Preview Newsletter
Ethicon Media Monitoring 4/20/2018
-
Vaginal mesh surgery exposed women to 'unacceptable risks'
Apr 19, 2018 | The Guardian
By Hannah Devlin
Women have been exposed to unacceptable risks through the use of vaginal mesh surgery, the government has acknowledged for the first time, as fresh evidence has revealed that thousands of women have suffered traumatic complications. -
Outraged MPs slam the vaginal mesh scandal as they recall the harrowing injuries inflicted upon women fitted with the controversial implants and say they deserve compensation
Apr 19, 2018 | Daily Mail
By Stephen Matthews
Horrified MPs today slammed vaginal mesh implants as they heard the harrowing stories of women left 'seriously damaged'. -
MPs urge ministers to 'act now' on vaginal mesh controversy
Apr 19, 2018 | Sky News
By Charlotte Lomas
The Government must act now to suspend all types of surgical mesh, MPs warned in a heated two-hour debate in the House of Commons. -
Vaginal mesh ‘biggest medical scandal’ since thalidomide, MPs told
Apr 19, 2018 | BT.com
Doctors are “voting with their feet” about the use of vaginal mesh, ministers have been told, amid claims it is the “biggest medical scandal” since thalidomide. -
Mesh scandal costing NHS millions, analysis shows
Apr 20, 2018 | Medical Plastics News
The figure comes from Carl Heneghan, professor of Evidence Based Medicine at the University of Oxford and clinical advisor to the APPG on Surgical Mesh, after the NHS published an audit into the number of women affected by the mesh scandal. -
The Bleeding Edge Doc Features Mesh Injuries
Apr 19, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Members of the Mesh Awareness Movement (MAM) are featured in the new documentary, The Bleeding Edge, which premieres at the Tribeca Film Festival this weekend!
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Vaginal mesh surgery exposed women to 'unacceptable risks'
Apr 19, 2018 | The Guardian
By Hannah Devlin
Women have been exposed to unacceptable risks through the use of vaginal mesh surgery, the government has acknowledged for the first time, as fresh evidence has revealed that thousands of women have suffered traumatic complications.
In a parliamentary debate on the use of the implants, Jackie Doyle-Price, junior minister at the Department of Health, said it was a “tragedy” that women who had put their trust in the medical establishment had “come out with the most debilitating injuries”.
“These products ... should only be used as an extreme measure,” she addded. “We should be very concerned by the extent to which these were adopted.”
Previously, the department of health had stated that the benefits of vaginal mesh surgery outweighed the risks.
Labour’s Emma Hardy, who secured the parliamentary debate on the issue, led calls to suspend the use of surgical mesh and for the government to consider launching a full public inquiry, adding that doctors and patients had been “voting with their feet” on the surgery.
The Kingston upon Hull West and Hessle MP said: “During the last nine years the figures show the number of women having the procedure has fallen by 48%, which to me says an awful lot about what the doctors are thinking about this. These women were injured, these women were ignored, these women are the victims of a scandal.”
Hardy cited figures from an NHS Digital report published this week showing that for every 100 women who have a vaginal mesh procedure, there 79 are subsequent gynaecology outpatients within a single year.
She used the backbench business debate to call for Nice guidelines for mesh in stress-related urinary incontinence to be brought forward from 2019 to 2018, and for pelvic floor physiotherapy to be routinely offered on the NHS to all new mothers.
“There is also still no physiotherapy universally available for all new mothers as standard, as there is in France, to stop these problems before they even arise,” she said.
MPs heard a series of harrowing accounts of constituents who had suffered life-altering complications due to surgery, including women left suicidal, of mesh embedded in pelvic tissue “like barbed wire”, of organs removed due to damage, loss of sex lives and the psychological trauma of being dismissed by doctors.
Labour’s Sharon Hodgson described how her 70-year-old mother had struggled with pelvic pain and urinary infections for the past five years after having mesh surgery.
Sarah Wollaston, the Conservative MP and chair of the Health select committee, criticised “cavalier attitudes” to the adoption of medical implants and a “wild west” where mesh was aggressively marketed without having undergone clinical trials.
“Many of the women that I have met, as I say, have had profound, life-changing injuries and I think they are entitled, many of these women, to compensation,” she added.
Labour’s Owen Smith, chair of the All-Party Parliamentary Group on surgical mesh, said there had been almost one million outpatient appointments linked to vaginal mesh, with costs to the NHS somewhere in the region of £250m.
A so-called “failure rate” of between 1% to 3% was not acceptable anyway, Mr Smith said, adding that the numbers “are far greater than that”.Government figures show that about 500 removal surgeries for vaginal mesh have taken place every year for the past decade. The initial keyhole surgery, usually takes less than half an hour and involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel and pelvic floor muscles. However, reversing the procedure can involve open surgery that is risky and complex since the mesh becomes embedded in muscle and sometimes attached to pelvic organs.
The latest figures, published this week, imply much higher complication rates than those previously reported in both industry-funded trials and a 2014 government report assessing the risks and benefits of vaginal mesh, which estimated the removal rate for TVT at 0.9% and the rate of complications, such as pain, at below 1.5%.
Owen Smith MP, chairman of the All Party Parliamentary Group (APPG) on surgical mesh, said: “These statistics show that the scale and complexity of the problems associated with mesh is far greater than has previously been accepted.
The government has asked Baroness Julia Cumberledge to investigate concerns about vaginal mesh, in a review that will also look at the pregnancy test Primodos, and an epilepsy drug.
https://www.theguardian.com/science/2018/apr/19/vaginal-mesh-surgery-exposed-women-to-unacceptable-risks
-
Apr 19, 2018 | Daily Mail
By Stephen Matthews
Horrified MPs today slammed vaginal mesh implants as they heard the harrowing stories of women left 'seriously damaged'.
The implants, dubbed 'barbaric, were branded the 'biggest medical scandal' since thalidomide during a lengthy debate in the House of Commons.
Outraged politicians relayed dozens of tales of mesh victims left debilitated by the controversial devices just days after a damning NHS audit into the devices.
Carol Monaghan, a Scottish National Party MP for Glasgow North West, asked why faulty cars could be recalled but mesh fitted into human bodies couldn't.
Senior Tory MP Julian Lewis told MPs that thousands of women would have 'turned down' mesh if they saw this 'ghastly catalogue' of complications.
Tory MP Sarah Wollaston, chairwoman of the Health select committee, declared many of the women fitted with mesh 'are entitled to compensation'.
Thousands of women have been maimed by mesh across the world and have been left on the brink of suicide, unable to work and reliant on wheelchairs.
Tireless fights by furious campaigners and 'meshed up' victims led to an internal investigation by the NHS. The results were published on Tuesday.
It revealed the risks of complications from mesh are around the 45 per cent mark - unlike Government assertions it is no more than three per cent.
However, while victims of mesh welcomed the damning decade-long review, Sling The Mesh stressed it 'doesn't show the true scale of the disaster'.
The 5,800-strong group have repeatedly called for a public inquiry and pushed for the two-and-a-half hour debate about vaginal mesh in the Commons today.
In the debate, Ms Monaghan told ministers that one consultant had told her trying to remove mesh was like 'trying to remove warm chewing gum from someone's hair'.
She said: 'If they discovered this kind of serious fault in a car they'd have recalled them all and stopped making them, so why didn't they do that with mesh?'
Ms Monaghan demanded a complete suspension of mesh implants, which are made of brittle plastic and can curl, twist and cut through tissue.
Mr Lewis, who represents New Forest East in Hampshire, said: 'I have a page here which lists some 50 different symptoms related to implant illness.'
He revealed how a constituent of his had said she could 'no longer carry out basic tasks at home or do things with my children due to the pain'.
A woman, who wished to remain unnamed, told Mr Lewis: 'The mesh implant I have had has, and is, continuing to destroy my life.'
Another constituent of his, known only as Helen, suffered terrible bowel problems, depression, loss of confidence and lack of self-esteem.
MPs were told Helen, who begged for her mesh to be removed, said: 'I feel let down by professionals who were supposed to treat me to the best of their ability.
'There's been information about the adverse effects of mesh around for years and yet these doctors are still happily inserting them into thousands of women.'
NHS Digital data showed nearly 130,000 patients have undergone a mesh procedure for incontinence or prolapse in the past decade.
However, hundreds of women left with life-changing injuries are undergoing surgery each year to have their vaginal mesh implants removed.
The procedures to implant mesh are given for incontinence and prolapse, both of which are common medical issues after childbirth.
Kevin Hollinrake, Tory MP for Thirsk and Malton, told of one constituent whose mesh pain was not believed and was instead referred to a psychiatrist.
Quoting her, he told the Commons: 'Within a few days of surgery I had severe pain in my groin and bladder, I was referred back to York Hospital on many occasions.
'The surgeon said he could find nothing wrong with me and recommended I saw a psychiatrist as he believed it was all in my head.'
'Eventually I was given an MRI scan and the mesh was found sticking into my bladder, I was then operated on to partially remove the mesh.
'After the operation the surgeon described the pain of the mesh sticking into me as being like barbed wire. Quite simply this operation has ruined my life.'
The All Party Parliamentary Group for Surgical Mesh demanded the audit, released yesterday, into mesh, in the hope of creating a 'clearer' picture of the scandal.
Owen Smith, Labour MP and chairman of the group, who welcomed the results of the investigation, also addressed his concerns over mesh in the Commons today.
He said there had been almost one million outpatient appointments linked to vaginal mesh, with costs to the NHS somewhere in the region of £250 million.
Mr Smith yesterday blasted the Government for repeatedly claiming that mesh was 'safe' and that just one to three per cent of women suffer complications.
Their own statistics showed around 40 per cent of women treated with mesh are subsequently undergoing outpatient treatment, he said then.
Emma Hardy, Labour MP for Kingston upon Hull West and Hessle, led calls in the Commons today to suspend the use of vaginal mesh.
Addressing the disaster, she said: 'These women were injured, these women were ignored, these women are the victims of a scandal.'
Labour MP Rupa Huq, of Ealing Central and Acton, asked: 'Would (Ms Hardy) not agree with me that this is really the biggest medical scandal since thalidomide?'
Ms Hardy replied that she 'completely' agreed and pointed to the figures earlier this week that showed the number of mesh procedures had halved in a decade.
She added: 'This shows that doctors and patients are voting with their feet about mesh and telling the world that they do not want to use it.'
Ms Hardy urged health watchdog Nice to bring forward its guidelines for mesh in stress-related urinary incontinence to later this year.
She said: 'I remain deeply concerned mesh has not yet been completely suspended and it remains possible for doctors to still use it
'There is also still no physiotherapy universally available for all new mothers as standard, as there is in France, to stop these problems before they even arise.'
http://www.dailymail.co.uk/health/article-5634875/Outraged-MPs-slam-vaginal-mesh-scandal-Commons-debate.html
-
MPs urge ministers to 'act now' on vaginal mesh controversy
Apr 19, 2018 | Sky News
By Charlotte Lomas
The Government must act now to suspend all types of surgical mesh, MPs warned in a heated two-hour debate in the House of Commons.
Labour's Emma Hardy led calls to halt use of the procedure while a review into the use of vaginal mesh is carried out.
The surgery, which usually takes less than half an hour, involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel.
Ms Hardy also urged the Government to consider bringing forward the UK health watchdog's 2018-19 guidelines on mesh for stress urinary incontinence, and to offer physiotherapy as standard for new mums on the NHS.
The Kingston upon Hull West and Hessle MP said: "During the last nine years the figures show the number of women having the procedure has fallen by 48%, which to me says an awful lot about what the doctors are thinking about this.
"These women were injured, these women were ignored, these women are the victims of a scandal."
Her speech was met with agreement from both sides of the house, with many MPs retelling emotional and traumatic stories of their constituents who have suffered life-changing consequences as a result of having vaginal mesh.
In a particularly powerful plea, Labour's Fiona Onasanya asked: "Why are we not suspending mesh? It is horrendous.
"How can we say the benefits outweigh the risks when some women are left in wheelchairs and in constant pain?"
Tory MP Sarah Wollaston, chairwoman of the health select committee, also criticised "cavalier attitudes" and a "wild west" in which mesh was aggressively marketed.
She added: "Many of the women that I have met have had profound, life-changing injuries and I think they are entitled, many of these women, to compensation."
Labour's Owen Smith said there had been almost one million outpatient appointments linked to vaginal mesh, with costs to the NHS somewhere in the region of £250m.
A so-called "failure rate" of between 1% and 3% was not acceptable anyway, Mr Smith said, adding that the numbers "are far greater than that".
Many of the MPs stopped to pay tribute to the bravery and determination of campaigners, all of them mesh-injured women, who were listening to the debate in the gallery wearing red and white polka dot bandanas.
Health minister Jackie Doyle-Price refused to suspend surgical mesh but did confirm the health watchdog NICE will publish draft guidelines on vaginal mesh to treat urinary incontinence by the end of the year.
She said: "This is a tragedy. We have women who put their trust in the medical establishment and came out of that with life-changing injuries.
"I want to continue this dialogue we are having. Mesh should only be used in extreme measures and we should be concerned."
https://news.sky.com/story/mps-urge-ministers-to-act-now-on-vaginal-mesh-controversy-11338195
-
Vaginal mesh ‘biggest medical scandal’ since thalidomide, MPs told
Apr 19, 2018 | BT.com
Doctors are “voting with their feet” about the use of vaginal mesh, ministers have been told, amid claims it is the “biggest medical scandal” since thalidomide.
Labour’s Emma Hardy led calls to suspend the use of surgical mesh following reports that many patients have suffered complications after being fitted with the medical products.
As campaigners from the group Sling the Mesh – wearing red and white polka dot bandannas – looked on from the public gallery, Ms Hardy urged the Government to consider launching a full public inquiry into its use.
The Kingston upon Hull West and Hessle MP said: “Out of all the people having the mesh insertion procedure the number of subsequent outpatient appointments per 100 for gynaecology is 79, and for rehabilitation, physiotherapy and occupational therapy its 43.
“And during the last nine years the figures show the number of women having the procedure has fallen by 48%, which to me says an awful lot about what the doctors are thinking about this.
“These women were injured, these women were ignored, these women are the victims of a scandal.”
Labour’s Rupa Huq (Ealing Central and Acton) intervened, asking: “Would (Ms Hardy) not agree with me that this is really the biggest medical scandal since thalidomide?”
Ms Hardy said she “completely” agreed that it was “an absolute scandal”, and said the data showed the number of operations using mesh had “halved over the last decade”.
“This shows that doctors and patients are voting with their feet about mesh and telling the world that they do not want to use it.”
She used the backbench business debate to call on the Government to commit to a “full and unequivocal suspension of mesh implant operations”, bring forward Nice guidelines for mesh in stress-related urinary incontinence from 2019 to 2018, and offer pelvic floor physiotherapy as standard on the NHS to all new mothers.
“I remain deeply concerned that mesh has not yet been completely suspended and it remains possible for doctors to still use it, especially in the case of stress urinary incontinence,” she said.
“There is also still no physiotherapy universally available for all new mothers as standard, as there is in France, to stop these problems before they even arise.”
MPs heard the story of one woman who had to be lifted up to walk, as well as the significant impact surgery had had on some women’s mental health.
Tory MP Sarah Wollaston, chairwoman of the Health select committee, also criticised “cavalier attitudes” and a “wild west” where mesh was aggressively marketed.
She added: “Many of the women that I have met, as I say, have had profound, life-changing injuries and I think they are entitled, many of these women, to compensation.”
Labour’s Owen Smith, a former shadow cabinet minister, said there had been almost one million outpatient appointments linked to vaginal mesh, with costs to the NHS somewhere in the region of £250 million.
A so-called “failure rate” of between 1% to 3% was not acceptable anyway, Mr Smith said, adding that the numbers “are far greater than that”.
http://home.bt.com/news/uk-news/vaginal-mesh-biggest-medical-scandal-since-thalidomide-mps-told-11364265356746
-
Mesh scandal costing NHS millions, analysis shows
Apr 20, 2018 | Medical Plastics News
The figure comes from Carl Heneghan, professor of Evidence Based Medicine at the University of Oxford and clinical advisor to the APPG on Surgical Mesh, after the NHS published an audit into the number of women affected by the mesh scandal.
A total of 993,035 women have attended outpatient appointments as a follow up after undergoing mesh surgery. Professor Heneghan states that the trend in outpatient appointments is the reverse of that which would be normal after successful surgery.
Professor Heneghan said: “These are the sorts of outpatient treatment numbers one would expect to see among a cohort of patients with multiple co-morbidities, not that you’d see among the relatively young and relatively cohort of women who have usually been operated on with surgical mesh for urinary incontinence.”
A parliamentary debate on surgical mesh is being held today (19 April), led by Emma Hardy, MP and vice chairman of the APPG on Surgical Mesh
“Despite some recent successes in the mesh campaign, there is still more work to be done both to help the victims of the current scandal and to make sure that nothing like this ever happens again. I believe the government now needs to fully suspend mesh operations and to bring forward the NICE guidance which is still not expected until 2019!"
"I also believe the government should urgently review the financial consequences of dealing with failed mesh procedures and should consider introducing post-natal pelvic floor physiotherapy for all new mothers on the NHS. That is standard in France, and in light of the shocking new analysis which reveals the cost of botched mesh ops, our government should bring forward a similar programme to both support the health and wellbeing of new mothers and to save NHS money in the longer term.” Hardy said.
https://www.medicalplasticsnews.com/news/mesh-scandal-costing-nhs-millions-analysis-shows/
-
The Bleeding Edge Doc Features Mesh Injuries
Apr 19, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Members of the Mesh Awareness Movement (MAM) are featured in the new documentary, The Bleeding Edge, which premieres at the Tribeca Film Festival this weekend!
The 99-minute documentary will be shown on Saturday, April 21, and Sunday, April 22,Tuesday, April 24, and Thursday, April 26.
The documentary features patients who have been victimized by three medical devices – Essure birth control devices, pelvic mesh and metal-on-metal hip implants.
Tammy Jackson and her family from Kentucky are featured. a premiere party hosted by Netflix will be held Saturday night.
Kirby Dick and his crew showed up at the Johnson & Johnson shareholders’ meeting in April 2017 as Tammy and other members of MAM protested J&J and made their feelings known to the shareholders and workers arriving at the annual event held in New Brunswick, New Jersey, the home of J&J.
Ultimately the filmmakers decided to eliminate the protest gathering as well as many others who were gathered at the event, including Bruce Rosenberg, hernia mesh patient and your editor.
Jackson says she helped Skype interview many mesh-injured women including Chrissy Brajcic, 42, who died last November after becoming septic following repeated infections after her mesh implant.
Instead, the director says he will dedicate the film to the memory of Chrissy.
Tammy says she told the director he was wrong not using Chrissy.
Jackson says she will be in New York City along with her husband Byron, and daughter, Byonia, who wants to be a doctor after witnessing her mother’s pain. Netflix will pay for the family’s trip, the first compensation they have received.
Tammy who has been septic three times in recent months, must travel with antibotics, an IV pole, and must undergo an infusion daily.
She will be transported in a wheelchair because “as far as I have to walk in airports, I can’t walk it. My feet go numb,” she tells MND.
According to the film’s release – “Each year in the United States, unparalleled innovations in medical diagnostics, treatment, and technology hit the market. But when the same devices designed to save patients end up harming them, who is accountable?
“With The Bleeding Edge, Academy Award®-nominated filmmakers Kirby Dick and Amy Ziering bring viewers a searing exposé of the medical device industry. The film follows the personal stories of those affected by medical technology gone wrong, giving voice to injured victims and uncovering frightening instances of corporate malpractice and the complex legal loopholes that have allowed them to go unpunished. It acts as a terrifying reminder that we are, indeed, living in the future, subjecting our bodies to everything from a seemingly innocuous sterilization device to a robotic surgeon that is the stuff of dystopian nightmares. These master documentarians have constructed a brilliant and eye-opening account that angers, enlightens, and calls audiences to action.”
The 99 minute documentary is produced by Los Angeles based Chain Camera and director Kirby Dick. The film was commissioned by Netflix and will run on that cable channel this summer.
https://www.meshmedicaldevicenewsdesk.com/the-bleeding-edge-doc-features-mesh-injuries/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested