Preview Newsletter
Ethicon Media Monitoring 4/2/2019
-
Vaginal mesh: new guidelines insufficient, say campaigners
Apr 2, 2019 | The Guardian
By Nicola Davis
New guidelines on the use of vaginal mesh have been met with anger by campaigners who say they do not sufficiently reflect the experiences of women who have been left with serious complications after such procedures. -
Outrage as officials recommend controversial vaginal mesh implant
Apr 2, 2019 | The Telegraph
By Henry Bodkin
A controversial vaginal mesh procedure will continue to be offered by the NHS despite being blamed for inflicting agony on thousands of women, officials have announced. -
Vaginal mesh ban can be lifted with changes, NICE says
Apr 2, 2019 | BBC News
By Anna Collinson and Jessica Furst
Controversial vaginal mesh implants can be offered again on the NHS in England once certain conditions are met, health watchdog NICE has said. -
Risky vaginal mesh operations should be the last resort, say health bosses - but campaigners are furious as they stop short of a complete ban
Apr 2, 2019 | Daily Mail
By Stephen Matthews and Kate Pickles
Mesh surgery should only be used as a last resort – with women having to opt-in after being informed of the risks, according to new official guidelines today. -
Vaginal mesh: New generation of women at risk of controversial procedure, campaigners warn
Apr 2, 2019 | The Independent
By Zoe Tidman
New guidelines on the use of vaginal mesh could expose a fresh generation of women to harm by not imposing greater restrictions on the controversial procedure, campaigners have warned. -
Vaginal mesh surgery to be allowed again following safety ban
Apr 2, 2019 | Sky News
By Charlotte Lomas
New guidelines from the health watchdog NICE published today will recommend that vaginal mesh surgery can be offered again by the NHS as long as certain conditions are met. -
Vaginal Mesh Patients 'Appalled' And 'Ignored' By New NICE Guidelines
Apr 2, 2019 | Huff Post
By Rachel Moss
Women who’ve suffered life-changing complications due to vaginal mesh have told HuffPost UK they’re “appalled” by new guidelines for the surgery, claiming they will put more women in danger. -
NICE launches surgery decision aids for stress urinary incontinence
Apr 2, 2019 | Nursing Times
Patient decision aids have been launched by the National Institute for Health and Care Excellence to help women choose a surgical option for stress urinary incontinence or pelvic organ prolapse. -
News Daily: Cabinet Brexit meeting, and vaginal mesh decision
Apr 2, 2019 | BBC News
By Justin Parkinson
...Vaginal mesh implants were halted across the UK last year after some women were left unable to walk, work or have sex because of them. -
Trust admits that patients should not have had pelvic floor mesh surgery
Apr 1, 2019 | British Medical Journal
By Clare Dyer
More than 50 patients who had controversial pelvic floor surgery involving artificial mesh should not have been operated on, an NHS trust has admitted. -
Ethicon pelvic mesh class wants expanded group definition, again
Apr 2, 2019 | Lawyerly
By Miklos Bolza
A class action against Johnson & Johnson unit Ethicon over allegedly faulty pelvic mesh implants is once more vying for an expanded group definition ahead... -
Dr Peter Petros assured a colleague he could 'mollify' investigators looking for answers
Apr 2, 2019 | Newcastle Herald
By Joanne McCarthy
Gynaecologist Peter Petros had already fended off two misconduct investigations when health officials sought answers about his financial interest in pelvic mesh surgery at Sydney Private Hospital in 2014.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Vaginal mesh: new guidelines insufficient, say campaigners
Apr 2, 2019 | The Guardian
By Nicola Davis
New guidelines on the use of vaginal mesh have been met with anger by campaigners who say they do not sufficiently reflect the experiences of women who have been left with serious complications after such procedures.
The use of plastic mesh in treating urinary incontinence and pelvic organ prolapse – conditions that are especially common after childbirth – has come under intense scrutiny. While many women have the mesh implanted without problem, for others it can lead to debilitating complications including mesh cutting into organs or through tissues, intense pain and recurrent infections.
Figures previously obtained by the Guardian show that about one in 15 women who had a common type of mesh called trans-vaginal tape inserted later had it removed as a result of complications, although full removal is far from simple.
