Independent review leads to decision to curb use of procedure for stress urinary incontinence
After years of controversy, NHS England has this week announced an immediate curb on vaginal mesh implants following serious safety concerns.
It has accepted the advice of a new review looking at harm reported by women who received the treatment for stress urinary incontinence.
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
And this has led to the announcement of a ‘pause’ in the treatment, which could lead to an eventual ban.
The review's chair, Baroness Julia Cumberlege, said she was ‘appalled at the seriousness and scale of the tragic stories’ her team had heard during their research.
Many women said the implants caused them agony by cutting into tissue. Others said they had been left with life-changing injuries.
The independent review found no evidence on the benefits for treating urinary incontinence that would outweigh ‘the severity of human suffering caused by mesh complications’ described by Baroness Cumberlege.
She added: "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.
"At this stage in our review we are not recommending a ban, but a halt to procedures."
The pause can be lifted if certain checks and measures are met by March 2019, added the review team. This includes keeping a register of every procedure and any complications.
And England's chief medical officer, Professor Dame Sally Davies, said mesh would remain a treatment of last resort for some, adding. “Carefully-selected patients will continue to have access in discussion with their consultant."
This decisive action from Baroness Cumberlege must be welcomed by both the medical profession and the thousands of women who have suffered from the use of vaginal mesh implants to treat stress urinary incontinence
It is estimated that more than 100,000 UK women have had a mesh fitted.
The net-like fabric can be attached into the wall of the vagina to act as a scaffold to support organs, such as the bladder, to keep them in the right place to help manage incontinence or another condition called prolapse.
To date, it's still unclear how many women have been adversely affected, although the Government is carrying out an audit to try to find out.
Health watchdog, NICE, has already recommended that vaginal mesh operations for treating organ prolapse should largely be stopped in England.
The use of vaginal mesh to treat urinary incontinence was not mentioned in the draft NICE guidelines, however.
The safety review chaired by Baroness Cumberlege is also looking at concerns about a hormone pregnancy test called Primodos and an epilepsy drug called sodium valproate, which have both been linked to birth defects.
Mesh used for bowel patients (rectopexy) has not been included in the temporary suspension.
Commenting on this week’s news, Christian Beadell, a senior solicitor at Fletchers Solicitors, a specialist serious injury and medical negligence law firm, said: “This decisive action from Baroness Cumberlege must be welcomed by both the medical profession and the thousands of women who have suffered from the use of vaginal mesh implants to treat stress urinary incontinence.
“While not going so far as a ban, the decision to now pause the use of mesh implants such as TVT and TOT until certain steps are taken to mitigate the risks of complications is a balanced approach which also recognises that many woman have had positive outcomes from the use of these devices.
“It is vital that from here on, all the agencies, including the Medicine Healthcare Regulatory Authority continue to work together to ensure that the relative risks and merits of these procedures, including pelvic organ prolapse repair, are thoroughly considered.
“The use of mesh implants has dramatically reduced in recent years with the growing awareness of the high complication rates and surgeons have started to accept that mesh is not the panacea that it was once thought to be.
The absence of an outright ban means that it is likely that private surgeons could still use mesh, but that in an NHS setting its use will be extremely limited and possibly non-existent
“What is important, however, is that patient autonomy is preserved so that women who have exhausted more-traditional surgical options and are prepared to accept the risks of a mesh repair are able to do so, in a safe environment with an appropriately-qualified surgeon.
“The absence of an outright ban means that it is likely that private surgeons could still use mesh, but that in an NHS setting its use will be extremely limited and possibly non-existent.”