Preview Newsletter
Ethicon Media Monitoring 7/10/2018
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Government halts vaginal mesh surgery in NHS hospitals
Jul 9, 2018 | The Guardian
By Hannah Devlin
The 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. -
Vaginal mesh surgery suspended in England over risk of 'life-threatening injuries'
Jul 10, 2018 | Sky News
By Charlotte Lomas
Vaginal mesh surgery to treat stress urinary incontinence is to be immediately suspended in England. -
Immediate stop to NHS mesh operations
Jul 10, 2018 | BBC News
NHS England is putting an immediate curb on mesh operations after safety concerns. -
Government review team is “appalled by the scale of tragic stories”. The most commonly used women’s mesh implant is suspended
Jul 10, 2018 | Cambs Times
Mesh implants to treat incontinence are being stopped immediately in hospitals across England after the Government stepped in just days after launching a safety review. -
Government Suspends Use of Vaginal Mesh To Treat Stress Incontinence
Jul 10, 2018 | HuffPost UK
By Rachel Moss
The use of vaginal mesh to treat stress urinary incontinence (SUI) has been suspended by the Department of Health and NHS England, meaning around 11,000 women per year will no longer receive the controversial surgery. -
NHS agrees to immediately halt use of surgical mesh following review
Jul 10, 2018 | Medical Plastics News
By Reece Armstrong
In a landmark moment for thousands of women across the UK, it has been announced that the NHS will immediately halt the use of surgical mesh for treating stress urinary incontinence (SUI). -
Government agrees to temporarily ban vaginal mesh implants for women with urinary incontinence
Jul 9, 2018 | The Independent
By Tom Embury-Dennis
The government has accepted a recommendation to temporarily ban vaginal mesh implants for women with urinary incontinence. -
NHS Health Heroes campaign: Surgeon who works day and night to help women told they imagined their pain
Jul 9, 2018 | Daily Mail
By Lucy Elkins
Ask urogynaecologist Sohier Elneil when she last had a proper holiday and she falls silent as she tries to work it out. -
Victory for the Mail! Officials SUSPEND the use of controversial vaginal mesh for incontinence after declaring the 'severity of human suffering outweighs the benefits'
Jul 10, 2018 | Daily Mail
By Stephen Matthews
Controversial vaginal mesh will no longer be used on thousands of women with stress urinary incontinence, officials declared today.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Government halts vaginal mesh surgery in NHS hospitals
Jul 9, 2018 | The Guardian
By Hannah Devlin
The 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.
It would effectively suspend the use of vaginal mesh implants in NHS hospitals, which would represent a major victory for campaigners. It follows an independent inquiry, ordered in February 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: “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, an investigation by the Guardian 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 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,” said Cumberlege.
“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: “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.theguardian.com/society/2018/jul/09/government-halts-vaginal-mesh-surgery-in-nhs-hospitals
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Vaginal mesh surgery suspended in England over risk of 'life-threatening injuries'
Jul 10, 2018 | Sky News
By Charlotte Lomas
Vaginal mesh surgery to treat stress urinary incontinence is to be immediately suspended in England.
The government has accepted the recommendation of a review into the safety of the medical devices, which called for a pause in the use of vaginal mesh implants until a set of conditions is met.
The Independent Medicines and Medical Devices Safety Review is yet to announce its terms of reference, but its chairwoman, Baroness Julia Cumberlege, came to the decision after gathering initial evidence from women and their families affected by surgical mesh procedures.
"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," she said.
"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."
The review into vaginal mesh was announced by former health secretary Jeremy Hunt earlier this year and its team will meet women across the country who have suffered serious complications.
Kath Sansom, founder of Sling the Mesh, has been fighting for vaginal mesh to be suspended for more than three years.
She 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 and I am delighted.
"We now hope that Baroness Cumberlege adds rectopexy mesh to the suspension, which is used to treat rectal prolapse."
Sky News first reported on the devastating complications of vaginal mesh three years ago. It is most commonly used to treat incontinence in women, mainly after childbirth.
The "quick-fix" operation lasts 20 minutes and involves inserting a mesh tape through the vagina to support the bladder like a sling.
The device is made out of plastic and once inside the body it can erode, stiffen and slice through neighbouring organs.
It has left thousands of women in chronic pain, some unable work, walk or have sex. Many have recurrent infections and are on permanent medication.
Jackie Cheetham had a mesh implant fitted more than 10 years ago to help improve her mild incontinence and is now in constant pain. The mother of four says the effects left her suicidal.
She told Sky News she had not been told of the risks, adding: "I was young, in my late 30s... went in for this operation and thought 'this is the beginning of me being able to run properly without wetting myself'."
But it was not long before she knew something had gone wrong.
"Within hours I was in pain, I came home and within days the pain was getting worse... in my groin, bladder, I had bladder spasms."
Owen Smith MP set up an all-party parliamentary group into surgical mesh implants and has been championing the issue for years.
"This is wonderful news and it is long overdue, 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," he said.
"Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury.
"She has obviously been left in no doubt - as those of us who have listened to women injured by mesh are in no doubt - that the risks far outweigh any benefits.
"Of course the reality of the situation is surgeons have already recognised that fact which is why the use of mesh has declined so precipitously over recent years.
"I hope that ministers in Wales and Scotland and civil servants in Northern Ireland will follow suit and halt the procedure."
https://news.sky.com/story/vaginal-mesh-surgery-suspended-in-england-over-risk-of-life-threatening-injuries-11431613
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Immediate stop to NHS mesh operations
Jul 10, 2018 | BBC News
NHS England is putting an immediate curb on mesh operations after 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.
The review's chair, Baroness Julia Cumberlege, said she was "appalled at the seriousness and scale of the tragic stories" that her team had heard.
Many women say the implants caused them agony by cutting into tissue.
Some say they have been left with life-changing injuries.
Claire Cooper, who had the implants, mistakenly had a hysterectomy after doctors were unable to diagnose what was causing her pain. She was left feeling suicidal and unable to have sex.
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.
Most patients suffer no ill effects, NHS England says.Not a total ban
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.
The 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.
A number of Scottish health boards have already stopped using mesh implants altogether, and in Wales the procedures are seen as a 'last resort'.
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.
https://www.bbc.com/news/health-44763673
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Jul 10, 2018 | Cambs Times
Mesh implants to treat incontinence are being stopped immediately in hospitals across England after the Government stepped in just days after launching a safety review.
The news has prompted celebrations for women across the UK in Sling The Mesh campaign, launched by our reporter Kath Sansom, in June 2015 with just 20 women.
The group now has more than 6,100 members.
Baroness Julia Cumberlege, leading the Government review, said “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.”
She added that it should not be used 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.”
Owen Smith, chairman of the All Party Parliamentary Group into mesh implants, said : “This is wonderful news and it is long overdue, 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.
“Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury.
“She has obviously been left in no doubt – as those of us who have listened to women injured by mesh are in no doubt – that the risks far outweigh any benefits.
“Of course the reality of the situation is surgeons have already recognised that fact which is why the use of mesh has declined so precipitously over recent years.
“I’m pleased that Jeremy Hunt has accepted Baroness Cumberlege’s recommendations and I expect that he will come to the House of Commons today to formally announce the decision and assure MPs that no mesh operations will take place during this suspension.
“I hope that ministers in Wales and Scotland and civil servants in Northern Ireland will follow suit and halt the procedure.
“The APPG on Surgical Mesh Implants, which I founded a year ago, has called from the beginning for the suspension of mesh and I am delighted that our call and the voices of women injured by the product are now being listened to.”
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, Kath added.
In 2014 campaigners from Scottish Mesh Survivors successfully lobbied Scottish government to call for a mesh suspension, but some health trusts continued to use it.
Carl Heneghan, 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 onto the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging harms.
“The ban 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 health care goes badly wrong and ensuring healthcare is based solely on high-quality research evidence.”
Linda Millband, of Thompson’s Solicitors said: “For all the women we act for, injured by the use of mesh for stress incontinence, the suspension comes too late - but if it prevents one more woman being left injured for life, as many of our clients have been, then that is welcome.”
She added that any mesh, wherever it is used, “is dangerous, destructive and in some cases, deadly.”
Baroness Julia Cumberlege, chair of the review, has advised the Department of Health and Social Care and NHS England that it should not be used until a set of conditions to mitigate the risks of injury are met by March 2019.
The Department and NHS England have accepted.
This follows NICE’s 2017 guidance that vaginal prolapse mesh is banned.
Conditions are:
• Surgeons should only undertake operations if they are appropriately trained and do them regularly.
• Women are logged on a national database.
• A register of operations is kept.
