Evidence
Alert

Using mesh does not improve results in vaginal prolapse surgery

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.

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.

Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre

 

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.

 

Commentaries

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