Updated 11/07/18
THE NHS HAS suspended all vaginal mesh operations in England after the chair of an independent review expressed concern about the risk of ‘life-changing and life-threatening injuries’ to women who undergo these procedures.
Baroness Julia Cumberlege, chair of the Independent Medicines and Medical Devices Safety Review announced this morning that she had advised the Department of Health in the UK and NHS England that there “must be an immediate pause” in the use of surgical mesh for the treatment of stress urinary incontinence.
The UK’s health watchdog Nice had already recommended at the end of last year that mesh devices should only be used for pelvic prolapse procedures in the context of research.
Both of these conditions can occur in women following natural childbirth and the use of mesh devices has been seen as the gold standard treatment globally since the late 90s. Some women who have had these procedures – including hundreds in Ireland – have reported serious complications with some suffering chronic pain for years after their surgery.
“We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively,” Baroness Cumberlege said today.
“We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.
I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly. Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now.
“My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment,” Cumberlege added.
She said at this stage her review is not recommending a ban, but a halt to procedures until March 2019.
Their use should only then be reintroduced if a number of conditions are met, she said, including the reporting of every procedure on a national database and the reporting of complications.
The Department and NHS England have accepted the recommendation.
The Scottish government had put in place a suspension in the use of mesh for stress urinary incontinence back in 2014 and clinicians in Wales have been informed to only use mesh as a last resort.
Following the decision of NHS England, surgeons in Northern Ireland have now also been told to stop using vaginal mesh.
Here, Health Minister Simon Harris has ordered a report on the use of these devices from the Chief Medical Officer. He also met last month with a number of women from the Mesh Survivors Ireland support group who suffered complications after these surgeries.
Following the meeting, a circular was issued by the HSE to all hospitals telling doctors they should only use mesh devices if conservative measures have failed. It also said women should be informed of all complications – including the risk of longterm pain.
However the Irish government has not put in place a suspension or ban like in other countries.
Sinn Féin TD Louise O’Reilly, who has been vocal on the issue in the Dáil, told TheJournal.ie that this news should be “considered seriously” by the Irish government.
She said after his meeting with affected women, Minister Harris “can be in no doubt about the impact of this on their health and their capacity to live their life”.
“We are all shocked by the cases that have come to public attention and I don’t think the minister can afford to ignore what is happening in Britain.”
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