• Complications are reported to MHRA by being linked to the register.
• Specialist centres for mesh removal and other aspects of mesh complication care must be accredited.
The safety review was announced in February 2018 by health secretary the Rt Hon Jeremy Hunt MP, who said the response to concerns was “not good enough” on three women’s health issues - mesh, the hormone pregnancy test Primodos and the anti-epileptic drug sodium valproate.
Rectopexy mesh will be looked at as part of the ongoing review.
http://www.cambstimes.co.uk/news/sling-the-mesh-baroness-cumberlege-incontinence-prolapse-1-5598900
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Government Suspends Use of Vaginal Mesh To Treat Stress Incontinence
Jul 10, 2018 | HuffPost UK
By Rachel Moss
The use of vaginal mesh to treat stress urinary incontinence (SUI) has been suspended by the Department of Health and NHS England, meaning around 11,000 women per year will no longer receive the controversial surgery.
Women around the world have reported life-changing side effects after receiving the treatment, including debilitating pain leaving some unable to walk, work or have sex.
Campaigners have long called for a ban on the mesh, and following initial meetings with women and families adversely affected by procedures, the Independent Medicines and Medical Devices Safety Review concluded there must be an immediate pause in the use of surgical mesh for the treatment of SUI.
The Department of Health and NHS England have both accepted the recommendation, which has been called “long overdue” by campaigners.
Vaginal mesh surgery, largely given to women who experience incontinence after childbirth, involves inserting a synthetic net material into the body to patch up an area of weak connective tissue or ligaments. It’s sometimes also referred to as tape or sling surgery. Alternative types of surgery and medication are still available for women with SUI.
Baroness Julia Cumberlege, who led the review, said the mesh should not be used for the treatment of SUI until a set of conditions to mitigate the risks of injury are met.
“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,” she said.
Between April 2008 to March 2017, 100,516 patients received vaginal mesh surgery for incontinence in England, equating to just over 11,000 each year, according to data from NHS digital.
Baroness Cumberlege said a set on conditions should be met before the use of surgical mesh for SUI resumes, and these should be met by March 2019.
“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,” she added. “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.”
The National Institute for Health and Care Excellence (NICE) has already recommended the use mesh for vaginal wall prolapse should be suspended and only used in the “context of research” while more is carried out.
Commenting on the latest suspension, chair of the All Party Parliamentary Group on Surgical Mesh Implants, Owen Smith MP, said: “This is wonderful news and it is long overdue, 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.
“I’m pleased that Jeremy Hunt has accepted Baroness Cumberlege’s recommendations and I expect that he will come to the House of Commons today to formally announce the decision and assure MPs that no mesh operations will take place during this suspension. I hope that Ministers in Wales
and Scotland and civil servants in Northern Ireland will follow suit and halt the procedure.”Kath Sansom, founder of campaign group Sling the Mesh, added: “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.”
Sansom has also called for the suspension of other mesh surgeries, such as rectopexy mesh, which is used when patients suffer faecal incontinence after a rectal prolapse. Members of the public have also previously told HuffPost UK they’ve experienced life-changing complications as a result of hernia mesh operations.
https://www.huffingtonpost.co.uk/entry/vaginal-mesh-suspension-means-11000-women-due-to-surgery-for-incontinence-this-year-now-wont_uk_5b436aeae4b05127ccf47459?guccounter=1
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NHS agrees to immediately halt use of surgical mesh following review
Jul 10, 2018 | Medical Plastics News
By Reece Armstrong
In a landmark moment for thousands of women across the UK, it has been announced that the NHS will immediately halt the use of surgical mesh for treating stress urinary incontinence (SUI).
The news follows recommendations from the Independent Medicines and Medical Devices Safety Review which states that there must be an immediate suspension in the use of surgical mesh for treating SUI.
Chair of the review, baroness Julia Cumberlege has advised the NHS and the Department of Health and Social Care that until a set of conditions to mitigate the risks of injury are met, surgical mesh should not be used. The NHS and the DoH have accepted the recommendation that these conditions should be met by March 2019.
Specifically, the review sets out five conditions which the NHS must meet by March 2019. These include surgeons only undertaking operations for SUI if they are appropriately trained and do them regularly; every operation is reported to a national database; a register of mesh operations is maintained; reports of complications through MRHA is linked to the register; and specialist centres for SUI mesh procedures are identified and accredited to help those affected by mesh, through removal procedures and other aspects of care.
The conclusions come following meetings held with women and families who have been unfortunately affected by surgical mesh procedures.
Announced by the government in February, the review examines the three major health scandals, including primodos, sodium valproate and of course, vaginal mesh.
Interestingly, from the evidence acquired within the review, Baroness Cumberlege states that the review team ‘has not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications’.
This is despite health and social care secretary Jeremy Hunt mentioning that a full ban on vaginal mesh products was not an option as ‘clinical experts here and abroad agree that when used appropriately, many women gain benefits from this intervention’.
Speaking about the review, baroness Cumberlege said: “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.
“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 & Social Care and NHS England support our recommendation, and I look forward to its quick implementation.”
In 2017, NICE recommended that surgical mesh for vaginal wall prolapse should only be used for research purposes. More recently it was announced that a review into the use of mesh on urinary incontinence in women is being delayed by two months.
Women and politicians have been tirelessly campaigning to stop the use of mesh for certain medical procedures as accounts of pain and life-changing effects have come to light over the years.
Whilst a welcome step towards proper regulation of these devices, the recommendation does not apply to mesh used for rectopexy procedures, though it is being considered separately within the review.
Kath Sansom, founder of campaign group Sling the Mesh 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 and I am delighted.
"We now hope that baroness Cumberlege adds rectopexy mesh to the suspension. This is used when patients suffer faecal incontinence after a rectal prolapse. This is even more taboo and more embarrassing than urinary incontinence. Women suffer the same grave, life changing complications. Many are suicidal. The main proponent of this mesh, Anthony Dixon, is suspended from Bristol NHS Trust and around 200 of his patients have been contacted to ask if they are suffering. It is vital there is a #metoo on rectopexy mesh."
“Sling the Mesh wants to ensure that, as a matter of urgency, women booked in for TVT, TVTO and TOT mesh sling incontinence operations in both NHS and private hospitals across the UK now have those surgeries cancelled.”
Chair of the APPG on Surgical Mesh Implants and labour MP Owen Smith, said: “This is wonderful news and it is long overdue, 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.
“Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury. She has obviously been left in no doubt – as those of us who have listened to women injured by mesh are in no doubt – that the risks far outweigh any benefits. Of course the reality of the situation is surgeons have already recognised that fact which is why the use of mesh has declined so precipitously over recent years.
“I’m pleased that Jeremy Hunt has accepted baroness Cumberlege’s recommendations and I expect that he will come to the House of Commons today to formally announce the decision and assure MPs that no mesh operations will take place during this suspension. I hope that ministers in Wales and Scotland and civil servants in Northern Ireland will follow suit and halt the procedure.
“The APPG on Surgical Mesh Implants, which I founded a year ago, has called from the beginning for the suspension of mesh and I am delighted that our call and the voices of women injured by the product are now being listened to.”
https://www.medicalplasticsnews.com/news/nhs-to-immediately-halt-use-of-mesh-follo/
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Government agrees to temporarily ban vaginal mesh implants for women with urinary incontinence
Jul 9, 2018 | The Independent
By Tom Embury-Dennis
The government has accepted a recommendation to temporarily ban vaginal mesh implants for women with urinary incontinence.
The Independent Medicines and Medical Devices Safety Review concluded there must be an immediate pause in the use of surgical mesh to treat stress-urinary incontinence (SUI) – a condition where urine leaks out when the bladder is under pressure.
It comes after the National Institute for Health and Care Excellence (NICE) ruled last year against vaginal mesh as a treatment for pelvic organ collapse, but stated devices could still be used to treat SUI and to repair hernias in men or women.
Campaigners hailed the latest decision and said it was “vindication” for thousands of victims who were left in agony after undergoing vaginal mesh procedures.
Around 100,000 women are estimated by NHS England to have a mesh device fitted. Estimates vary over the extent of complications; NHS England figures say they occur in 3 to 5 per cent of women, but academics say it is closer to 10 per cent.
The risk rate of mesh to treat prolapse has been shown to be far higher than for incontinence or hernia: around 40 per cent.
Activists have predicted it could affect one woman in three, and politicians have called it the “biggest health scandal since thalidomide”.
The review looked into tens of thousands of cases where women were given harmful mesh implants. Baroness Julia Cumberlege, chair of the review, said the pause should last until March 2019, when conditions to mitigate the risk of injury could be put in place.
“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,” she said in a statement. “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.”
