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Ethicon Media Monitoring 7/12/2018
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Vaginal mesh: It's a bitter sweet initial victory for a Devon woman after horrific implant
Jul 11, 2018 | Devon Live
By Anita Merritt
A Devon woman who has relentlessly campaigned to stop the use of vaginal mesh implants after being left a virtual recluse due to the pain following surgery is celebrating an initial victory, and will now play a part in trying to get it permanently banned. -
One Woman Opens Up About Agonising Experience Of Vaginal Mesh Surgery
Jul 10, 2018 | Women's Health
By Abbi Henderson and Roisín Dervish-O’Kane
When you hear the word ‘mesh’, what comes to mind? -
Joy as surgery which caused ‘agonising pain’ is suspended
Jul 11, 2018 | Eastbourne Herald
By Ginny Sanderson
A Pevensey woman whose life is at risk due to vaginal mesh is relieved the surgery has been suspended across the country. -
Vaginal-mesh implants have finally been suspended in England
Jul 11, 2018 | The Pool
By Zoë Beaty
“Utter jubilation,” Kath Sansom said this morning, “that’s what these women are feeling. When I told them the news, they sobbed. -
Now Northern Ireland suspends use of vaginal mesh implants
Jul 11, 2018 | Belfast Telegraph
By Lisa Smyth
Surgeons in Northern Ireland are to be told to stop using vaginal mesh - one day after health officials suspended use of the implants in England. -
UK orders that mesh implants be stopped immediately
Jul 11, 2018 | Medical Brief
The UK government has accepted the use of vaginal mesh implants to treat complications after childbirth should be stopped immediately to prevent further risk of “life-changing and life-threatening injuries” to women, reports The Guardian. -
Government announces immediate ‘pause’ in use of vaginal mesh
Jul 11, 2018 | Nursing Times
The government and NHS have accepted a recommendation from the Independent Medicines and Medical Devices Safety Review to pause the use of vaginally inserted surgical mesh.
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Vaginal mesh: It's a bitter sweet initial victory for a Devon woman after horrific implant
Jul 11, 2018 | Devon Live
By Anita Merritt
A Devon woman who has relentlessly campaigned to stop the use of vaginal mesh implants after being left a virtual recluse due to the pain following surgery is celebrating an initial victory, and will now play a part in trying to get it permanently banned.
This week the government announced it has called for a pause in the use of vaginal mesh implants used in vaginal mesh surgery to treat stress urinary incontinence until a set of conditions is met.
It follows the recommendation of a review into the safety of the medical devices which has included stories like that of Susan Morgan, of Brixham, who endured so much pain after her surgery she thought she was going to die and her quality of life is so poor she is now virtually a recluse.
Baroness Julia Cumberlege, chairwoman of the Independent Medicines and Medical Devices Safety Review, came to the decision of suspending the surgery after gathering initial evidence from women and their families affected by surgical mesh procedures.
Susan says she has been invited to meet Julia when she comes to Exeter later this year as part of the review.
Baroness Cumberlege said: “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.
“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.”
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.
Mother-of-two Susan is among those women who is the shell of the person she once was.
At the age of 51, she was advised a urinary incontinence procedure would achieve her wish of being able to enjoy ballroom dancing.
Instead she has no control over her bladder and remains in constant pain from the vaginal mesh trans vaginal tape (TVT), which she says feels like a chemical burn and cheese wire inside her body.
Welcoming the halt in the surgery, Susan said: “Baroness Cumberlege has listened and believed the devastating stories that patients injured with mesh have to tell regarding their life changing injuries.
“I am so pleased she has put a halt to these procedures while more evidence of ‘life changing’ stories comes forward.
“I and many other women have campaigned for many years while in hideous pain and I can only thank Baroness Cumberlege for believing in us when many did not and I will be speaking to her later this year when she visits Exeter.”
NHS England have said most patients suffer no ill effects following mesh implants.
England’s chief medical officer, Prof Dame Sally Davies, said mesh would remain a treatment of last resort for some: “Carefully selected patients will continue to have access in discussion with their consultant.”
Baroness Cumberlege said 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”.
“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, says the review team.
This includes keeping a register of every procedure and any complications.
To date, it’s still unclear how many women have been adversely affected by mesh. The government is carrying out an audit to try to find out.
https://www.devonlive.com/news/devon-news/vaginal-mesh-its-bitter-sweet-1775051
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One Woman Opens Up About Agonising Experience Of Vaginal Mesh Surgery
Jul 10, 2018 | Women's Health
By Abbi Henderson and Roisín Dervish-O’Kane
Let’s play a quick game of word association. We’ll start…
When you hear the word ‘mesh’, what comes to mind?
Perhaps the plastic packaging that's wrapped around citrus fruits, or maybe even the kind that’s used as a net to catch fish.
But, what about the type that’s used in vaginal mesh surgery?
No? Let us fill you in.
Today, the government announced that vaginal mesh surgery used to treat stress urinary incontinence will be suspended – with immediate effect – in NHS hospitals in England.
Branded the ‘mesh scandal’, the polypropylene netting implant was originally thought to resolve post-birth complications for women, however, NHS records reveal that as many as one in 15 women fitted with the most common type of mesh later required surgery due to complications. And to put that into perspective, 92,000 women have had vaginal mesh implants fitted in England alone.
The suspension follows an independent inquiry held earlier in the year, which resolved that surgery must be halted until risks have been removed.
Baroness Julia Cumberlege, who chaired the Independent Medicines and Medical Devices Safety Review ordered by health secretary, Jeremy Hunt, said: “I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.
"We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. We must stop exposing women to the risk of life-changing and life-threatening injuries.”
Complications from vaginal mesh surgery can include chronic pain, recurrent infections, an inability to have sex and even walk.
Women’s Health writer, Roisín Dervish-O’Kane, spoke to Sarah Palmer, 49, from Henley, who recalls her experience of vaginal mesh surgery.MY EXPERIENCE OF VAGINAL MESH IMPLANTS AND SURGERY
"‘I’m going to lose everything.’ This fear kept me awake for most of last summer.
I run a Pilates studio and, as a single mum to two boys, I need the income.
But the pain in my legs and pubic bone was so intense, I struggled to lie down, let alone teach.
Then there was the ever-present UTI that meant sex with my new partner was out of the question.
I had panic attacks so severe, my doctor prescribed strong antidepressants.
And for what?
A few months earlier, I’d had a TVT mesh fitted to help stem the ‘little leaks’ I experienced when working out. The consultant pitched the mesh as my only option and I believed her.
I had the procedure, then passed out from the pain.
This was written off as a standard post-op niggle. But I am a fit woman who knows her body. Something was wrong.
Finding the Sling The Mesh Facebook page triggered both horror and relief.
I felt sick that there was a piece of plastic inside me that doctors weren’t trained to remove, and stupid for not researching the procedure before I’d had it done. But most of all, I felt angry.
These women weren’t imagining this agony – and neither was I.
Through STM, I met Dr Elneil, who explained that I’d had an inflammatory response to the plastic.
In a complex four-hour operation, she removed the mesh lodged next to my bladder – and restored continence using my own tissue.
Now, I’m teaching again, and hoping to rebuild my fitness. But thousands of others haven’t been so lucky and that fills me with anger – and determination to keep talking: to my clients, my friends, my sons.
Knowledge is power, and shame won’t keep us quiet any more."
http://www.womenshealthmag.co.uk/health/symptom-checker/8721/vaginal-mesh-implants/#
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Joy as surgery which caused ‘agonising pain’ is suspended
Jul 11, 2018 | Eastbourne Herald
By Ginny Sanderson
A Pevensey woman whose life is at risk due to vaginal mesh is relieved the surgery has been suspended across the country.
Kate Langley has been campaigning for years for it to be banned after suffering internal injuries and extreme chronic pain because of the so-called ‘non-invasive’ procedure.
Yesterday (Tuesday) it was announced the use of the mesh to treat urinary incontinence has been halted in England with immediate effect.
Mrs Langley said, “I am over the moon that all my and other women’s campaigning has finally paid off. No other women will suffer like I and many have.
“The result is fantastic. We would prefer a full ban rather than a suspension but hopefully that will happen in the future.
“It’s one step at a time. This is a massive breakthrough to stop lots of women getting hurt.
“We have been campaigning for awareness and more and more women have been finding out about it. There were people thinking they were the only ones with this problem.
“I know in Eastbourne hospital people have been offered this even in the last few weeks. It ruins your whole life.”
The mother of two had the surgery in 2012 and said ‘it’s been awful since’.
“It has been a nightmare few years,” she said, “I ended up with agonising pain, I was in hospital 82 times with it.”
She said the problems started very soon after the mesh was inserted, and it felt like contractions.
At first no one could figure out what was wrong then one doctor discovered the mesh had gone through her vagina.
Mrs Langley, who still lives with constant pain, said, “I have had so many major operations in a bid to be well again. I’m left with a piece of mesh close to an artery in an extremely difficult place to operate, if left it may cut through and potentially kill me however the operation is also life threatening.”
Her last hope is a top London trauma surgeon who has won awards for removing bomb shrapnel and may be able to remove the last piece.
The beautician, who has struggled to get back to work, said, “I feel like I was robbed. I haven’t been able to do as much with my kids as I would have liked to.
“Like walking along the seafront. It’s robbed my daughter’s childhood.
“But I’m one of the lucky ones, a lot of women are in wheelchairs.”
“I can’t believe it’s happened to me. It’s one of those things. You have to deal with it don’t you?”
She said if anyone is seeking support they should look up Sling the Mesh. The group which has been campaigning to ban the surgery and has been supporting women affected.
It started out with around 30 people, including Mrs Langley, but has now grown to more than 6,000.
Its founder Kath Sansom said, “This is incredible news and vindication for more than 6,100 members of Sling The Mesh who have been maimed by this operation and then ignored, some for years.
“It is testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result.
“We now hope Baroness Cumberlege adds rectopexy mesh to the suspension. This is used when patients suffer a rectal prolapse. This is even more taboo and more embarrassing than urinary incontinence. It is vital there is a #metoo on rectopexy mesh.”
As a matter of urgency, women booked in for TVT, TVTO and TOT mesh sling incontinence operations in both NHS and private hospitals must cancel, she added.
https://www.eastbourneherald.co.uk/news/joy-as-surgery-which-caused-agonising-pain-is-suspended-1-8563519
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Vaginal-mesh implants have finally been suspended in England
Jul 11, 2018 | The Pool
By Zoë Beaty
“Utter jubilation,” Kath Sansom said this morning, “that’s what these women are feeling. When I told them the news, they sobbed. Sobbed as though they were grieving. These emotions run that deep for the women involved. And now, the government is finally listening to them. They are elated. And so am I.”
It’s been three years since Kath Sansom began a grassroots “Sling the Mesh” campaign to suspend – and eventually, she hopes, ban – the use of mesh tape as a fix for women suffering stress urinary incontinence. Since she began, she has relentlessly lobbied MPs and gathered the horrifying stories of hundreds of women who have undergone mesh surgery. For a while, despite tenacious campaigning, it looked like no one was listening or, at least, no real action was being taken. Until now.
Yesterday, “out of the blue”, says Sansom, the government announced that it would be suspending the use of mesh surgery for urinary incontinence in England with immediate effect. The news comes after an independent review made the recommendation to the then-health secretary, Jeremy Hunt, just one month into their investigation. “We didn’t expect to hear anything until at least Christmas,” Sansom says, delightedly.
The Independent Medicines and Medical Devices Safety Review came to the decision after initial talks with women affected by mesh implants and their families. Baroness Julia Cumberlege, chair of the inquiry, said that she had been “appalled at the seriousness and scale of the tragic stories” heard in the early stages of the review. “We have heard from many women who are suffering terribly,” she said. “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.”
The review told Hunt, while in his former role of health secretary, that mesh for urinary incontinence should be suspended without further delay and not reinstated as a medical device until their criteria of safety conditions has been met. The conditions outlined state that: surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly; that they report every procedure to a national database; that a register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery; that reporting of complications via MHRA (the Medicines and Healthcare Products Regulatory Agency) is linked to the register and that 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.
However, Owen Smith MP, speaking on the Victoria Derbyshire show this morning, predicted that the government won’t be able to meet such criteria – which essentially spells the end for the controversial device. He called for ministers in Scotland and Wales, and civil servants in Northern Ireland, to follow suit in a statement, adding that the suspension is “long overdue” and that “it is also a complete vindication of all those women who have campaigned tirelessly to suspend mesh and highlighted the damage the procedure has caused to many women.”
The NHS has been using mesh-tape implants since the mid-1990s. The device – a polypropylene strip, or plastic panel – is cut to size and then surgically inserted via the vagina or abdomen to treat women suffering from stress incontinence and pelvic organ prolapses (POP), as well as hernias. It’s a quick operation – around 20 minutes – and was seen as a “quick fix” to alleviate taboo symptoms often suffered by women after childbirth. An estimated 92,000 women were fitted with vaginal inserts in England between April 2007 and March 2015.
But, while the operation is swift, the effects, say Sansom and thousands of others, can be long-lasting – and devastating. Since the material used can shrink and erode once inside the body, it has, in some women, cut through the bladder, bowel, and/or vaginal wall, slicing the flesh in a “cheese grater” effect. Women report severe pain, being unable to be active or even walk, as well as their emotional health and sex lives being severely affected.
Yet despite hundreds upon hundreds of women speaking out about the effects – and hundreds of thousands around the world; the US and Australia have both seen multi-million dollar cases brought against manufacturers of the device – and ongoing media outrage, our government had taken little action. Perhaps, some might say, until the power in this case was handed to a woman – Baroness Cumberlege – the gravity of the scandal was never truly seen, or taken seriously.
Previous reports have seen surgeons joking on email about the devastation mesh has caused to women – one court case brought against manufacturers Johnson & Johnson exposed an Australian medic suggesting that a woman left unable to have vaginal intercourse should “try anal”, for example. And that feeling – of being overlooked and undermined – is yet another thing that the women suffering the effects of mesh have had to carry with them.
“When this review was first started, we were promised that it would be run independently, and thoroughly,” Sansom explains, “but we were all, naturally, quite cynical. We didn’t quite believe it. Today, though, we can see that they really meant it. Within days of launching a safety review they have called it – they have suspended it because of queries over its safety. We weren’t expecting it at all. It’s been such a long time coming.
“This feels so wonderful because you can see that [Cumberlege] means it when she says that she is appalled at the suffering of women she’s spoken to – the women who are suffering because they’ve gone through this simple little fix because they’ve had babies, and now their lives are shattered. I think she’s shocked at the depth and the scale of suffering. You’ve got to hear those stories yourself, sometimes, to see the carnage.”
However, despite today’s celebrations, this is far from the end for the campaign to abolish the use of mesh. This suspension specifically bans vaginal-mesh implants for urinary incontinence – but the problematic material and device is still being used in hernia operations, to treat rectal prolapse and in abdominal prolapse ops. “And also – my big bug bear,” says Sansom, “there’s a trial going on in the UK at the moment for men’s mesh slings. This particular study, the Master study, is trialling putting mesh slings into men who have had prostate cancer and had a prostatectomy and then suffer incontinence as a result. But, again, none of them are being warned of the risks. And that really concerns me.”
There is much left to do. And, for too many women to mention, it’s too late – just last year, 42-year-old Chrissy Brajcic died due to complications from vaginal-mesh surgery, and many other lives are already irreversibly changed. But, for now, finally, a little hope has prevailed for the women behind this campaign – and, they say, for the millions of women who might be saved from going through similar ordeals. As we’ve seen time and time again of late, it’s a triumph for the tenacity of women and the strength of their stories, reaching above the parapet to change the status quo. As Sansom says, it’s “bloody brilliant”.
https://www.the-pool.com/news-views/latest-news/2018/28/zoe-beaty-reports-vaginal-mesh-implants-suspended
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Now Northern Ireland suspends use of vaginal mesh implants
Jul 11, 2018 | Belfast Telegraph
By Lisa Smyth
Surgeons in Northern Ireland are to be told to stop using vaginal mesh - one day after health officials suspended use of the implants in England.
Northern Ireland chief medical officer (CMO), Dr Michael McBride, is writing to health trusts here to advise a pause in mesh surgery similar to that being put in place in England.
It comes after an independent review into the use of the controversial implants recommended the immediate suspension of surgical mesh for the treatment of stress urinary incontinence.
Baroness Julia Cumberlege, who is heading up the review, said she has been "appalled at the seriousness and scale of the tragic stories we have heard from women and their families".
She advised the Department of Health in England to suspend the use of the mesh implants until all necessary steps could be taken to mitigate the risk of injury to patients, and gave a deadline of next March.
Campaign group Sling the Mesh NI had been left horrified after it initially emerged that the suspension was not being immediately implemented in Northern Ireland too.
However, a spokeswoman from the Department of Health announced yesterday that Dr McBride is taking action to ensure the same standards are put in place here.
"The Chief Medical Officer Dr Michael McBride will be writing to Trusts advising that a pause in mesh surgery be introduced similar to that being put in place in England," she said.
Jackie Harvey from Sling the Mesh last night welcomed the development. "We are delighted and relieved to hear that the CMO has decided to temporarily suspend the use of vaginal mesh in line with the recommendations announced by the Cumberlege Review.
"This will undoubtedly save more women in Northern Ireland from being exposed to the harm that these implants can cause, which can be life-changing.
"During this suspension we will continue to push for a permanent suspension and also for those already suffering from mesh complications to be put on patient pathways which are fit for purpose to treat the serious issues involved."
Almost 7,000 women in Northern Ireland had vaginal mesh implants between 2005 and 2015.
The majority of women will not suffer complications from the procedure - and it is not known exactly how many people in Northern Ireland are currently experiencing problems - however, Sling the Mesh NI has more than 500 members.
Affected women have told how their lives have been turned upside down as a result of the implants. Some have even considered suicide as they can no longer cope with the agony they experience as a result of mesh tearing internal tissue and vital organs.
SDLP health spokesperson Mark H Durkan welcomed the call by Dr McBride.
Mr Durkan said: "The action taken by the Department of Health today to request that all trusts ban vaginal mesh surgery is the right call.
"The harrowing accounts from women across Northern Ireland that I have heard, and there are many more stories to be told, highlight the urgent need for the trusts to ban this practice immediately as requested.
"It is frustrating that once again patients in Northern Ireland have had to wait for this news due to the political void.
"However, I would commend the Department for taking this action that will prevent any more women from sustaining both mental and physical injuries that can result from this practice."
Mr Durkan added: "The Department of Health must now clarify what plans are in place to help those women who are still suffering because of this practice."
https://www.belfasttelegraph.co.uk/news/health/now-northern-ireland-suspends-use-of-vaginal-mesh-implants-37102522.html
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UK orders that mesh implants be stopped immediately
Jul 11, 2018 | Medical Brief
The UK government has accepted the use of vaginal mesh implants to treat complications after childbirth should be stopped immediately to prevent further risk of “life-changing and life-threatening injuries” to women, reports The Guardian. It would effectively suspend the use of vaginal mesh implants in National Health Service (NHS) hospitals, which would represent a major victory for campaigners. It follows an independent inquiry, ordered by the Health Secretary Jeremy Hunt, which concluded the surgery must be stopped until steps have been taken to mitigate the risks to patients.
Julia Cumberlege, who chaired the review, said in the report: “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.”
Until 2017, government guidelines had stated the surgery was safe and effective.
However, the report says, an investigation found one in 15 women given a mesh implant later required surgery to have it removed, with some suffering life-altering complications.
In December, National Institute for Health and Care Excellence (Nice)guidelines recommended that mesh should no longer be used to treat prolapse. The report says the latest recommendations relate to the treatment of urinary incontinence, for which tens of thousands of women have been given the implants in the past decade.
Baroness Cumberlege has put forward conditions that need to be met by March 2019 before the use of vaginal mesh can be considered safe. The Department of Health and NHS England have accepted the recommendation.
The conditions are that surgeons should only undertake the operations if they are appropriately trained, and only if they undertake the operations regularly. The review also recommended the creation of a registry to keep track of any complications.
In 2014 the Scottish government put in place a suspension in the use of mesh for stress urinary incontinence.
“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. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications,” Cumberlege is quoted in the report as saying. “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 until the conditions we have laid down are met. I am pleased that both the Department of Health and Social Care and NHS England support our recommendation, and I look forward to its quick implementation.”
Carl Heneghan, a professor of evidence-based medicine at Oxford University, said: “The ban on mesh for stress urinary incontinence reflects the inadequate evidence base that let risky mesh devices on to the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging harms.
“It is the right thing to do as it prevents further unnecessary injuries, however, it has come too late for many thousands of women who face lifelong disabling complications.”
“We now need to learn some serious lessons and not repeat the mistakes of the past. Including listening to patients when healthcare goes badly wrong and ensuring healthcare is based solely on high-quality research evidence.”
Kath Sansom, the founder of the campaign group Sling the Mesh, said in the report: “This is incredible news and vindication for more than 6,100 members of Sling the Mesh who have been maimed by this operation, and then ignored, some for years. It is testament to people power. Our members have written, emailed, attended parliament and lobbied to get this result and I am delighted.”
However, she added: “There is no suspension in Northern Ireland or Wales. It is paramount these women are also protected by a suspension.”
https://www.medicalbrief.co.za/archives/uk-orders-mesh-implants-stopped-immediately/
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Government announces immediate ‘pause’ in use of vaginal mesh
Jul 11, 2018 | Nursing Times
The government and NHS have accepted a recommendation from the Independent Medicines and Medical Devices Safety Review to pause the use of vaginally inserted surgical mesh.
As a result, it said the use of vaginally inserted surgical mesh for stress urinary incontinence would be paused until a set of conditions to reduce the risk of injury were met.
Under the rules, they will only be used when there is no alternative and after “close and comprehensive” consultation between patient and clinician, with “rigorous oversight and governance at all times”.
The Independent Medicines and Medical Devices Safety Review made the interim recommendation following a programme of engagement with patients and patient groups.
The review was set up in February and is chaired by Baroness Julia Cumberlege. Its aim is to review what happened in each of the cases of primodos, sodium valproate and surgical mesh, including whether the processes pursued to date have been sufficient and satisfactory.
It also recommended that the pause should be extended to include vaginally inserted mesh to treat pelvic organ prolapse, and that the pause should be implemented through a high vigilance regime of restricted practice.
NHS England was now working with other health agencies to pause procedures quickly and safely, said the government.
In addition, a clinical advisory group has been established to ensure that appropriate measures are put in place to give effect to the high vigilance programme.
Meanwhile, NHS England and NHS Improvement have written to providers to ensure that provider medical directors and nurse directors are equipped with advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment.
Health minister Lord O’Shaughnessy said: “The department’s top priority is patient safety, and we have therefore immediately accepted Baroness Cumberlege’s recommendation.
“Our new approach, with a high vigilance programme of restricted practice, will radically reduce the number of women have vaginal meshes inserted, and ensure that when it does happen, it is only after close consultation with their clinician and with extremely thorough clinical oversight and governance,” he said.
Jackie Doyle-Price, mental health and inequalities minister, said: “We need to put in place a consistent, high quality service that meets the conditions set out by Baroness Cumberlege.
“Only then can women be confident when they are considering an operation to treat pelvic organ prolapse or stress urinary incontinence – conditions that cause not just physical discomfort but long lasting psychological effects,” she said.
https://www.nursingtimes.net/news/policies-and-guidance/government-announces-immediate-pause-in-use-of-vaginal-mesh/7025243.article
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