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Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA update: vaginal tapes for stress urinary incontinence

The MHRA have recently updated their page on vaginal tapes for stress urinary incontinence:

Vaginal tapes for stress urinary incontinence

Patients should be aware that the role of the MHRA is primarily for ensuring that medical devices and medicines work as intended and are acceptably safe. We are unable to answer clinical questions, which should be addressed to your GP in the first instance for possible onward referral to the appropriate clinical specialist.

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. Work continues on this and we expect a final report soon. We will then 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.

The ‘NHS Information Centre for Health and Social Care’ recently provided Hospital Episode Statistics data indicating there are about 13,000 operations a year implanting tapes for stress urinary incontinence and about 600 i.e. 4.6% partial or total removals of these SUI tapes. The MHRA is currently working closely with the NHS Information Centre on further statistics related to vaginal mesh and tapes and interpretation of their data.

In March 2012 the MHRA launched the Clinical Practice Research Datalink (CPRD) which will enable us to have better access to NHS data.”

To see a list of adverse events that clinicians should report to MHRA and the updated web page, click on link:

http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice–M–T/Syntheticvaginaltapesforstressincontinence/index.htm

Comment from tvtinfo:

It is interesting to see that the MHRA is now claiming to be examining statistics from the NHS Information Centre.  However, it seems that data on TVT and TOT surgery has been recorded in the Hospital Episode Statistics since 2006 and it is disappointing that the MHRA has only recently decided to make use of this information.  One would expect such an organisation to be pro-active in its activities to monitor the safety of devices and protect the public from harm.

These statistics give a strong indication that problems with sub-urethral mesh implants are severely under-reported on the MHRA reporting system and in the research.  The data on mesh removals and partial removals reveal some of the costs of failed TVT surgery.  Plus, there are numbers of patients accessing numerous other NHS services because of their TVT complications, thus adding to the costs of failed TVT and TOT surgery.

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Discussion

One thought on “MHRA update: vaginal tapes for stress urinary incontinence

  1. It is not before time that The MHRA in The United Kingdom started to be more transparent and give more information out into the public domain. It would seem that The MHRA and the NHS Hospital Resource Statistics have not been communicating with each other about transvaginal mesh removal stats.

    Posted by Teresa Hughes | June 8, 2012, 10:40 pm

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