Preview Newsletter
Ethicon Media Monitoring 10/16/2017
-
Mesh surgeon investigated by NHS trust in Bristol
Oct 16, 2017 | BBC
A surgeon who carried out mesh surgery that left women in severe pain is being investigated by his NHS trust. -
Mesh victims head to Westminster to urge ministers to suspend ops that ruined their lives
Oct 15, 2017 | The Sunday Post
THE voices of Scotland’s mesh victims will be heard at Westminster this week as the Government is urged to suspend the controversial procedures. -
Surgeon warned patient safety experts that mesh implants were risky but they took no notice of him
Oct 13, 2017 | Wisbech Standard
By Kath Sansom
Vincent Argent, a gynaecologist who refused to use mesh implants, said: “I strongly advised NICE that mesh procedures were risky and there was a major lack of safety data and long term outcomes. -
Complications ensue: Behind the vaginal mesh scare
Oct 16, 2017 | Mims Today
By Zayani Bhatt
The transvaginal mesh (also known as urogynaecological mesh) is a polypropylene mesh that is implanted to permanently fix pelvic organ prolapse and stress urinary incontinence. -
Pioneering hidden device could spare millions of women from the 'stigma of incontinence'
Oct 14, 2017 | The Daily Mail
By Jo Macfarlane
A pioneering hidden device could help millions of women who suffer in silence with an embarrassing condition linked to childbirth. -
Is Abdominal Mesh Overused?
Oct 14, 2017 | Lawyers and Settlements
By Gordon Gibb
New Orleans, LAA recent hernia mesh lawsuit was filed at the end of September in Louisiana by a plaintiff who underwent surgical repair for a hernia a year ago this month, only to experience surgical mesh side effects that necessitated revision surgery just six months later.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Mesh surgeon investigated by NHS trust in Bristol
Oct 16, 2017 | BBC
A surgeon who carried out mesh surgery that left women in severe pain is being investigated by his NHS trust.
Tony Dixon, who is based in Bristol, uses a technique known as mesh rectopexy to fix bowel problems, often caused by childbirth.
Several women are considering legal action after being treated by him.
Mr Dixon said he was unable to comment because of the investigation, but the BBC understands he denies doing anything wrong.
He works at Southmead Hospital and at the Spire private hospital in Bristol.
One of Mr Dixon's patients, Sam van der Heijden from Hastings in East Sussex, said she was left with major pain and complications after Mr Dixon inserted the mesh in 2011.
She had had previous surgery with someone else and was facing a difficult future.
"I researched on the internet and Mr Dixon came up as the pioneer of mesh rectopexy," she said.
"So I thought, right, if I'm having problems I need to go to the best.
"He said [it] will solve all your problems. Because I believed he was the expert I didn't question it."
Another surgeon told the BBC in their opinion her mesh was not attached where they would expect it to be.
Concerns have also been raised by patients who said they were not fully warned of possible complications.
ynaecologist Dr Sohier Elneil has taken on the care of several patients from all over the UK who were operated on by Mr Dixon in Bristol.
"There might be patients in whom it has been absolutely fine, but we now know there are many patients who are suffering as a consequence of this type of surgery," she said.
"This year alone we've operated on seven such cases.
"It worries me when you start to hear the same name or same technique or the same problem in women from different parts of the country."
Mr Dixon is being investigated by Southmead Hospital, where he currently cannot perform mesh operations.
The General Medical Council (GMC) is also investigating, and has stopped him from performing another form of corrective surgery, known as a Starr procedure (stapled transanal resection of the rectum), for a year from August 2017.
Mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
The mesh, usually made from synthetic polypropylene, is intended to repair damaged or weakened tissue.
Mr Dixon has his supporters, and the BBC has been told he is pioneering, experienced and conscientious.
The Pelvic Floor Society (PFS) says up to 2.5% of women who have mesh surgery will suffer complications, but it can bring life-changing benefits.
The society's Andrew Williams said it was "up to the woman herself" to discuss with her surgeon the "risks and benefits".
One surgeon told the BBC that complications arising from mesh surgery, a procedure which became common in about 2004, could not have been foreseen.
The PFS said it began to recognise complications in 2014, but its chair could not say whether surgeons should have mentioned complications before then.
Two Bristol law firms are considering legal action, after taking on 16 women who were operated on by Mr Dixon.
Madeleine Pinschof from Thompsons Solicitors said the majority had suffered "debilitating complications... far worse than before they had these procedures".
"Certainly we don't believe that all of the possible complications had been explained," she said.
Luke Trevorrow from solicitors Irwin Mitchell said he suspected there may be "more patients out there who have received treatment from Mr Dixon who are equally concerned".
North Bristol NHS Trust, which runs Southmead Hospital, said it was investigating concerns raised over "certain pelvic floor repair procedures" and said Mr Dixon was "not currently providing these procedures" at the trust.
Spire Bristol Hospital's director, Dan Rees Jones, said Mr Dixon was currently not permitted to perform procedures and was "restricted to outpatient follow-up appointments" while the NHS trust completes its investigation.
He added that complications relating to Mr Dixon's practice at the hospital "fall within normal parameters".
Claims by women that the mesh surgery left them with long-term health problems will be investigated on Inside Out West on BBC One at 19:30 BST on Monday 16 October.
http://www.bbc.com/news/uk-england-bristol-41596436
-
Mesh victims head to Westminster to urge ministers to suspend ops that ruined their lives
Oct 15, 2017 | The Sunday Post
THE voices of Scotland’s mesh victims will be heard at Westminster this week as the Government is urged to suspend the controversial procedures.
East Renfrewshire MP Paul Masterton, one of the speakers at Wednesday’s parliamentary debate on the issue, will highlight the life-changing injuries suffered by women in Scotland to hammer home his call for suspension and a safety review.
He said: “The many women I’ve met through Scottish Mesh Survivors have left me in no doubt over what must happen now. I fully intend being their voice in this debate.”
Kath Sansom, of the UK’s Sling The Mesh campaign group said injured women across the country will be represented.
Hundreds of thousands of women worldwide have reported injuries from the implants, used to treat bladder problems and pelvic organ prolapse, but medical watchdogs insist the benefits outweigh the risks.
Mr Masterton said: “Mesh procedures must be suspended until manufacturers can prove their devices are safe.
“Surgical mesh must be reclassified to reflect the injuries suffered by thousands of women across the country.
“Many of the studies and reports into the safety of these devices have been funded in some way by manufacturers.
“Injured women are the evidence of what has gone wrong, not flawed figures.”
Last month, a woman in Philadelphia was awarded £42 million in damages over injuries she sustained from one of the devices most often used in Scotland.
Manufacturers have paid more than £3billion to victims in the US, Scotland faces its biggest ever health claim against the NHS with almost 450 cases, and thousands more are taking legal action.
Scotland became the first country in the world to suspend the use of mesh in 2014 after a successful petition by Elaine Holmes, from Newton Mearns, and Olive McIlroy, from Renfrew, who both suffered crippling injuries.
They both resigned “in disgust” from the safety review commissioned by the Scottish Government after it was revealed all four medical experts on the panel had financial links to mesh manufacturers.
Campaigners, who also claimed ‘“vital safety evidence” was “tampered with” in Scotland’s review, said they are delighted the UK Government has woken up to the scandal.
Ms McIlroy, 60, said: “The UK Government has the opportunity to really make a difference and protect patients from further devastating injuries.
“It’s too late for all of us, but they need to prevent devices being introduced without rigorous safety tests and introduce a register so problems can be flagged up.
“We hope the UK Government grasp that opportunity.”
https://www.sundaypost.com/fp/mesh-victims-head-to-westminster-to-urge-ministers-to-suspend-ops-that-ruined-their-lives/
-
Surgeon warned patient safety experts that mesh implants were risky but they took no notice of him
Oct 13, 2017 | Wisbech Standard
By Kath Sansom
Vincent Argent, a gynaecologist who refused to use mesh implants, said: “I strongly advised NICE that mesh procedures were risky and there was a major lack of safety data and long term outcomes.
“The advice was over-ruled by surgeons with a vested interest in promoting mesh procedures.
“The Government must act as this is the biggest scandal since the thalidomide case.
“Vaginal mesh operations are Russian Roulette procedures.
“The real risk of complications is about one in six. This is very common on the nationally agreed scale of risk and high for an operation for a benign, but distressing, condition.”
The revelation comes as pressure mounts from campaigners around the world for the procedure to be banned saying it is the biggest health scandal of this century.
Journalist Kath Sansom, who launched Sling The Mesh in 2015, said the operation, which uses a mesh implant to strengthen weakened pelvic floors of women often caused by childbirth, said it has destroyed the lives of thousands globally.
The mesh is also used to fix hernias.
Kath’s campaign has been backed by Labour front benchers who are calling for a public inquiry like that running in Australia where Kath and Scottish campaigners gave evidence last month.
The scandal-hit mesh implants will be debated in Westminster on Wednesday 18 amid mounting pressure to suspend the controversial procedure while a full audit is carried out.
More than 100,000 women have received mesh implants and tapes across the UK in the last 10 years alone.
The debate was secured by MP Emma Hardy, who said: “After meeting with women from my constituency regarding Sling The Mesh I’m delighted to have secured a debate on this issue.”
MP Owen Smith leads an all party parliamentary group (APPG) into mesh. He said: “I will invite all 650 MPs. This is a serious health issue and is not going away.”
Kath said: “When we first hit media headlines six months ago we had 1,100 members and now we have more than tripled to 3,400.
“We have people joining daily who feel isolated and alone, they truly thought, as their surgeons had led them to believe, they were a mystery patient.
“We are delighted that at last our voices are being heard. We want to protect women of the future from being damaged from what is sold as a simple 20 minute fix yet has devastating quality of life risks.”
For women worldwide, promised a quick fix to embarrassing problem of prolapse or incontinence, the operation has left some losing full use of their legs, some are in wheelchairs or use sticks, suffering chronic pain, UTIs and many have lost sex lives.
Some are suicidal and others have considered Dignitas rather than face a daily battle with excruciating pain.
After previously denying their implants were causing women’s discomfort, mesh manufacturer Johnson & Johnson was ordered to pay out $57 million to a sufferer from Philadelphia last month after a jury found the company negligent and its product defective.
The giant has appealed.
The NHS and MHRA state risk is only one to three per cent of women will suffer complications.
Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, has also called for a public inquiry.
Shadow health minister Sharon Hodgson has backed him, and said the procedure carries “unacceptable complication rates.”
During health questions in the Commons Health Minister Jackie Doyle-Price told MPs she knew many women suffer substantial side effects and complications after the procedure, but it was ‘equally the case that many women also experience considerable relief from symptoms’.
She said NICE strongly recommends the implants are not offered routinely for the first surgical intervention in prolapse, and that the current guidance was being updated and would be published early next year.
MP Paul Masterton said: “Women like Elaine Holmes, co-founder of the Scottish Mesh Survivors group, have to live with the catastrophic consequences of transvaginal mesh implants.
“With health regulators across the globe now waking up to the scandal and issuing alerts or de registering mesh devices, will Ministers join me in urging the MHRA immediately to reclassify this damaging procedure as high risk?”
MP Karin Smyth added that hearing how mesh has ruined previously healthy women’s lives is “truly harr
http://www.wisbechstandard.co.uk/news/sling-the-mesh-surgeon-tried-to-warn-about-its-high-risk-in-2003-1-5235723
-
Complications ensue: Behind the vaginal mesh scare
Oct 16, 2017 | Mims Today
By Zayani Bhatt
The transvaginal mesh (also known as urogynaecological mesh) is a polypropylene mesh that is implanted to permanently fix pelvic organ prolapse and stress urinary incontinence. However, increasing numbers of lawsuits from women who have suffered lifelong complications such as infection, erosion of the vaginal tissues and organ perforation because of the design and implantation technique mean that new patients of the treatment are entirely put off.
To date, more than 100,000 women have sought compensation from maker, Johnson & Johnson, for their injuries and many have resulted in multimillion-dollar settlements. Fifty-one-year-old Ella Ebaugh, for example, was awarded USD57 million in damages – after the mother of five was left with a mangled urethra, bladder spasms and continual pelvic pain. Many others have been left with chronic pain, unable to walk or have sex.
Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in the UK, according to NHS data from the Hospital Episodes Statistics, obtained by the Victoria Derbyshire programme. About one in 11 women has experienced problems, the data suggests. In addition, tshere are now fighting class actions in Australia and America – claiming the global healthcare giant did not investigate proper clinical trials on the possible complications of the mesh. Yet, president of the Australian Association Dr Michael Gannon says only “a minority of women having these kinds of operations have been damaged”.
Device feasibility is still being debatedGannon, an obstetrician who has treated women harmed by the meshes shared, “we seem to have forgotten how many women have been helped by these operations over the journey in acknowledging that some may have been harmed by it.” The mesh, when used for hernia operations, is vastly more successful. Urogynaecology Society of Australia director, Jenny King echoes in agreement.
According to one expert, Prof Carl Heneghan, manufacturers have to provide little evidence before their product is clinically approved and made available on the NHS. "The regulatory body... doesn't even look at the device," he added.Upon hearing that the device may be banned in Australia, King said it was “hysterical” because they had positive outcomes for women who were unable to undergo other major surgeries. Instead, she said, doctors should be more discriminatory in their use – avoiding operations on younger and healthy women. King herself said she was “timid” in her use, which she regretted sometimes as it meant some women had to undergo multiple surgeries.
Yet, a study published in the JAMA Surgery journal in 2015 discovered that one in 30 women, who have the mesh inserted, need surgery less than 10 years later to have it removed or replaced. This is compounded by the fact that since the mesh is designed to stay in the body forever, tissue and blood vessels grow around it, meaning multiple surgeries are required anyway to remove it, piece by piece.
Gannon believes that the media play a role in exaggerating the problem. Whilst acknowledging his sympathy for the women for whom the mesh has not worked, he iterated that “stories like theirs are highly charged, emotional stories that make for good copy and its inevitable the media would report them. It’s less interesting to talk to a woman who had an operation five years ago and their lives have been made a whole lot better.”
However, CEO of the Health Issues Centre in Australia, Danny Vadasz begs to differ, claiming this is “the wrong way to look at it”. Citing the example of thalidomide, which was prescribed to pregnant women to treat insomnia and morning sickness, but caused severe deformities in the babies born to these women remarked, “no one said, ‘Oh yes, but hundreds of thousands of women got a good night’s sleep on the drug – and that outweighs the harm’.” Concern about the device continues to grow; device classified as “high-risk”The US Food and Drug Administration (FDA) has reclassified the device as “high risk” – putting forward justification that it is not more effective than alternative treatments; and that complications from it are not rare. In fact, Johnson & Johnson’s parent company, Ethicon has altogether pulled the device from the market in America.
Although the manufacturer responded that they have acted “ethically and responsibly” in developing and selling the implant, internal company emails that were disclosed during Ebaugh’s trial show that this was not, in fact, the case. For example, when it became evident that the success rates for the device were “way below” those of its predecessors, senior executives suggested, “stop[ping] for a while such publications that could compromise the future”.
Additionally, many male executives allegedly exhibited blasé recklessness saying that sex with a patient with mesh complications must be “like screwing a wire brush”. They also launched an aggressive marketing campaign, downplayed the lack of controlled trials and tried to stop French health authorities publishing a report warning against the device.
During a trial for two Australian women who had suffered debilitating complications, the managing director of Johnson & Johnson Medical in Australia, Gavin Fox-Smith, was asked if he was personally affected by the women’s statements, Fox-Smith said, “our job is to make patients better. So, for me it’s really tough, it’s nowhere near as tough as what the patients have to deal with.”
Vadesz says, “to me, it’s a part of this larger, poor attitude towards women and not explaining the risks to them so they can give informed consent to procedures.” MIMShttps://today.mims.com/complications-ensue-behind-the-vaginal-mesh-scare
-
Pioneering hidden device could spare millions of women from the 'stigma of incontinence'
Oct 14, 2017 | The Daily Mail
By Jo Macfarlane
· Stress incontinence is caused by a weakening of the pelvic-floor muscles
· May affect three million women in UK, many too embarrassed to seek help
· But a new pessary launched this weekend claims to reduce the risk of leaks
A pioneering hidden device could help millions of women who suffer in silence with an embarrassing condition linked to childbirth.
Stress incontinence is caused by a weakening of the pelvic-floor muscles which control the flow of urine, and can lead to involuntary leaks during exercise such as running or yoga, or while coughing and sneezing.
It may affect three million women in the UK, many of them too embarrassed to seek help. Actresses Kate Winslet and Loose Women host Nadia Sawalha have admitted to suffering in an effort to raise awareness.
Controversy over a surgical solution, the vaginal mesh implant, which has left a significant number of patients with traumatic complications, has also deterred women from speaking to their GP.
But a new pessary being launched this weekend at the Scottish Fitness Expo claims to reduce the risk of leaks while allowing women to manage the problem themselves at home.
The reusable rubber device, called URESTA, is designed in a bell shape which, when inserted, supports the bladder muscles and prevents urine escaping. It is washable and can be used all day, including during activities such as aerobics.
At the moment, women who choose not to talk to their GP rely on buying incontinence pads from the supermarket, which can cost up to £300 a year.
The URESTA was designed by Canadian urogynaecologist Scott Farrell and has been used by 10,000 women in Canada.
Dr Farrell made the prototype out of plasticine from his daughter’s toy box. He said: ‘I had a patient a few years ago who was a bagpipe-player who leaked when she played. The pessary stopped it and she was able to continue in competition.
‘Another patient wanted to climb Mount Everest. She got to base camp and was very happy.’
The condition is linked to childbirth, but can also be caused by pressure on the bladder muscles caused by obesity or pregnancy. Neurological illnesses such as MS and Parkinson’s can also affect bladder function.
There are other pessaries on the market, but these are generally only for more serious problems such as pelvic prolapse.
There are also surgical options using plastic mesh or tape to support the bladder, but this has led in some cases to complications such as pain, organ removal and psychological problems.
A starter pack of three sizes of pessary is on the MediPlus website for £130. The firm has applied for the product to be made available on the NHS.
One British woman, 35, who did not want to be named, developed stress incontinence after the birth of her daughter, now six.
She said: ‘Since having the pessary, it’s given me the freedom to get back into keeping fit and doing physical activities with my daughter, without the worry of any embarrassing accidents.’
Consultant urogynaecologist Wael Agur, from NHS Ayrshire and Arran, said he had given the pessary to several patients.
‘It can take five to six years from the onset of incontinence to a woman talking to a professional because of the stigma of the condition. Many women also don’t want to go down the surgical route, put off by the problems associated with the mesh.
‘The pessary involves self-management, which also saves patients from clogging up the physiotherapy route.’
http://www.dailymail.co.uk/health/article-4980824/Device-spare-women-stigma-incontinence.html
-
Oct 14, 2017 | Lawyers and Settlements
By Gordon Gibb
New Orleans, LAA recent hernia mesh lawsuit was filed at the end of September in Louisiana by a plaintiff who underwent surgical repair for a hernia a year ago this month, only to experience surgical mesh side effects that necessitated revision surgery just six months later. The Bard Ventralex ST Hernia Mesh, manufactured by C.R. Bard (Bard) and Davol Inc. (Davol), is alleged to have left plaintiff Richard Stipelcovich in “excruciating” abdominal pain.
Abdominal mesh has been often in the news over allegations of surgical mesh complications and other surgical mesh side effects. In May of last year, Johnson & Johnson’s Ethicon unit withdrew its Ethicon Physiomesh from the market due to numerous reports of complications. It should be noted that the exit of Physiomesh was not, technically a recall. That said, it has been reported that Ethicon has no intention of returning Physiomesh to the market any time soon, if at all.
In his surgical mesh side effects lawsuit filed against C.R. Bard and Davol, Stipelcovich alleges the Ventralex mesh inserted into his abdomen for his hernia repair in October, 2016 has numerous defects that carries the potential to abrade tissue and cause painful and permanent consequences. Ultimately, Stipelcovich asserts the Bard Ventralex Hernia Mesh failed to repair his hernia, according to his hernia patch lawsuit.
“Before Plaintiff suffered the injuries complained of herein, Defendants were on notice of numerous bodily injuries caused by [Bard Ventralex], and based thereon, Defendants knew or should have known that the Product caused an unreasonably high rate of infection, extrusion, perforation, chronic pain and/or abscess in people implanted with the Product,” the complaint said.
Stipelcovich and his doctor would not have used Bard Ventralex hernia mesh to repair the plaintiff’s incarcerated umbilical hernia had information and warnings been properly disclosed, according to the complaint.
In Canada, the investigative unit of the CTV Television Network reports that of the 100,000 hernia repairs performed in Canada every year, more than 90 percent utilize abdominal mesh. Complications from abdominal mesh products in general are high, according to CTV’s W5 (09/30/17). And while there are many in the medical community who expound the virtues of surgical mesh, others question its widespread use. In other words, surgical mesh should remain an option that is only employed when it makes sense for the patient.
Dr. John Morrison, who practices in Chatham, Ontario, is sought after for his skills at surgical mesh removal.
“I’ve seen hernia mesh erode into the adjacent tissues, the tissue that’s beside it,” Morrison told W5. He has also seen mesh erode into the spermatic cord, the rectum in female patients with pelvic mesh, “and actually hang out through the anal canal and the patient come (sic) to me thinking they had hemorrhoids. That was from one of these pelvic meshes.” Morrison is quick to point out he is not against surgical mesh, suggesting that surgical mesh should remain an option for some patients.
What he does decry is its widespread use. “I am against the absolute use of mesh in every case. I would much prefer a surgeon to say ‘hey, do we actually need to use mesh in this position? Does this patient require mesh?’” Morrison told W5that he advocates giving patients a choice between mesh, and older techniques where a patient’s own tissues are used for the repair.
Dr. Vladimir Iakovlev, director of Cytopathology at St. Michael’s Hospital in Toronto, has examined over 500 mesh specimens removed from patients experiencing complications.
Iakovlev says the mesh is implanted flat but in the body can fold, and shrink – sometimes up to 50 per cent of their original size, he told W5.
He has seen nerves, blood vessels and scar tissue having grown into the mesh fibers – “like a rebar in concrete,” he said, adding that it makes the mesh difficult to remove.
Iakovlev also said that almost all mesh products move. “Some mesh move just microns, very little, some mesh move all the way through the bowel,” he said, in comments to CTV, adding the polypropylene mesh degrades and becomes brittle over time in the body.It’s important to note that what Iakovlev sees remains a rare occurrence, happening in only a fraction of mesh patients. But it’s enough to worry him, he says.
The Shouldice Hospital in Thornhill, a part of Metropolitan Toronto, is a world-renowned private hospital that specializes in hernia repair and attracts patients from across North America and beyond. Billed as the global leader in hernia repair, Shouldice does not use abdominal mesh in any of their hernia repairs, preferring instead the exclusive use of a patient’s own tissue.
In Louisiana, the hernia patch lawsuit filed late last month is Richard Stipelcovich v. C.R. Bard and Davol, Inc., Case No. 2:17-cv-09656, filed September 26th, 2017 in the US District Court, Eastern District of Louisiana.https://www.lawyersandsettlements.com/articles/mesh-complications/surgical-mesh-lawsuit-hernia-7-22644.html
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested