A mesh sling surgically implanted to cure women suffering embarrassing leaks, usually caused by pregnancy, has been criticised for causing serious complications, pain and discomfort.
he National Institute for Health and Care Excellence, NICE, which sets guidelines for care in hospitals across Britain, said the mini sling should not be used unless there are proper plans in place for follow up care if things go wrong.
The report by NICE, which is still under consultation, said:
• Data collection on mini slings was “disappointing” and there needs to be further research and long term studies
• Mini slings should not be used unless there are special arrangements for following up a woman’s care
• If a surgeon implants mesh as part of a trial patients must be fully informed of “the uncertainty” over safety including the potential for “serious long term complications.”
• All women having mini slings must be added on a national register held with a professional body like the British Society of Urogynacology.
• Surgeons trialling mini slings must tell their NHS Trust bosses
The report has been welcomed by UK campaigners in Sling the Mesh and Scottish Mesh Survivors who are delighted that complication concerns are being taken seriously.
Sling the Mesh campaigner Kath Sansom said: “None of the mesh slings used today have been given long term human trials and none of them have been properly studied for the impact on how they can greatly impact on a woman’s quality of life with risks including, chronic infections, allergic reactions, pain walking, fibromyalgia and losing a sex life forever due to pain.”
Olive McIlroy of Scottish Mesh Survivors said: “The uncertainty about the procedure’s safety and efficacy speaks for itself.
“The potential for the procedure to fail and for serious long-term complications is an unacceptable risk for even one patient and merits an immediate cessation of this and similar pelvic polypropylene mesh procedures.
“The best thing NICE can do is introduce a mandatory independent registry to follow existing patients and then act on the long term data.
“All polypropylene mesh devices should be kept out of operating theatres, that would ensure patient safety.”
Mini sling trials began two years ago when Scotland suspended two other styles of plastic mesh sling in June 2014.
Scotland is waiting for its final report into mesh slings, due out this summer.
In the meantime, mini sling trials have begun in hospitals across England – locally trials are set to start at the Queen Elizabeth Hospital in King’s Lynn.
Across Britain hospital bosses look to NICE guidelines as the benchmark for how they run services and treat patients.
If a NICE report is critical then it is unlikely a hospital would wish to fly in the face of its recommendations.
The guidelines are currently in the consultation stage and are set to be approved in September 2016.
A spokesman for the MHRA said: “MHRA are aware of the NICE Interventional Procedure document currently out for public consultation on single-incision short sling (mesh) insertion for stress urinary incontinence in women.
“We note the provisional recommendations made and await publication of the final document.”
The mesh mini sling guidelines are currently in the consultation stage and are set to be approved in September 2016.
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