The move is a win for campaigners, who are also pushing for a suspension of the use of mesh in rectopexy procedures. This will be considered separately by Baroness Cumberlege’s review.
"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,” said Kath Sansom, founder of campaign group Sling the Mesh.
"It is testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result and I am delighted.
"We now hope that Baroness Cumberlege adds rectopexy mesh to the suspension. This is used when patients suffer faecal incontinence after a rectal prolapse. This is even more taboo and more embarrassing than urinary incontinence. Women suffer the same grave, life changing complications.”
Owen Smith MP, chair of the All Party Parliamentary Group on Surgical Mesh Devices, said: “This is wonderful news and it is long overdue, 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.
“Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury. She has obviously been left in no doubt – as those of us who have listened to women injured by mesh are in no doubt – that the risks far outweigh any benefits.
“Of course the reality of the situation is surgeons have already recognised that fact, which is why the use of mesh has declined so precipitously over recent years.”
He added: “I hope that ministers in Wales and Scotland and civil servants in Northern Ireland will follow suit and halt the procedure.”
Around 10,000 UK women a year are implanted with a plastic mesh device, which is inserted into the walls of the vagina to treat incontinence and prolapse – common side effects following childbirth.
The plastic is known to erode and disintegrate, and can slice through organs and vaginal walls.
Some women are unable to walk or stand properly, and almost all affected report chronic pain, infections and loss of sex life.
At least one woman has died following complications from her mesh implant. Chrissy Brajcic, 42, of Ontario, Canada, was left bedridden and in constant pain after the procedure, which was to treat minor incontinence.
Brajcic eventually became resistant to antibiotics used to treat her recurrent infections. She contracted sepsis and died of organ failure.
https://www.independent.co.uk/news/health/vaginal-mesh-implants-government-review-women-urinary-incontinence-health-risk-latest-a8439266.html
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Jul 9, 2018 | Daily Mail
By Lucy Elkins
Ask urogynaecologist Sohier Elneil when she last had a proper holiday and she falls silent as she tries to work it out.
‘Three, no, I think it was four years ago,’ she says hesitantly.
It’s not that she couldn’t do with one — as a full-time consultant in the NHS at University College London Hospital, 12-hour days are routine.
But while all but emergency surgery is normally abandoned at the weekends, Miss Elneil can often be found scrubbing up and getting ready to operate on even non-emergency cases on Saturdays or Sundays.
‘I am very tired,’ she admits. ‘But if I go on a long break, it means more women might be left waiting in pain, and I can’t have that.’
It comes as little surprise to learn that her patients refer to her as ‘the angel’. ‘It’s a shame we can’t clone her on account of her empathy alone — I have never met a surgeon like her,’ is how one patient describes Miss Elneil.
She specialises in treating women’s problems, such as prolapse and urinary incontinence, but in 2004 her work took a new path when a patient was referred to her complaining of crippling pelvic pain.
‘I asked her when had it all started, and she said: “It was when they put this tape in to help with incontinence,” ’ says Miss Elneil. She investigated and found that the tape, a kind of plastic mesh, had disintegrated.
After complex surgery to remove it, the patient’s pain was gone and she was able to return to normal life.
Miss Elneil has since performed more than 250 similar operations on women given the mesh — known as tension-free vaginal tape (TVT) — which stop leaks by acting as a hammock to support the bladder.
Though it is successful in many women, in some, the mesh has broken up, causing bleeding, pain and even perforating organs.
‘I think the most harrowing case was a lawyer I saw last year who was in absolute agony from the moment she had the tape inserted, and by the time I saw her, just six weeks later, she was talking about suicide because she couldn’t live with what her life had become,’ says Miss Elneil. ‘She was bent doubt with pain and had to abandon all her work.
‘As I was operating on her, I could see the tape was embedded into the tissues and there was ulceration in places — doing the surgery was not nice.
‘I kept thinking: “How did it get this bad in six weeks?”. Cases like this keep me going — why in this day and age women should be suffering so makes me very angry.’
For a long time, she was one of only two surgeons in the country offering this surgery, says Carl Heneghan, a professor of evidence-based medicine at Oxford University, who has appeared alongside Miss Elneil before a parliamentary committee investigating the mesh.
‘When she started, she was going against the mainstream, which insisted that there was nothing wrong — but she had the moral view that she had to respond to what these women were saying and do something. But she isn’t only compassionate, she is also a very skilled clinician.
‘The surgery she does is intricate and complex — the mesh can get infected and embedded in the vagina, the bowel, anywhere, and it’s a very delicate operation to try to remove it — there aren’t many people who could do it, or even attempt to do it.’
Professor Heneghan, who recently communicated with Baroness Julia Cumberlege, the chair of an official review into the mesh, compares the situation to the Thalidomide scandal.
‘That’s because the Thalidomide scandal lead to a change in the way we look at drug regulation and drug trials. And the same is happening now with medical devices such as mesh — people now realise we need more evidence when we bring them on to the market and Sohier has played her part in raising that awareness.’
For the women themselves, it can feel like she’s the only one on their side. Because by the time they get to see Miss Elneil, they will often have been in pain for years. Adding insult to injury, some have been told their symptoms were all in their head.
‘And then you walk into Miss Elneil’s consulting room and she is so calm and takes you seriously,’ says Arlene Simmons, 66, who had a TVT inserted in 2002.
‘She is so full of warmth. When I came out of my first consultation with her I was crying — for all that I had lost, but also now at last I had a way forward, a chance to regain my old life.’
Mother-of-three Arlene, from Larne in Northern Ireland, is now on the waiting list to have the tape removed after 15 years of ‘agony’ — ‘ever since I came round from the op’.
Despite the pain and her constant urinary tract infections, the original surgeon said there was nothing wrong. Meanwhile, the incontinence it was meant to treat returned, forcing her to give up her job at a building society.
It was through a Facebook group that she came across other women who had also been affected and who were lining up to sing Miss Elneil’s praises.
‘Most surgeons take their holiday and go home at night and forget about you — Miss Elneil never forgets,’ says Arlene, who is married to Christopher, a retired manager.
‘We have a lady whose local authority refused to fund a referral for the mesh removal, and Miss Elneil emails her to check she’s OK, and tells her she is doing what she can to help persuade the authority to change its mind and urges her to keep on fighting for it.
‘Another lady I’m in touch with told me she had booked in for surgery with Miss Elneil on the NHS on a Sunday.
‘I said: “No one has scheduled surgery on a Sunday — you must have your dates wrong.”
‘But I was wrong — sure enough, Miss Elneil was operating on a Sunday. This particular lady didn’t go down to theatre until 6pm in the evening as the surgery before had been more difficult than planned.
‘As a result, she didn’t come out of theatre until 8.30pm and Miss Elneil was back in surgery on Monday morning.’
Even after the patients have been discharged, Miss Elneil keeps in touch, getting her team of nurses to call former patients to check they are doing ok.
‘Miss Elneil doesn’t just operate and go — she came to see me three times in my four days on the ward, at all times of the night and day, and was so kind,’ says Lynne Sharman, 62, who had the surgery nine weeks ago after seven years of constant pain.
‘Right from day one of the operation to fit the tape, it felt as though someone was stabbing around my pelvis with a screwdriver,’ says Lynne, who is from Reading and is married to retired investment director John.
‘Yet when I went back a few weeks later, the surgeon said he was very pleased with how the operation went, and that I would get used to the pain.’
‘But I couldn’t work in the garden, walk the dog, do the housework — bending, lifting, running; it was all out.
‘What I find so impressive is about Miss Elneil is that she really cares and has had the courage to stand up to the medical establishment.’
Indeed, while her work has brought plaudits from patients, Miss Elneil has encountered hostility from other health professionals for raising concerns about the mesh, when for a long time the conventional view was that the mesh couldn’t be the cause of any problems.
‘At times it has been unpleasant, people don’t like to have their work questioned,’ says Miss Elneil.
‘It’s very difficult to stand firm when you are going against a swathe of colleagues. The pressure is to cave in and go with the mainstream viewpoint, but she didn’t,’ adds Professor Heneghan.
‘I know people have had a go at her — they have used various ruses to try to downplay her achievements or undermine what she does — and I’m sure it hurts — but it doesn’t stop her.’
Late last year, Miss Elneil co-authored a report published in Scientific Reports — Nature outlining for the first time the extent of the problem, finding that 10 per cent of the 10,000 to 15,000 women who have been given the mesh each year in the UK end up with serious complications.
‘It took me and my six co-authors four years to work on that paper and get the data right, and it really put the cat among the pigeons,’ she says.
‘It gave us evidence for the first time that, yes, this tape can cause problems.’
And as the Mail reports today, Baroness Cumberlege has now called for an immediate suspension of vaginal mesh surgery for stress incontinence at NHS hospitals — until a series of conditions can be met.
It is a vindication of the women affected, and of the work of Miss Elneil.
But there are still many women who need surgery to remove the tape.
Miss Elneil says: ‘I’ve now operated on more than 250 of these women and it’s a really hard surgery because the mesh gets embedded in the muscles and everywhere.
‘Even though we scan our patients, you never know what you will find until you open the lady up — and sometimes it can be quite upsetting.
‘To be honest, on occasions I feel bereft because I feel so emotional about it; you realise how much this woman must have been suffering.
‘And there are a lot of women in this position. The numbers on my waiting list are overwhelming and are backing up into February,’ says Miss Elneil, who has been a surgeon for more than 26 years.
For her to operate at a weekend requires a certain amount of arm-twisting with the powers that be at her hospital. ‘I’m very lucky at UCLH [University College London Hospital] — the minute I want to do an extra list at the weekend, most of my theatre staff and the anaesthetists I work with will volunteer to work with me, which is pretty amazing, as they are giving up what would be time off.
‘But obviously the trust has to fund the running of the theatre and the staff’s time, so while they agree to it most of the time, I can’t always do it.’
As well as operating round the clock, at the weekends she also slots in sessions to train other surgeons in the intricacies of removing the mesh.
‘I have to hand this on, it’s an important part of job so we can help more women.’
With so much going on in her life, Miss Elneil, who has a stepdaughter aged 20, admits that it’s often her lawyer husband, whom she’s known since childhood, who has to run the household.
‘He is very good and looks after lots of things for me — I’d be lost without him.’
But all this work means little time for a social life.
‘Luckily, my husband has always been very understanding and has given me the freedom to do what I needed to do.’
It was another man in her life, her father — himself a doctor — who first encouraged her to devote herself to the health of women. She grew up in Africa and trained initially in Zimbabwe.
As she prepared to start her career as a surgeon, her father, who had two other daughters, urged her: ‘Do something to help women.’
And at some personal cost, that’s exactly what she’s done.
http://www.dailymail.co.uk/health/article-5935393/Surgeon-works-day-night-help-women-told-imagined-pain.html
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Jul 10, 2018 | Daily Mail
By Stephen Matthews
Controversial vaginal mesh will no longer be used on thousands of women with stress urinary incontinence, officials declared today.
Outraged campaigners have fought against the use of the 'barbaric' implants for years as thousands have been maimed by the procedure.
They have welcomed the 'incredible news' that the government has accepted an immediate suspension on the procedure, common after childbirth.
It is not a complete ban, but a halt to implementing mesh until a list of five strict conditions laid down by 'appalled' reviewers have been met.
Bu victims hope it sets the groundwork for an outright ban, as the review has so far found no evidence the benefits of mesh outweigh the severity of human suffering.
The full recommendations of the review, announced by Health and Social Care Secretary Jeremy Hunt in February, is expected to be publicised next year.
'People power'
Kath Sansom, founder of campaign group Sling the Mesh, which represents those affected by mesh implants, said: 'This is incredible news.
'It is testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result and I am delighted.
She added it was 'vindication' for the 6,100 members of the group, 'who have been maimed by this operation and then ignored, some for years'.
'MailOnline has been key in this suspension with the regular stories, telling of the devastation of the lives of women and their families.
'This has contributed to making the NHS, and other regulatory bodies, accountable for an operation sold to us as low risk.'
Sling The Mesh hopes that Baroness Julia Cumberlege, who led the review, adds rectopexy mesh - used for rectal prolapse - to the suspension.
Ms Sansom said: 'This is even more taboo and more embarrassing than urinary incontinence. Women suffer the same grave, life changing complications.'
Brittle plastic that can curl
Vaginal mesh implants, made of brittle plastic that can curl, twist and cut through tissue, have been branded the 'biggest medical scandal' since thalidomide.
Thousands of women have been maimed by mesh across the world and have been left on the brink of suicide, unable to work and reliant on wheelchairs.
Tireless fights by campaigners, backed by MailOnline, and 'meshed up' victims have led to internal investigation by the NHS and debates in the House of Commons.
http://www.dailymail.co.uk/health/article-5934491/Victory-Mail-Officials-SUSPEND-use-vaginal-mesh.html
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