Preview Newsletter
Ethicon Media Monitoring 10/18/2017
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Vaginal mesh implant victims take fight to Westminster
Oct 17, 2017 | BBC
A group of women from Northern Ireland who say they've been left in chronic pain after having vaginal mesh implants are taking their fight to Westminster. -
Mesh implant complication rate higher than official figures
Oct 18, 2017 | Sky News
By Charlotte Lomas-Farley
MPs will debate the risks associated with mesh implants after thousands of women said the device has perforated organs, caused chronic pain and left them unable to work or have sex. -
Labour calls for immediate end to use of vaginal mesh implants
Oct 18, 2017 | The Guardian
By Rowena Mason
Labour has called for an immediate halt to the use of vaginal mesh implants and urged the government to launch an independent inquiry into the “ongoing public health scandal” surrounding the treatment of women for urinary incontinence and pelvic prolapse. -
Labour backs a public inquiry into controversial vaginal mesh implants that have left thousands of women on the brink of suicide as pressure mounts to ban the procedure
Oct 18, 2017 | The Daily Mail
By Alexandra Thompson
Labour is backing a public inquiry into controversial vaginal mesh implants that has left thousands of women depressed, unable to have sex and on the brink of suicide due to their excruciating pain. -
Labour calls for public inquiry into vaginal mesh implants
Oct 18, 2017 | The Independent
By Tom Peck
The party will also call for all use of the products to be suspended while an inquiry takes place -
Journalist Kath Sansom was 'wreck' after vaginal mesh implant
Oct 18, 2017 | Sky News (In Yahoo News)
By Kath Sansom
I set up the support page Sling the Mesh on Facebook two years ago, in June 2015, just 10 weeks after I had a mesh implant to treat incontinence from childbirth. -
Mesh implants: A common procedure with serious risks
Oct 18, 2017 | The Globe and Mail
By Andre Picard
On Wednesday, British parliamentarians will debate if a public inquiry into a common surgical procedure called TVT (transvaginal mesh implant) is needed – the latest victory of an increasingly vocal campaign called "Sling the Mesh." -
Surgical mesh injuries rising, ACC figures show
Oct 18, 2017 | New Zealand Herald
By Amy Wiggins
The number of people who have laid claims with ACC for injuries caused by the use of surgical mesh has continued to climb despite problems with the product being well known, new figures show. -
Pelvic mesh scandal: Northern Ireland victims to have their say at Westminster
Oct 18, 2017 | Belfast Telegraph
By Angela Rainey
A debate on the safety of pelvic mesh implants today at Westminster is being backed by five women from Northern Ireland. -
Calcot woman takes campaign against vaginal mesh implant to Parliament
Oct 18, 2017 | Getreading
By Nathan Hyde
A grandmother from Calcot is calling on the Government to ban a highly controversial medical procedure which has left her in "constant pain". -
Ella Ebaugh on Struggling in Silence
Oct 17, 2017 | Mesh Medical Device Newsdesk
Ella Ebaugh recently survived a grueling five-week trial against Johnson & Johnson over the complications from two of her pelvic mesh implants. Jurors awarded her a record $57 million, the highest jury award so far in the Philadelphia Court of Common Pleas. -
Blockus Mesh Trial Ahead in Philadelphia
Oct 18, 2017 | Mesh Medical Device Newsdesk
Blockus is from Hunlock Creek, Pennsylvania where she lives with her husband Eugene. The defendant corporation are Ethicon, and C.R. Bard Inc. as well as Sofradim Production SAS, Tissue Science Laboratories Limited, Secant Medical and Prodesco, Inc. The trial was moved from June 19. 1307-00707 Judge Arnold New, Court of Common Pleas Philadelphia County. -
Judge Overseeing Pennsylvania Transvaginal Mesh Lawsuits Allows Plaintiffs to Conduct Additional Ethicon Depositions
Oct 17, 2017 | RX Injury Help (blog)
By Sandy Liebhard
The Pennsylvania judge overseeing dozens of transvaginal mesh lawsuits in the Philadelphia Court of Common Pleas will allow plaintiffs to conduct limited depositions of a corporate designee and the strategic sourcing manager for Ethicon, Inc.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Vaginal mesh implant victims take fight to Westminster
Oct 17, 2017 | BBC
A group of women from Northern Ireland who say they've been left in chronic pain after having vaginal mesh implants are taking their fight to Westminster.
They'll join women from across the UK as it will be debated in Parliament for the first time.
The women had mesh or tape implants which are devices used to treat organ prolapse and urinary incontinence.
They will hear MPs discuss the procedure on Wednesday.
While it's a successful operation in a majority of cases, for others it has gone badly wrong leading to persistent pain, sexual problems or erosion of the mesh inside their bodies.
The Labour Party is expected to announce its backing for a public inquiry into the use of surgical mesh implants, and will also call for use of the products to be stopped in England immediately.
Jackie Harvey, from Banbridge in County Down, is among the local women who have travelled from Belfast to London for the debate.
She says they are backing calls for an inquiry - and for a ban.'Chronic pain'
"We would like a public inquiry because we believe that many women have been going to their surgeons and have been told that mesh is not harming them.
"We don't believe this because it has happened to us.
We can say happily that we have been harmed by this stuff and we want the true scale of this scandal to come out."
Jackie now runs an online forum to support those affected which has around 250 members.
It's not clear how many people in Northern Ireland are affected by the issue.
The BBC has used Freedom of Information legislation to obtain this detail but figures are patchy due to the way operations have been recorded across the health trusts.
http://www.bbc.com/news/uk-northern-ireland-41658370
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Mesh implant complication rate higher than official figures
Oct 18, 2017 | Sky News
By Charlotte Lomas-Farley
MPs will debate the risks associated with mesh implants after thousands of women said the device has perforated organs, caused chronic pain and left them unable to work or have sex.
The Labour Party has announced its backing a call for a public inquiry into the mesh procedures and called for products to be stopped immediately in England while this is ongoing.
Around 15,000 women every year have a vaginal mesh procedure which is used to treat stress urinary incontinence and involves inserting a plastic tape through the vagina and around the urethra to support the bladder.
The official complication rate for mesh procedures is 1-3% yet latest hospital figures obtained by Sky News show that it's higher, with almost 10% of women suffering adverse effects.
Urogynaecologist Sohier Elneil says one of the key problems with mesh is that it can change once inside the body. It can become brittle, erode and slice through organs like the bladder.
:: I was a 'physical wreck' after vaginal mesh implant
"It's a huge problem," Dr Elneil said.
"I think it's bigger than Thalidomide, because the numbers of those affected are much more.
"And if we look at the problem globally then it's worse than the metal-on-metal hips and the PIP scandal as well."
Dr Elneil is one of few surgeons trained to remove mesh implants, a highly dangerous operation as the implants are designed to be permanent.
She says she used to see one or two women a month but now treats up to eight every week.
She said: "In England there's been this feeling that the number of women affected wasn't that great but not everyone was submitting their data, so there was very minimal information to make a decision on.
"Now with the latest reports, quite clearly this is a game changer and the procedure needs to be re-evaluated."
Kath Sansom had a mesh implant fitted to treat mild incontinence caused by childbirth.
After suffering chronic pain, she started a campaign Sling the Mesh to provide support for others and call for the suspension of mesh implants to bring England in line with Scotland, where they were suspended in 2014.
The campaign group now has more than 3,000 members.
She said: "The medical professionals are all very good at denying there's a problem or saying you are a mystery patient.
"There is also an element of misogyny whereby your pain is belittled because, to look at us women, none of us look ill or in pain.
"The damage is hidden.
"This makes it easier to be shuffled off into a corner and ignored."
As Sky News first reported two years ago, for many patients the procedure can be quick and successful but thousands have suffered debilitating conditions, are on daily medication and some now struggle to walk.
But there's another issue Ms Sansom says is rarely discussed - the effect mesh has on a woman's sex life. For hundreds of women they say the pain they suffer makes having sexual intercourse impossible.
She said: "The impact on women is so devastating.
"It's such a personal thing and anyone in a healthy relationship will want an intimate relationship and when that is taken away it robs them of a massive part of being a couple and puts a huge strain on relationships and family life.
"It's so cruel."
NHS England and various clinical bodies, including the Royal College of Obstetricians and Gynaecologists, maintain that, for many patients, mesh is a safe and effective option that greatly helps with conditions which can be distressing for those affected.
They support the view of the official regulator of mesh, the Medicines and Healthcare products and Regulatory Agency (MHRA), which says there's not enough evidence to justify a ban.
The MHRA's director of devices John Wilkinson said: "There is no regulatory reason to take the product off the market because if it is used in the right circumstances with the right patients appropriately consented and aware of the risks then we have no evidence that the product should be taken off the market."
Vaginal mesh implants are, however, the subject of huge litigation. Sky News has learnt that across the world more than 55,000 women are suing one manufacturer of mesh, Johnson and Johnson.
In the UK, pressure is also mounting, with 400 women taking legal action against the pharmaceutical giant in what lawyers say could become the biggest medical case in UK history.
In a statement, Ethicon, the sister company of Johnson and Johnson which makes mesh products in the UK, said: "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.
"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/mesh-implant-problem-bigger-than-thalidomide-11086074
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Labour calls for immediate end to use of vaginal mesh implants
Oct 18, 2017 | The Guardian
By Rowena Mason
Labour has called for an immediate halt to the use of vaginal mesh implants and urged the government to launch an independent inquiry into the “ongoing public health scandal” surrounding the treatment of women for urinary incontinence and pelvic prolapse.
Sharon Hodgson, the shadow public health minister, said the government must stop allowing the use of mesh implants before a debate in parliament about their safety, after reports that some women have suffered debilitating complications including perforated organs and chronic pain.
The National Institute for Health and Care Excellence (Nice) is due to publish updated guidance for the use of mesh implants in January, after NHS England said in a report in July that the treatment for urinary incontinence and prolapse “is a safe option for women”.Guardian Today: the headlines, the analysis, the debate - sent direct to you
Read more
However, since then further evidence has emerged about apparently high rates of complications, and the issue is gaining political momentum. The Guardian revealed in August that thousands of women have undergone surgery to have vaginal mesh implants removed during the past decade, suggesting that about one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted due to complications.
Hodgson said the issue had become a “public health scandal” as mesh implants have left some women in permanent pain, unable to walk and unable to work.
“This is an ongoing public health scandal and the government need to do much more to support those affected,” she said. “Mesh implants should be taken off the market now until we know more about the threat they pose to women’s safety.
“The government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.
“Labour is calling for a full inquiry to uncover the extent of the harm done by mesh implants so we can be sure that this never happens again.”
However, some leading gynaecologists have warned that a ban would risk depriving women of the option of a treatment that, for incontinence at least, has been shown to be effective.
The debate in Westminster Hall has been called by the Labour MP Emma Hardy and the issue has also been repeatedly raised by Owen Smith, a shadow cabinet minister, who chairs the all-party parliamentary group on surgical mesh implants.
Hardy said her email inbox has been filling up with people telling her their horrific stories after having mesh implanted.
“I was first alerted to the issue of mesh complications after a constituent contacted me who had been suffering in silence for years. I hope that the government will take action and heed Labour’s call for a public inquiry into the use of mesh,” she said.
Smith also said mesh injury was “one of the worst medical issues” he had come across as an MP.
“Since working with Sling the Mesh campaign, I have been contacted by
countless women from right across the UK who have shared their heartbreaking
stories of their suffering following mesh surgery. The government must immediately review all mesh surgery and suspend the use of mesh until more is known about its risks,” he said.Kath Sansom, a campaigner at Sling The Mesh, said: “People are waking up to the global scandal that is surgical mesh implants and at last it is on the political agenda at Westminster.”
Last week, the health minister Jackie Doyle-Price told MPs she was aware women had suffered complications, but added that it was “equally the case that many women also experience considerable relief from symptoms”. Doyle-Price said: “I think it’s very important that the work that Nice are doing should be allowed to be undertaken so that we can actually make a very clear view of this.”
Sohier Elneil, a consultant urogynaecological surgeon at University College Hospital, London, is calling for the use of mesh procedures for incontinence and prolapse to be stopped for two years. “The time has come for us to truly revisit everything we know about both these clinical states,” she said. “Clearly, the knowledge we have had to date has been limited both in scope and relevance. A change needs to happen now.”
https://www.theguardian.com/society/2017/oct/18/labour-calls-for-immediate-end-to-use-of-vaginal-mesh-implants
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Oct 18, 2017 | The Daily Mail
By Alexandra Thompson
· Labour is calling for the procedure to be immediately stopped during the inquiry
· Mesh implants' impact will be debated by MPs at Westminster Hall at 9.30am
· More than 800 women are suing the NHS and the implant's manufacturers
· The NHS has been accused of sweeping complications under the carpet
· Mesh manufacturer Johnson & Johnson paid out $57 million last month
Labour is backing a public inquiry into controversial vaginal mesh implants that has left thousands of women depressed, unable to have sex and on the brink of suicide due to their excruciating pain.
The party is also calling for the procedure to be immediately stopped in England while the inquiry is underway.
Labour's backing comes as MPs prepare to discuss the impact of mesh implants in a debate taking place in Westminster Hall at 9.30am today.
More than 800 women are suing the NHS and the implants' manufacturers after complaining of crippling pain in a scandal that has been compared to thalidomide.
The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention.
After previously denying their implants were causing women's discomfort, mesh manufacturer Johnson & Johnson paid out $57 million to a sufferer from Philadelphia last month after a jury found the company to be negligent and its product defective.
Pressure is mounting for a UK ban of the 'gold-standard' treatment for urinary stress incontinence and pelvic organ prolapse.
'A public health scandal'
Sharon Hodgson MP, Labour's Shadow Public Health Minister, said: 'Mesh implants have left women in permanent pain, unable to walk, and unable to work. This is an ongoing public health scandal and the Government need to do much more to support those affected.
'Ministers have said NICE will publish updated guidance for these products but not until January 2018. Mesh implants should be taken off the market now until we know more about the threat they pose to women's safety.
'The Government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.
'Labour is calling for a full inquiry to uncover the extent of the harm done by mesh implants so we can be sure that this never happens again.'
Today's debate was called by Emma Hardy, MP for Kingston upon Hull West and Hessle.
'I'VE BEEN ON THE BRINK OF SUICIDE. MY KIDS KEPT ME GOING'
A mother-of-three has revealed she was on the brink of suicide after suffering agonising pain from a vaginal mesh implant she had fitted.Janette Nelson, 43, from Newtownards, Northern Ireland, said the only think that kept her going was her children, but she still battles guilt every day as she depends on them to help her wash, dress and even catheterise after the procedure left her unable to control her bladder.
The former hairdresser also blames her implant for the breakdown of her relationship as her boyfriend left her when the pain was too severe for her to have sex.
Unable to work, her career has also been destroyed.
'My children lost their mummy'
Ms Nelson had the most common type of mesh, known as TVT, fitted in March 2012 in an attempt to cure her urinary stress incontinence.
She said: ‘Immediately once my tape was fitted I woke up with excruciating pain in my groin; its indescribable.’
Just one week later, Ms Nelson wet herself while out with her children and now relies on her eldest daughter to help her catheterise every day.
Due to the excruciating pain of the mesh, Ms Nelson has been forced to rely on her mother and sister to help her raise her children.
She said: ‘My children lost their mummy. I’ve been on the brink of suicide.
‘My kids kept me going. I was useless as a mum but I’m still their mum. It’s all been about me for the past few years.’
'My boyfriend left me because of it'
As well as affecting her as a parent, Ms Nelson also blames the implant for the loss of her love life and career.
She said: ‘I had a boyfriend when this started but the sex was excruciating, neither of us could cope with it. My boyfriend left me because of it.
‘I used to work as a hairdresser; always on my feet, always very confident, but now I can hardly walk and I can’t control my bladder so I can't work. It’s really knocked my confidence.'
Government rejects a ban
Last month the Government released its three-year investigation into the mesh scandal and rejected calls for a widespread ban on the implants, which can shrink, twist and curl at the edges, leading to nerve damage.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience side effects.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can affect up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Suspended in Scotland
The implants' use has been suspended in Scotland since 2014 pending a safety review, however, hundreds of women are still believed to be having the surgery.
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence. It was dubbed the 'gold-standard' treatment.
Due to it not requiring specialist training to implant, outraged women have since called for tougher regulations in order to conduct such surgery.
More than 10,000 women a year have the procedure. Some 7,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.
http://www.dailymail.co.uk/health/article-4988870/Labour-backs-public-inquiry-vaginal-mesh-implants.html
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Labour calls for public inquiry into vaginal mesh implants
Oct 18, 2017 | The Independent
By Tom Peck
The party will also call for all use of the products to be suspended while an inquiry takes place
Labour is calling for a public inquiry into the use of vaginal mesh implants, and will also call for the use of the controversial products to be halted with immediate effect while the inquiry takes place.
Surgical mesh implants have been used to treat a number of conditions in women, including internal organ prolapse and incontinence, but high numbers of women have begun to come forward claiming the procedures have left them in debilitating pain.
On Wednesday morning, MPs will discuss the impact of mesh implants in a debate called by Emma Hardy, MP for Kingston upon Hull West and Hessle.
Speaking ahead of the debate, Sharon Hodgson MP, Labour’s Shadow Public Health Minister said:
“Mesh implants have left women in permanent pain, unable to walk, and unable to work. This is an ongoing public health scandal and the Government need to do much more to support those affected.
“Ministers have said NICE will publish updated guidance for these products but not until January 2018. Mesh implants should be taken off the market now until we know more about the threat they pose to women’s safety.
“The Government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.
“Labour is calling for a full inquiry to uncover the extent of the harm done by mesh implants so we can be sure that this never happens again.”
https://www.independent.co.uk/news/uk/politics/vaginal-mesh-implants-surgical-mesh-labour-public-inquiry-sharon-hodgson-a8005786.html
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Journalist Kath Sansom was 'wreck' after vaginal mesh implant
Oct 18, 2017 | Sky News (In Yahoo News)
By Kath Sansom
I set up the support page Sling the Mesh on Facebook two years ago, in June 2015, just 10 weeks after I had a mesh implant to treat incontinence from childbirth.
The pain in my legs and feet was so intense, along with burning pains in my vagina - like being cut with a cheese wire - that I knew something was terribly wrong.
When I told my surgeon of the pain I was suffering I was ignored. He told me I must have a slipped disc.
I had walked into the operating theatre as one of the fittest mothers in her 40s you could wish to meet - a keen high board diver, mountain biker and boxer - and emerged a physical wreck.
When I searched online I discovered women worldwide suffering similar problems. All were being ignored, not only by their surgeons but also by the media.
It probably needed a journalist to be mesh injured to provide the final media push needed for the issue to get to Westminster.
That journalist just happened to be me - a mum-of-two living in a small Fenland town more used to writing stories about animal rescues or council planning agendas than being suddenly caught up in what some medical professionals describe as the biggest health scandal of our time.
:: Mesh implant problem 'bigger than Thalidomide'
The mesh fight began in Britain in 2007 with TVT Mum, Meshies United, TVT Info, Welsh Mesh Survivors and Scottish Mesh Survivors - the latter achieving so much with a suspension of the plastic pelvic implants in Scottish Parliament in 2014 and a subsequent independent inquiry into its safety.
Many other groups globally have fought for years too, all with one common goal - to stop others suffering as we have done.
Over and again we have told our stories. That is what we were prepared to do, as it was the only way to make people sit up and take notice, to realise the scale of personal tragedy that mesh can cause when it goes wrong.
Harry Evans, editor of the Sunday Times when the Thalidomide scandal broke in the 60s and 70s, said you must tell a story over and over until people get it. He ran Thalidomide articles every week for months until finally everybody realised what a huge scandal it was.
And so it is with mesh. Globally, men and women injured by both pelvic and hernia mesh implants have told their stories. And finally people get it.
Now the women and men in Sling the Mesh have helped trigger a debate in Parliament and we are calling for mesh procedures to be stopped immediately.
When undergoing this surgery it is Russian roulette as to whether it will be successful or not. We hope that the British government will agree this is a risk not worth taking with a woman's health.
https://uk.news.yahoo.com/journalist-kath-sansom-wreck-vaginal-mesh-implant-014900288.html
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Mesh implants: A common procedure with serious risks
Oct 18, 2017 | The Globe and Mail
By Andre Picard
On Wednesday, British parliamentarians will debate if a public inquiry into a common surgical procedure called TVT (transvaginal mesh implant) is needed – the latest victory of an increasingly vocal campaign called "Sling the Mesh."
Roughly 75,000 British women underwent the surgery – which is common after childbirth – between 2006 and 2016, and more than 800 are suing. Activists want TVT outlawed and compensation for those harmed.
There are similar moves afoot in Scotland, Australia, New Zealand, the United States and Canada – although in North America, most of the action is in the courts, not in the political sphere.
In September, a Pennsylvania woman, Ella Ebaugh, was awarded $57-million (U.S.) in a lawsuit against Ethicon (a subsidiary of Johnson & Johnson). The jury ruled that the mesh maker marketed a product that was defectively designed, inadequately tested and which caused grave harm. Ms. Ebaugh's urethra was shredded by the mesh and she lives with debilitating pain.
Ethicon is appealing the award, but the case has shone a spotlight on an issue that has been long-simmering but has received little media attention.
The exception is CTV medical reporter Avis Favaro, who has followed the story doggedly since the first warnings were issued in 2010, and recently broadcast a hard-hitting W5 documentary entitled Mesh Misery.
TVT is a non-invasive operation used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The mesh procedure has been done since the 1960s, but numbers exploded after 2010, when manufacturers began aggressively marketing their products.
SUI is a condition in which urine leaks when coughing, sneezing, laughing or with exertion. The bladder and urethra are supported by pelvic-floor muscles and these can be weakened by childbirth.
POP is a condition where pelvic organs (uterus, bladder, rectum) bulge from their natural position into the vagina.
In both cases, a mesh can be implanted in the form of a sling to provide extra support.
(Mesh surgery is also done commonly for hernias and there are complications and lawsuits in some of those cases too, but they have not led to the same public outcry.)
The surgeries are often effective, but, for some women, there are dire consequences, such as chronic pain, infections and an inability to have sex or even walk.
Blue-ribbon panels who studied the issue in both Britain and Scotland concluded that TVT can be a legitimate treatment of SUI, but not for POP, except in rare instances.
The experts also highlighted four problems: The procedure has been overused; surgery is often performed by doctors who are inadequately trained; many women were given inadequate information about the benefits and risks; and most of the products were approved without adequate testing or study of long-term impacts.
To make matters worse, the women who were in pain were rarely taken seriously – an all-too-common reality for those with "invisible" chronic pain.
In the CTV documentary, Ms. Favaro featured patients who went from being healthy young moms to being so disabled that they require a wheelchair. One woman likened her pain to being constantly pierced by barbed wire, but couldn't find a surgeon who would remove the mesh. (The mesh, made of pliable plastic, is designed to provide permanent support, but it can sometimes become rigid and pierce the vaginal wall or bladder, or cause chronic inflammation.)
Conditions such as incontinence and prolapse can be anything from embarrassing to painful, so they can't be ignored. There are non-surgical treatments, but for serious cases, surgery is required. That can be done using a mesh device, or with a more invasive technique that can also lead to complications.
In the British press, TVT has been likened to thalidomide, but that is a poor comparison. Many women benefit from mesh surgery after childbirth. If it is done appropriately and properly, complications can be minimized.
In both Britain and Scotland, the formal examinations came up with some practical solutions, notably ensuring patients know the risks, that surgeons be qualified and that better tracking be done to understand the long-term impacts and why some patients suffer so severely.
Canadian women would benefit from a similar exercise in this country.
Whether a broader public inquiry is required for cathartic and compensatory reasons is another matter – a political, not a medical decision.
https://beta.theglobeandmail.com/opinion/mesh-implants-a-common-procedure-with-serious-risks/article36599820/?ref=http://www.theglobeandmail.com&
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Surgical mesh injuries rising, ACC figures show
Oct 18, 2017 | New Zealand Herald
By Amy Wiggins
The number of people who have laid claims with ACC for injuries caused by the use of surgical mesh has continued to climb despite problems with the product being well known, new figures show.
These figures come just a day before surgical mesh patients campaigning for restrictions on its use are to meet with the Ministry of Health over concerns around its use.
ACC figures showed 810 treatment injury claims relating to surgical mesh were made over the 12 fiscal years to June 30 this year. Of those, 640 claims were accepted and 170 declined.
The number of claims increased from 44 in 2007/08 to 85 in 2008/09 and 91 in 2009/10.The number of claims then dipped for two years and started increasing again in 2012/13. The claims count peaked in 2016/17 with more than 150.
ACC had already paid out $13.2 million for surgical-mesh related claims during that period.
As well as more people suffering injuries from the treatment, the rise could in part be explained by media coverage around the issue, the health select committee review and more awareness of treatment injuries, the ACC report stated.
In 2012, it was first revealed surgical mesh that had been the subject of lawsuits overseas was still being implanted in hundreds of New Zealanders. Its use has continued since then.
Medsafe acting group manager Derek Fitzgerald said the Ministry of Health's position remained that the benefits of using mesh outweighed the risks if used by appropriately trained surgeons and in carefully selected patients.
But Carmel Berry, one of the founders of Mesh Down Under, has lived in pain ever since surgical mesh was used to repair a prolapsed uterus in 2004.
Ever since, she has been fighting to make sure other people are spared the agony she faces each day.
But despite an inquiry by the Health Select Committee which released its findings in August last year, Berry says not much has changed.
"Certainly nothing's changed in terms of rising numbers of people making ACC claims for treatment injuries from surgical mesh," she said.
On Friday Berry and other mesh patients will meet with representatives of the Ministry of Health, Medsafe and respective medical colleges to discuss the issues around its use.
Fitzgerald said the Ministry rejected claims little had been done to implement the recommendations.
The select committee made seven recommendations around the use of surgical mesh which included setting up a registry for the use of the product and complications with it; a review informed consent procedures around its use; ensuring the coding for mesh use in clinical notes was consistent; encouraging the use of the adverse events reporting system; ongoing education for surgeons on the use and removal of mesh; and expanding Medsafe's role to assess the quality and safety of medical devices before they could be used in New Zealand.
The registry and making Medsafe responsible for assessing products would be addressed as part of the development of a new comprehensive regulatory regime to regulate therapeutic products in New Zealand which was currently being drafted, he said.
He said meetings had also been held with professional colleges to discuss training and changes to information given to patients, while coding had been discussed with health boards, and adverse event reporting forms had been simplified.
Berry said she was happy mesh was no longer the recommended treatment option for pelvic organ prolapse but was concerned the same issues would be found with synthetic midurethral slings, which were made of mesh and used in women with stress urinary incontinence, in a few years' time.
One American study showed at least 15 per cent of women who had the procedure experienced a serious negative outcome.
Berry believed steps needed to be taken to make sure the risk was more clearly relayed to women so they could make an informed decision on whether to go ahead with the procedure or not.
The Ministry of Health had also asked district health boards to make sure mesh was recorded as part of the description in every surgery where it was used but Berry said that did not appear to be happening in many cases.
Data supplied to her by the Ministry of Health showed only 72 of the 204 sling procedures done between April and July had mesh recorded despite the fact it was a mesh treatment, she said.
"Not much has changed but things are getting worse. We don't know if that's because people are having more surgery with mesh or people are more aware about what the issues are and are speaking out on them."
http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11934446
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Pelvic mesh scandal: Northern Ireland victims to have their say at Westminster
Oct 18, 2017 | Belfast Telegraph
By Angela Rainey
A debate on the safety of pelvic mesh implants today at Westminster is being backed by five women from Northern Ireland.
Jackie Harvey from Banbridge; Paula Cairnduff and Susan McLarnon from Belfast; and Arlene Simmons and Iris Henderson from Larne, are supporting the national campaign, Sling the Mesh.
Together they will unite with women and medical professionals from across the UK at 9.30am to lobby politicians after the debate, calling for a public inquiry into their usage.
The women, who also represent Meshed Up NI, which has more than 300 members, have all been treated with pelvic mesh for common conditions caused by childbirth such a prolapses and urinary incontinence.
Made of polypropylene plastic, the same mesh is also used to repair hernias.
They said the aim was to have the 20-minute procedure outlawed, as it has been in Scotland since 2004, as it causes "life-changing injuries".
Ms Harvey suffered 12 years of pain after having a mesh implant inserted in March 2005 when she was 36, having suffered urinary incontinence after having her second child.
She said she was not made aware of the risks associated before she had the surgery and that eight years later she started to experience extreme pain in her legs, hips and feet, which made walking painful and any form of exercise impossible.
Doctors referred her to an orthopaedic consultant to run tests on her bones, as well as a rheumatologist who confirmed that she did not have arthritis.
Then, after reading an article about the Sling the Mesh campaign, Ms Harvey (49) said she had a "lightbulb" moment and realised it was the implant that was the problem.
She was referred to a gynaecologist who said they could find nothing wrong, but Ms Harvey was unconvinced and so sought a private second opinion in England.
She underwent a scan in London which found her mesh was wrongly positioned, then paid £8,000 to have it removed in March earlier this year at a hospital in Oxford.
Ms Harvey said although she was still in pain, it brought her "immediate relief".
"I was tired of feeling ill and exhausted," she said.
"I had no quality of life due to the pain. I couldn't sit in a restaurant or stand for very long, so I just stayed in.
"The problem was there are no surgeons here that are qualified to remove the implants, which embed after six weeks then corrode into organs like the bowel, bladder and vaginal walls, so trying to remove them is like picking chewing gum out your hair.
"They cut through the organs like cheesewire, causing horrendous pain, and I was sick of being looked at as some middle-age hypochondriac whenever I asked for help.
"It has taken us women to come out and talk about personal issues like our vaginas to highlight this - it's really awful but it had to be done.
"Really, I dodged a bullet as my mesh would have embedded in my bladder like so many others.
"It's really awful hearing how these meshes have taken away people's lives, their marriages and jobs and even their internal organs. I still have a lot of anger about what happened to me, but other women have suffered worse."
Concerns regarding the implants can be reported through the yellow card scheme at the Medicines and Healthcare Products Regulatory Agency or the Adverse Incident Centre at Stormont.
http://www.belfasttelegraph.co.uk/news/pelvic-mesh-scandal-northern-ireland-victims-to-have-their-say-at-westminster-36236700.html
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Calcot woman takes campaign against vaginal mesh implant to Parliament
Oct 18, 2017 | Getreading
By Nathan Hyde
A grandmother from Calcot is calling on the Government to ban a highly controversial medical procedure which has left her in "constant pain".
Lynne Sharman, 62, and a group of 25 campaigners are heading to Parliament on Wednesday, October 18 to call for pelvic mesh implants to be suspended so a public inquiry into the procedure can be held.
There will be a two-hour debate on the implants and the devastating effects they have had on women across the country at the House of Commons.
The plastic implants are used to treat pelvic organ prolapse and incontinence after childbirth, but they can twist and cut into nearby tissue.
Thousands of women, who are part of the Sling The Mesh campaign, say they suffer with severe pain and have been left unable to walk, work or have sex, since getting the implant.
Ms Sharman said: "They have been called the biggest health disaster of the 21st century.
"They can leave sufferers in chronic pain, with nerves damaged, disabled, incontinent, even wheelchair bound, and many women have as a result lost their husbands, their jobs, and their homes.
"More than 100,000 women have been given mesh implants and tapes in the last decade alone on the NHS and studies say at least one in 10 suffer so that is at least 10,000 women out there with problems.
"Women have been fighting for 10 years to get these mesh operations stopped and finally for the first time we are getting a debate in Westminster - we are really pleased it is happening but also saddened that it has taken this long.
“I am one of the lucky ones – I had the operation in 2011, and had it reversed in two stages. However, I will never get back to the old me, and I am in constant pain.
"My husband now has to perform many of the simple tasks round the house that I can no longer do, and even a simple walk on the beach is a struggle.
"Picking up grandchildren is a definite no no.”
She added: "Many consultants perform the operation, but very few can reverse it. This operation should be stopped until they have a true picture of the failure rate and the possible consequences."
The issue was raised in Parliament in July, when MP Owen Smith said many women will be "deeply disappointed" that the NHS refused to stop using the mesh.
More than 800 women are said to be taking legal action against the NHS and the manufacturers of the implants.
http://www.getreading.co.uk/news/health/calcot-woman-takes-campaign-against-13769627
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Ella Ebaugh on Struggling in Silence
Oct 17, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, October 16, 2017 ~ Ella Ebaugh recently survived a grueling five-week trial against Johnson & Johnson over the complications from two of her pelvic mesh implants. Jurors awarded her a record $57 million, the highest jury award so far in the Philadelphia Court of Common Pleas.
There are more than 130 cases set to be heard in this venue over pelvic mesh, most of them naming defendant Johnson & Johnson and its Ethicon medical device division, all of them claiming the pelvic mesh products are defectively designed. Some meshes have even been removed from the market, but not all, even the ones found to be defective.
In the case of Ebaugh, the TVT-Secur is off the market in a quiet removal by J&J, but the TVT remains sold and implanted in women. It is called by medical societies “The Gold Standard.”
Her case has been appealed by J&J. Ebaugh reminds us here that money does not return a quality of life.
Jurors decided the TVT and TVT-Secur Ebaugh received led to her life-altering and permanent injuries. Ebaugh tells Mesh News Desk that despite the verdict, the suffering goes on.
“I pray and support all my mesh sister’s and their husband that stand by our sides as we suffer every day with these horrific defective mesh devices that were implanted in us to treat what was suppose to be a minimally invasive surgery for stress urinary incontinence.”
“I had 2 mesh devices implanted in 2007 to treat my stress urinary incontinence. Several years later the mesh eroded into my urethra and bladder. I’ve had several surgeries to try and remove the mesh. I suffered various injuries including extensive scarring to my urethra, intrinsic sphincter deficiency, chronic urinary tract infections, excruciating chronic pain, dyspareunia.”
“I have anger towards J&J/Ethicon because we introduced evidence during my 5 week trial that proved J&J/Ethicon intentionally manipulated the literature regarding problems with the mesh and withheld information about complications and injuries from doctors.”
“I suffer with psychological torment, fatigue because I wake up every hour to go to the bathroom, severe depression because of my excruciating pain and the burden to my family, I have no desire to go on, grief knowing I can’t do the things I use to do, anxiety when leaving the house because of having accidents, brain fog and confusion, guilt because I can’t visit family and friends. I use to be very social, not anymore.”
“I say I’m okay even though I’m not it’s just easier that way. This is why I struggle in silence.”
“I have a teenage son that still needs his mom so I keep everything inside so I don’t worry him. I struggle every day to get out of bed. It hurts to sit, it hurts to stand and it hurts to walk this mesh has ruined my life. My urethra is mangled I have bladder spasms, I can’t control my urine flow like most women. Minor daily task takes me all day. I was called fat, ugly and lazy and that hurts. Just because you can’t see my pain doesn’t mean I’m not in pain. I don’t want sympathy or attention I’m just trying to go on so I can see my son graduate.”
“It should be a crime that J&J/Ethicon is allowed to get away with ruining so many lives for their own greed.”
“I had a wonderful team of lawyers who believed in me and a wonderful jury of 12 that unanimously found J&J/Ethicon liable for their defective mesh.”
“I was awarded a large settlement but no amount of money can take away my pain and loss time with my family who I love dearly. I probably won’t see any money in my lifetime because of all the appeals.”
“I just pray that all my mesh sister’s and husbands get their day in court. Nobody should have to endure this excruciating pain for the rest of their lives. If you are lucky enough to get a trial date, be prepared for the defense lawyers to make you out to be the bad guy instead of the victim. I’m so thankful that I had pictures of the mesh in my urethra and bladder because mysteriously my treating doctors didn’t have them. Please don’t let anybody tell you your pain isn’t real. Your pain is real. I see a psychologist who is working with me on finding a new normal which is one day at a time.”
“Please keep fighting because if we don’t the bad guys will win.”
“God Bless and Good Luck my Friends.”
https://www.meshmedicaldevicenewsdesk.com/ella-ebaugh-struggling-silence/
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Blockus Mesh Trial Ahead in Philadelphia
Oct 18, 2017 | Mesh Medical Device Newsdesk
November 6 2017 Patricia Blockus Et al vs Ethicon Women’s Health and Urology.
Blockus is from Hunlock Creek, Pennsylvania where she lives with her husband Eugene. The defendant corporation are Ethicon, and C.R. Bard Inc. as well as Sofradim Production SAS, Tissue Science Laboratories Limited, Secant Medical and Prodesco, Inc. The trial was moved from June 19. 1307-00707 Judge Arnold New, Court of Common Pleas Philadelphia County.
She was implanted with a Prolift pelvic organ prolapse (POP) mesh anda PelviSoft Acellular Collagen BioMesh made by Bard. See Bard here. Bard claims its PelviSoft is highly effective for posterior vaginal wall defects and is “ideal for use in repairing rectocele and cystocele prolapse.” It was developed after Pelvicol another biomesh and is made by C.R. Bard in Covington Georgia. The promotional material does not say where the “natural” mesh is derived but further research finds it is made frm porcine (pig) dermis or skin.
http://m.bardmedical.com/media/3266/PelviSoft%C2%AE%20Brochure.pdfPorcine dermis study, randomized control trial, with 12 month followup. Using a cure definition is anatomic with no pelvic organ prolapse at Stage 2 or greater. 57 patients. Published in Obstetrics and Gynecology January 2013 by Patrick Culligan MD, Division of Urogynecology Atlantic Health System, Morristown, NJ. Patrick.culligan@atlantichealth.org
– https://www.ncbi.nlm.nih.gov/pubmed/23262939?dopt=Abstracthttps://clinicaltrials.gov/ct2/show/NCT00564083
She was implanted with Prolift March 19, 2007 and the PelfiSoft July 28, 2008 both at Gesinger medical Center in Danville, PA to treat pelvic organ prolapse. The implant surgeon is Barbara Plucknett, MD. She underwent one explantation July 28, 2008 by Dr. Mitesh Parekh, MD.
The complaint states negligence, manufacturing defect, failure to warn, defective product, design defect and common law fraud, the first among 16 claims. The Block family asks for unitive damages.
Documents here
https://fjdefile.phila.gov/efsfjd/zk_fjd_public_qry_03.zp_dktrpt_framesThis trial culminates what each side has learned about the other. As a result, the Blockus case is document-heavy. Many of the principals you’ve seen before.
On May 5, 2017, Johnson & Johnson and Ethicon filed motions to preclude the testimony of expert Peggy Pence, Ph.D., Uwe Klings, M.D., Ph.D and Daniel Elliott, M.D.. This was done under Pennsylvania Rule of Evidence 702, known as the Frye Motion for the case it cites Frye v. United States, 293 Ethicon had filed almost idential Frey motions to preclude testimony in the Hammons case against Ethicon.
With Peggy Pence, for example, Pence is a regulatory expert with more than 40 years experience in bringing medical devices to market. Dr. Pence has testified that the Proliftwas misbranded when brought to market because the manufacturer made false and misleading statements.
Prolift actually was marketed by Ethicon prior to having any FDA clearance at all. It was only when Prolift M+ was submitted for FDA clearance did the FDA even know the existence of Prolift. Then andonly then did the FDA issue it clearance to market, three years after it was already being sold!
This information was introduced in the Linda Gross Prolift trial in 2013.
Dr. Uwe Klinge is a biomaterials scientist who collects explanted hernia mesh for a decade and examines their properties. Ethicon does not want him to testify about Ethicon’s purported knowledge and state of mind, about degradation of mesh and particle loss.
Ethicon wants to exclude the testimony of Dr. Daniel Elliott that Prolift is defective and had a duty as a medical device manufacturer to make a safe and effective product.
Blockus will feature the Klinge expert report, Peggy Pence Expert Report, Daniel Elliott expert report. Klosterhalfen foreign body carcinogenesis of surgical meshes. Defense has filed motions to exclude Peggy Pence as it was entered before in Hammons, Carlina and Beltz. Also motions to exclude Klinge as filed in Hammons, Carlino, Engleman and Beltz. Motions to exclude Bruce Rozenszweig as an expert witness. There is a Motion in limine to eliminate the Chevron MSDS and any discussion of Johnson & Johnson shreading of documents pertaining to its transvaginal mesh production. See MND story here. There is a motion to eliminate discussions heard in the Budke death trial and the Linda Gross Prolift trial in New Jersey.
Motion for Summary judgment filed by Ethicon October 6, citing she filed outside of her statute of limitation. Ms Blockus should have been aware of her mesh injury July 2008 and October 2010 and/or should ha ve been aware of the 2008 and 2011 FDA Public Health Notices.
Ms. Blockus said shewas not aware her injuries might be linked to mesh until she saw television commercials after which she filed her lawsuit. “Defendant says “a plaintiff cannot just sit back and wait to see a lawyer television advertisement before filing suit when there is similar, if not more detailed, information from a government source regarding a potential causal connection between a product and certain symptoms that has been accessible and available to the publc for 5 years.”
Between March 2007 and November 2011 she says she experienced ongoing pain and urinary symptoms, four mesh erosions and underwent four surgical procedures to correct the erosions. She also had an additional prolapse device implanted.
Also listed for trial is Hespe v Boston Scientific Trial date certain January 22, 2018
There are 131 records found waiting for trial in this pelvic mesh mass tort in Philadelphia.
Diaz trial date certain April 30 2018 Diaz v Ethicon, Trial date certain for Rubio v Ethicon, Trial date certain Deimler, Hespe Mccormick, Komarnicki v Ethicon.
Hespe v Boston Scientific has a trial date of J anuary 22, 2018.
https://www.meshmedicaldevicenewsdesk.com/blockus-mesh-trial-ahead-philadelphia/
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Oct 17, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
The Pennsylvania judge overseeing dozens of transvaginal mesh lawsuits in the Philadelphia Court of Common Pleas will allow plaintiffs to conduct limited depositions of a corporate designee and the strategic sourcing manager for Ethicon, Inc.
Ethicon is facing more than 100 lawsuits in Philadelphia, all of which were filed on behalf of women who say they suffered serious complications due to the company’s allegedly defective transvaginal mesh products.
On October 13th, Judge Arnold New granted Ethicon’s motion for a protective order blocking additional depositions focusing on its relationship with a materials supplier.
But according to The Legal Intelligencer, he also ruled that plaintiffs could conduct two depositions related to a jurisdictional dispute that was ignited due to the recent U.S. Supreme Court ruling in Bristol-Myers Squibb v. Superior Court of California. That ruling limited plaintiffs to filing suit in jurisdictions where defendants are headquartered or where their injuries are alleged to have occurred.
Ethicon has argued that the High Court’s ruling means that 90 pelvic mesh lawsuits filed by out-of-state plaintiffs must be dismissed from the Pennsylvania mass tort program.
Plaintiffs countered by pointing out that Ethicon obtained plastic mesh materials used in its implants from Secant, a biomaterials supplier based in Bucks County, Pennsylvania.Transvaginal Mesh Litigation
Transvaginal mesh devices are intended to treat women suffering from pelvic organ prolapse and stress urinary incontinence. However, the U.S. Food & Drug Administration (FDA) has warned that such devices may cause serious and life changing complications, including mesh erosion, perforation, scarring and adhesions, chronic pain, infections, and organ damage.
The agency has also warned that complications associated with transvaginal mesh prolapse repair were not rare and expressed concerns that the risks associated with such procedures may not outweigh their benefits.
Four Pennsylvania juries have so far awarded Ethicon transvaginal mesh plaintiffs damages of $2.16 million, $12.5 million, $13.5 million and $20 million. While one jury did rule in favor of Ethicon, the judge overseeing the case recently granted the plaintiff a new damages hearing after finding that the verdict was inconsistent with the evidence.
More than 54,000 women are currently pursuing pelvic mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against Boston Scientific Corp., C.R. Bard, Inc., and other device makers.
Trials in other jurisdictions have produced verdicts for both plaintiffs and defendants. A significant number of cases have also been settled.
https://www.rxinjuryhelp.com/news/2017/10/17/judge-overseeing-pennsylvania-transvaginal-mesh-lawsuits-allows-plaintiffs-to-conduct-additional-ethicon-depositions/
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