The National Institute for Health and Care Excellence (Nice) clinical guidelines for urinary incontinence and pelvic organ prolapse continue to include surgical use of mesh as one option for women with particular conditions. However, the guidelines say surgery should only be offered to women for whom non-surgical approaches have failed or been rejected. They also stress that women must be counselled about the possible complications and that both short- and long-term outcomes must be recorded in a national registry.
In the case of surgical procedures including the use of mesh, the authors write: “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.”
But campaigners say the guidelines do not do justice to women’s experiences.
Kath Sansom, of the 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 Labour MP Owen Smith, the chairman of the all-party parliamentary group on surgical mesh, criticised the guidelines.
“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.”
Smith said the guidelines were not clear enough that mesh should only be used when more conservative and non-mesh approaches have failed.
The authors explained that they kept mesh as a surgical option in certain cases of pelvic organ prolapse because for some women it could bring benefits.
“The committee acknowledged the public concern about the risks of procedures involving the insertion of mesh products. However, they agreed that women should not be denied effective surgical options,” they wrote. “Instead, they should be fully informed and supported by their doctor to make the right decision about their treatment.”
A similar statement was made regarding the continued availability of mesh surgery for urinary incontinence.
At present, the use of mesh for either condition, when inserted through the vaginal wall, is subject to “high vigilance restriction” – meaning many patients have had their surgery put on hold.
Dr Paul Chrisp, the director for the centre for guidelines at Nice, said that new tools to help patients to navigate the options open to them would help women make the best decision for themselves. “This might include the decision not to have surgery at all,” he said.
https://www.theguardian.com/society/2019/apr/02/vaginal-mesh-new-clinical-guidelines-insufficient
-
Outrage as officials recommend controversial vaginal mesh implant
Apr 2, 2019 | The Telegraph
By Henry Bodkin
A controversial vaginal mesh procedure will continue to be offered by the NHS despite being blamed for inflicting agony on thousands of women, officials have announced.
The synthetic mesh is surgically woven into the pelvis as a treatment for urinary incontinence and pelvic organ prolapse.
Campaigners have branded today’s recommendations by the National Institute of Health and Care Excellence (NICE) as “appalling”, saying they “clear the way for the next generation of women to be harmed”.
The organisation, which decides what drugs and procedures must be offered by NHS doctors, said the “true prevalence of long-term complications following surgery with mesh is unknown”.
However, it has stressed that patients should be given alternative therapies, such as help with lifestyle changes and bladder training, before being offered a vaginal mesh.
It also ordered the establishment of a national database to better track complications from the procedure, as well as six-month follow-up appointments for all patients.
Around 92,000 women had a vaginal mesh implant in England in the eight years up to March 2015, with estimates suggesting almost 10 per cent experienced problems.
Kath Sansom, from the 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.
“We told our stories and NICE ignored us.
However, NICE insisted that under its guidelines there is “almost always” an alternative option to mesh surgery.
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.
Today’s updated guidelines are independent form a Government-ordered safety review being undertaken by Baroness Julia Cumberledge.
Owen Smith, who chairs the All Party Parliamentary Group on Mesh, said the guidelines “do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery”.
https://www.telegraph.co.uk/news/2019/04/01/outrage-officials-recommend-controversial-mesh-implant/
-
Vaginal mesh ban can be lifted with changes, NICE says
Apr 2, 2019 | BBC News
By Anna Collinson and Jessica Furst
Controversial vaginal mesh implants can be offered again on the NHS in England once certain conditions are met, health watchdog NICE has said.
Some women have been left unable to walk, work or have sex after having the implants, which are used to treat pelvic organ prolapse and incontinence.
Use of vaginal mesh was halted across the UK last year amid safety concerns.
NICE said operations must be performed by specialist surgeons at specialist centres before their reintroduction.
All instances - and outcomes - of vaginal mesh operations should also be recorded on a national database "to help with future decision-making", it said.
The NHS is not compelled to act on the guidelines - which are for England only - but services are expected to take NICE recommendations into account when planning and delivering care.'Disregarding women'
Under the new guidelines, each patient would receive a "decision aid" - detailing all the latest evidence on available treatments - and mesh implants would be used only after non-surgical options, such as lifestyle changes and pelvic floor training, had failed.
NICE said the "limited evidence" meant "the true prevalence of long-term complications following surgery with mesh is unknown".
But Labour MP Owen Smith, who chairs a cross-party group of MPs on surgical mesh implants, told the BBC's Victoria Derbyshire programme he was "deeply disappointed".
"The updated guidelines appear to disregard mesh-injured women's experiences by stating that there is no long-term evidence of adverse effects," he said.
"Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored."
He called for the continued suspension of vaginal mesh until an independent review - led by Baroness Julia Cumberlege - published its findings later this year.
Baroness Cumberlege told the Victoria Derbyshire programme now was not the time for the pause on vaginal mesh to end.
"We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated," she said.
"Those conditions have not yet been met and it is clear to us that it will be some considerable time before they are.
"This means that, now and for the foreseeable future, mesh should not be used to treat stress urinary incontinence, either in the NHS or the independent sector.
"The scale and intensity of this tragedy is truly shocking - lives have been ruined."
Studies suggest as many as one in 10 patients can experience complications including chronic pain and difficulties walking.
'I tried to kill myself'
Jackie Cheetham says she has tried to kill herself on several occasions because of the complications caused by her mesh implant.
"I have constant pain in my groin and down my leg," she says.
"I don't sleep at night. I can't walk far. We've lost our house, as I couldn't work anymore.
"It almost cost me my marriage.
"I have tried to overdose several times. I felt like an unfit mother. I couldn't work and I thought, 'What's the point?'"
Ms Cheetham says when she had the implant - to treat incontinence - she was given a leaflet by her surgeon "but it definitely didn't say I would be left in lifelong pain".
And despite surgery to remove it, some mesh still remains inside her.
Campaign group Sling the Mesh founder Kath Sansom said the NICE guidelines were effectively "no different from what was published in 2003".
"They are so weak - they clear the way for the next generation of women to be harmed," she said.
"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."
An official at England's Department of Health and Social Care said: "NICE's new guidelines and patient decision aids on managing urinary incontinence and pelvic organ prolapse will help women make more informed choices about their treatment.
"The use of vaginal mesh was paused to ensure that patients receive a high-quality and consistent service.
"Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant."
The Royal College of Obstetricians and Gynaecologists (RCOG) and the British Society of Urogynaecology (BSUG) said they welcomed NICE's recommendation "that the full range of non-surgical options should be offered to women before any surgical procedures" and "fully endorse" NICE's patient decision aids.
But they added it was "important to note" that a period of "high-vigilance" remained regarding the implants' use.
https://www.bbc.com/news/health-47735253
-
Apr 2, 2019 | Daily Mail
By Stephen Matthews and Kate Pickles
Mesh surgery should only be used as a last resort – with women having to opt-in after being informed of the risks, according to new official guidelines today.
The advice, from the National Institute for Health and Care Excellence (Nice), recognises there is ‘public concern about mesh procedures’.
Currently, there are restrictions on the controversial procedure, which is used for stress urinary incontinence and pelvic organ prolapse.
Nice said these will remain in place until all operations and complications are registered on a national database. After that, only expert surgeons based at specialist centres will carry out operations for the common disorders – usually stemming from natural childbirths.
The new guidelines have been drawn up by the NHS standards watchdog following a long-running campaign by the Daily Mail’s Good Health team. It highlighted how thousands of women have suffered constant pain, nerve damage and ruined sex lives as a result of the plastic mesh breaking up and migrating to other parts of the body.
Last year, the Government suspended use of vaginal mesh pending an ongoing review.
In a series of recommendations, NICE today said women should only be offered the procedure if non-surgical interventions are either rejected or fail.
Where it is agreed to use surgical mesh or tape, women must be informed of the risks which could include dyspareunia – painful sexual intercourse – pain and other problems.
Last night, the Royal College of Obstetricians and Gynaecologists (RCOG), and The British Society of Urogynaecology (BSUG), welcomed the guidelines. But furious campaigners said the measures have not gone far enough and that the procedure should be banned.
Kath Sansom, of Sling The Mesh, said failure to do so was ‘clearing the way for the next generation of women to be harmed’. ‘It’s Groundhog Day. They [NICE] are ignoring the elephant on the kitchen table.
‘And they have opened the floodgates for thousands of women, including our daughters and granddaughters, to be maimed by mesh in future.’
NHS data shows more than 100,000 patients have undergone a mesh procedure for incontinence or prolapse in the past decade, after its introduction as a cheaper alternative to pelvic repair operations involving the patient’s own tissue.
If implanted near the vagina or bowel, experts say it can set up an infection which may degrade the material. This causes it to break up and fragments can burrow into tissue.
Studies have suggested anything between 10 and 40 per cent of patients have suffered damage. While not issuing a blanket ban, the guidance states women should first consider the range of non-surgical options.
For urinary incontinence, these include lifestyle interventions such as caffeine reduction, modifying fluid intake and weight loss; physical therapies, such as pelvic floor muscle training; behavioural therapies, such as bladder training programmes; or medication.
Those suffering with pelvic organ prolapse can ease symptoms by losing weight, pelvic floor muscle training and pessary management.
If women decide on surgery, any complications should be investigated by consultants.
Women considering surgery should use new patient guides to help determine options. Complications related to the device should be reported, with details put in a national database. Dr Paul Chrisp, from Nice, said: ‘[The guidelines] will ensure each woman is able to decide which option is best.’
Experts say medical devices are poorly regulated. A Department of Health and Social Care spokesman said: ‘Nice’s new guidelines will help women make more informed choices.’
https://www.dailymail.co.uk/health/article-6857387/Fury-health-chiefs-U-turn-dramatic-decision-ban-vaginal-mesh.html
-
Vaginal mesh: New generation of women at risk of controversial procedure, campaigners warn
Apr 2, 2019 | The Independent
By Zoe Tidman
New guidelines on the use of vaginal mesh could expose a fresh generation of women to harm by not imposing greater restrictions on the controversial procedure, campaigners have warned.
Advice published by the National Institute for Health and Care Excellence(Nice) recognised there is public concern surrounding the use of mesh procedures.
However, it said there was “some evidence of benefit” for using surgery – including mesh – to manage stress urinary incontinence or pelvic organ prolapse.
The guidelines state there is “limited evidence” on potential long-term harms caused by the procedure.
However, the new advice did recommend women with stress urinary incontinence or pelvic organ prolapse are first asked to consider non-surgical options.
Labour MP Owen Smith, chairman of the All Party Parliamentary Group on Surgical Mesh, said the guidelines did not go far enough in acknowledging the “terrible problems” some women had faced following mesh surgery.
“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 added.
Kath Sansom, of campaign group Sling The Mesh, said she was “appalled and claimed new guidelines were virtually indistinguishable from those issued in 2003.
“They are so weak, they clear the way for the next generation of women to be harmed,” she said. “We told our stories and Nice ignored us.”
Vaginal mesh is a net-like implant used to provide additional support for damaged organs or treat incontinence.
However, large numbers of women in the UK have reported serious side effects as a result of the surgery, with more than 800 taking legal action against the NHS over the surgery.
Potential side effects from implants include painful sexual intercourse for both men and women, urinary and bowel problems and pain in the back, abdomen or pelvic regions.
The UK government suspended certain mesh procedures in July until certain conditions were met, although the surgery is still sometimes available under a “high vigilance” programme.
A Department of Health and Social Care (DHSC) spokeswoman said: “We know that for some people mesh has had some unwanted and serious consequences. Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant.”
But campaigners are concerned the new guidelines do not fully recognise the perceived dangers of the surgery, with the suggestion there is little evidence for negative long-term effects of mesh causing particular anger.
Ms Sansom told The Independent there was a “black hole” in the medical database because, in the past twenty years of mesh use, doctors tended to only ask about incontinence in the post-op consultations.
A woman could have lost her job, marriage and sex life but was considered a success for not wetting herself,” she added.
https://www.independent.co.uk/news/health/vaginal-mesh-guidelines-procedure-surgery-a8850116.html
-
Vaginal mesh surgery to be allowed again following safety ban
Apr 2, 2019 | Sky News
By Charlotte Lomas
New guidelines from the health watchdog NICE published today will recommend that vaginal mesh surgery can be offered again by the NHS as long as certain conditions are met.
In July 2018 vaginal mesh procedures, used to treat incontinence in women, were halted as part of an independent safety review led by Baroness Cumberlege, days after she had spoken to women injured by mesh.
The aim of the moratorium was to allow conditions to mitigate the risk of injury to be put in place.
Thousands of women have suffered life-changing complications as a result of the procedure which is used to treat stress urinary incontinence and pelvic organ prolapse brought on after childbirth.
The mesh implants are made out of plastic and designed to support weakened muscles like the bladder, or those that facilitate the functions of the vagina or bowel.
But some of the devices have cut through organs, caused permanent nerve damage and left some women unable to walk, work or have sexual relationships.
The highly anticipated guidelines from NICE, the first to be published in six years, will still offer mesh procedures as a second-line option after physiotherapy and once the pause on mesh surgery is lifted.
The guidelines also reintroduce the use of mesh for prolapse surgery which was banned in 2017.
In the documents, NICE said: "The benefits and risks of each type of treatment are laid out to ensure every women is fully informed. Where the evidence is limited, this is also highlighted."
"There are a number of procedures recommended by NICE, including mesh procedures."
This is despite the admission in the guidelines that evidence into the long-term harm of mesh is limited.
Dr Sohier Elneil, a leading surgeon in mesh removal, said she is surprised the NICE guidelines were published ahead of the conclusion of the Cumberlege review.
She said: "Having worked on reviews like this, the guidelines are not dissimilar to those of 2013. We have to bear in mind the complex issue we are facing and the fact we still do not know what the real complication rate is."
"There is a huge amount of discussion in the guidelines and random trial but none that look into a large group of women."
"We need to do a retrospective assessment of what has been happening over the last 20 years. In my opinion mesh needs to be something offered as a last resort, when everything else has failed."
Dr Elneil receives around three hundred emails a day from women in distress, wanting help with a mesh complication.
"For me it has become a fight for justice," she said.
"We have qualified the problem in a group of women but not quantified it for the general population. It's a huge problem."
Julie Gilsenan, 42, from Liverpool, had vaginal mesh surgery in 2017 to treat her mild incontinence.
She was immediately left in chronic pain and decided to undergo surgery to remove it, which is highly dangerous as the devices are designed to be permanent.
Julie's condition is now worse than ever.
She can now longer work as a paramedic, is on the highest strength pain medication and struggles to get washed or dressed without the help of her husband.
She said: "I was running 5k a day before my surgery, and working long shifts as a paramedic.
"Now I spend most of my time on the couch."
"Mesh has robbed me of my life."
She added: "The pain wakes me up. It is in my hips, my groin and the front of my legs, it's always there."
"There is no let up."
"I just wish I could go back, my life has totally changed. I want to be helping people, saving lives. I don't want this to be my future."
The independent review into the safety of Medicines and Medical Devices chaired by Baroness Cumberlege is due to report back later this year.
https://news.sky.com/story/vaginal-mesh-surgery-to-be-allowed-again-following-safety-ban-11681775
-
Vaginal Mesh Patients 'Appalled' And 'Ignored' By New NICE Guidelines
Apr 2, 2019 | Huff Post
By Rachel Moss
Women who’ve suffered life-changing complications due to vaginal mesh have told HuffPost UK they’re “appalled” by new guidelines for the surgery, claiming they will put more women in danger.
The updated guidelines released on Tuesday by the National Institute for Health and Care Excellence (NICE), come after thousands of women worldwide reported complications from the surgery, include debilitating pain that left women unable to walk, work or have sex, and impacted patients’ mental health.
The new NICE guidelines state that while there is “evidence of benefit” of the surgery, often offered to women experiencing stress urinary incontinence (SUI) following childbirth, “there is limited evidence on possible long-term harms of all surgical options”.
Kath Sansom, who founded the campaign group Sling The Mesh after her own surgery left her in “intense pain”, said she is “appalled” by the move.
“Despite political campaigns and the obvious suffering of many women, these guidelines are no different from what was published in 2003,” she told HuffPost UK. “They are so weak it feels like ground hog day… we told our stories and NICE ignored us.”
According to the new guidelines, women with stress urinary incontinence or pelvic organ prolapse should be given “detailed information to help them decide on what treatment is right for them”.
The guidelines detail available alternatives to surgery, but do not stipulate that surgery should only be offered when other options have failed.
MP Owen Smith, chair of the All Party Parliamentary Group on Surgical Mesh Implants, said the new guidelines “do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery”.
Smith said he was “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”.
Karen Preater, 42, from Rhyl, North Wales, is also angered by the latest update. “These new guidelines let down every single woman, not only in Wales but in the United Kingdom and are paving the way for our daughters and granddaughters to suffer unnecessarily,” said Preater.
She had mesh surgery in 2007 due to stress incontinence when her youngest child was born at 10lb, and has since had to leave her job due to the intense pain she suffers and the drowsiness caused by her painkillers. She has also struggled to empty her bladder fully since the surgery and still uses catheters.
“I live with pain 24 hours a day, simple activities like walking upstairs can make the pain more severe, I’ve lost my confidence, my purpose and rely on others to help me out,” she said. “It’s also taken a toll on my mental health, I’ve had times when I just want to fall asleep and not wake up.”
Research from Sling The Mesh has found that more than half of patients who suffer complications have suicidal thoughts.“If a men’s operation was creating this level of harm it would have been stopped a long time ago,” Sansom said.
Heidi Siggers, 49, had mesh inserted seven years ago due to a womb prolapse after her youngest son was born. “Within a year I was experiencing sharp pain in my side going down to the top of my vagina and I had severe fatigue,” she explained. “Seven years on I have constant pain of various levels and my prolapse is back.”
She finds it difficult to go out, but the pain is also making it increasingly difficult to operate the 70ft longboat that is her family home. The mum-of-three is currently waiting for an operation to remove her mesh, but would like to see the procedure completely banned.
“It’s literally devastating so many women’s lives,” she said. “There’s currently a backlog for removal yet some surgeons continue to put it in. We’ve had to cancel our holiday this year as I don’t know if I’ll be having an operation or not.”
MP Owen Smith added that the new NICE guidelines appear to disagree with guidance the organisation released in 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,” he said.
While she is pleased NICE is now advising against mesh as a first-line treatment for incontinence, Smith argues that the new guidelines fail to clearly outline that mesh should only be used once other methods and non-mesh surgery have failed.
“It is vital that a proper continence care pathway is established, with surgery as a last resort,” he said.
https://www.huffingtonpost.co.uk/entry/vaginal-mesh-patients-appalled-and-ignored-by-new-nice-guidelines_uk_5ca21032e4b0474c08d1e4fc?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAEe4EwBoGI4CtnIokpgSAWfyg9tBuQ01ZnyDaHD8WXQPhxolffZYWT2IR4eHwFVJQbdOwrqdLD5mxVFooIEz8hkHTVkwWld-vssl9umKkndTOloG_UzVwTg3PMTXX_WXA_qJZROv3yC3xjnTqUJnCR7hKShhvuBktAXoFqgqs928
-
NICE launches surgery decision aids for stress urinary incontinence
Apr 2, 2019 | Nursing Times
Patient decision aids have been launched by the National Institute for Health and Care Excellence to help women choose a surgical option for stress urinary incontinence or pelvic organ prolapse.
It comes in the wake of the national “pause” on the use by the NHS of surgical mesh or tape to treat stress urinary incontinence and for urogynaecological prolapse, and an ongoing independent review.
NICE’s new clinical guideline for urinary incontinence and pelvic organ prolapse recommends that women should use decision aids to reach an “informed decision” about their care.
Three patient decision aids will be launched alongside the final publication of the guideline today, said the institute. They cover surgery for stress urinary incontinence, surgery for vaginal vault prolapse and surgery for uterine prolapse.
The aids “place the woman at the heart of the decision”, said NICE, so they can work alongside their clinician to “pick the best course of treatment for her”.
The decision aids “detail every surgical option” NICE recommends women should be offered, using the “best available evidence”, said the institute.
They also “make clear” what non-surgical options NICE recommends as alternatives for stress urinary incontinence, vaginal vault prolapse and uterine prolapse.
The benefits and risks of each type of treatment are laid out to ensure every woman is “fully informed”, said NICE, including highlighting where evidence was limited.
Patients, clinical experts and professional bodies were involved in the development of the patient decision aids, which are endorsed by NHS England and organisations representing surgeons.
There are a number of non-surgical options to treat both urinary incontinence and pelvic organ prolapse, which should be considered before surgery.
Non-surgical options for urinary incontinence include lifestyle interventions, such as caffeine reduction; physical therapies, such as pelvic floor muscle training; behavioural therapies, such as bladder training; and medicines.
Meanwhile, non-surgical options for pelvic organ prolapse include lifestyle modification, such as losing weight if the woman is overweight and minimising heavy lifting; topical oestrogen; pelvic floor muscle training; and pessary management.
If non-surgical options have not worked or if the woman decides against them, she may wish to discuss a surgical option with her clinician, noted NICE.
If alternative surgical procedures are not suitable for or acceptable to the woman to manage stress urinary incontinence, it said clinicians should consider intramural bulking agents.
There are a number of procedures recommended by NICE, including mesh procedures. While there was evidence of benefit, there was limited evidence on possible long-term harms of all surgical options, stated NICE.
In particular, the true prevalence of long-term complications following surgery with mesh was “unknown”, it highlighted.
If a woman’s chosen intervention was not available from the consulting surgeon, she should be referred to an alternative surgeon, the NICE guideline recommended.
In cases where it was agreed to use surgical mesh or tape, women must be fully informed of the risks, for example, dyspareunia – painful sexual intercourse – and other problems, said the guideline.
A follow-up appointment should be offered within six months to all women who have had urinary incontinence or prolapse surgery.
Complications related to the device should be reported to the Medicines and Healthcare products Regulatory Agency and details of the complications should be collected in a national database.
In July 2018 a national “pause” was announced by the government on the use by the NHS of surgical mesh or tape to treat stress urinary incontinence and for urogynaecological prolapse where the mesh was inserted through the vaginal wall.
This “pause” takes the form of a high vigilance restriction period during which certain conditions apply.
It will remain in place until a number of conditions are met including registering all operations and any complications on a national database, and that surgery be performed by specialist surgeons based at specialist centres.
At the time of publication of this updated guideline, the high vigilance restriction was still in place and, until it is ends, professionals should continue to follow its requirements, said NICE.
Baroness Julia Cumberlege is also leading the Independent Medicines and Medical Devices Safety Review, which was initiated by the Department of Health and Social Care in February 2018.
The review is looking into the use of abdominal and vaginal pelvic mesh procedures. The review is still in progress and at present there is no date set for publication.
NICE said its clinical guideline was completely independent of the Cumberlege review and was being published now within its “normal timeframe”.
This is the first national guideline to comprehensively cover the assessment and conservative treatment of pelvic organ prolapse, it noted.
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
“[They] 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,” he said.
“It will ensure each woman is able to decide, with the help of her clinician, which option is best for her,” he said. “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,” he noted.
“If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can,” he said. “Surgeons must also record any intervention using surgical mesh/tape in a national database.”
https://www.nursingtimes.net/news/policies-and-guidance/nice-launches-surgery-decision-aids-for-stress-urinary-incontinence/7028444.article
-
News Daily: Cabinet Brexit meeting, and vaginal mesh decision
Apr 2, 2019 | BBC News
By Justin Parkinson
Brexit: May plots next moves after MPs turn down alternative plansTheresa May will convene her cabinet later, as she tries, once again, to make progress on Brexit. This follows MPs last night rejecting four alternative proposals that some of them - rather than the government - had put forward.
Up for discussion at 10 Downing Street is whether the PM should put her own Brexit deal with the EU before Parliament once more. Ministers insist this is the only way forward.
The UK has 10 days to seek another delay to Brexit or leave the EU without a deal. After the failure of his own proposal last night, Conservative MP Nick Boles resigned from his party to sit instead as "an Independent Progressive Conservative".
BBC political editor Laura Kuenssberg says the latest events make two outcomes more likely: leaving the EU without a deal and a general election taking place. Hear her thoughts and those of our other experts on Brexitcast.
Also, find out how your MP voted and what children think about Brexit.Vaginal mesh: NHS ban 'can be lifted with changes'
Vaginal mesh implants were halted across the UK last year after some women were left unable to walk, work or have sex because of them. But the implants, used to treat pelvic organ prolapse and incontinence, are to be offered again by the NHS in England, provided certain conditions are met. The health watchdog NICE said operations had to be carried out by specialist surgeons and that these should be recorded on a national database.
https://www.bbc.com/news/uk-47733148
-
Trust admits that patients should not have had pelvic floor mesh surgery
Apr 1, 2019 | British Medical Journal
By Clare Dyer
More than 50 patients who had controversial pelvic floor surgery involving artificial mesh should not have been operated on, an NHS trust has admitted.
North Bristol NHS Trust has told 57 women and men who had the procedure at Southmead Hospital in Bristol that they should have been offered alternative treatment first. The review follows an independent investigation into laparoscopic ventral mesh rectopexy (LVMR) cases between 2007 and 2017.
Surgeon Tony Dixon, a pioneer in the use of the technique, was suspended in 2017 after concerns were raised. He has also had his practising privileges withdrawn by the private …
Access to full text unavailable – subscription required.
Story can be found here: https://www.bmj.com/content/365/bmj.l1503
-
Ethicon pelvic mesh class wants expanded group definition, again
Apr 2, 2019 | Lawyerly
By Miklos Bolza
A class action against Johnson & Johnson unit Ethicon over allegedly faulty pelvic mesh implants is once more vying for an expanded group definition ahead...
Access to full text unavailable – subscription required.
Story can be found here: https://www.lawyerly.com.au/ethicon-pelvic-mesh-class-wants-to-expand-group-definition-again/
-
Dr Peter Petros assured a colleague he could 'mollify' investigators looking for answers
Apr 2, 2019 | Newcastle Herald
By Joanne McCarthy
Gynaecologist Peter Petros had already fended off two misconduct investigations when health officials sought answers about his financial interest in pelvic mesh surgery at Sydney Private Hospital in 2014.
So when he emailed former University of Newcastle associate professor andgynaecologist Richard Reid about the investigation into their joint surgery at the hospital, he assured his colleague he could "mollify" investigators.
For the next two years Dr Petros gave "misleading and untruthful information" to investigators in a "drip feed of information and misinformation", a tribunal was told on Monday.
But Health Care Complaints Commission investigators kept digging, barrister for the HCCC Kate Richardson, SC said.
They found the family trust company structure that showed how Dr Petros benefited from the surgery using his mesh device, and how he resigned his directorships within weeks of the complaint that started the HCCC investigation.
Dr Petros is facing professional misconduct proceedings after a woman implanted with his Tissue Fixation System (TFS) pelvic mesh device at Sydney Private Hospital without her consent suffered severe and permanent injuries.
The woman complained about why Dr Petros was in the operating theatre in 2013 when Dr Reid implanted the device without her knowledge, and why Dr Petros's financial interest was not disclosed.
But the tribunal heard Dr Petros had disclosed his invention of the device and "continuing involvement" with it to a Sydney Private Hospital medical advisory committee made up of surgeons and hospital executives.
Hospital chief executive Michelle Sloane is expected to give evidence on Tuesday about how the medical advisory committee required Dr Petros to supervise Dr Reid for three months after Dr Reid was suspended following a surgical emergency involving a woman patient.
Ms Sloane will also give evidence about how a condition of Dr Reid's reinstatement was that he "adopt... the Tissue Fixation System (TFS) for his pelvic floor surgical cases" after his suspension was lifted.
The TFS device was cancelled by Australia's medical device regulator, the Therapeutic Goods Administration, in November, 2014, less than 18 months after the hospital committee directed its use by Dr Reid.
The TGA cancelled the device after Adelaide firm TFS Manufacturing, owned by former Newcastle Falcons basketballer Paul Zadow, failed to provide evidence to substantiate the device's safety and efficacy.
The tribunal heard Dr Petros's family trust company made substantial loans of more than $2 million to TFS Manufacturing, including a single loan of $1.2 million to the company in 2016 during a period when it was fighting the TFS cancellation.
In a recorded interview with HCCC investigators, after Dr Petros was warned it was an offence to give false evidence, he said he had divested himself of any commercial interest in the TFS device.
Asked what his on-going interest in the device was, if it wasn't money, Dr Petros replied: "Love."
"There was not only no disclosure of his interest in the device, there was misinformation," Ms Richardson told the tribunal.
"There was no disclosure of anything to do with the loans until November, 2016. For a full 18 months there was not a word about substantial loans from the family trust to the device manufacturer."
The tribunal was told Dr Petros admitted two of the charges against him - that he had a financial interest in the device between 2009 and July 7, 2014 as a beneficiary of the family trust that owned the company that held the intellectual property in the TFS device.
He denied he received a financial interest from the loans after the tribunal heard he signed a licence deed with TFS Manufacturing that paid him no fees or royalties, and where interest on the loans accrued but was not paid.
The tribunal was told Dr Petros resigned as director of the family trust and company on July 7, 2014 and his son Emmanuel took over as director only three days before an HCCC deadline for responding to its initial investigation letter.
"There's a fair bit of magic about that date," Ms Richardson told the hearing.
It continues in Sydney on Tuesday.
https://www.theherald.com.au/story/5986291/mesh-doctors-drip-feed-of-misinformation/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested