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.
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.