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Medicines and Healthcare products Regulatory Agency (MHRA), News & Updates

MHRA commission independent review of vaginal tapes and mesh

In light of an increasing number of adverse events and patient concerns being reported in recent years, the Medicines and Healthcare Products Regulatory Agency (MHRA) has launched an investigation to better understand the use of the mesh used to treat pelvic organ prolapse and the complications associated with their use.

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. 

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).

Click on links below to see MHRA latest news on mesh for pelvic organ prolapse and stress urinary incontinence:

MHRA Notice on mesh used for pelvic organ prolapse: Vaginal mesh for pelvic organ prolapse

MHRA Notice on mesh used for stress urinary incontinence: Vaginal tapes for stress urinary incontinence

The MHRA have stated that the findings of this research will be published 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”.

TVTinfo Comment added 3rd June 2012

Unfortunately, it is currently understood by the author that no patient groups or representatives were involved in the above meeting and that the medical professionals involved are (or were, at the time of the meeting) proponents of synthetic mesh used to treat pelvic floor dysfunction.

Your view

What do you think about the MHRA?  Do you think their actions are sufficient?  Do you think they should be doing more?  Do you think they should have involved patient groups in their review?

Please leave a comment.

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Discussion

3 thoughts on “MHRA commission independent review of vaginal tapes and mesh

  1. I would really welcome a discussion on the MHRA. Feel free to leave comments.

    Posted by tvtinfo | May 15, 2012, 4:29 pm
  2. The MHRA should have long ago had patient groups/advocates on board to have listened to the stories of what has happened to women and men regarding serious complications.

    Let us hope that a forthcoming meeting soon with people representatives and The MHRA will open up that opportunity to go forward and work with each other.

    Posted by Teresa Hughes | June 8, 2012, 11:15 pm
  3. I quite agree, as far as I am aware the meetings and workshops which they have held this year and last did not involve any patient groups and were attended, to my knowledge, by clinicians who are pro-mesh.

    I am delighted to hear that the MHRA are now meeting up with patient representatives and I really hope that they will listen to our concerns about synthetic meshes.

    Posted by tvtinfo | June 9, 2012, 4:52 pm

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