Publication - Advice and guidance

Synthetic Vaginal Mesh Mid-urethral Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence in Women

Published: 25 Jun 2014
Part of:
Health and social care
ISBN:
9781784126131

This Booklet gives detailed information about the synthetic mid-urethral sling procedure.

Synthetic Vaginal Mesh Mid-urethral Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence in Women
Possible Risks of this Procedure

Possible Risks of this Procedure

The tables below are designed to help you understand the risks associated with this type of surgery (based on the RCOG Clinical Governance Advice, Presenting Information on Risk). The terms used to denote the degree of risk in the main table are explained here:

Term

Equivalent numerical ratio

Equivalent environment

Very common

1/1 to 1/10

One person in a family

Common

1/10 to 1/100

One person in a street

Uncommon

1/100 to 1/1000

One person in a village

Rare

1/1000 to 1/10 000

One person in a small town

Very rare

Less than 1/10 000

One person in a large town

General Risks of Surgery

Any surgical procedure has its risks and potential problems. The following are possible problems that you may experience:

  • Anaesthetic risks: This is rare unless you have specific medical problems. Death is very rare. Your anaesthetist will discuss with you in detail.
  • Bleeding: You should expect some vaginal bleeding after the operation. The risk of major bleeding, which is severe enough to need a blood transfusion, is small but it can happen with any operation.
  • Infection: The risk of infection at any of the wound sites is common, and you will receive antibiotics in theatre to reduce such risk. One in ten women will need a course of antibiotic to treat a urine infection. Serious hospital-acquired infections (e.g. MRSA and Clostridium Difficile)
    are rare.
  • Deep Vein Thrombosis (DVT): A clot in the deep veins of the leg. While the overall risk is common (4-5%), the majority pass unnoticed and resolve spontaneously. It is rare for a clot to migrate to the lungs and cause serious problem following day-surgery (less than 1% of those who get a clot). However, there have been deaths following such clots and, therefore, special stockings and/or injection to thin the blood are provided to all patients.

Specific Complications and Risks*

Complication

Risk

Mesh exposure (erosion) into the vagina

Common. The vaginal skin over the sling may not heal properly or get infected. Could also be due to inflammation, foreign body reaction or unusual immune response. It can happen years after surgery. Further surgery may be required to cover the sling or to partly remove it (please see below).*

Recognised damage to the bladder or urethra during the procedure

Common, especially with the retropubic approach. When discovered during the procedure, the sling is removed and replaced correctly. Long-term problems following this complication are unlikely.

Failure of the procedure to stop urine leakage

Common. Persistence or recurrence of urinary leakage after some time. This can happen years after the sling has been inserted even if it cured your symptoms originally. You may need further surgery for incontinence and success rates may be lower.

Problems with the need to pass water more often than normal or having trouble getting to the toilet in time

Common. Overactive bladder symptoms are managed with physiotherapy and/or drug treatment.

Temporary problems emptying bladder fully

Common. May require short-term home catheterisation (indwelling or intermittent) for few days or weeks.

Temporary pain in the pelvic area or at the site of the sling insertion (the groin area or inner thigh in transobturator procedure) or during sexual intercourse.

Common. Often resolves spontaneously or with painkillers.

Chronic pain in the pelvic area, at the site of the sling insertion or during sexual intercourse (due to vaginal scarring)

Common with transobturator tape, affecting the groin area and/or inner thigh. Could be due to nerve damage/irritation.

Uncommon with retropubic tape. Repeat procedures to remove the sling may be necessary (see below).*

Persistent problems emptying bladder fully with recurrent urinary tract infections

Uncommon. May require further surgery to release, cut or remove the sling.* Urine leakage may return and you may need further surgery.

Mesh extrusion (erosion) into the urethra or the bladder

Rare. This may lead to fistula formation and can occur years after surgery. Could be due to spontaneous sling displacement or unrecognised damage to the bladder or urethra during the procedure. Requires further surgery to remove the sling (see below).

Injury to other organs such as bowel and major blood vessels

Rare. An abdominal operation may be necessary to resolve the problem.

Chronic problems emptying bladder fully

Rare. May require long-term self-catheterisation for months/years.

Death

Very rare.

* The risk levels quoted are those reported in medical literature and confirmed/endorsed by the National Institute of Health and Clinical Excellence. Data from large relevant registries are not yet available at the time of writing this leaflet.

*Risks if the mesh tape is to be removed

Repeat procedures may be necessary and complete sling removal may not be possible to do safely. Referral to a different hospital (with a mesh removal team) may be required and, even after complete removal, symptoms may persist. Partial or complete removal of the mesh sling may result in the operation no longer working so you may need further surgery for incontinence.

Risks of not having this procedure
(Doctor to document in space provided)

Further notes on risks

  • The risks of any surgical procedure are increased above the average risks if you have any significant medical conditions, if you are over-weight or if you have previously had surgery for a similar problem.
  • The National Institute for Health and Clinical Excellence has produced further information regarding the risks of vaginal slings in August 2013. You are able to access this using the following link: http://publications.nice.org.uk/urinary-incontinence-cg171/recommendations
  • The Medicines and Healthcare products Regulatory Agency (MHRA) produced further information regarding the risks of vaginal slings in November 2012. You are able to access this using the following link: http://www.mhra.gov.uk - go to search box and type 'synthetic vaginal slings'.
  • The sling is a synthetic mesh permanent implant and it is strongly recommended you consider this procedure only after your family is complete. There is an anticipated increased risk of failure following pregnancy and childbirth. Please discuss with your GP and surgeon if you intend to have more children.

Is there any research being carried out in this area?

Your surgeon or specialist/research nurse will inform you about any relevant research studies taking place in the hospital. All surgical procedures, even those not currently the subject of active research, should be subjected to rigorous clinical audit so that we can analyse our results to inform future practice. In this way, we can learn how to improve our techniques and our results; this means that our patients will get the best treatment available.

If your hospital is running a research project in this field, you may be asked if you wish to participate and, if you agree, to sign a special consent form to this.

Information and support

  • Continence Services
    Telephone:
    Opening hours:
  • Gynaecology Inpatient Ward
    Telephone:
    Opening hours:
  • Your GP

Contact

Email: Kerrie Mulloy