Preview Newsletter
Ethicon Media Monitoring 4/3/2019
-
NICE guidance overlooks serious risks of mesh surgery
Apr 2, 2019 | British Medical Journey
By Harriet Pike
New national guidance on urinary incontinence and pelvic organ prolapse in women neglects the serious risks associated with the use of mesh in surgery, MPs and campaigners have warned. -
'Thousands' of women suffering after vaginal mesh surgery 'disregarded' say campaigners
Apr 2, 2019 | ITV News
"Thousands" of women have been ignored despite suffering pain and complications after having vaginal mesh surgery, campaigners say. -
Vaginal mesh op U-turn sparks anger after thousands of women left crippled by controversial op
Apr 3, 2019 | The Sun
By Miranda Larbi
Campaigners are up in arms over the government's new official guidelines on the use of vaginal mesh - claiming that it disregards the agonising experience of thousands of women. -
Four women fitted with vaginal mesh reveal how it has cut their husbands' penises, left them suicidal and forced them to rely on crutches as ban on controversial implant is OVERTURNED
Apr 2, 2019 | Daily Mail
By Alexandra Thompson, Sam Blanchard and Vanessa Chalmers
It's a controversial implant hailed as a 'quick fix' despite maiming thousands of women across the world. -
Campaigners 'Appalled' by NICE Vaginal Mesh Guidance
Apr 2, 2019 | Medscape
By Peter Russell
Campaigners opposed to the use of surgical mesh to treat stress urinary incontinence or pelvic organ prolapse in women have reacted with dismay to updated guidelines from the health watchdog which suggested the procedure could be used again in England if certain conditions were met. -
Campaigners criticise `weak´ vaginal mesh guidelines
Apr 2, 2019 | Press Association (In Daily Mail)
Campaigners have criticised new official guidelines on the use of vaginal mesh, suggesting they disregard the experiences of “thousands” of women. -
Reintroducing vaginal mesh implants would be ‘betrayal’, say MSPs
Apr 2, 2019 | Press Association (In The Sunday Post)
Vaginal mesh was banned across the UK last year due to safety concerns, with hundreds of Scottish women suffering chronic pain from the implants used to treat bladder and bowel conditions. -
Journalist ‘appalled’ at new guidance on op which left her a ‘physical wreck’
Apr 2, 2019 | HoldtheFrontPage
By David Sharman
A campaigning journalist who has fought to ban an operation which left her a “physical wreck” says she is “appalled” by new guidelines on the procedure. -
Health regulator takes step towards lifting vaginal mesh implant ban
Apr 2, 2019 | New Scientist
By Adam Vaughan
The UK health regulator has taken the first step towards NHS England lifting a temporary ban on the use of vaginal mesh implants. -
Vaginal mesh implant surgery can be offered on NHS again after changes, health watchdog says
Apr 2, 2019 | inews.co.uk
By Jasmine Andersson
The NHS health watchdog has given the green light to doctors to reintroduce controversial mesh implants. NICE, the regulatory body responsible for deciding what drugs and services the NHS offers, said vaginal mesh implants will be available once again on the NHS – but under stricter guidelines. -
New vaginal mesh guidelines 'insufficient' and potentially harmful
Apr 2, 2019 | News-Medical.net
By Sally Robertson
The NICE watchdog has controversially announced that the surgical use of plastic mesh for the treatment of urinary incontinence and pelvic organ prolapse will be made available again on the NHS in England, providing certain criteria are met. -
NHS Could Start Using Vaginal Mesh Again Following Ban
Apr 2, 2019 | The Speaker
By Abigail Hunt
Guidance from health watchdog NICE has said vaginal mesh can now be offered again by the NHS if certain conditions are met. -
Peter Petros's time being cross examined could be 'significantly reduced', a tribunal hears
Apr 2, 2019 | Newcastle Herald
By Joanne McCarthy
A pelvic mesh surgeon's cross examination about a near-fatal mesh incident at Sydney Private Hospital in 2013 could be "significantly reduced" after a tribunal was told he was considering "making admissions".
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
NICE guidance overlooks serious risks of mesh surgery
Apr 2, 2019 | British Medical Journey
By Harriet Pike
New national guidance on urinary incontinence and pelvic organ prolapse in women neglects the serious risks associated with the use of mesh in surgery, MPs and campaigners have warned.
The final recommendations of the UK National Institute for Health and Care Excellence, published this week,1acknowledge that use of mesh surgery to treat these conditions is subject to a period of “high vigilance restriction.” However, the All Party Parliamentary Group on Surgical Mesh Implants said in a press statement that the guidelines “disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects.”
The guidelines also seem to contradict NICE advice issued at the end of 2017 that mesh for vaginal prolapse should be restricted to research because of safety concerns.23 No such statement appears in the latest guidance.
Owen Smith …
Access to full text unavailable – subscription required.
Story can be found here: https://www.bmj.com/content/365/bmj.l1537
-
'Thousands' of women suffering after vaginal mesh surgery 'disregarded' say campaigners
Apr 2, 2019 | ITV News
"Thousands" of women have been ignored despite suffering pain and complications after having vaginal mesh surgery, campaigners say.
Guidance from the National Institute for Health and Care Excellence (Nice), published on Tuesday, recognises there is “public concern about the use of mesh procedures”.
There is “some evidence of benefit” for using surgery – including mesh – to manage stress urinary incontinence or pelvic organ prolapse, it said.
However, there is “limited evidence” on the long-term harms.
“In particular, the true prevalence of long-term complications is unknown,” the guidance states.
The new Nice guidance recommends that women with stress urinary incontinence or pelvic organ prolapse first consider non-surgical options.
The body said that patients thinking about surgery should be given thorough information to help them reach a decision and told about the possible risks of mesh procedures, such as painful sexual intercourse.
Labour MP Owen Smith, chairman of the All Party Parliamentary Group on Surgical Mesh, said the guidelines “do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery”.
“I am deeply disappointed that 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.”
Mr Smith added: “While I am pleased that Nice is now advising against mesh as a first-line treatment for incontinence, the new guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed.
“It is vital that a proper continence care pathway is established, with surgery as a last resort.”
A video report by ITV News Political Correspondent Libby Wiener previously explored the issue of vaginal mesh surgery:
Kath Sansom, of campaign group Sling The Mesh, said: “We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are 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.
“We told our stories and Nice ignored us.”
In July, the Government announced a “pause” on some mesh procedures in England, until certain conditions were met.
The surgery is not the subject of a “blanket ban” and remains available in some circumstances under a “high vigilance” programme.
Pelvic organ prolapse is where one of the organs in the pelvis, such as the womb, bowel, bladder or top of the vagina, moves down from its normal position and bulges into the vagina.
Non-surgical options recommended as treatment by Nice include losing weight, topical oestrogen and pelvic floor muscle training.
For urinary incontinence, caffeine reduction, pelvic floor muscle training, bladder training and medicines are all recommended.
Under the guidance, women considering surgery should use new patient guides to help them determine whether it is the right option for them.
A follow-up appointment will be offered within six months to those who opt for a procedure, and those who have had complications will be referred to a specialist centre.
Any complications will be recorded on a national database, the guidance states.
Dr Paul Chrisp, director for the centre for guidelines at Nice, said: “The patient decision-making aids developed by Nice in association with patients, clinicians and professional bodies will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure.
“It will ensure each woman is able to decide, with the help of her clinician, which option is best for her.
“This might include the decision not to have surgery at all.”
A Department of Health and Social Care (DHSC) spokeswoman said: “We know that for some people mesh has had unwanted and serious consequences.
“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.”
An independent review into the use of mesh procedures, initiated by the DHSC and led by Baroness Julia Cumberlege, is ongoing.
https://www.itv.com/news/2019-04-02/campaigners-criticise-weak-vaginal-mesh-guidelines/
-
Vaginal mesh op U-turn sparks anger after thousands of women left crippled by controversial op
Apr 3, 2019 | The Sun
By Miranda Larbi
Campaigners are up in arms over the government's new official guidelines on the use of vaginal mesh - claiming that it disregards the agonising experience of thousands of women.
The National Institute of Health and Care Excellence (Nice) has said that there's "some evidence of benefit" for using mesh to manage stress urinary incontinence or pelvic organ prolapse.
But it also acknowledges that little is known about the potential long-term complications.
Nice recommends that women with these issues first look at non-surgical options - but that doesn't go far enough, campaigners say.
Labour MP Owen Smith, chairman of the All Party Parliamentary Group on Surgical Mesh, said the guidelines "do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery".
Disregarding women's experiences"I am deeply disappointed that 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."
Mr Smith added: "While I am pleased that Nice is now advising against mesh as a first-line treatment for incontinence, the new guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed.
"It is vital that a proper continence care pathway is established, with surgery as a last resort."Surgery should be the last resort
Non-surgical options for urinary incontinence include lifestyle changes like reducing the amount of caffeine and fluids consumed, and losing weight.
Pelvic floor muscle training, behavioural therapies for bladder training and medication are all also options.
Pelvic organ prolapse can also be treated without surgery by getting women to avoid any heavy lifting, reducing the risk of constipation, and getting them to do pelvic floor muscle training.
Last year, we reported the story of mum Susan Morgan, who claimed that she'd been left suicidal from her vaginal mesh implant which felt like it was cutting into her internal organs like a "cheese wire".
Susan says the operation has taken away her career, family and her freedom over the last nine years and she has barely been able to leave her house in Brixham, Devon.'Nice has ignored us'
Kath Sansom, of campaign group Sling The Mesh, said: "We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are 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.
"We told our stories and Nice ignored us."
The government announced back in July that it was putting a "pause" on mesh operations in England until certain conditions were met.
It isn't subject to a blanket ban yet but women thinking about having the surgery should try other options first, and be offered six-month follow-up appointment after the op to make sure that there are no issues arising from it.
Any complications are then meant to be logged on a national database.
Last year, hundreds of women allegedly sought legal action against botched vaginal mesh implants which left them unable to walk or have sex without being in severe pain.
Thousands more were reportedly forced to have their implants removed because of complications.Mesh is still an option for some women
Draft guidelines from health watchdog Nice say the implants should not be used for routine operations.
They can cut into the vagina and women have described constant and horrific pain, leaving them unable to walk, work or have sex
Dr Paul Chrisp, director for the centre for guidelines at Nice, said: "The patient decision-making aids developed by Nice in association with patients, clinicians and professional bodies will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure.
"It will ensure each woman is able to decide, with the help of her clinician, which option is best for her.
"This might include the decision not to have surgery at all."
A Department of Health and Social Care (DHSC) spokeswoman said: "We know that for some people mesh has had unwanted and serious consequences.
"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."
An independent review of mesh procedures is currently ongoing.
https://www.thesun.co.uk/news/8773235/vaginal-mesh-op-uturn-anger/
-
Apr 2, 2019 | Daily Mail
By Alexandra Thompson, Sam Blanchard and Vanessa Chalmers
It's a controversial implant hailed as a 'quick fix' despite maiming thousands of women across the world.
But health officials were yesterday accused of ignoring women injured by vaginal mesh by failing to ban the procedure.
Last year, the Government suspended use of the brittle devices, common for incontinence and prolapse, pending an ongoing safety review.
But the procedure can be offered to women on the NHS in England again, once certain conditions are met, the watchdog NICE said.
Hoping to persuade chiefs to overturn their decision, four women – mothers, wives and grandmothers – have told MailOnline exactly how vaginal mesh ruined their lives.
And their array of horrifying side effects range from constant suicidal thoughts, being unable to have sex and left reliant on crutches to walk.
I didn't even realise I had vaginal mesh - until the 'poisonous' shards of plastic cut my husband's penis during sex
When Natalie Finbow was fitted with vaginal mesh for incontinence a decade ago, she could not imagine the daily agony it would eventually cause her.
Nor did the 52-year-old have any idea the seemingly harmless implant could cut her husband Adrian’s penis during sex and cause it to bleed.
In a stark admission to MailOnline, the grandmother, from Tharston in Norfolk, revealed that is exactly what happened – and not just the once.
Mrs Finbow, an author, did not know the ‘poisonous’ mesh was to blame for the gruesome accidents with her 54-year-old partner until four months ago.
She paid to have private scans, which showed the extent of the damage caused by the brittle implant inside her, after doctors had dismissed her for years.
They said her crippling pains were caused by scar tissue and even warned her real agony was ‘all in your head’.
Now, Mrs Finbow, who is reliant on crutches to walk because of the pain, is unable to leave her house without fearing she will wet herself.
And if she squeezes her legs too tight to hold it in, she said she can feel the vaginal mesh implant slicing her insides. The sheer agony means she can no longer work.
In tears, she told MailOnline that she feels like she has been ‘robbed of life’, adding: 'I was living the dream. But I've changed completely. My confidence, everything, it's just gone.
'What's the point of being here? I look out the window and it's glorious sunshine and I can't get out. I look at my husband and I feel I'm robbing him of his life too.’
Mrs Finbow, who has nine grandchildren, added: ‘This year will go by and nothing will be done again. I lose another year of my life.'
She described the NICE guidance as being 'unbelievable', adding: 'It's plastic, it's poison, and I just want it out of my body and to have our life back.'
My sex life has been totally destroyed by mesh and surgery to remove the brittle implant is 'not an option'
Six years ago Karen Preater was an active and confident mother with a successful career, working as an account manager for a Yellow Pages.
But, just one day after being given a vaginal mesh implant to treat her mild urinary incontinence five years ago, her life was turned upside down.
The mother-of-three quit her job within a month because she didn't know if the pain would ever stop, and couldn't drive herself or her children anywhere.
Now aged 42, Ms Preater takes a cocktail of 19 pills a day to cope with the excruciating pain caused by the device and relies on a walking stick to get around.
And she has heartbreakingly revealed she is in constant pain, can't urinate normally or have sex, suffers from depression and is racked with guilt over the person she has become.
'This [mesh] has definitely changed me as a person,' she told MailOnline. 'I live in a nice area of North Wales and the long walks with the dog or swimming with the children just don't happen any more.
'The intimate side of my life is totally destroyed. We did what we could but I would be in massive amounts of pain for days afterwards so it wasn't enjoyable for either of us.
'The weight of guilt is the worst thing, over how my children's lives have been affected – they have to help me so much but I get annoyed and cry easily.'
As soon as she came out of the operating room in 2014 Ms Preater, from Rhyl, knew something was wrong because she had excruciating pain in her left thigh.
'It was like a sharp pain which was constant and got worse whenever I moved,' Ms Preater said, adding she couldn't walk because it was unbearable to put any weight on my leg.
Despite expecting a quick recovery, Ms Preater spent eight nights in hospital laying in agony and being given morphine while doctors tried to find a painkiller suitable to send her home with.
The pain has now spread to her hip, thigh and groin. And she revealed she also suffers numbness in the top of her leg and a 'crawling ant sensation' all over her back.
One doctor has admitted her agony is down to nerve damage caused by the mesh, which was attached too tightly to her bladder and in the wrong position on one side.
Removing it would be 'extremely high risk', may not work and could even make it worse, something Ms Preater said is 'not an option'. So she must live with it.
'I would rather live with incontinence,' she told MailOnline. 'It was manageable, I just wanted to find out how to stop it getting worse. They sold mesh to me and made it sound fantastic.
'I wouldn't want this to happen to anybody else. The new guidelines are not fit for purpose and they just haven't listened to any of us.'
I couldn't sit, put on socks or even tie my shoelaces because of the unbearable pain from my mesh
Jackie Harvey initially thought everything was 'wonderful' after she was fitted with vaginal mesh to treat her incontinence 15 years ago.
But five years later, the 50-year-old could no longer sit, put on socks or even tie her shoelaces because of the unbearable pain she was in.
Now, Mrs Harvey, from Bainbridge in Northern Ireland, compares herself to a slug because of the devastating effect the 'quick fix' of mesh has had on her life.
The mother-of-two even claims she was never warned of the risks of the procedure, with her consultant acting like it was 'the best thing since sliced bread'.
In a fierce attack on mesh, Mrs Harvey, who runs Northern Ireland's Sling The Mesh branch, branded the implant 'a quick fix but a lifetime of misery'.
She paid £7,500 to have the mesh removed in England – but still endures 'substantial' pain in her back and legs.
Mrs Harvey, who has Bupa healthcare, was referred to a private consultant in 2005 when she went to her GP complaining of mild stress incontinence.
Just four weeks later, then aged 36, she was under the knife having a TVT implant fitted.
With everything initially going to plan, Mrs Harvey put it down to age when she started experiencing leg pain a year later.
Things then took a dramatic turn for the worse when the discomfort became so severe she would leave dropped objects on the floor because it was too agonising to bend down.
'I thought my spine would break,' Mrs Harvey said. 'I became a slug. I lost interest in going out because I couldn't walk far and needed a seat.'
Mrs Harvey eventually went to see a consultant in 2015, who referred her to a spinal specialist and for an MRI scan.
However, the medics could find nothing wrong and refused to accept mesh may be to blame for her symptoms. 'I thought I was going crazy,' Mrs Harvey said.
Things finally became clearer when Mrs Harvey read about Sling The Mesh later that year, with sufferers reporting the same symptoms she was battling every day.
Determined to have her implant removed, Mrs Harvey refused to wait the 18 months required to have her implant taken out on the NHS – and paid to go private.
I felt like I was being ripped open with a knife - the agony made me want to end it all
Sarah Smith was filled with hope when told a simple medical procedure could repair two of problems she had suffered with since childbirth.
But instead of improving her life, the operation left the 37-year-old feeling suicidal after her vaginal mesh eroded into her urethra.
Ms Smith, a mother to Oliver, 10, and Evie, eight, likened the pain to childbirth and being ripped open with a knife.
She had a vaginal mesh fitted at 30 years old after giving birth to her 'whopper' baby boy caused her to suffer prolapse and urinary incontinence.
Her doctor described the mesh as 'tape' and reportedly gave no explanation of its potential risks. It was sold to her as being ‘quick, easy and successful’.
But the mother-of-two knew something was wrong as soon as she came around from the surgery, which nurses reportedly 'dismissed'.
The zookeeper soon fell into a deep depression and became unable to get out of bed or hold her two young children.
Ms Smith also endured agonising pain across her lower abdomen, legs and pelvis, which she likened to 'a permanent UTI'.
She blames mesh for her being unable to pass 'more than a teaspoon of urine' for months, which forced her to be fitted with a catheter.
Ms Smith also claims the implant 'flared up her bowel', causing her to 'soil herself for nine days'. Despite her symptoms, she claims doctors insisted it would all settle down in time.
In a brutally honest interview, she told MailOnline she was even tempted to veer her car off the road and told her partner their children would be better off without her.
Ms Smith, from Bedford, was eventually referred to a specialist, who removed her mesh on May 30 last year.
Although no longer in pain Ms Smith still battles incontinence, which causes her to 'pour out urine' while mucking out the animals.
In the past five years, Ms Smith estimates she has spent £5,500 on incontinence pads alone.
She fears she may have to sell her home after prescriptions and travelling to hospital appointments has left her £20,000 in debt.
https://www.dailymail.co.uk/health/article-6865259/Four-women-fitted-vaginal-mesh-reveal-left-suicidal.html
-
Campaigners 'Appalled' by NICE Vaginal Mesh Guidance
Apr 2, 2019 | Medscape
By Peter Russell
Campaigners opposed to the use of surgical mesh to treat stress urinary incontinence or pelvic organ prolapse in women have reacted with dismay to updated guidelines from the health watchdog which suggested the procedure could be used again in England if certain conditions were met.
The National Institute for Health and Care Excellence (NICE) acknowledged "public concern" about the risks associated with vaginal mesh and some other surgical procedures, and said there was "substantial uncertainty about the long-term complications associated with each procedure".
It said there was "evidence of benefit" for mesh procedures but "limited evidence on the long-term adverse effects".
A committee decided that "women should not be denied effective surgical options" and said it was important that patients should be fully informed and supported by their doctor to make the right decision for their treatment.
However, the NICE guideline – which applies only to England – recommended that non-surgical options to treat both urinary incontinence and pelvic organ prolapse should be considered before surgery was contemplated.Mesh Surgery 'Paused'
The use of vaginal mesh implants to treat complications after childbirth was paused in NHS hospitals in England last year following preliminary recommendations from an independent review set up to examine the issue. This instituted a period of 'high vigilance restriction' on the use of a group of procedures, including vaginally inserted mesh and tape to treat stress urinary incontinence and pelvic organ prolapse.
Baroness Cumberlege, chair of The Independent Medicines and Medical Devices Safety Review, said she would examine the new NICE guideline. She said: "We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. 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."
Hundreds of women have reported disabling conditions as a result of the procedure, which involves inserting a net-like fabric into the vagina to support the bladder, womb, or bowel.
"The scale and intensity of this tragedy is truly shocking, lives have been ruined, said Baroness Cumberlege, who is a former health minister.
Campaigners took to Twitter to express opposition to the guideline. Kath Sansom, of campaign group Sling The Mesh, told the Press Association: "We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are 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.
"We told our stories and NICE ignored us."Patient Decision Aids
NICE said it had published 'patient decision aids' to help women with stress urinary incontinence or pelvic organ prolapse who were thinking about surgery to decide what treatment was right for them. These also make clear what non-surgical options NICE recommends as alternatives.
Dr Paul Chrisp, director for the centre for guidelines at NICE, said: "It will ensure each woman is able to decide, with the help of her clinician, which option is best for her. This might include the decision not to have surgery at all.
"Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can."
In cases where it is agreed to use surgical mesh or tape, women must be fully informed of the risks, the NICE committee said in the guideline. Patients who have undergone urinary incontinence or prolapse surgery should be offered a follow-up appointment within 6 months, it said.
NICE also recommended establishment of a national database to record all procedures involving the use of surgical mesh or tape "to help with future decision making".
It said in the meantime, the national 'pause' in procedures would remain in place until a number of conditions are met including national database registration, and surgery being performed by specialist surgeons at specialist centres.Understanding the Risks
A Department of Health and Social Care spokesperson said: "We know that for some people mesh has had unwanted and serious consequences. 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) welcomed NICE's guidance, and the patient decision aids. A joint statement said: "While the period of high vigilance continues, healthcare professionals should continue to follow any restrictions.
"The RCOG and BSUG remain firmly committed to meeting the conditions set out by the Independent Medicines and Medical Devices Safety Review to ensure women receive the safest and most effective treatments."
Publication of the review's report is expected later this year.Trust Apologises Over Mesh Surgery
Last week, North Bristol NHS Trust apologised after a review revealed that 57 patients who received a laparoscopic ventral mesh rectopexy (LVMR) procedure during pelvic floor surgery should have been offered alternative treatments prior to surgery.
The Trust said that another 73 patients considered by the review, led by expert clinicians, were told the surgery they received at Southmead Hospital between 2007 and 2017 was appropriate.
A further 13 patients have been told that investigations into their cases were ongoing and would be completed as soon as possible.
Dr Chris Burton, medical director at North Bristol NHS Trust, said: "I want to apologise to all patients who have received surgery unnecessarily – it is unacceptable and we are taking it extremely seriously.
"We took immediate action to ensure this couldn’t happen again and have been supporting patients where they need it.
"We will keep investigating to ensure we have identified those patients affected by these issues, and to find out what happened to learn lessons for future care."
https://www.medscape.com/viewarticle/911123
-
Campaigners criticise `weak´ vaginal mesh guidelines
Apr 2, 2019 | Press Association (In Daily Mail)
Campaigners have criticised new official guidelines on the use of vaginal mesh, suggesting they disregard the experiences of “thousands” of women.
Guidance from the National Institute for Health and Care Excellence (Nice), published on Tuesday, recognises there is “public concern about the use of mesh procedures”.
There is “some evidence of benefit” for using surgery – including mesh – to manage stress urinary incontinence or pelvic organ prolapse, it said.
However, there is “limited evidence” on the long-term harms.
“In particular, the true prevalence of long-term complications is unknown,” the guidance states.
The new Nice guidance recommends that women with stress urinary incontinence or pelvic organ prolapse first consider non-surgical options.
The body said that patients thinking about surgery should be given thorough information to help them reach a decision and told about the possible risks of mesh procedures, such as painful sexual intercourse.
Labour MP Owen Smith, chairman of the All Party Parliamentary Group on Surgical Mesh, said the guidelines “do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery”.
“I am deeply disappointed that 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.”
Mr Smith added: “While I am pleased that Nice is now advising against mesh as a first-line treatment for incontinence, the new guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed.
“It is vital that a proper continence care pathway is established, with surgery as a last resort.”
Kath Sansom, of campaign group Sling The Mesh, said: “We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are 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.
“We told our stories and Nice ignored us.”
In July, the Government announced a “pause” on some mesh procedures in England, until certain conditions were met.
The surgery is not the subject of a “blanket ban” and remains available in some circumstances under a “high vigilance” programme.
Pelvic organ prolapse is where one of the organs in the pelvis, such as the womb, bowel, bladder or top of the vagina, moves down from its normal position and bulges into the vagina.
Non-surgical options recommended as treatment by Nice include losing weight, topical oestrogen and pelvic floor muscle training.
For urinary incontinence, caffeine reduction, pelvic floor muscle training, bladder training and medicines are all recommended.
Under the guidance, women considering surgery should use new patient guides to help them determine whether it is the right option for them.
A follow-up appointment will be offered within six months to those who opt for a procedure, and those who have had complications will be referred to a specialist centre.
Any complications will be recorded on a national database, the guidance states.
Dr Paul Chrisp, director for the centre for guidelines at Nice, said: “The patient decision-making aids developed by Nice in association with patients, clinicians and professional bodies will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure.
“It will ensure each woman is able to decide, with the help of her clinician, which option is best for her.
“This might include the decision not to have surgery at all.”
A Department of Health and Social Care (DHSC) spokeswoman said: “We know that for some people mesh has had unwanted and serious consequences.
“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.”
An independent review into the use of mesh procedures, initiated by the DHSC and led by Baroness Julia Cumberlege, is ongoing.
https://www.dailymail.co.uk/wires/pa/article-6876795/Campaigners-criticise-weak-vaginal-mesh-guidelines.html
-
Reintroducing vaginal mesh implants would be ‘betrayal’, say MSPs
Apr 2, 2019 | Press Association (In The Sunday Post)
Vaginal mesh was banned across the UK last year due to safety concerns, with hundreds of Scottish women suffering chronic pain from the implants used to treat bladder and bowel conditions.
The National Institute for Health and Care Excellence (NICE) in England has published new guidelines saying the devices could be offered in certain situations and as long as more information is recorded.
Despite the updated advice for surgeons in England, the Scottish Government indicated it had no plans to allow the implants to be reintroduced in Scotland’s health service.
Quite how NICE has managed to reach this verdict is a mystery and brave campaigners will very understandably be demanding answersJackson Carlaw MSP
Former Scottish health secretary Alex Neil said: “The NICE guidelines published today are extremely disappointing.
“These guidelines don’t reflect the reality across the UK, where so many women’s lives have been destroyed by the use of mesh.
“Further, it doesn’t recognise the expertise outwith the UK that could be better learnt from so there is greater access to full mesh removal surgery here.
“It’s a poor report and it certainly isn’t putting patients at the centre of consideration.”
Scottish Conservative interim leader Jackson Carlaw said: “This is an astonishing decision and a betrayal to the many women whose lives have been ruined by this procedure.
“Quite how NICE has managed to reach this verdict is a mystery and brave campaigners will very understandably be demanding answers.
“In Scotland, we have a moratorium on mesh implants, and I urge the Scottish Government to keep this in place.”
https://www.sundaypost.com/news/uk-news/reintroducing-vaginal-mesh-implants-would-be-betrayal-say-msps/
-
Journalist ‘appalled’ at new guidance on op which left her a ‘physical wreck’
Apr 2, 2019 | HoldtheFrontPage
By David Sharman
A campaigning journalist who has fought to ban an operation which left her a “physical wreck” says she is “appalled” by new guidelines on the procedure.
Cambs Times journalist Kath Sansom, left, has hit out at “weak” new guidance by the National Institute for Health and Care Excellence on the subject of mesh implants for women encountering bladder problems after childbirth.
Last year the government suspended the controversial treatment for women thanks to Kath’s Sling The Mesh drive.
But now she has shared her despair after NICE today (Tuesday 2) published updated clinical guidelines, which Kath claims are “no different” from those published 16 years ago.
Said Kath: “We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are 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. The whole process has been a total whitewash.
“We told our stories and NICE ignored us. NICE also ignored important scientific evidence showing mesh risk is at least 1 in 10 suffering, by deliberately omitting a key study of NHS figures.
“Our Sling The Mesh survey shows 1 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 auto immune disease.
“These are unacceptable risks from what is sold to women as a simple fix. If a men’s operation was creating this level of harm it would have been stopped a long time ago.”
Labour MP Owen Smith, chair of the All Party Parliamentary Group on Surgical Mesh Implants, has backed Kath in her criticism.
He said: “The APPG has for years called on NICE to update its guidelines on stress urinary incontinence and while I am pleased it has finally listened, the new guidelines do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery.
“I am deeply disappointed that the updated guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects. Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored.
“It is worrying that the new guidelines disagree with NICE guidance of December 2017 on pelvic organ prolapse, which stated mesh should only be used for research purposes. I cannot understand why NICE appears to have effectively lifted its ban on mesh for prolapse, and I have serious concerns that as a result, women undergoing mesh surgery for prolapse may not be aware of the potential risks.
“While I am pleased that NICE is now advising against mesh as a first-line treatment for incontinence, the new guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed. It is vital that a proper continence care pathway is established, with surgery as a last resort.
“It is imperative that the new guidelines do not undermine the important work currently being undertaken by Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review, which is due to report later this year. While this is ongoing and until the safety of mesh can be proven, it must remain suspended.”
The guidelines for urinary incontinence and pelvic organ prolapse recommends that women should use decision aids to reach an informed decision about their care.
Dr Paul Chrisp, director for the centre for guidelines at NICE, said: “The patient decision-making aids developed by NICE in association with patients, clinicians and professional bodies will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure.
“It will ensure each woman is able to decide, with the help of her clinician, which option is best for her. This might include the decision not to have surgery at all.
“Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can. Surgeons must also record any intervention using surgical mesh/tape in a national database.”
https://www.holdthefrontpage.co.uk/2019/news/campaigning-journalist-appalled-at-new-guidance-on-operation-which-left-her-a-physical-wreck/
-
Health regulator takes step towards lifting vaginal mesh implant ban
Apr 2, 2019 | New Scientist
By Adam Vaughan
The UK health regulator has taken the first step towards NHS England lifting a temporary ban on the use of vaginal mesh implants.
The implants are used to treat incontinence and prolapse in women, often after childbirth. Their use was paused last year to allow for a safety review, after women reported severe pain and complications. Around one in 10 recipients have had complications within five years of surgery, according to one study.
Now the National Institute for Health and Care Excellence (NICE) has said the ban could be lifted if certain conditions are met. These include establishing a national database to record procedures and complications, and that only specialist surgeons at specialist centres carry out the surgery.
The guidelines also recommend that people are offered booklets, called “decision aids”, that clearly set out the possible risks of vaginal mesh implants. Women who opt for surgery over physical therapies should be warned that the implants may cause pain, including during sex.
But campaigners say the new guidelines aren’t materially different from ones published 16 years ago. “They are so weak, they clear the way for the next generation of women to be harmed,” Kath Sansom of Sling The Mesh said in a statement.
https://www.newscientist.com/article/2198424-health-regulator-takes-step-towards-lifting-vaginal-mesh-implant-ban/
-
Vaginal mesh implant surgery can be offered on NHS again after changes, health watchdog says
Apr 2, 2019 | inews.co.uk
By Jasmine Andersson
The NHS health watchdog has given the green light to doctors to reintroduce controversial mesh implants. NICE, the regulatory body responsible for deciding what drugs and services the NHS offers, said vaginal mesh implants will be available once again on the NHS – but under stricter guidelines.
Recorded on a national database The mesh implants, which are used to address pelvic prolapse and incontinence, were stopped on the National Health Service after thousands of women complained of life-altering complications related to the implant. Women said they have been left unable to walk, work or have sex thanks to the mesh.
