Preview Newsletter
Ethicon Media Monitoring 10/2/2017
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Vaginal mesh 'disaster' could be 'worse than Thalidomide', experts warn
Sep 30, 2017 | Sky News
By Charlotte Lomas and Aubrey Allegretti
Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history. -
Revealed: Johnson & Johnson's 'irresponsible' actions over vaginal mesh implant
Sep 29, 2017 | The Guardian
By Hannah Devlin
A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices. -
Vaginal mesh scandal: women don’t need body-shaming on top of their pain
Oct 2, 2017 | The Guardian
By Barbara Ellen
The ongoing vaginal mesh implant scandal is a complex affair, with group lawsuits erupting all around the world, including the US, the UK and Australia. -
Mesh implant firm in record £42million damages payout after woman left in 'excruciating pain'
Oct 1, 2017 | Daily Record
Ella Ebaugh, 52, said she will 'suffer for the rest of her life' but Johnson & Johnson said they will appeal the decision. -
In America, mesh victim wins £42m payout. In Scotland, ministers spend just £4500 on inquiry into the scandal
Oct 1, 2017 | Sunday Post
By Marion Scott
And yesterday Neil Findlay, chairman of Holyrood’s health committee, described the £4500 spent on the mesh implant safety review as a “disgraceful pittance.” -
Blog: Increasing claims for injuries caused by TVT vaginal mesh
Oct 2, 2017 | Irish Legal
By Claire McDaid
TVT, tension free vaginal tape, also known as vaginal mesh, was advertised as an innovative new product when it was introduced to the market; a simple procedure that provided an effective solution to bladder prolapse, a condition suffered by many women. -
One in ten women go to hospital for mesh complications, says landmark study, amid anger that patients are not being listened to
Oct 1, 2017 | Wisbech Standard
By Kath Sansom
A landmark study shows one in ten women suffer problems after having the most commonly used mesh operation given to hundreds of patients every year on the NHS. -
Maker of Vaginal Mesh Implant Found to Be Negligent
Sep 30, 2017 | Newser
By Michael Harthorne
Woman wins $57 million lawsuit against Johnson & Johnson -
As lawsuits mount, doctors insist surgical mesh is an important tool
Sep 30, 2017 | CTV
By Elizabeth St. Philip and Avis Favaro
For a common surgical tool, mesh is certainly attracting a lot of controversy. -
Ethicon Responds to Canadian TV Investigation on Mesh
Oct 1, 2017 | Mesh Medical Device Newsdesk
Johnson & Johnson and its Ethicon division that makes medical devices rarely speaks for the record in defense of its pelvic mesh products. -
Welcome October- Media Tsunami Over Mesh Mess
Oct 1, 2017 | Mesh Medical Device Newsdesk
This past month has seen an incredible uptick in the number of mainstream media stories generated on the mesh controversy. Canadian television, Australia, UK, Scotland – all front page stories on the mesh controversy! -
Is the FDA Helping Companies Dodge Liability? Hernia Mesh Litigation Provides a Current Example
Oct 2, 2017 | The Ring of Fire
By KJ McElrath
A disturbing piece of information has come up in the course of current litigation over the Ethicon Physiomesh hernia patch, suggesting that the Food and Drug Administration may be aiding and abetting the Johnson & Johnson subsidiary – whether by design or by accident. -
Austria Just Enforced Burka Ban, and Other News Women Need To Know This Week
Oct 1, 2017 | Vogue
By Mary Wang
... In more evidence that healthcare is skewed against women: Johnson & Johnson introduced a vaginal mesh implant without a clinical trial, and then went on to market it for five years despite knowing its higher rate of failure. -
First Transvaginal Mesh Lawsuit Heading to Trial in Ireland
Oct 2, 2017 | RX Injury Help
By Laurie Villanueva
Courts in the Republic of Ireland are getting ready to convene that nation’s first trial involving transvaginal mesh.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Vaginal mesh 'disaster' could be 'worse than Thalidomide', experts warn
Sep 30, 2017 | Sky News
By Charlotte Lomas and Aubrey Allegretti
Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history.
An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.
Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".
Speaking about the scale of the scandal, he said: "I think this is the worst one that we'll ever see in my lifetime because of the scale of the number of women affected."
More than 75,000 women in England had the procedure - known as TVT - between 2006 and 2016, according to NHS data.
One in 15 have had the implant removed.
The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.
While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.
The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.
Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.
She is now registered disabled, is in chronic pain and survives on benefits.
"I'm not the woman I used to be," she told Sky News. "I feel like a helpless no-hoper. I think I'd be better off dead; I don't want to live like this. I want my old life back."
Professor Heneghan, from the University of Oxford, said Lesley's case is not unique, and warned that the UK is heading for a "major disaster".
"Every young woman I have talked to has not been told about the adverse consequences," he told Sky News.
Professor Heneghan said the NHS was not offering the operation to patients based on "need" but on what manufacturers with a commercial interest wanted.
The mentality, he said, was: "Get people through the system - in and out."
One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.
Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.
David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a "significant" medical case.
Total compensation, he claimed, could "run into the billions of pounds, which would make it the largest medical case in UK history".
A spokesperson for Johnson & Johnson told Sky News implantable mesh was "backed by years of clinical research" and that "Ethicon is confident in its products".
They said the use of pelvic mesh devices is "supported by medical experts around the world".
The spokesperson added: "Ethicon is defending lawsuits concerning the use of our pelvic mesh products.
"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."
http://news.sky.com/story/vaginal-mesh-legal-action-could-be-bigger-than-thalidomide-11060083
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Revealed: Johnson & Johnson's 'irresponsible' actions over vaginal mesh implant
Sep 29, 2017 | The Guardian
By Hannah Devlin
Woman awarded record $57m damages over implant launched with no clinical trial and marketed despite higher failure rate
A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices.
Internal company emails disclosed in a US court case, in which a 51-year-old woman was awarded a record $57m in damages this month, also show that senior executives even briefly considered suppressing unfavourable data that “could compromise the future” of the device.Analysis What does pelvic mesh do and why are women suing over it? – explainerUrogynaecological mesh is used to treat stress incontinence and pelvic organ prolapse – and its use has triggered class actions in the US, UK and Australia
Read more
J&J’s Ethicon unit was found by a US court to be liable for the serious injuries Ella Ebaugh suffered after receiving a mesh implant to treat urinary incontinence. The mother of five said she was left with a mangled urethra, bladder spasms and continual pelvic pain after an unsuccessful procedure that led to three revision surgeries to remove mesh that had cut into her urethra and migrated to her bladder.
But documents submitted to the court show J&J staff had raised concerns about the “spinning of data” in emails and male executives are seen bantering about a suggestion that sex with an earlier patient with mesh complications must be “like screwing a wire brush”.
When it emerged from initial data that the success rates for a new device looked to be “way below” those seen for previous products, Ethicon’s director of sales, Xavier Buchon, suggested in an email “stop[ping] for a while such publications that could compromise the future”.
The J&J implant, used to treat urinary incontinence, was launched in 2006. Despite the early indications of a high failure rate, it was only withdrawn in 2012 after being used in thousands of operations in the US, the UK and Australia. The documents raise uncomfortable questions for the manufacturers of vaginal mesh products, which are the subject of growing controversy.
The implants, which reinforce tissue around the urethra, are widely used to treat incontinence, and for the majority of women the procedure is quick and successful. However, some women have suffered debilitating complications, including severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.
Class action law suits are underway in Australia and the US, where lawyers claim that patients have been exposed to unacceptable risks; in England, NHS data suggests as many as one in fifteen women later requires full or partial removal of the implant.
Ebaugh, whose case was heard in Philadelphia, said that her complications have left her with constant pelvic pain, meaning for example, that although she attended her daughter’s recent wedding, she was unable to enjoy it. “I feel like I’m on fire down there,” she said in an interview with CBS.
The tranche of documents, revealed during the trial, places a spotlight on tensions between Ethicon’s commercial and clinical divisions at the time it launched its “miniature” mesh product, called the TVT-Secur, in 2006.
The company hoped that the new device, which was smaller and required fewer incisions, would reduce complications seen with its earlier devices. But getting to market ahead competitors, who had similar offerings in the pipeline, was described as “priceless” in company documents. It was approved for use without a trial under US and European equivalence rules, which allow this when a new device is similar to existing ones.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, condemned the decision to launch a device before a trial, saying this had “led to direct patient harms”. “It has made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients,” he added.
Prof Bernard Jacquetin, an eminent French gynaecologist whose early study on TVT-Secur had led to misgivings among J&J management, told the Guardian the company had acted “irresponsibly” by launching the device without adaquate evidence.
Ahead of the device’s original launch, Jacquetin was invited to the US to give advice on the new design, but was taken aback when he was presented with a boxed-up product ready for release. Jacquetin and colleagues later carried out a study in 40 patients, which found success rates of 77% two months after surgery, compared to the roughly 85-90% success rate commonly reported for Ethicon’s original TVT mesh device.
On learning that Jacquetin’s results did not look promising (though not referring to the eventual 77% figure), marketing manager, Fabrice Degeneve emailed his superiors to ask: “How should we handle this without compromising the use of this new technique?”
Ethicon’s director of sales, Xavier Buchon, replied: “This is for sure a big concern,” before suggesting withholding results while the company reviewed the patients to be included in the analysis. “No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion,” he added.
In the event, the findings were presented at a major international conference and Jacquetin said he never felt pressure to bury unfavourable results. But he adds: “I was really disappointed. I told many people at Ethicon it was not [a good device].”
In 2012, TVT-Secur was withdrawn from the market, along with three other mesh products. J&J declined to provide exact figures on how many women had received the implants.
In other emails, J&J staff complain of colleagues “constantly spinning data” and of a dangerous blurring of the “lines between commercial and research” divisions. “I am continually amazed and surprised at our need to push back,” wrote Judi Gauld, Ethicon’s former clinical director in Scotland.
Other emails show a blasé attitude to distressing complications. In one, dated from 2003, a surgeon sought advice on treating a patient with a 2cm stretch of mesh poking through her vaginal wall. “Sex is like screwing a wire brush according to her spouse,” the doctor wrote. Martin Weisberg, Ethicon’s medical director, replied: “I’ve never tried the wire brush thing so I won’t comment.”
Following the trial, Ebaugh’s lawyer, Kila Baldwin, said in a statement: “I am pleased the jury recognised the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly.”
Johnson & Johnson said they plan to appeal the verdict. In a statement, the company said: “We believe the evidence in the Ebaugh trial showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems.
“Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.”
https://www.theguardian.com/society/2017/sep/29/revealed-johnson-johnsons-irresponsible-actions-over-vaginal-mesh-implant
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Vaginal mesh scandal: women don’t need body-shaming on top of their pain
Oct 2, 2017 | The Guardian
By Barbara Ellen
The ongoing vaginal mesh implant scandal is a complex affair, with group lawsuits erupting all around the world, including the US, the UK and Australia. Last week, Johnson & Johnson’s Ethicon unit was ordered to pay a record $57m in damages to a woman called Ella Ebaugh. The J&J implant, launched without a clinical trial, is still marketed, often in cases involving traumatic births, years after it was known to cause appalling problems to women such as Ebaugh, including intense pelvic pain and torn bladders and vaginas, leading to agonising sex and incontinence.
While many women don’t have problems with vaginal meshes, those who do suffer horribly.
If that’s not bad enough, emails showed J&J staff bantering about a spouse’s observation that having sex with them was akin to “screwing a wire brush”. A male Ethicon medical director replied: “I’ve never tried the wire brush thing so I won’t comment”. For me, this was one of the points where the red mist descended – it was just the sheer lack of basic human respect shown towards women going through every shade of hell and humiliation, some of them for years on end.
The time factor is an issue in itself. With other types of meshes still being used, questions need to be asked. Why have women taken so long to come forward with problems, while others have been so quickly browbeaten into accepting, first, terrible treatment and advice and then condescension when meshes fail? It seems to me that some of it could be due to the culture of systemic female body-shaming, the only difference being that, this time, the body-shaming is all on the inside.
Most people, especially women, know about “regular” (external) body-shaming – too fat, too thin, too young, too old, too dark, too pale, etc, etc… We all know the drill by now. Throughout her life, the average woman finds herself routinely judged on her outward appearance (and usually found wanting) as surely as a reluctant hound dragged around the ring at Crufts.
Internal body-shaming is different but just as complicated. While some women are naturally modest and reserved about certain parts of their body (vaginas, bladders, bowels), when something goes wrong, this swiftly mutates into intense shame and humiliation. Sadly, too often, this can lead to problems being overlooked and sidelined, with women suffering in silence for much longer than they would with, say, a sore arm or back.
In this context, sexual problems are embarrassing enough, but if symptoms include incontinence women may feel that they’re disgusting and expect others to be disgusted by them too. This is the battered, unsure, despairing self-image and inner monologue that these women would have to carry into consulting rooms, both for the treatment and resulting problems. Adding this psychological dimension, it’s hardly surprising some of the mesh-sufferers haven’t always been in the most assertive of moods when they have been fobbed off, sidelined and patronised about their symptoms.
Of course, in a feminist utopia, it wouldn’t be like this – all women would feel that they could loudly, proudly own, name, examine and fight for every last inch of their bodies. They would realise that it’s nonsensical to feel ashamed of a particular ailment just because it relates to a certain part of their anatomy. In the real world, it doesn’t always work out like this. Nor is it a form of weakness. Some experiences are so horrible that they can effectively disable and muzzle the strongest-minded of women.
I’m not arguing that all women are actively engaged in an old Les Dawson-style sketch, awkwardly miming to each other about their “down-belows”. However, I do wonder how much of this inbuilt shame played a part in the vaginal mesh scandal.
I also wonder, with rising anger, how much their intrinsic sense of embarrassment could be used against vulnerable women – intimidating and silencing them, when they are at their lowest ebbs.
https://www.theguardian.com/commentisfree/2017/oct/01/vaginal-mesh-scandal-women-dont-need-body-shaming
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Mesh implant firm in record £42million damages payout after woman left in 'excruciating pain'
Oct 1, 2017 | Daily Record
Ella Ebaugh, 52, said she will 'suffer for the rest of her life' but Johnson & Johnson said they will appeal the decision.
A mesh implant by Johnson & Johnson was launched without a clinical trial and sold for five years after the company learned of concerns about its failure rate.
Details of concern about the product came out during a US court case last week when 52-year-old Ella Ebaugh was awarded a record £42.million in damages for injuries she sustained after having it fitted.
Documents submitted to the court – which found J&J’s Ethicon unit liable – showed senior executives discussing suppressing data which could “compromise the future” of the device.
Other emails showed staff raising concerns about spinning of data and blurring of lines between commercial and research departments.
Some of the criticism came from Judi Gauld, Ethicon’s former clinical director in Scotland.
She wrote in one email: “I am continually amazed at our need to push back.”
The implant was launched in 2006 but despite the early signs it had a higher failure rate, it was only withdrawn in 2012. It had been used in thousands of operations in the US, UK and Australia.
Ebaugh was one of the patients. She said: ‘I’m in excruciating pain. When I’m standing it hurts, when I’m sitting it hurts. ‘I will suffer for the rest of my life. ‘My urethra is mangled. I feel like I’m on fire, you know, down there.’
Johnson & Johnson say they will appeal the verdict.
They said: “We believe the evidence in the Ebaugh trial showed Ethicon’s devices were properly designed."
http://www.dailyrecord.co.uk/news/health/mesh-implant-firm-record-42million-11268209
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Oct 1, 2017 | Sunday Post
By Marion Scott
THE PUBLIC inquiry into the NHS mesh scandal cost the Scottish Government barely £5000, it has emerged.
And yesterday Neil Findlay, chairman of Holyrood’s health committee, described the £4500 spent on the mesh implant safety review as a “disgraceful pittance.”
The revelation came as a woman in the United States won £42.5m in compensation after being crippled by mesh surgery as awards given to victims in the States climbed above £2 billion.
In Scotland, hundreds of women given the implants were left with life-changing injuries. Some have to use wheelchairs as they can no longer walk.
Campaigners have asked the Scottish Parliament’s public petitions committee to indefinitely suspend the controversial surgical procedures to treat bladder problems and pelvic prolapse. They are also urging Health Secretary Shona Robison to revisit the recent safety review report.
Mr Findlay, a Labour MSP, said: “We’re facing one of the biggest medical scandals in NHS history with hundreds of women in Scotland left crippled with pain, and our Government is so concerned it deemed the inquiry was worth less than they spent hiring a car for Nicola Sturgeon when she spent five days in California in April.
“I’m not in favour of throwing public money about, but is that really what those women’s lives are worth? Scotland was taking the lead in what has become a global medical scandal and we blew it.”
One medical expert, urogynecologist Dr Wael Agur, and two patient representatives resigned from the inquiry in disgust before the report was published in March.
Campaigner Elaine Holmes, of the Scottish Mesh Survivors group, said: “The £4500 is an indication of the significance the Government has given this scandal.”
A Scottish Government spokesperson last night confirmed the £4500 spend, adding: “The Independent Review considered high-quality evidence that was produced according to international guidelines. The review members, who offered a range of experience and expertise, provided their time free of charge.”
https://www.sundaypost.com/fp/in-america-mesh-victim-wins-42m-payout-in-scotland-ministers-spend-just-4500-on-inquiry-into-the-scandal/
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Blog: Increasing claims for injuries caused by TVT vaginal mesh
Oct 2, 2017 | Irish Legal
By Claire McDaid
TVT, tension free vaginal tape, also known as vaginal mesh, was advertised as an innovative new product when it was introduced to the market; a simple procedure that provided an effective solution to bladder prolapse, a condition suffered by many women. However, as the years have passed, it has become clear that a high number of women who underwent surgery to have the mesh inserted have suffered painful and often permanent symptoms.
Increasing number of women pursuing claims for injuries caused by TVT vaginal mesh
TVT is a mesh implant that is inserted into a woman’s vagina to support the bladder. This support many be required after childbirth, a hysterectomy or a pelvic organ prolapse. Childbirth or age can cause a weakening of the ligaments that support the urethra and because of this urine can be unintentionally released when pressure is put on the bladder. This pressure can be as little as coughing, sneezing or laughing. TVT was promoted as a solution to incontinence problems and indeed thousands of women in the UK opted for the TVT procedure to support the bladder; at that time unaware of the severity of the consequences which have since come to light.The side effects vary but most who have had a negative experience report the pain as constant and chronic. Some have had to give up employment or change their once-active lifestyle. Many victims cannot walk or drive for long periods of time. The mesh can cause internal cuts and may eventually protrude, causing harm to the patient and any potential partners.
The mesh was designed to be a permanent solution to bladder prolapse; as a result its removal is a complex procedure. Some patients have underwent numerous surgeries to remove the mesh in pieces. Others have been told that it simply cannot be removed due to its positioning near a nerve. Remedial surgery is not always an option and even in cases where there is a potential surgical solution, there is a high risk of pain and further problems.
The consequences of TVT can be devastating and this was initially recognised in the USA where an action has been taken against the manufacturers of the product, Johnson & Johnson and its subsidiarity, Ethicon. $11.1 million has been paid out to those affected.Similarly, in the UK in the past 18-24 months, actions have been commenced against the NHS and the manufacturer.
Alarmingly, the NHS still prescribes TVT. The body responsible for checking the product, the Medicines and Healthcare Products Regulatory Agency, has stated that the benefits still outweigh the disadvantages. There has been a call to suspend its usage in Scotland and the rest of the UK may follow suit while the extent of the serious consequences is established.
In recent months, we have taken instructions from a number of women who have suffered adverse effects as a result of TVT. If you have undergone this procedure in a hospital in Northern Ireland and are concerned about or suffering from symptoms similar to those mentioned above, please do not hesitate to contact us. Worthingtons has a dedicated team of experienced litigation solicitors that specialise in medical negligence claims and who will gladly provide advice on all aspects of medical negligence claims in Northern Ireland.
http://www.irishlegal.com/8759/blog-increasing-claims-for-injuries-caused-by-tvt-vaginal-mesh/#
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Oct 1, 2017 | Wisbech Standard
By Kath Sansom
Woman wins $57 million lawsuit against Johnson & Johnson
A landmark study shows one in ten women suffer problems after having the most commonly used mesh operation given to hundreds of patients every year on the NHS.
The figure means mesh is high risk, according to a table published by the British Medical Journal, and is equivalent to one woman in every small office suffering, while her nine colleagues are fine.
The study has been published amid growing anger that women were used as “window dressing” in NHS working groups that never looked at the safety of polypropylene plastic used to make the controversial devices.
The latest study by seven British medics, shows one in ten women need a hospital admission for mesh complications.
However, in reality the number suffering will be much higher say campaigners, as it does not include women going back and forth to GPs asking for help with pain or chronic urinary tract infections or women treated in private hospitals.
Kim Keltie, Newcastle University researcher and London mesh removal surgeon Suzy Elneil, led the study, which looked at more than 92,000 women over eight years.
Ms Keltie said: “We estimate 9.8 per cent undergoing mesh insertion for stress urinary incontinence experienced a complication within 30 days or five years. This is likely to be a lower estimate of the true incidence.
“Safety of these procedures is the subject of international debate and scrutiny,” Ms Keltie said, “with court actions against mesh manufacturers in countries, including Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, USA and Venezuela.
“Some manufacturers have withdrawn their products from sale.
“There is uncertainty about the rates of complications in surgery and in the longer term, concern that rates in everyday practice may be higher than previously identified.”
In Scottish Parliament this week MSP Jackson Carlaw said campaigners Elaine Holmes and Olive McIlroy were duped into thinking their voices would be heard when in fact they were used as “window dressing” in a patient safety review which left out vital evidence in the final published report, branded a whitewash.
During the petitions committee hearing, where women from around the world were invited to write to parliament, MSP Neil Findlay said the number of emails from women suffering was so overwhelming it made him want to either cry or smash his computer screen.
Surgeon Wael Agur was among clinicians involved in the mesh working groups but he resigned after an entire chapter written by him was left out of the final Scottish report.
The chapter was in an easy to understand format with tables to illustrate the figures, so that both patients and surgeons could understand the risks of mesh, he said.
However, the chapter was removed and instead the information dropped into another section of the final review, written in such a convoluted style, that even as a surgeon he struggled to understand it, he said.
In addition, mesh reviews focused on advantages like being cheaper, shorter time in theatre, shorter hospital stay, shorter anaesthetic time, shorter recovery time, he added.
They did not focus on disadvantages of a life time of chronic pain, infection and losing sex life. Average time for mesh problems to cut in was 4.5 years, he said.
“Even if the risk is small the stakes are quite high,” he said.
During the petitions committee hearing he called for:
• A public inquiry into mesh.
• A transparent MHRA database so the public can search all reports made about complications of all drugs and medical devices.
HISTORY OF THE MESH WORKING GROUPS:
Made up of clinicians and patients, they were set up in Scotland and England in 2013. But in both countries patient reps resigned because:
• Their views were dismissed.
• They could not discuss safety of the plastic mesh material.
• They were unable to discuss safety of the blind nature of the operation.
• NHS never commissioned funds to look into mesh safety in general yet the final reports say mesh is a safe and effective treatment option.
• Patients in both countries were not invited to meetings for almost a year running up to publication of the final reports in 2017.
GLOBAL UPDATES:
• Scotland - a suspension of mesh was called for in 2014 by former health secretary Alex Neil who branded the mesh implant crisis a “worldwide catastrophe”. He has demanded a global summit into the growing controversy.
• England - MP Owen Smith launched an All Party Parliamentary Group into mesh. A total of 18 mesh complication specialist centres have been set up. None are in Wales, Northern Ireland or Scotland.
• Wales - A working group has been promised by the chief medical officer of Wales, Dr Frank Atherton. Prior to that women were referred back to the MHRA report which says mesh is a safe and effective treatment option.
• Northern Ireland - The Public Health Agency commissioned a workshop for surgeons to consider improved patient care and better consent. A meeting on October 9 will provide feedback. However, there is no local government in Northern Ireland as it collapsed at the start of the year so politically the situation is stagnant.
• In the UK, all surgical mesh is ear marked to become higher risk devices by 2020 under EU regulations. The Government’s health select committee has launched a working group into what will happen to regulations for all medicines and devices under BREXIT.
• In America more than 100,000 women are taking legal action. The states of Washington, Kentucky and California are taking legal action against Johnson and Johnson under consumer protection laws.
• Australia - a senate inquiry began in September 2017 and is likely to last until November. Led by senator Derryn Hinch, he says it is the biggest medical disaster since thalidomide.
• In Canada documentary makers from CTV cover the global mesh misery. Watch on You Tube
• Globally, mesh implant tapes are the most common surgery to treat women’s urinary incontinence with 3.7 million meshes sold worldwide between 2005 and 2013.
• Read latest news and research on Sling The Mesh or Scottish Mesh Survivorswebsite.
NHS ENGLAND STATISTICS:
• In the last decade 1,272 adverse mesh events have been reported to the MHRA.
• A total of 4,848 mesh tapes for incontinence have been removed in England. There are no figures for prolapse mesh removal.
• That means less than a quarter of removals have been reported as an adverse event to the MHRA.
• Of the 1,272 adverse events only 697 reports were made by surgeons.
• 12 members of the public reported organ perforation.
• 14 surgeons reported organ perforation.
http://www.wisbechstandard.co.uk/news/mesh-womens-health-hospital-vagina-scotland-sling-the-mesh-1-5217787
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Maker of Vaginal Mesh Implant Found to Be Negligent
Sep 30, 2017 | Newser
By Michael Harthorne
Woman wins $57 million lawsuit against Johnson & Johnson
Johnson & Johnson must pay a Pennsylvania woman $57 million after internal emails revealed in court it launched a new vaginal mesh implant without a clinical trial, continued to push the implant for five years despite knowing its success rate was "way below" earlier versions, and tried to quash data that "could compromise the future" of the implant, the Guardianreports. “I’m in excruciating pain when I’m standing, it hurts when I’m sitting," Ella Ebaugh tells CBS Philadelphia. The 51-year-old had J&J's vaginal mesh device implanted to treat urinary incontinence. It cut into her urethra and entered her bladder, and she's so far had three surgeries to remove it. Some mesh is still stuck in her urethra. “My urethra is mangled and I will suffer for the rest of my life,” Ebaugh says.
On Thursday, a jury awarded Ebaugh $57 million, finding J&J unit Ethicon was guilty of negligence and making a defective product. The Philadelphia Inquirer notes it was the fifth and largest verdict awarded in a vaginal mesh lawsuit. Internal J&J emails revealed employee concerns about the "spinning of data" and executives making light of a doctor's comments that having sex with a patient suffering vaginal mesh complications was "like screwing a wire brush." Documents show Ethicon was hurrying to get the new implant out, saying beating competitors to market was "priceless." J&J plans to appeal the verdict in the Ebaugh case. It's estimated thousands of women received the Ethicon implant between 2006 and 2012, and class-action lawsuits are underway in the US and Australia.
http://www.newser.com/story/249389/woman-wins-57m-vaginal-mesh-lawsuit.html
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As lawsuits mount, doctors insist surgical mesh is an important tool
Sep 30, 2017 | CTV
By Elizabeth St. Philip and Avis Favaro
For a common surgical tool, mesh is certainly attracting a lot of controversy.
Just ask Chrissy Brajcic. She was a healthy, happily married mom of two boys, with a thriving interior design business.
Today, she is house bound and bed-ridden, battling constant infections and chronic pain after getting a plastic mesh implant to treat a common female disorder.
Four years ago, Chrissy had stress urinary incontinence (SUI) -- trouble controlling urine -- which began after giving birth to her second child.
Her doctor recommended treatment with a mesh sling -- a product made from a long narrow strip of polypropylene, a type of plastic. It is designed like a hammock, to support the urethra -- the tube connecting the bladder to the outside of the body.
He described the operation as simple and low risk, Chrissy said.
But within hours of her mesh surgery, she knew something was wrong.
“The pain got worse, and worse, and worse, and finally it was like my insides were ripping out, I couldn't pee hardly at all,” she told W5.
Chrissy said it took over a year to find a doctor skilled enough to remove the mesh. The implant is designed to be permanent and hers had to be extracted, piece by piece, in a five-hour procedure.
Even when the implant was finally gone, Chrissy said she was still in pain.
“Once they took the mesh out, it caused so much trauma ... my pelvic floor is now collapsing and falling out,” she said.
She has chronic infections and pain from nerve damage that sends her to hospital nearly once a month.
"I can’t walk, I can’t take my kids to the park. Every little thing I do is such a huge ordeal to even get myself out of the house,” she told W5, in tears.
“[I feel] anger that my life was taken away from me and my kids.”
Chrissy has launched a lawsuit for over $5 million against Johnson & Johnson, Ethicon and Gynecare Worldwide -- the makers of the surgical mesh her doctor implanted in her.
She is not alone.
In Canada, there are thousands of women joining class action lawsuits or filing their own cases against the makers of pelvic mesh devices, claiming the products caused irreparable harm.
In the U.S.. patients have filed over 100,000 cases against several companies like CR Bard, AMS, Boston Scientific, Johnson& Johnson and its subsidiary, Ethicon.Mesh history
The lawsuits and controversy are just the latest development in a saga that began over 15 years ago.
The first female pelvic products for SUI came on the market in the 1990s . By the early 2000s, mesh makers had also developed transvaginal kits to treat a condition called pelvic organ prolapse (POP) –where the muscles that hold pelvic organs in place become weak from childbirth or age.
Companies marketed their implants as a quicker and easier way of fixing both conditions. Doctors could perform the procedure in under an hour, using minimally-invasive surgery.
Patients could go home the same day -- a big advantage over traditional repair which used a woman’s own abdominal tissue and involved long surgeries and recoveries.
However, in 2008, the news started to shift.
The U.S. Food and Drug Administration issued a safety warning, indicating that “rare” complications -- including pain, tissue erosion, infection, and painful intercourse -- were associated with transvaginal mesh used to treat SUI and POP.
In Canada, there were similar advisories in 2010 and 2014, with officials stating doctors should inform patients of the risks before they undergo surgery.
In the U.K., injured women are becoming more vocal -- holding protests in front of parliament in London, determined to bring a hidden problem into the public eye.
“There are women in wheelchairs or walking with sticks because of this operation. Others with life-altering chronic pain, on cocktails of high dose medication. Many can no longer work, marriages have broken down and all for a 20-minute, day case operation that was supposed to improve their quality of life,“ said Kath Sansom. She launched Sling the Mesh, an awareness campaign to warn women about possible complications after she suffered severe pain in her legs following her mesh surgery in 2015.
Sansom’s group is calling for investigations to find out how many U.K. women are affected and how the mesh products were approved.
In the meantime, Sansom believes England should suspend the use of all female mesh implants like officials did in Scotland in 2014. Former Scottish health secretary Alex Neil recently described the issue as a “global catastrophe” and is calling for an international summit to examine the issue.
Hernia meshNow, some doctors are starting to question hernia mesh -- a product used in about 100,000 hernia repairs in Canada every year. It is the standard of care, according to most surgical advisory groups.
But Dr. John Morrison questions its widespread use.
“I've seen hernia mesh erode into the adjacent tissues, the tissue that's beside it. I've seen mesh erode into …. the spermatic cord. I've had ... patients with the mesh erode into the rectum and actually hang out through the anal canal," Dr. Morrison told W5 from his clinic in Chatham, Ont.
Dr. Morrison is a surgeon who is performing more mesh removals and receives calls from across Canada from patients desperate for help.
“They feel that nobody will listen to them. And that is the most striking feature of all, that they are getting passed from one professional to another to another," he said.
Twenty-six-year-old Keith Richter is still waiting for his referral to see Dr. Morrison so he can remove his hernia mesh, which was implanted four years ago.
He said the pain prevents him from playing hockey and going skateboarding -- activities he loves. He fears his injury may make him unable to work.
"I just sit on the couch and do nothing I feel useless. I am not a useless kid. I am a very hard worker. And now I am useless. Can't do nothing. It sucks,” he said, wiping away tears. He has joined a class action lawsuit against C R Bard and Bard Canada, the maker of his implant.Mesh under the microscope
While the battle heats up in court, one doctor is studying mesh in the lab to uncover why some patients experience problems.
Dr. Vladimir Iakovlev is the director of Cytopathology at St. Michael’s hospital. He has examined over 500 specimens removed from patients experiencing complications.
The products are implanted flat, but in the body they can fold up and shrink -- sometimes up to 50 per cent of their original size, he said.
His examination confirmed nerves, blood vessels and scar tissue have grown into the mesh fibres – “like a rebar in concrete.” He said this makes the product difficult to remove and can cause pain in some patients.
When he examines a sample under a microscope, he can see that mesh sometimes moves from the site of repair to puncture surrounding tissues like the bowel or the vagina.
"I find that almost all meshes moves. Some mesh move just microns, very little, some mesh move all the way through the bowel,” he said.
These complications happen in only a fraction of patients, he said, but often enough to worry him. He said the polypropylene mesh degrades and becomes brittle over time in the body.
He said we need more studies to understand long-term risks.
The debate over mesh also raises questions about how these mesh products were initially approved.
In most countries, including Canada, new medical devices get quick approvals if they are similar to medical devices already on the market -- a common procedure called “substantial equivalence.”
Critics claim that stricter human testing should be required for all medical devices before they are sold on the open market.
Many patients are demanding registries to track all implanted medical devices so that problems can be identified quickly.
Doctors: Mesh is a valuable tool being malignedAcross North America there are surgeons who specialize in hernias and in female pelvic disorders who steadfastly believe that mesh is an important tool. They say negative press around the world is giving mesh a bad name and scaring patients from a product that might help them.
“If you come to one of our clinics and talk to most of the patients that I see, they're overjoyed and thrilled with the experience that they've had with mesh fixing their problems,” said Dr. Colleen McDermott, a urogynecologist based in Toronto who uses mesh regularly to treat incontinence.
“Unfortunately there's no media coverage about that, right? Because people who are happy don't usually talk about it," she told W5.
One patient she treated “could not leave her house because she was just constantly, just constantly wet and changing pads and changing Depends and undergarments because she was soaked all the time. ... We cured her.“
But not all doctors have the experience or skill to perform these procedures, and Dr. McDermott wonders if this is partially to blame for complications some patients are experiencing worldwide.
In the early 2000s, "the companies that were producing these devices were targeting the generalists to do them and inviting them down to do these 3 or 4 day courses somewhere nice and learn how to do them. And then these physicians were going back to their practice and doing a lot of them because they’re quick, can have an easy patient turnover, usually patients go home the same day,” said Dr. McDermott, who received three years of specialized training to implant mesh.
“The problem is that you can't learn how to do these procedures in 4 days.”
Dr. David Urbach, surgeon‐in‐chief at Women's College Hospital, said he uses mesh in virtually all hernia repairs.
He believes complications for pain and other problems are rare – one to two per cent. But with so many hernia mesh repairs done every year, it means about 1,000 to 2,000 people could end up with complications and chronic pain.
“That may seem like a huge problem, and it is a problem to people who are personally affected, but it’s really a consequence of the fact that this is such a common procedure, even if the risk of severe problems is quite low,” he explained.
“No one's arguing that hernia repair is perfect, or that mesh repairs are perfect, but we think on balance, that the risks of using mesh repairs are outweighed by the benefits of mesh repairs.”
He and Dr. McDermott stressed the need for informed consent so patients are made well aware of the risks as well as the benefits.
McDermott spends 45 minutes reviewing options other than mesh -- like laser therapy or physiotherapy. Though she said often these treatments can cost thousands of dollars and may be out of reach for many patients.
She is also very careful not to offer mesh to patients who have a higher risk of complication -- such as women with fibromyalgia, autoimmune diseases or any history of chronic pain.
Questions remainThe Canadian Institute for Health Information data shows that in 2016, 972 people had pelvic mesh removed -- that’s almost three removals a day.
Considering these are permanent devices, the removal rates beg research into why.
Dr. Morrison is removing several a month. He wonders if mesh is offered too often for hernia repair. There are studies that suggest that younger patients and smokers are at higher risk for post-operative pain.
He also said patients can explore alternatives like getting hernias repaired using their own tissue. The Shouldice Hospital in Thornhill, Ont.,which specializes in hernia repairs, does not use mesh -- with studies showing low complication rates and low hernia recurrences.
"I am not against mesh. 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?’ … It may save them major grief years down the road,” Dr. Morrison said.
The numbersThere are some 25,000 surgeries to treat stress urinary incontinence done annually in Canada; about 90 per cent with meshThere are approximately 100,000 hernia repairs in Canada, over 90 per cent with meshStudies on mesh complications have been quite mixed -- ranging from 1 to 2 per cent for SUI to 15 percent and higher for POP.
LawsuitsIn the U.S. there have been several large settlements in female pelvic mesh lawsuits. Some woman in Canada have settled with mesh makers quietly. The exact terms of settlements were not publicly disclosed.
In 2016 Bard Canada, the makers of Avaulta, Align, and Adjust brands of transvaginal mesh, agreed to pay some $2.4 million to settle claims against three products: Avaulta, Align, and Adjust. There were 30 eligible Primary Claimants. After legal costs they received about $60,000 dollars in compensation.
More resourcesCANADIAN UROLOGICAL ASSOCIATION POSITION STATEMENT
STRESS URINARY INCONTINENCE (SUI)
In 2016, the Canadian Urological Association issued a position statement stating that the medical literature supports the use of mesh sling to treat SUI and that complications rates are low. However, surgeons performing these procedures should be well trained and be able to deal with complications should they arise. Also, patients should be told of the risk and benefits before they consent to surgery.
PELVIC ORGAN PROLAPSE (POP)
The Canadian Urological Association says the medical literature does not support the routine use of transvaginal mesh for prolapse repair.
It is a position supported by the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology and the American College of Obstetricians and Gynecologists.
However, the American Urogynecologic Society UAS stresses there is an important role for the selective use of mesh for POP.
FDA
Since the federal Food and Drug Administration updated their warning in 2011, surgical mesh used for POP repair has been reclassified as a high risk device and one that requires more stringent approval than before.
AUSTRALIA
Australia is looking at Reclassification of all implantable surgical mesh medical devices from a Class IIb (medium to high risk) to Class III (high risk) to align itself with European medical device regulations.
http://www.ctvnews.ca/w5/as-lawsuits-mount-doctors-insist-surgical-mesh-is-an-important-tool-1.3610891
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Ethicon Responds to Canadian TV Investigation on Mesh
Oct 1, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 30, 2017 ~ Johnson & Johnson and its Ethicon division that makes medical devices rarely speaks for the record in defense of its pelvic mesh products.
However, the healthcare giant is speaking about a Canadian Television report that criticizes the company for its family of polypropylene (PP) pelvic and hernia meshes. CTV, Canadian Television and its W5 unit, continues its close-up look at the pelvic mesh controversy.
After producing similar stories in 2013 and again in 2016 (See coverage here), Avis Favaro, Medical Correspondent and producer Elizabeth Dr. Philip has produced Mesh Misery, a two-part investigation on mesh usage in Canada.In Part One, Favaro talks to mother of two, Chrissy Brajcic. Within hours of her surgical implant of a polypropylene (PP) plastic mesh sling, she knew something was wrong. The pain got worse and worse and soon she couldn’t urinate at all. After more than one year, it took a surgeon five hours to extract pieces of mesh from her pelvis. Brajcic continues to endure chronic infections that have her hospitalized almost monthly, as well as pain from nerve damage.
Being sold on the device, Brajcic was told the “problem mesh” had been taken off the market, this was a “different” mesh, not the one the subject of many lawsuits she asked about.
She is one of thousands of women in Canada who have filed product liability lawsuits against Ethicon, the Johnson & Johnson (J&J) subsidiary that makes the mesh implants. More than 120,000 lawsuits have been filed against seven mesh makers in the states (55,500 against J&J), as well as thousands around the globe.
The same questions that surround PP pelvic mesh are being asked of the PP hernia mesh that is used in nearly a million surgeries a year.
Patient Keith Richter, 26-year-old says he “can’t do s***” after his hernia implant with a PP mesh made by C.R. Bard, he tells Favaro as he tears up.
The Canadian Urological Association still supports the use of mesh to treat SUI but not pelvic organ prolapse (POP), except in some circumstances. Many physicians continue to believe that PP pelvic and hernia mesh does not cause pain and that the complication rate is 1-2%. Others say the complication rate can range as high as 30%.
Dr. John Morrison of Chatham, Ontario, Canada is a surgeon who believes in patients in pain. He is interviewed by CTV.
“They feel nobody will listen to them, thay are passed from one professional to another,” he says he hears constantly. He’s seen mesh erode into neighboring tissue, the spermatic cord, vas deferens, erode into the rectum, for example, where it can nick the bowel and cause deadly sepsis.
Dr. Vladamir Iakovlev, of St. Michaels Hospital is the director of Cytopathology. He was also an expert in the case of Egneyhem v. Boston Scientific in Miami where he showed jurors some specimens under the electron microscope that he has removed from patients experiencing complications. More than half of the specimens are bunched up, and harden, however in some patients it does not. No one knows why.
Mesh degrades, becomes brittle, and can migrate. Dr. Iakovlev says, and he believes a study is needed to follow patients for at least ten years to get the true complication rate.
Dr Colleen McDonald, a urogynecologist from Toronto, implants and removes mesh. She would have mesh, she tells Favaro.
In her only criticism, she says the companies producing these devices were targeting the generalist doctors and inviting them to do 3-4 day courses to learn how to implant mesh. You can’t learn that in four days, she says. It’s given mesh a bad name. In the right hands, mesh can be used successfully, she says.
Here are Parts 1 & 2 of CTV’s Mesh Misery.Stats from Canada: Approximately 25,000 surgeries to treat stress urinary incontinence every year in Canada, 90% with mesh100,000 hernia repairs with over 90% done with mesh.Statement from Ethicon
In response to W5’s investigation, here is a statement issued Saturday, September 30, from Ethicon, a subsidiary of Johnson & Johnson:“We empathize with all women suffering from stress urinary incontinence, a condition that can be serious and debilitating. Pelvic mesh devices have helped millions of women suffering from stress urinary incontinence. There are limited treatment choices for women with stress urinary incontinence seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment. Ethicon is confident in the positive impact our pelvic mesh products have had on the vast majority of women who have chosen this treatment option. In addition, the evidence shows that Ethicon acted appropriately and responsibly in the research, development and marketing of its TVT device for the treatment of stress urinary incontinence.”
Despite repeated requests, C. R. Bard, Inc. did not provide comment.
https://www.meshmedicaldevicenewsdesk.com/ethicon-responds-canadian-tv-investigation-mesh/
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Welcome October- Media Tsunami Over Mesh Mess
Oct 1, 2017 | Mesh Medical Device Newsdesk
Welcome October 2017 to Mesh Medical Device News Desk~
This past month has seen an incredible uptick in the number of mainstream media stories generated on the mesh controversy. Canadian television, Australia, UK, Scotland – all front page stories on the mesh controversy!
Calls from media coming into Mesh News Desk (Mesh Medical Device News Desk) like never before in its entire 6 year history and reporters are really interested in the nuts and bolts of this story.
Finally!!!!
Thank you if you have worked with your local media to raise awareness on this important issue! Thank you, thank you!
The media coverage is not good news for the manufacturers of polypropylene mesh who continue to insist that adverse events or complications are very low, while they continue to lose millions in court and have their products judged defective. The truth is estimates on injuries are not known but estimated to be as high as 30%.
It is not good news for the many doctors who cling to the outdated notion that a device that has harmed hundreds of thousands is the “Gold Standard.”
As I write this AUGS, the American Urogynecological Association is preparing to hold its industry-supported annual meeting in Providence, Rhode Island Oct. 3-7. Having attended it last year (and being disinvited after a series of stories) the medical society continues to shun patient presence while highlighting Key Opinion Leaders who head many of the sessions while serving as consultants to industry.
There continues to exist a huge disconnect between actual patient outcomes and the medical societies continued insistence on retropubic and transobturator midurethral slings as a first-line treatment for SUI. Patient presence would help. See AUGS on industry underwriters.
Welcome to lawyer, Sheila Bossier of Bossier and Associates as a new advertiser to Mesh News Desk! Ms. Bossier is one of the few remaining lawyers who is committed to seeing through mesh injuries to trial or settlement, especially considering mesh is still being used and injuries will continue to occur.
Mesh Medical Device News Desk is advertiser-based, and very appreciative of your donations to keep the door open. We are NOT a legal referral service and your name is never shared.
And hernia implanted patients continue to call Mesh News Desk and patient advocate, Bruce Rosenberg at record numbers. Best to text him at 954-701-5094. He may be able to direct you. Information here should not substitute for legal or medical advice from professionals!
If you have a mesh implant please 1) keep your medical records 2) familiarize yourself with the manufacturer and type of mesh you have 3) if you are represented by a law firm, insist on seeing a copy of your case and make sure it has been filed, get a case number. If you are not yet represented, be a wise consumer and negotiate your contract with a law firm. As they say, everything is negotiable!
Mesh News Desk (MND or MMDND) has been covering the issues surrounding pelvic and hernia mesh for more than five years now.
Please enter your search terms in the Search Bar to do research. If you click on the headers such as “Legal” “News” “Medical” you will see stories filed under that topic, more than 1,000 now. Please do not use your last names when you comment! You can also post anonymously, making up a name.Your donations help keep the doors open. Your purchase of BeautyCounter products will help sustain Mesh Medical Device News Desk. Start Shopping here! Thank you.
https://www.meshmedicaldevicenewsdesk.com/welcome-october-media-tsunami-mesh-mess/
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Is the FDA Helping Companies Dodge Liability? Hernia Mesh Litigation Provides a Current Example
Oct 2, 2017 | The Ring of Fire
By KJ McElrath
A disturbing piece of information has come up in the course of current litigation over theEthicon Physiomesh hernia patch, suggesting that the Food and Drug Administration may be aiding and abetting the Johnson & Johnson subsidiary – whether by design or by accident. It is a loophole that Ethicon’s attorneys are attempting to use in order to “prove” that the defendant was not liable for patient injuries – and moreover, allows the corporate recidivist to cast itself in a positive light.
Approximately one year ago, the law firm representing Ethicon sent a letter to plaintiffs’ counsel, accusing them of making “false and misleading statements” about their client’s product. Specifically, what had been referred to by the plaintiffs as a “worldwide recall” was technically a “market withdrawal.” What is the difference – and how might this affect the present cases?
The short answer is that a “recall” is issued when a product has been shown to cause injury. During a recall, safety alerts are issued to consumers. A “market withdrawal” is a voluntary action on part of the company, but does not mean there are any problems with the product – at least, none that the manufacturer will acknowledge. As far as this concerns the Physiomesh, it involves the infamous 510(k) Clearance process, to which our stories refer frequently.
In 2010, Ethicon got FDA approval for the original Physiomesh through the 510(k) program, claiming that the product was “substantially similar” to its predecessor, the Proceed Hernia Patch. Over the next four years, Ethicon received a number of complaints from physicians and patients – but no action was taken. Instead, the company filed a 510(k) application in June 2014 for an “improved” version, the Physiomesh Open. FDA approval was granted four months later.
Meanwhile, reports of injuries kept coming in. Ethicon finally issued a Field Safety Notice in May of 2016, announcing that the company was “voluntarily” taking the product off the market. However, the company refused to take responsibility, stating only that it was “unable at this time to characterize all factors contributing to higher rates [of failure].” It also suggested that surgeons might be at fault, referring to “operative and patient factors.”
That Field Safety Notice and subsequent “Market Withdrawal” was prompted by reports from independent hernia registries in Europe. Significantly, Ethicon did issue product recalls in Europe and Australia, where health authorities issued warnings about the product. However, because it was simply called a “market withdrawal” in the US, the FDA did not issue any warnings – and now, lawyers for Ethicon are claiming this lets their clients off the hook.
This is not the first time the FDA has appeared to be covering for a medical device manufacturer. While there is little doubt that Ethicon will ultimately be held liable for knowingly manufacturing and marketing a defective product, this issue of recalls vs. “market withdrawals” adds more questions about the FDA and whether they are really protecting the public – or corporate interests.
https://trofire.com/2017/09/30/fda-helping-companies-dodge-liability-hernia-mesh-litigation-provides-current-example/
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Austria Just Enforced Burka Ban, and Other News Women Need To Know This Week
Oct 1, 2017 | Vogue
By Mary Wang
Dear women, let's catch you up on all the good and bad news for us this week.
Let's start with the good news:
Yetnebersh Nigussie, a blind human rights lawyer born in Ethiopia, has wonwhat's been called the "alternative Nobel Prize" from Sweden-based Right Livelihood award foundation. Nigussie became an advocate for inclusive education in a country where, according to her, stigma drives 60% of fathers to leave families with disabled children.
Claire Whelan, an 88-year-old nun from Indiana, is now directing her environmental activism to the state's legal battle against solar panels. When the state Senate passed a bill that made solar panels more expensive, Whelan joined a state-wide drive to get more people on board with solar energy. Rely on Whelan to tell us that God has created the sun for a purpose.
But, there was also enough bad news:
Austria has started enforcing its ban on burkas and niqabs. According to the government, mandating women to show their face from the hairline to the chin is about "protecting Austrian values."
In more evidence that healthcare is skewed against women: Johnson & Johnson introduced a vaginal mesh implant without a clinical trial, and then went on to market it for five years despite knowing its higher rate of failure. 51-year-old Ella Ebaugh, who used the mesh to treat urinary incontinence, suffered from a range of symptoms including a mangled urethra, bladder spasms, and continual pelvic pain. Ebaugh took the company to court and was awarded $51 million in damages.
Saudi Arabia has announced that women are finally allowed to drive in the country, though the news was quickly accompanied by a outcry about the things Saudi women are still unable to do on their own, like traveling, getting a divorce, or owning a passport. Saturday Night Live's Michael Che quipped on the show's season premiere that this comes only "years after cars are allowed to drive themselves."
And in case you've missed it:
French-Cuban duo Ibeyi sampled a Michelle Obama speech on a song titled "No Man Is Big Enough for My Arms." The former FLOTUS is heard saying that "the measure of any society is how it treats its women and girls."
Graham Norton confronted Reese Witherspoon with a video alleging that Trump copied his Liberty University commencement speech from Elle Woods, the symbol of female empowerment Witherspoon played in Legally Blonde.
Trump dug out his favorite attack for powerful women and called San Juan mayor Carmen Yulín Cruz "nasty".
A new Louis Bourgeois show opened at MoMA, and according to Vogue.com's Bridget Read, it's a must-see for women of the digital generation.
Julia Louis Dreyfus, our favorite Veep, announced that she has breast cancer. In doing so, she also made a powerful political statement.
A 46-year-old female professor was dragged off of a Southwest flight by three male airport police officers, highlighting the dangers of travel for passengers of color.
We made a list of women-led podcasts that give the dating advice you actually want to hear.
Michelle Obama got real about the women who voted for Trump.
We wondered: Does 9 to 5 hold up as a feminist classic?
Author Claire Messud penned a story for Vogue's October issue about how to protect your daughter from mean girls.
https://www.vogue.com/article/burka-ban-saudi-women-news-women-need-to-know
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First Transvaginal Mesh Lawsuit Heading to Trial in Ireland
Oct 2, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
Courts in the Republic of Ireland are getting ready to convene that nation’s first trial involving transvaginal mesh.
In an interview with thejournal.ie.com, one transvaginal mesh attorney disclosed that she had been contacted by roughly 25 women who experienced “unidentified pain” following implantation of the devices, which are intended to treat women with pelvic organ prolapse and stress urinary incontinence.
“It really is a case of people not knowing what is causing their problems and they are just putting up with it in a real Irish mammy way. They think this is what happens when you have a baby. And some people are just embarrassed to talk about it,” she said.
“Some of the women, the state they’ve been left in, they suffer terrible pain and some are getting addicted to painkillers that they’ve been prescribed.”
Another attorney told thejournal.ie.com that one of his client’s transvaginal mesh lawsuit will be heading to court in the next few months.
“I’m surprised there hasn’t been more of these cases. I suspect there are quite a substantial number of cases in Ireland where people haven’t linked the problems with the device,” the attorney said.Transvaginal Mesh in the U.S.
The U.S. Food & Drug Administration (FDA) warned in 2008 that it had received more than 1,000 reports of serious transvaginal mesh complications during the previous three-year period.
That warning was renewed in July 2011, after the number of injury reports logged by the agency had tripled. The FDA also reversed its opinion that complications related to transvaginal prolapse repair were rare, and questioned whether such procedures offered any additional benefits compared to traditional non-mesh surgery.
Hundreds of thousands of women have since filed transvaginal mesh lawsuits in the U.S. Numerous cases have gone to trial in recent years, with juries delivering verdicts for both plaintiffs and defendants. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.
Most recently, a jury in Philadelphia, Pennsylvania awarded more than $57 million in compensatory and punitive damages to a woman who suffered serious complications following implantation of two TVT mesh devices manufactured by Johnson & Johnson’s Ethicon, Inc. subsidiary.
Other transvaginal mesh manufacturers involved in the U.S. litigation include American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic.
https://www.rxinjuryhelp.com/news/2017/09/29/first-transvaginal-mesh-lawsuit-heading-to-trial-in-ireland/
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