symptoms improved in both groups and were no better in women who had mesh compared with women who had a standard surgical repair (mean difference in POP-SS 0.00, 95% confidence interval [CI] −0.70 to 0.71).  The average improvement was eight points (and two points is the minimum change regarded as important)
  • Similarly, the improvement in symptoms at one year was no better in women who had biological graft repair than in women who had a standard repair (mean difference in POP-SS −0.15, 95% CI −0.93 to 0.63).
  • There was no difference in the quality of life between groups, in terms of how much symptoms interfered with daily life.
  • Apart from mesh-related complications, less than one in 10 women experienced serious complications such as infection, pain or urinary retention up to one year after surgery, with no significant differences between operations.
  • With mesh, about 12% of women had complications including exposure of the mesh, three-quarters of whom needed surgical removal of the mesh to relieve symptoms.
  • Compared with standard repair, using a synthetic mesh cost an additional £363 per woman and biological graft an extra £565.
  • Mesh was no better than standard surgery in secondary prolapse repair though here the numbers of women were smaller.

What does current guidance say on this issue?

NICE guidance (2008) on surgical repair of vaginal wall prolapse using mesh (currently being updated) advises that mesh (synthetic or biological) may give better outcomes than repair without mesh. However, data on safety and effectiveness, particularly long term, is limited. Therefore, the procedure is only advised with special arrangements for clinical governance, consent and audit or research. Clinicians need to ensure that patients understand there is uncertainty about long-term results and a risk of complications, including sexual dysfunction and erosion into the vagina, which would require additional procedures.

NICE is currently updating its guidance on urinary incontinence in women to include management of pelvic organ prolapse for England and Wales. Scotland has already reviewed the literature and published a report that includes the first of these two trials. 

What are the implications?

Previous evidence on synthetic meshes and biological grafts suggested some benefit, though the trials were smaller and arguably poor quality. This large well-conducted study indicates that these materials give no additional benefit, with additional adverse effects in a minority of women and yet cost more. This conclusion is a little less reliable in women having secondary repair because of smaller numbers in the trial.

Some surgeons may still consider these approaches appropriate for certain women; however, they should clearly highlight the limitations of the evidence and the risks.   

NHS England’s Mesh Working Group is currently investigating the use of meshes, and the Scottish Independent Review has cautioned their use pending further research. The findings of these trials are likely to inform these reviews and forthcoming NICE updates.

Citation and Funding

Glazener CM, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet. 2017;389(10067):381-92.

Glazener C, Breeman S, Elders A, et al. Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study results from the PROSPECT Study. Health Technol Assess. 2017;20(95).

The project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 07/60/18).

Bibliography

Brincat C, Brubaker L. Mesh, graft, or standard repair for prolapse surgery? Lancet. 2017;389(10067):334-36.

Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016;(2)CD012079.

NHS Choices. Pelvic organ prolapse. London: Department of Health; 2015.

Scottish Government. Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women: Final report; 2017.

Why was this study needed?

The organs within a woman’s pelvis are normally held in place by ligaments and muscles. When these support structures become stretched, for example by childbirth, pelvic organs can slip and bulge (prolapse) into the front or back wall of the vagina. This study considers both types of prolapse, which can affect the bladder or bowel respectively.

Conservative management can help many women with vaginal prolapse, but 10% require surgery. Traditional surgical repair uses the woman’s own (native) tissue. However, these repairs fail for around a third of women, who then need further surgery.

The additional use of a synthetic mesh or a biological tissue graft could better hold the prolapsed organs in place and so potentially improve cure rates and reduce NHS costs. However, there have been concerns about the possible lack of long-term benefits and the adverse effects of using these materials.  

What did this study do?

The PROSPECT study (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials) comprised randomised controlled comparisons and cohorts totalling 3089 women having surgery for vaginal prolapse at 35 UK hospitals.

In randomised women having a first (‘primary’) prolapse repair, native repair was compared to mesh in 865, and to biological graft in 735. In randomised women having a repeat (‘secondary’) repair, the totals were 107 and 71 respectively. The other women or their surgeons had a strong preference for one technique, so they were not randomised and did not contribute to the main analysis.

The main outcomes were prolapse symptoms one year after surgery (measured using the Pelvic Organ Prolapse Symptom Score, POP-SS), quality of life and cost.

What did it find?

  • One year after primary surgery, prolapse symptoms improved in both groups and were no better in women who had mesh compared with women who had a standard surgical repair (mean difference in POP-SS 0.00, 95% confidence interval [CI] −0.70 to 0.71).  The average improvement was eight points (and two points is the minimum change regarded as important)
  • Similarly, the improvement in symptoms at one year was no better in women who had biological graft repair than in women who had a standard repair (mean difference in POP-SS −0.15, 95% CI −0.93 to 0.63).
  • There was no difference in the quality of life between groups, in terms of how much symptoms interfered with daily life.
  • Apart from mesh-related complications, less than one in 10 women experienced serious complications such as infection, pain or urinary retention up to one year after surgery, with no significant differences between operations.
  • With mesh, about 12% of women had complications including exposure of the mesh, three-quarters of whom needed surgical removal of the mesh to relieve symptoms.
  • Compared with standard repair, using a synthetic mesh cost an additional £363 per woman and biological graft an extra £565.
  • Mesh was no better than standard surgery in secondary prolapse repair though here the numbers of women were smaller.

What does current guidance say on this issue?

NICE guidance (2008) on surgical repair of vaginal wall prolapse using mesh (currently being updated) advises that mesh (synthetic or biological) may give better outcomes than repair without mesh. However, data on safety and effectiveness, particularly long term, is limited. Therefore, the procedure is only advised with special arrangements for clinical governance, consent and audit or research. Clinicians need to ensure that patients understand there is uncertainty about long-term results and a risk of complications, including sexual dysfunction and erosion into the vagina, which would require additional procedures.

NICE is currently updating its guidance on urinary incontinence in women to include management of pelvic organ prolapse for England and Wales. Scotland has already reviewed the literature and published a report that includes the first of these two trials. 

What are the implications?

Previous evidence on synthetic meshes and biological grafts suggested some benefit, though the trials were smaller and arguably poor quality. This large well-conducted study indicates that these materials give no additional benefit, with additional adverse effects in a minority of women and yet cost more. This conclusion is a little less reliable in women having secondary repair because of smaller numbers in the trial.

Some surgeons may still consider these approaches appropriate for certain women; however, they should clearly highlight the limitations of the evidence and the risks.   

NHS England’s Mesh Working Group is currently investigating the use of meshes, and the Scottish Independent Review has cautioned their use pending further research. The findings of these trials are likely to inform these reviews and forthcoming NICE updates.

Citation and Funding

Glazener CM, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet. 2017;389(10067):381-92.

Glazener C, Breeman S, Elders A, et al. Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study results from the PROSPECT Study. Health Technol Assess. 2017;20(95).

The project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 07/60/18).

Bibliography

Brincat C, Brubaker L. Mesh, graft, or standard repair for prolapse surgery? Lancet. 2017;389(10067):334-36.

Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016;(2)CD012079.

NHS Choices. Pelvic organ prolapse. London: Department of Health; 2015.

Scottish Government. Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women: Final report; 2017.

Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)

Published on 25 December 2016

Glazener, C. M.,Breeman, S.,Elders, A.,Hemming, C.,Cooper, K. G.,Freeman, R. M.,Smith, A. R.,Reid, F.,Hagen, S.,Montgomery, I.,Kilonzo, M.,Boyers, D.,McDonald, A.,McPherson, G.,MacLennan, G.,Norrie, J.

Lancet , 2016

BACKGROUND: The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. METHODS: We did two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of secondary and tertiary referral hospitals) in the UK. We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres. We randomly assigned participants by a remote web-based randomisation system to one of the two trials: comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial). We assigned women (1:1:1 or 1:1) within three strata: assigned to one of the three treatment options, comparison of standard repair with mesh, and comparison of standard repair with graft. Participants, ward staff, and outcome assessors were masked to randomisation where possible; masking was obviously not possible for the surgeon. Follow-up was for 2 years after the surgery; the primary outcomes, measured at 1 year and 2 years, were participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN60695184. FINDINGS: Between Jan 8, 2010, and Aug 30, 2013, we randomly allocated 1352 women to treatment, of whom 1348 were included in the analysis. 865 women were included in the mesh trial (430 to standard repair alone, 435 to mesh augmentation) and 735 were included in the graft trial (367 to standard repair alone, 368 to graft augmentation). Because the analyses were carried out separately for each trial (mesh trial and graft trial) some women in the standard repair arm assigned to all treatment options were included in the standard repair group of both trials. 23 of these women did not receive any surgery (15 in the mesh trial, 13 in the graft trial; five were included in both trials) and were included in the baseline analyses only. Mean POP-SS at 1 year did not differ substantially between comparisons (standard 5.4 [SD 5.5] vs mesh 5.5 [5.1], mean difference 0.00, 95% CI -0.70 to 0.71; p=0.99; standard 5.5 [SD 5.6] vs graft 5.6 [5.6]; mean difference -0.15, -0.93 to 0.63; p=0.71). Mean prolapse-related quality-of-life scores also did not differ between groups at 1 year (standard 2.0 [SD 2.7] vs mesh 2.2 [2.7], mean difference 0.13, 95% CI -0.25 to 0.51; p=0.50; standard 2.2 [SD 2.8] vs graft 2.4 [2.9]; mean difference 0.13, -0.30 to 0.56; p=0.54). Mean POP-SS at 2 years were: standard 4.9 (SD 5.1) versus mesh 5.3 (5.1), mean difference 0.32, 95% CI -0.39 to 1.03; p=0.37; standard 4.9 (SD 5.1) versus graft 5.5 (5.7); mean difference 0.32, -0.48 to 1.12; p=0.43. Prolapse-related quality-of-life scores at 2 years were: standard 1.9 (SD 2.5) versus mesh 2.2 (2.6), mean difference 0.15, 95% CI -0.23 to 0.54; p=0.44; standard 2.0 (2.5) versus graft 2.2 (2.8); mean difference 0.10, -0.33 to 0.52; p=0.66. Serious adverse events such as infection, urinary retention, or dyspareunia or other pain, excluding mesh complications, occurred with similar frequency in the groups over 1 year (mesh trial: 31/430 [7%] with standard repair vs 34/435 [8%] with mesh, risk ratio [RR] 1.08, 95% CI 0.68 to 1.72; p=0.73; graft trial: 23/367 [6%] with standard repair vs 36/368 [10%] with graft, RR 1.57, 0.95 to 2.59; p=0.08). The cumulative number of women with a mesh complication over 2 years in women actually exposed to synthetic mesh was 51 (12%) of 434. INTERPRETATION: Augmentation of a vaginal repair with mesh or graft material did not improve women's outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication. Therefore, follow-up is vital to identify any longer-term potential benefits and serious adverse effects of mesh or graft reinforcement in vaginal prolapse surgery. FUNDING: UK National Institute of Health Research.

The Pelvic Organ Prolapse Symptom Score (POP-SS) is a validated tool to measure symptoms of pelvic organ prolapse. The seven items ask women about the frequency of prolapse symptoms in the preceding four weeks, with each item scored from 0 (never) to 4 (all the time). The total score can range from 0 to 28. A two-point change in score is considered clinically meaningful.

Expert commentary

The use of transvaginal mesh and biological grafts for vaginal prolapse is controversial and any benefit remains unproven. Many mesh products have been withdrawn because of concern about rates of complications and medical litigation. This study is the largest randomised study looking at both synthetic and biological grafts and comparing them to native tissue repair (where only a woman’s own tissues are stitched). It is adequately powered and at two-year follow-up shows no benefit of the use of any biological or synthetic grafts in improving prolapse symptoms compared to native tissue repair. There is a 12% rate of mesh exposure or extrusion; most were minor problems. 

Mr Ash Monga, Consultant Gynaecologist, Southampton University Hospital