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All types of surgery for pelvic organ prolapse are safe; they have similarly low rates of side effects and of severe complications. However, new research found that some women had severe pain 2 years after surgery, regardless of the type of surgery they had.

In pelvic organ prolapse, one or more of the pelvic organs – womb, bowel, vagina or bladder – slip down from their natural position. This can cause pain and discomfort, and surgery may be recommended. Surgery can involve repair of the woman’s own (native) tissue, or may use an implant (graft) of animal tissue. A plastic mesh was previously another option to hold the pelvic organs in place.

Serious safety concerns about vaginal mesh led to new guidance in December 2017, which stated that mesh should no longer be used. In July 2018, the Government announced a ‘high vigilance restriction’ on procedures, including mesh, to treat prolapse.

Previous studies have explored the complications of mesh surgery alone, without comparing it to other types of surgery. This study, called PROSPECT, was the first to look at mesh surgery alongside other surgical approaches in women. It previously reported that native tissue surgery, graft and mesh are similarly effective in addressing the symptoms of prolapse in the first 2 years after treatment.

The current analysis gives a detailed breakdown of the complications of each surgical approach. The results should help women who are considering, or have had, surgical treatment.

What’s the issue?

In pelvic organ prolapse, one or more of the pelvic organs – the womb, bowel, vagina or bladder – slip down from their natural position and bulge into the vagina. Prolapse may occur in the front and/or back wall and/or the top of the vagina.

Half of all women over 50 will have some symptoms of prolapse. By the age of 80, more than one in 10 have had surgery for the condition. Prolapse can cause symptoms such as pain, discomfort and a feeling of heaviness. It can cause bladder and bowel problems, and interfere with sexual activity.

Non-surgical treatments are normally offered in the first instance. These include weight loss, exercises to strengthen pelvic floor muscles, a ring pessary (a device inserted into the vagina to control prolapse) or hormone treatment. Where these treatments are not sufficient, surgery may be an option.

Surgery for prolapse aims to support the pelvic organs and reduce symptoms. Approaches include:

  • repair of the woman’s own (native) tissue
  • an implant of animal tissue (graft) which supports the pelvic organs until new natural tissues grow in its place
  • a plastic mesh that remains permanently inside the body; either using a mesh inlay (cut to size for an individual) or a mesh kit (already cut).

The large PROSPECT study, published in 2017, included women across the UK. This long-term study compared repair, graft and mesh, to address prolapse of the front and back wall of the vagina. Women reported similar outcomes and quality of life 2 years after surgery, regardless of which type of surgery they had. Rates of serious complications were also comparable across the treatments.

However, ongoing concerns about mesh surgery, led to the First do no harm report from the Independent Medicines and Medical Devices Review, chaired by Baroness Cumberlege. Published in 2020, it highlighted serious side effects related to mesh; it stated there is a risk of harm not only from the initial operation but also from subsequent surgery to remove mesh (where there are complications). The report called for further studies into the risks of mesh surgery for prolapse.

Following this report, researchers re-analysed data from the PROSPECT study to look in more detail at complications with different types of prolapse surgery.

What’s new?

The PROSPECT study included women at 35 UK hospitals who had prolapse of the front and/or back wall of the vagina. They either had first-time surgery, or a repeat operation. A total of 2,632 women were included in the analysis. Most (1,712) had repair of their own tissue; 360 received a graft and 560 had mesh surgery (482 mesh inlay; 78 mesh kit).

Women filled in postal questionnaires and described ongoing complications 2 years after surgery. All methods of prolapse surgery were effective. Before surgery, 8% women reported extreme pain or discomfort; 2 years later, this had improved in all 4 groups (tissue repair, graft, mesh inlay, mesh kit).

All methods were safe and severe complications were uncommon. But some developed, regardless of the method of surgery.

2 years after surgery:

  • 3% women in all groups had new, extreme pain
  • 2.4% women in all groups experienced an infection
  • 4.3% women in all groups had been re-admitted to hospital; the most common reasons were vaginal adhesions (parts of the vagina stick together), urinary retention (inability to fully empty the bladder), infection and constipation.

Some complications were more or less common with different types of surgery:

  • New severe vaginal pain during or after sex was reported by around 3.5% women who had tissue repair or graft, by fewer (1.4%) who had mesh inlay but more (4.8%) who had mesh kits.
  • New vaginal tightness was reported by 1.6% women who had tissue repair and 1.2% of those who had a graft; it was less common (0.3%) in those who had a mesh inlay but more so (3.6%) in those who had mesh kit.
  • New urinary incontinence was reported by 6.2% women who had tissue repair, graft or mesh inlay; rates were lower (2.8%) with mesh kit.
  • Repeat prolapse surgery was rare (0.3%) and only carried out for women who received mesh inlay.
  • Mesh became exposed in 12% women who had mesh surgery (either inlay or kit), but most (64%) had no symptoms; 8% women who had mesh surgery had further surgery to remove some or all of the mesh.

