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Vaginal mesh ban can be lifted with changes, NICE says

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98355399 mesh - Vaginal mesh ban can be lifted with changes, NICE says

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The mesh implants are used to ease incontinence and to support organs

Controversial vaginal mesh implants can be offered again on the NHS in England once certain conditions are met, health watchdog NICE has said.

Some women have been left unable to walk, work or have sex after having the implants, which are used to treat pelvic organ prolapse and incontinence.

Use of vaginal mesh was halted across the UK last year amid safety concerns.

NICE said operations must be performed by specialist surgeons at specialist centres before their reintroduction.

All instances – and outcomes – of vaginal mesh operations should also be recorded on a national database “to help with future decision-making”, it said.

The NHS is not compelled to act on the guidelines – which are for England only – but services are expected to take NICE recommendations into account when planning and delivering care.

‘Disregarding women’

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Under the new guidelines, each patient would receive a “decision aid” – detailing all the latest evidence on available treatments – and mesh implants would be used only after non-surgical options, such as lifestyle changes and pelvic floor training, had failed.

NICE said the “limited evidence” meant “the true prevalence of long-term complications following surgery with mesh is unknown”.

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Owen Smith said he had “serious concerns” women would not be made aware of the potential risks

But Labour MP Owen Smith, who chairs a cross-party group of MPs on surgical mesh implants, told the BBC’s Victoria Derbyshire programme he was “deeply disappointed”.

“The updated guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects,” he said.

“Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored.”

He called for the continued suspension of vaginal mesh until an independent review – led by Baroness Julia Cumberlege – published its findings later this year.

Baroness Cumberlege told the Victoria Derbyshire programme now was not the time for the pause on vaginal mesh to end.

“We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated,” she said.

“Those conditions have not yet been met and it is clear to us that it will be some considerable time before they are.

“This means that, now and for the foreseeable future, mesh should not be used to treat stress urinary incontinence, either in the NHS or the independent sector.

“The scale and intensity of this tragedy is truly shocking – lives have been ruined.”

Studies suggest as many as one in 10 patients can experience complications including chronic pain and difficulties walking.

‘I tried to kill myself’

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Jackie could no longer work because of the pain caused by her implant

Jackie Cheetham says she has tried to kill herself on several occasions because of the complications caused by her mesh implant.

“I have constant pain in my groin and down my leg,” she says.

“I don’t sleep at night. I can’t walk far. We’ve lost our house, as I couldn’t work anymore.

“It almost cost me my marriage.

“I have tried to overdose several times. I felt like an unfit mother. I couldn’t work and I thought, ‘What’s the point?'”

Ms Cheetham says when she had the implant – to treat incontinence – she was given a leaflet by her surgeon “but it definitely didn’t say I would be left in lifelong pain”.

And despite surgery to remove it, some mesh still remains inside her.

Campaign group Sling the Mesh founder Kath Sansom said the NICE guidelines were effectively “no different from what was published in 2003”.

“They are so weak – they clear the way for the next generation of women to be harmed,” she said.

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Kath Sansom said adversely-affected women had been “ignored”

“We told our stories and NICE ignored us.

“Our Sling The Mesh survey shows one in 20 women have attempted suicide and more than half have regular suicidal thoughts because of chronic pain, loss of sex life, constant infections and autoimmune disease.”

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The mesh is made of a polypropolene, a type of plastic

An official at England’s Department of Health and Social Care said: “NICE’s new guidelines and patient decision aids on managing urinary incontinence and pelvic organ prolapse will help women make more informed choices about their treatment.

“The use of vaginal mesh was paused to ensure that patients receive a high-quality and consistent service.

“Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant.”

The Royal College of Obstetricians and Gynaecologists (RCOG) and the British Society of Urogynaecology (BSUG) said they welcomed NICE’s recommendation “that the full range of non-surgical options should be offered to women before any surgical procedures” and “fully endorse” NICE’s patient decision aids.

But they added it was “important to note” that a period of “high-vigilance” remained regarding the implants’ use.

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