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Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA update: vaginal mesh for pelvic organ prolapse

The MHRA have recently updated their webpage (see earlier posts) on meshes used for pelvic organ prolapse (POP): 

Vaginal mesh for pelvic organ prolapse 

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 mesh implants used to treat pelvic organ prolapse (POP) include a range of different types of mesh implanted in the pelvic floor area in a number of different ways to support the vaginal wall and/or internal organs. The mesh can be synthetic, ‘biological’ or a combination of the two and it may be absorbable or non-absorbable.

In light of an increasing number of adverse events and patient concerns being reported, the MHRA has launched an investigation to better understand the use of these devices and the complications associated with their use.

The MHRA held a workshop in March 2012 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, NICE, the University of Aberdeen Health Services Research Unit, and representatives of some manufacturers of these devices, to consider how to make this a safer procedure.

The meeting covered:

  • types of vaginal mesh
  • clinical experience, training and outcomes of prolapse surgery
  • complications arising from the use of vaginal mesh
  • NICE/IPAC guidance
  • adverse event reporting
  • responsibilities of involved parties (clinicians, regulators and manufacturers).

Further information on the outcomes of this workshop will be made available shortly.

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. “

It is interesting to note the following statement included in the update:

“For the following procedures [mesh implants for pelvic organ prolapse] NICE guidelines state that current evidence on the efficacy and safety of these procedures is inadequate in quantity and quality. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.”

For further information on this update and the various procedures involving treatment of prolapse plus a list of adverse events which should be reported to the MHRA, see link: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice–M–T/Vaginalmeshforpelvicorganprolapse/index.htm

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Discussion

2 thoughts on “MHRA update: vaginal mesh for pelvic organ prolapse

  1. It will be interesting to see the outcome results of the review on transvaginal tapes that was commissioned in February 2012.

    Posted by Teresa Hughes | June 8, 2012, 10:43 pm
  2. Yes I am eagerly awaiting the outcome of this recent study.

    Posted by tvtinfo | June 9, 2012, 7:31 pm

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