There were no clear trends; all types of surgery came with a low risk of complications.

Why is this important?

The Cumberlege report called for further studies to inform women of the risk of complications with mesh for prolapse surgery.  This study provides important new information by comparing the risks with mesh with those of tissue repair or graft.

The findings demonstrate the safety of first-time and repeat surgery for prolapse. They also highlight the likelihood of life-changing complications that some women experience after all types of prolapse surgery. These include infection, urinary retention and vaginal adhesions.

These risks should be highlighted to all women considering surgery in patient information and in counselling before surgery.

What’s next?

Prolapse is a long-term condition and women need to be followed up for longer periods after surgery. The research team will continue to collect data on the women in the PROSPECT study for at least 14 years after surgery.

Further research is needed to determine the best methods to treat the complications of prolapse surgery. For example, vaginal adhesions may increase pain during or after sex and may even result in women no longer being able to have penetrative sex. Future studies should evaluate whether oestrogen or vaginal inserts can help to prevent vaginal adhesions.

You may be interested to read

This NIHR Alert is based on: Reid FM, and others. How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? BJOG 2021; 128:13

The earlier PROSPECT study: Glazener, CMA, and others. Mesh, graft or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised controlled trials (PROSPECT). The Lancet 2017;389:10067

Royal College of Obstetricians & Gynaecologists pelvic organ prolapse patient information leaflet.

National Institute for Health and Care Excellence (NICE) guidance: Urinary incontinence and pelvic organ prolapse in women: management. NICE guideline [NG123] 2019; and Transvaginal mesh repair of anterior or posterior vaginal wall prolapse. NICE Interventional procedures guidance [IPG599]. 2017

The First do no harm report for the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege


Funding: This study was supported by a grant from the NIHR Health Technology Assessment Programme 

Conflicts of Interest: Completed disclosure of interest forms are available to view online as supporting information.

Disclaimer: NIHR Alerts are not a substitute for professional medical advice. They provide information about research which is funded or supported by the NIHR. Please note that views expressed in NIHR Alerts are those of the author(s) and reviewer(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.


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Comments

Study author

This study provides more information to help clinicians counsel women about the risks of prolapse surgery. In our earlier work, we didn’t find any differences in women’s quality of life two years after all types of prolapse surgery, which we would have expected to pick up if something was causing significant harm.

The key finding from this study was that both primary and secondary prolapse surgery is safe, no matter which operation is used: native tissue repair, graft or mesh. All these procedures had low rates of side effects and severe complications two years following surgery. But some complications – such as infections, urinary retention and vaginal adhesions – were common across all types of prolapse surgery.

Clinicians are currently called on to counsel women about the risks and benefits of removing mesh for pain, where it hasn’t become exposed or extruded into surrounding organs. Our study does not answer this important question, but it demonstrates similar rates of severe newly arising pain and vaginal pain during or after sex after each type of prolapse surgery.

Fiona Reid, Consultant Urogynaecologist, Manchester University NHS Foundation Trust 

Pelvic, Obstetric and Gynaecological Physiotherapy 

This study will add significantly to the necessary understanding of what data and what information is required to create the best possible care package for surgical repair of pelvic organ prolapse.

The acknowledgement that prolapse is a long-term condition and complications from treatments for prolapse may develop some time following the intervention suggests that a multidisciplinary approach that includes optimal patient information should be aimed for at the earliest opportunity in the prolapse journey.

Pelvic health physiotherapists are at the forefront of supporting women with post operative complications and new symptoms, and this study will help clinicians to offer better information that might help women be clearer about the possible risks of any surgery – whether mesh is involved or not.

Kate Lough, Chair of the Pelvic, Obstetric and Gynaecological Physiotherapy (POGP), a professional network 

Clinician

As a urogynaecologist, I frequently advise women regarding the surgical and non-surgical management of pelvic organ prolapse.

The results of this study will be reassuring to both healthcare professionals and patients as the data suggest that prolapse surgery is on the whole safe and with a low complication rate – and that there is not much difference in the complication rate comparing mesh surgery to non-mesh surgery.

Linda Cardozo, Professor of Urogynaecology, King’s College Hospital NHS Foundation Trust

Clinician

This study gives vital information to share with patients about the risks of vaginal surgery. It will help with the consent procedure.

Currently, vaginal mesh cannot be used for prolapse surgery unless for research as per 2019 NICE guideline. This study therefore adds to the research base on vaginal mesh.

George Araklitis, Department of Urogynaecology, King’s College Hospital NHS Foundations Trust

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