Vaughan Gething, Cabinet Secretary for Health and Social Services
In February 2018, the Secretary of State for Health and Social Care announced an Independent Medicines and Medical Devices Safety Review to be led by Baroness Julia Cumberlege into how patient concerns about three specific areas of women’s health – sodium valproate, primodos and vaginal mesh - have been responded to and how the way the healthcare system responds to concerns and can be improved.
Following discussions with patients who have experienced complications following surgical mesh procedures Baroness Cumberlege recommended to Ministers in England that there should be a “pause” in the use of surgical mesh for the treatment of stress urinary incontinence (SUI) until the following conditions are met:
• Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly;
• Surgeons report every procedure to a national database;
• A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;
• Reporting of complications via MHRA is linked to the register;
• Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh; and
• NICE guidelines on the use of mesh for SUI are published.
Although Baroness Cumberlege’s advice covers England only, I believe that the principle of high vigilance to ensure mesh use is restricted until these conditions are met also applies here in Wales and is consistent with the recommendations made by the review panel which I set up at the end of last year.
It is my expectation that sufficient levels of clinical governance, including consent, audit and research are in place in health boards in Wales to ensure that all women can be confident that all possible safeguards are in place. The evidence we have already of a significant reduction in the use of vaginal mesh procedures in Wales suggests a “pause” is already largely in place, driven by a change in clinical decision making during recent years. However, it is my expectation that these additional restrictions will be the case until the requirements for increased safeguards can be met.
The chief medical officer for Wales, Dr Frank Atherton, has written to medical directors drawing their attention to Baroness Cumberlege’s advice confirming that it is consistent with the Wales review panel’s recommendations. My officials will need to work with the relevant UK professional bodies to determine which arrangements must be in place for Medical Directors to sign off suitable service arrangements.
The Women’s Health Implementation Group, chaired by Tracy Myhill, is meeting in August to start to oversee the implementation of the recommendations made by the review panel in Wales and the new arrangements which now need to be put in place.
The report of the Welsh Mesh Review Group can be found at: