Vaginal tapes for stress urinary incontinence

Vaginal tapes are implanted to treat stress urinary incontinence (SUI) (leaking urine with coughing, sneezing or exertion). They are placed under the urethra like a sling or hammock to keep the urethra in the correct position. There are a number of manufacturers who sell these devices in the UK. The majority are made from a polypropylene mesh.

The MHRA has seen a recent increase in numbers of adverse event reports in comparison to numbers received in previous years, increasingly from patients. As a result, the MHRA has launched an investigation to better understand the use of these devices and the complications associated with their use.

To this end the MHRA held a workshop in March 2011 under the chairmanship of Professor Paul Abrams, which included representatives of the Royal College of Obstetricians and Gynaecologists, the British Association of Urological Surgeons, the British Society of Urogynaecology, and representatives of some manufacturers of these devices, to consider how to make insertion a safer procedure. The meeting covered:

• product development
• introducing a new device into clinical practice
• device implantation in a safe environment
• reporting of patient outcomes and adverse events
• responsibilities of involved parties (clinicians, regulators and manufacturers).

 

An article that summarises these discussions has been published in the journal European Urology

Abrams P, et al. Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe. Eur Urol (2011)

European Urology website (external link)

As a result of this workshop, and in conjunction with the MHRA, the British Association of Urological Surgeons has published a patient information leaflet, which is intended to supplement any advice patients may already have been given by their GP or other healthcare professionals.

British Association of Urological Surgeons - Bladder procedures (external link) (under ‘Procedures for urinary incontinence’; see ‘Sling procedure for urinary incontinence – female’). It includes information on what the procedure involves, what to expect before and after the procedure, and possible side effects.

In February 2012, the MHRA commissioned an independent review of all current and up-to-date evidence on the use and potential problems associated with both vaginal tapes and mesh for stress urinary incontinence and pelvic organ prolapse. This is expected shortly. We will publish the findings of this research as quickly as possible so that surgeons and doctors can give the best information possible to patients about the benefits and risks of this type of surgery.

Further information

Further guidance on the use of incontinence tapes can be found on the NICE (National Institute for Health and Clinical Excellence) website:

Urinary incontinence: the management of urinary incontinence in women (external link)

NICE also provides advice for patients contemplating this procedure:

Urinary incontinence: understanding NICE guidance (external link)

The MHRA is still gathering information on the use and complications associated with these devices and would encourage reporting of adverse events to us.

Reporting a safety problem with a device

Questions to ask

Questions that patients who may be undergoing insertion of vaginal tapes for stress urinary incontinence should discuss with their surgeon prior to surgery:

• What are the different devices available?
• Pros and cons of different devices
• What happens if this particular surgery does not work?
• Has the surgeon performed this operation before and if so in how many patients?
• Has the surgeon performed an audit of his or her results of the procedure proposed?
• If so, what were the success and complication risks?