But NICE believes there is “limited evidence” to prove the mesh should be withdrawn from the NHS completely. After assessing the potential health impact of the mesh through an independent review, NICE said the paucity of evidence meant “the true prevalence of long-term complications following surgery with mesh is unknown”.
The watchdog, however, said it will introduce stricter criteria around the mesh. Baroness Cumberlege, who led the review, told the Victoria Derbyshire Show patients will receive a “decision aid” which will help them decide whether or not they want the mesh.
The Baroness and her team also ruled the device should be inserted by specialist surgeons. Women should opt for lifestyle changes and pelvic floor exercises before they are offered the mesh, the report also recommends.
And to ensure there are as a few complications as possible in the future over mesh use, each time a vaginal mesh is inserted, it will be recorded on a national register. The Baroness called the fallout from the mesh “truly shocking.”
"The scale and intensity of this tragedy is truly shocking – lives have been ruined,” the Baroness told the programme. Can’t walk, work or have sex Hundreds of women are suing the NHS after suffering life-altering effects at the hands of the mesh before it was withdrawn from use in July 2018.
Women with the implants said they were unable to walk, work or have sex after the implant was fitted.
One woman told i she gets persistent urinary tract infections as frequently as twice per month, and has been forced to give up her job.
Another said she finds sex excruciatingly painful, and the protruding mesh injures her husband during sex. Jackie Cheetham told BBC News she was suicidal after suffering complications.
“I have constant pain in my groin and down my leg,” she said. “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?'”
‘Thousands of women have faced life-changing injuries’ NICE said operations must be performed by specialist surgeons at specialist centres before their reintroduction.
Founder of campaign group Sling The Mesh Kath Sansom called the new regulations “weak.”
The group gathered testimonies to campaign for the mesh to be withdrawn. Ms Sansom told BBC News: “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.”
The chair of a cross-party body assessing medical implants said he was “deeply disappointed” with the board’s decision.
Labour MP Owen Smith said: “The updated guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects.” “Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored.”
A spokesperson 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.”
https://inews.co.uk/news/health/vaginal-mesh-implant-surgery-nhs-ban-lifted-nhs-problems/
-
New vaginal mesh guidelines 'insufficient' and potentially harmful
Apr 2, 2019 | News-Medical.net
By Sally Robertson
The NICE watchdog has controversially announced that the surgical use of plastic mesh for the treatment of urinary incontinence and pelvic organ prolapse will be made available again on the NHS in England, providing certain criteria are met.
Estimates have previously shown that around one in 15 women who had one form of the implant needed to have it removed later due to complications, such as the mesh cutting through tissues or into organs and causing intense pain and recurrent infection.
Some studies have suggested that as many as one in ten women have been left unable to work, walk or engage in intercourse and last year, use of the implants was suspended across the UK due to safety concerns.
Now, the new guidelines have recommended that vaginal mesh implants continue to be included as an option for women who have certain conditions.
The guidelines do say that the implants should only be offered to women in cases where non-surgical procedures have failed or been rejected; that women must receive counselling about potential complications and that all short- and long-term outcomes must be recorded in a national registry.
However, protestors from the campaign group Sling the Mesh say the recommendations do not do justice to women’s experiences.
Commenting on the use of the surgical implants, the NICE authors say: “There is some evidence of benefit, but limited evidence on long-term effectiveness and adverse effects. In particular, the true prevalence of long-term complications is unknown.”‘NICE ignored us’
Sling the Mesh campaigner, Kath Sansom, is appalled by the guidelines and says they are no different to those published in 2003, despite the campaigns held and the suffering that has been reported by so many women.
They [the guidelines] are so weak, they clear the way for the next generation of women to be harmed. We told our stories and NICE ignored us.”
Labour MP Owen Smith, chairman of the all-party parliamentary group on surgical mesh, also criticised the move, saying he is disappointed that women’s injuries seem to have been disregarded with the statement that there is “no long-term evidence of adverse effects.”
“Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored,” says Smith, who had previously called for the use of vaginal mesh to be suspended until an independent review led by Baroness Julia Cumberlege had published its findings later this year.‘Mesh should not be used to treat stress urinary incontinence’
Cumberlege, chair of the Independent Medicines and Medical Devices Safety Review, believes now is not the time for the suspension on vaginal mesh to be lifted.
"We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. Those conditions have not yet been met and it is clear to us that it will be some considerable time before they are,” she says.
[...] Now and for the foreseeable future, mesh should not be used to treat stress urinary incontinence, either in the NHS or the independent sector.”
Baroness Julia Cumberlege‘Non-surgical options should be offered to women’
In support of the guidelines, the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology have welcomed the recommendation that “the full range of non-surgical options should be offered to women before any surgical procedures" and they "fully endorse" NICE's patient decision aids.
However, the organizations add that it is important to note that a period of “high-vigilance” remained regarding use of the implants.
https://www.news-medical.net/news/20190402/New-vaginal-mesh-guidelines-insufficient-and-potentially-harmful.aspx
-
NHS Could Start Using Vaginal Mesh Again Following Ban
Apr 2, 2019 | The Speaker
By Abigail Hunt
Guidance from health watchdog NICE has said vaginal mesh can now be offered again by the NHS if certain conditions are met.
Procedures using vaginal mesh to treat incontinence in women were stopped in July 2018 as a safety ban was put in place by Baroness Cumberledge, following her communication with women who were injured by the mesh.
The transvaginal tape (TVT) has been widely used in procedures across Europe and the US for more than 15 years and has left thousands of women suffering life-changing complications, with some left unable to walk, work or have sex.
Advice released by the National Institute for Health and Care Excellence (NICE) acknowledged there is a public health concern regarding the mesh, but said evidence revealed there are some benefits of its use in surgery and “limited evidence” on the long-term harm the procedure could possibly cause.
In the release, NICE stated: “The benefits and risks of each type of treatment are laid out to ensure every woman is fully informed. Where the evidence is limited, this is also highlighted.
“There are a number of procedures recommended by NICE, including mesh procedures,” they added.
Often the NHS’s services are expected to listen to NICE guidance when planning and delivering care, however, are not compelled to act on every recommendation made – creating uncertainty and scope for female prolapse sufferers to be injured in the future.
The guidance suggested women should consider non-surgical options such as physiotherapy before opting for the mesh surgery to resolve stress urinary incontinence and pelvic organ prolapse – commonly caused by giving birth.
But chairman of the All Party Parliamentary Group on Surgical Mesh, Labour MP Owen Smith, thinks affected women are being ignored.
“While I am pleased that NICE is now advising against mesh as a first-line treatment for incontinence, the new guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed,” he said.
However, Mr Smith said he was “deeply disappointed” that the guidelines appear to disregard mesh-injured women’s experiences with NICE stating there is no long-term evidence of the adverse effects.
He added: “Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored.”
An independent investigation into the use of transvaginal mesh in procedures is being led by Baroness Julia Cumberledge and has yet to come to a conclusion – sparking some controversy that NICE should have waited for the results before releasing its new guidelines.
https://speakerpolitics.co.uk/headlines/1174-nhs-to-start-using-vaginal-mesh-again-following-ban
-
Peter Petros's time being cross examined could be 'significantly reduced', a tribunal hears
Apr 2, 2019 | Newcastle Herald
By Joanne McCarthy
A pelvic mesh surgeon's cross examination about a near-fatal mesh incident at Sydney Private Hospital in 2013 could be "significantly reduced" after a tribunal was told he was considering "making admissions".
Gynaecologist and pelvic mesh device inventor Peter Petros could amend his response to professional misconduct charges on Wednesday after evidence on Tuesday about a woman left in "dire" circumstances who required 14 units of blood following mesh surgery.
The woman was implanted with Dr Petros's Tissue Fixation System (TFS) device by gynaecologist Richard Reid only one week after the Ashfield hospital allowed him to return to surgery under Dr Petros's supervision, and on condition he used the TFS device for certain procedures.
Dr Reid was under conditions imposed by the NSW Medical Council at the time because of previous serious incidents involving women patients. In 2018 he was found guilty of professional misconduct after 17 women were left with serious injuries following mesh surgery at the Ashfield private hospital, with the majority receiving the TFS device.
Dr Petros started working at Sydney Private Hospital in March, 2013 after the Medical Board of Australia withdrew professional misconduct proceedings raised against him in 2011 following mediation.
The NSW Civil and Administrative Tribunal hearing new professional misconduct proceedings against Dr Petros was told he advised a Sydney Private Hospital medical advisory committee of surgeons and hospital executives that he invented the TFS and "received no income from its sale".
Dr Petros has already admitted to the tribunal that he received a financial benefit from the device between 2009 and July 7, 2014 through a complex financial arrangement involving a family trust company and the licensing of the device to Adelaide firm TFS Manufacturing, owned by former Newcastle Falcons basketballer Paul Zadow.
The undisclosed financial benefits he received from that arrangement formed part of the NSW Health Care Complaints Commission professional misconduct proceedings against him.
On Tuesday gynaecologist Tony Geraghty told the tribunal Dr Petros's financial benefit from the device Dr Reid was ordered to use at the hospital while under Dr Petros's supervision was "a conflict of interest because there was an incentive for the device to be used".
Patients had to be advised because Dr Petros had a "vested interest in the device" as inventor and promoter, Dr Geraghty.
The HCCC launched its investigation into Dr Petros after a woman left with serious and permanent injuries after she was implanted with the TFS device at the hospital, without her knowledge or consent, complained about Dr Petros's undisclosed conflict of interest.
The disclosure to patients was even more necessary after the Australia's medical device watchdog, the Therapeutic Goods Administration, cancelled the TFS in November, 2014, Dr Geraghty said. It was one of the first pelvic mesh devices in the world to be cancelled Mr Zadow's company failed to substantiate evidence of safety and efficacy. TFS Manufacturing lost its appeal against the cancellation in December.
The tribunal was told the medical advisory committee conducted a root cause analysis of a near fatal incident in June, 2013 after Dr Reid cut a major blood vessel while implanting the TFS device in a woman under Dr Petros's supervision.
Dr Geraghty described the unusual TFS procedure devised by Dr Petros according to his controversial "integral theory" as a "relatively blind procedure" because of how the device was implanted through a woman's vagina.
It required a surgeon to "put a device into tissue you hope is not vascular tissue (a blood vessel)", Dr Geraghty said.
The near-fatal incident was "very serious" and "you would have thought (the hospital's medical advisory committee) would have met to discuss the whole supervisory process", Dr Geraghty said.
He criticised a report about the incident by Dr Petros to the medical advisory committee, saying the "seriousness of the situation... seems to be unstated".
The hearing continues.
https://www.theherald.com.au/story/5989899/mesh-doctor-peter-petros-considers-a-plea-change/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested