Preview Newsletter
Ethicon Media Monitoring 8/11/2017
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Transvaginal Mesh Cases in MDL – Who Is Settling, Who Isn’t
Aug 11, 2017 | Mesh Medical Device Newsdesk
Look at multidistrict litigation for transvaginal mesh cases in the U.S. and specifically the numeric listing of cases found in the Southern District of West Virginia. Which product liability cases remain opened and which are listed as closed? -
The vaginal mesh implant scandal that's left hundreds of women in agony
Aug 10, 2017 | Netdoctor
By Lydia Smith
A plastic net-like medical device, it is used to treat pelvic organ prolapse and incontinence, conditions that commonly occur after childbirth. Between 2007 and 2015, more than 90,000 women in England were treated with a polypropylene material that is inserted into the body as a mesh patch or vaginal tape to repair damaged or weakened tissue. -
Women’s lives have been ruined by vaginal mesh NHS implant
Aug 10, 2017 | Gears Of Biz
By Victoria Ritter
Two women have today revealed how their lives have been destroyed after having a controversial vaginal mesh implant fitted. -
Damning studies showing complication rates of vaginal mesh
Aug 10, 2017 | Gears Of Biz
By Victoria Ritter
The NHS has been accused of ignoring damning studies that show the damage controversial vaginal mesh procedures cause is much higher than the health service is willing to admit. -
Georgia Widow Blames Physiomesh for Husband’s Death
Aug 10, 2017 | The Legal Examiner
By Roopal Luhana
The Ethicon Physiomesh multidistrict litigation continues to grow in the Northern District of Georgia. All federally filed cases were transferred there in June 2017, with District Judge Richard R. Story overseeing the pre-trial proceedings.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Transvaginal Mesh Cases in MDL – Who Is Settling, Who Isn’t
Aug 11, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 10, 2017 ~ Look at multidistrict litigation for transvaginal mesh cases in the U.S. and specifically the numeric listing of cases found in the Southern District of West Virginia. Which product liability cases remain opened and which are listed as closed?
The numbers reveal which company is the last holdout to transvaginal mesh settlements.
MDL.
Also known as multidistrict litigation. Early in 2012, a three-judge panel, the Judicial Panel on Multidistrict Litigation (JPML) , decided that Charleston, WV, the Southern District of WV, should be the home to amass the growing number of transvaginal mesh cases in federal court there. There were only a couple thousand then.
Judge Joseph Goodwin was chosen to be the head of the MDL whose job it was to move the cases through the court as quickly as possible. Amassing cases in one court meant there would be no conflicting lower court rulings that would have to be sorted out. Consistency and efficiency.
No one had any idea the transvaginal mesh MDL would grow this large.
Today, there are nearly 104,000, product liability claims in that court, more then any other mass tort ever amassed in a single court.
Johnson & Johnson leads the way with 38,956 cases filed, followed by Boston Scientific at 25,029; AMS at 21,127; CR Bard at 15,491; Coloplast at 2,610; Cook at 629; and Neomedic at 137.
There have been 320 new cases added to the MDL since June 21, 2017. Ethicon alone added 209 new cases.Which ones are settling?
Among the larger manufacturers, AMS leads the way with 81.6% of its cases listed as closed.
As we know, “Closed” only means its on the road to settlement, it may not be settled yet.
The plaintiff may eventually reject the settlement dollars, but it is still listed as “Closed” while that discussion ensues.
Percentage of cases settled:Coloplast – 91.8%Neomedic – 91%AMS – 81.6%CR Bard – 67.4%
Boston Scientific – 60%Ethicon – 19.8%Cook – 19.5%ETHICON
All of this is to say that among the larger mesh manufacturers, Ethicon ( Johnson & Johnson), CR Bard, AMS (American Medical Systems/Endo) and Boston Scientific, Ethicon is the last to the settlement table and is still choosing instead to face injured plaintiffs in a trial setting.
At this writing, the Ebaugh v. Ethicon trial is underway in the Philadelphia Court of Common Pleas.
That venue plans a succession of pelvic mesh product liability cases, most of them naming Ethicon. It is also the venue J&J/Ethicon would like to see remove 91 cases filed by women who do not live in Pennsylvania, subsequent to a U.S. Supreme Court decision.
See a MND back story here.
Boston Scientific will face a pelvic mesh trial October 30, 2017 in Los Angeles where the issue of counterfeit polypropylene resin smuggled into the U.S. from China will be heard for the first time. Stay tuned.
https://www.meshmedicaldevicenewsdesk.com/transvaginal-mesh-cases-mdl-settling-isnt/
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The vaginal mesh implant scandal that's left hundreds of women in agony
Aug 10, 2017 | Netdoctor
By Lydia Smith
Women have been left physically and psychologically scarred
Until this year, not many people had heard of vaginal mesh implants - let alone the problems associated with them.
A plastic net-like medical device, it is used to treat pelvic organ prolapse and incontinence, conditions that commonly occur after childbirth. Between 2007 and 2015, more than 90,000 women in England were treated with a polypropylene material that is inserted into the body as a mesh patch or vaginal tape to repair damaged or weakened tissue.
It has been sold as a simple, low-risk procedure, but hundreds of women have been left with debilitating pain and unable to walk, work or have sex. Major complications can occur, such as the implant - made from the same material as drinks bottles - shrinking or degrading, cutting through organs and tissue and leading to infection.Lives turned upside down
Women have been left physically and psychologically scarred.
Claire*, now 35, is one of the many women who have had their lives turned upside down by the mesh implant. She suffered a prolapse after the birth of her second daughter and had a hysterectomy and a TVT mesh - trans-vaginal tape - fitted four years ago.
"Since then I have had eight operations to remove mesh that had eroded into my back, my vagina, my bowel and my bladder," she says. "I was on antibiotics on and off for over two years and had infection after infection."
"I was literally unable to leave my house for months as I smelt awful from all the infections. I had to leave my job and my children lost their mum, as I was in so much pain I couldn't even take them to the park."
Claire has since had the mesh fully removed, but still suffers from chronic pain. She also suffered another prolapse. "I should be having another op in the next few months to try and fix this but they have no idea how it will work out as I'm full of scar tissue," she says.
The NHS puts the risk of complications with these operations at 1 to 3%. But a 2012 Government report found 15% of vaginal mesh procedures resulted in complications, although it isn't clear how many patients had problems before the procedure.
"Risk of possible complications include mesh erosion, infection and bleeding, and the strain of future pregnancies may cause the prolapse to recur," says Godze Zorlu, Royal College of Obstetricians and Gynaecologists. "Pain and dyspareunia - painful sex - also occur after native tissue (non-mesh) prolapse surgery," he added.Chronic pain
Mesh is also widely used by the NHS to treat hernias - but like vaginal mesh surgery, this has left many women with chronic pain.
Jessica*, 33, was diagnosed with a hernia in February and decided to have keyhole surgery to repair the injury using a mesh - believing her recovery time would be shorter and she could return to work.
Before the surgery, Jessica was fit - running twice a week, biking, hiking and more.
"I'd just got my own flat in London and I had a job I loved in marketing," she says. "I also had a boyfriend of a year or so. It seemed serious and we were already discussing getting married and starting a family."
Jessica was nervous about the operation, so her surgeon told her not to Google it. She had two meshes fitted to repair two hernias. "I think they go from my hip area to my pubic bone on both sides. They also used a lot of absorbable surgical screws, more than you are supposed to," she says.
Nearly five months on, Jessica has been signed off work and is unable to work without shooting pains in her leg. "When I do walk, the most I can manage is 100 yards - and I'm overtaken by 75-year-olds," she says. "I'm being cared for by my parents, who are pensioners, and I've moved back in with them."
Having the mesh implants has affected all aspects of Jessica's life. "My boyfriend has vanished and I've been told that the mesh has 'set like concrete inside me' and that if I do have children it will be much more painful," she says. "I am constantly in pain, but it's worse before my period, as I get ovarian cysts, and these are right behind where the mesh and screws were put in."
She has also spent £8,000 trying to fix the problem. "My next step is to try radiofrequency nerve ablation, then further surgery to partially remove the mesh and staples if that doesn't work," Jessica explains.
"Taking it out is major, risky surgery, with a six-month recovery time and no guarantees it'll work as all the nerve endings and pain pathways are already damaged."
One issue many women suffering from mesh implants have brought up is informed consent. Many are told they are going to have a common, low-risk operation, but aren't told the complications they could face. An estimated one in 11 suffer problems as a result of the mesh.
"I was only ever told about the risk of a general anaesthetic – nothing whatsoever about the risk of mesh," Jessica says.Legal action
More than 800 women are taking legal action against the NHS and mesh manufacturers. In the US, thousands of women have successfully sued mesh manufacturers and received payouts totally billions of dollars.
In July, campaigners from the group Sling the Mesh took their fight to Parliament, to push for trans-vaginal mesh procedures to be banned, stricter regulation and a national registry to track transvaginal mesh complications.
Many are calling for women to be made more aware of the alternatives to mesh, including "bulking agents" such as collagen to treat incontinence, as well as tissue grafts to treat prolapse.
"I think people need to be informed of the risk, and given options," Jessica says. "Mesh might be right in some select circumstances. But people need to be made aware of the risks and pure tissue repairs need to be made available on the NHS so people can choose."
http://www.netdoctor.co.uk/healthy-living/sexual-health/a28664/vaginal-mesh-implant-scandal/
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Women’s lives have been ruined by vaginal mesh NHS implant
Aug 10, 2017 | Gears Of Biz
By Victoria Ritter
Two women have today revealed how their lives have been destroyed after having a controversial vaginal mesh implant fitted.
Julie Gilsennan, 41, from Liverpool, went from running 5k before her surgery to now wetting herself – despite the procedure being designed to stop incontinence.
Lizzy Ford, 54, of Scottish Borders, who once relied on her motorbike will never be able to don her helmet and biker leathers again. She has also blamed the implant, which has left her in debilitating pain, on the breakdown of her marriage.
But these women are just the tip of the iceberg. Thousands more have been left suicidal, reliant on wheelchairs and unable to have sex again because of the ‘gold-standard’ NHS treatment.
The scandal came to light earlier this year, but its true extent is yet to be uncovered – though mounting pressure is being placed on health officials to address concerns.
Campaigners have helped gather momentum for a public inquiry into the implants, mostly through Sling The Mesh – run by former sufferer Kath Sansom, 49.
But she said the NHS is sweeping the topic under the carpet. However, her tireless campaigns have helped to raise a debate about the matter in Parliament. She has been supported by an MP leading calls for further investigations over the devices.
Labour’s Owen Smith, who represents Pontypridd, said many women were promised the treatment would work, without being fully aware of the devastating risks.
It’s ‘unacceptable’ that there is a two-year wait before the English and Welsh health watchdog releases its updated guidelines on mesh, he said.
Here MailOnline reveals the stories of Mrs Gilsenan and Ms Ford as we back the calls for a suspension to the controversial procedure.
A mother-of-five who had a vaginal mesh implant fitted for mild stress incontinence now has to rush to the toilet and has even wet herself on several occasions as a result of the procedure.
Julie Gilsennan, 41, from Liverpool, had an implant fitted on February 1 as she would experience leaking if she coughed, sneezed or lifted something heavy, which was impractical given her job as a paramedic.
Although she can now sneeze without leaking, Ms Gilsennan has been left with an overactive bladder that makes her desperate for the toilet within 20 minutes of drinking.
Previously highly active, Ms Gilsennan even ran 5km the day before having the implant fitted, yet she now struggles to move as she suffers unbearable pain.
The agony has even forced her to quit her highly-challenging career as a paramedic in order to work from home alone.
Ms Gilsennan was told she would need up to six weeks off work after having the mesh fitted, however, she has been unable to return to work as a paramedic and instead works from home processing complaints to the ambulance service.
She said: ‘I loved my job, I did it for 12 years. I miss being out on the road with colleagues and talking to people. Now I’m trapped inside my house.
‘I’m in immense pain permanently. It’s like a cheese wire, glass pain in my groin.
‘I also have constant pain across my hips as if I have arthritis. I can’t return to work as a paramedic.’
Ms Gilsennan is on a waiting list to have the implant removed and is hopeful it will occur next year.
Yet, it is unclear what complications she may suffer even after the mesh has been taken out.
Ms Gilsennan said: ‘Once it’s out I can hopefully return to work as a paramedic but I’m not sure.
‘I can now cough without leaking but the mesh has given me an overactive bladder.
Different types of mesh implants include:
‘Drinking a small bottle of water makes me desperate for the toilet within 20 minutes and I need to stay hydrated as a paramedic.
‘I have wet myself on a number of occasions because I can’t get to the toilet on time.
‘I can live with some pain but I can’t work as a paramedic if I have an overactive bladder.’
Aside from her overactive bladder, Ms Gilsennan describes how the implant has had an impact on both her physical and mental health.
She said: ‘The day before my surgery I ran 5km and now I struggle to walk.
‘I also struggle to sit for a long time.
‘I’ve gained over a stone in weight because I can’t exercise and that’s depressing.
‘The mesh has also definitely affected my mental health, being in chronic pain is so draining.’
The procedure has also had an impact on her relationship, as Ms Gilsennan, who claims she was a patient person before the procedure, says coping with the pain has made her more irritable towards her husband.
The couple’s sex life has also been affected, as Ms Gilsennan finds intercourse too painful.
Ms Gilsennan went to her GP for advice and was offered no alternative aside from an implant, despite reports that physiotherapy cures such incontinence in up to 80 per cent of cases.
Senior doctors have already called for a public inquiry into the use of vaginal mesh surgery in Britain, saying it could be akin to the thalidomide scandal.
The scandal of the procedure, used to treat problems caused by childbirth, came to light earlier this year, has seen more than 800 women sue the NHS and device manufacturers.
But experts said the true number of victims could be much higher than officially reported and that hospital readmission rates for one form of mesh surgery is as high as 19 per cent.
A meeting held at the Houses of Parliament was organised by Labour MP for Pontypridd Owen Smith, along with campaign group Sling the Mesh, which wants to see the procedure banned entirely.
Speaking at the gathering in April, Carl Heneghan, professor of evidence-based medicine at the University of Oxford said: ‘With thalidomide you could see the visual representation. [With mesh] you can’t see it.
‘We should have a public inquiry.’
Thalidomide was prescribed by doctors in the 1950s and 1960s as a treatment for morning sickness or insomnia – but it was withdrawn from sale in 1961 after babies were born with limb deformities and other damage.
Its UK manufacturer, Distillers Biochemicals, paid around £28million compensation following a legal battle by the families of those affected.
She said: ‘My doctor didn’t offer any alternatives. They just said the implant was wonderful, the best thing ever and “perfect for your and your lifestyle”.
‘They made no mention of the consequences.’
Ms Gilsennan believes the implant scandal has been deliberately covered up by the NHS.
She said: ‘The truth about vaginal meshes has been swept under the carpet, they should have been withdrawn years ago.
‘I feel really angry towards the NHS and Johnson & Johnson for manufacturing this.
‘It’s just not safe to have a piece of plastic inside you.’
Yet, despite her complications, Ms Gilsennan is thankful to have escaped the ordeal of other sufferers.
She said: ‘I still consider myself lucky. Some women have had these cut through their vaginas and erode away their organs.’
An avid motorbike rider will never be able to put her helmet on and sit on the saddle again – because of her vaginal mesh.
Lizzy Ford, 54, from the Scottish Borders, was fitted with the TVTO sling to combat her incontinence in June 2010.
But her body almost instantly succumbed to the horrendous pain, and she was left unable to walk without any help.
She now needs an electric wheelchair if she wants to go a far distance, and uses crutches if she needs to briefly use her legs.
Ms Ford, who is now in the process of a separation with her husband, even blamed the mesh on the breakdown of her marriage.
The only thing she was able to do each day was to drive down to the shops each day – but now her life is totally different following the removal of the mesh.
She told MailOnline: ‘That’s the day I was reborn because that’s how it feels. My mobility is actually worse but I don’t have the mesh itself.
‘I feel well. I don’t feel poisoned as I had been as I felt my immune system was shutting down. The mesh has had a huge part in the breakdown of my marriage.
‘I felt like I was on my death bed this time last year. I was on so much pain relief, morphine, opiates, everything.
‘My last seven years have been a living hell, a living nightmare.’
Ms Ford, who first learnt to ride her motorbike when she was 16, was very active before the accident that shattered her leg 18 years ago.
But the pain in her right calf never affected her mobility on the devastating scale that the controversial mesh did.
After undergoing two years of operations to fix her broken leg she was able to straight back onto her bike.
However, after having the procedure to fit TVTO seven years ago at Borders General Hospital, Melrose, she had to give up her bike for good.
Her surgeon suggested this ‘gold-standard 20-minute’ fix that would transform her life and combat her weak bladder.
Following the operation she instantly struggled to walk, describing her walk out of the hospital as one of the longest she’s ever had.
Blood tests were conducted – but nothing came back. Ms Ford was then sent to a psychiatrist when she was told the pain was in her head.
Her now-retired consultant, who originally fitted her with the TVTO, even said she was the only one who had reported such problems.
She said: ‘I had my mesh and I had a problem with my mobility, shooting pains down my leg, round my groin and in my hips.
‘I kept going back to the doctor and at no point did he say it had anything to do with the mesh.’
Health officials need to ‘pull their finger out’ and update their guidelines over vaginal meshes, claims an MP leading calls for further investigations over the scandal-hit devices.
Labour’s Owen Smith, who represents Pontypridd, said many women were promised the ‘gold-standard’ treatment without being fully aware of the devastating risks.
Mr Smith said it was ‘unacceptable’ that there is a two-year wait before the English and Welsh health watchdog releases its updated guidelines on mesh.
He told MailOnline: ‘I think NICE (National Institute for Health and Care Excellence) should pulls their finger out and produce guidelines much quicker than 2019.
‘Areas like this are contentious and there are legitimate concerns about its [vaginal mesh]safety and efficacy.’
Mr Smith added: ‘[There is] an emerging weight of evidence that suggests this as a much of a problem than the clinical fraternity are acknowledging.
‘There’s a strong case to say we should suspend use of mesh in light of all of these questions until we get an answer.
‘Lives have been wrecked by it and that can’t be allowed to happen to another generation.’
Following tireless pursuits of the truth by campaigners who have raised concerns over the devices’ safety, NICE has been forced to re-asses its position.
Officials expect the updated guidance on treating urinary incontinence with vaginal mesh to be released in February 2019.
Dr Martin Allaby, consultant clinical adviser for the NICE centre for guidelines and member of the Mesh Oversight Group, said: ‘NICE committed to review its interventional procedures guidance on the safety and effectiveness of mesh and I’m pleased to say we’re well on the way to completing this.
‘We’ve also recently begun updating our clinical guideline on urinary incontinence. The scope for this has been expanded to encompass the entire pathway of care – surgical and non-surgical – for both POP and SUI.
‘As is the case with all our guidance, we will actively seek out and take into account the views of patients so that their experiences are reflected in best practice care for these conditions in the future.’
Ms Ford’s fortunes changed when she read something in her local paper two years ago about other women with similar symptoms who had been given the mesh.
After years of relentless campaigning to have her TVT removed, she was granted an investigation at Queen Elizabeth University Hospital, Glasgow.
A consultant immediately asked Ms Ford if she wanted it removed when she inserted a camera into her bladder to see what was going on.
To her relief, the TVT eventually came out on her birthday 12 weeks later on February 16 earlier this year – but she will never escape the side effects.
She has since had advised all other women to think very carefully before they choose to have the procedure.
The NHS tried to dodge media attention over the vaginal mesh implants that left hundreds of women in agony, it was revealed in April.
The procedure cut into their vaginas and left many in discomfort so severe they have been left unable to work, walk or have sex.
It emerged the NHS actively sought to avoid courting headlines over the matter after minutes from an NHS meeting in October were leaked.
They showed an agreement to ‘take the press element out of’ a campaign for women experiencing complications from the devices.
The meeting’s minutes, seen by the Press Association, outlined the Medicines & Healthcare products Regulatory Agency’s (MHRA) yellow card campaign, which targets under-reporting of mesh complications.
Officials said they should ‘look into taking the press element out of the mesh yellow card campaign’ and ‘investigate whether there can be a general yellow card campaign, of which mesh is one element, to avoid media attention on mesh’.
Ms Ford added: ‘There are operations out there that are far more effective [than TVTO]– but they cost more. This is put into you for life.
‘It was never designed to come out, it was designed to stay in.’ She added surgeons have often described their attempts at taking out the mesh as trying to remove chewing gum from hair.
Ms Ford continued: ‘It grates off, it splinters, it goes into the bowel, it goes into the bladder, it goes into the vaginal wall – it’s outrageous.
‘Things you think can’t be connected to mesh, they are. It poisons you and breaks you down.’
The former Tesco worker was forced to give up her job because she was struggling to walk up and down the aisles while the mesh was fitted.
She then began working for a charity, organising events for the elderly in her local community – but the pain made her quit that, too.
Ms Ford decided to go to college to study, but she was forced to give that up too because of the mental side effects.
She told MailOnline: ‘My world was taken away from me until eventually I had two hours a day on a Friday working on a till. That was my world.’
Ms Ford described the initial operation to put in the mesh as ‘guesswork’, as they surgeons ‘go in blind’ with no idea ‘where they put it’.
Due to a lack of surgeons she is unable to have the remaining clamps removed as they are fixed in.
A spokesperson for Johnson & Johnson UK said: ‘Implantable mesh devices, which are backed by years of clinical research, have undergone rigorous regulatory reviews and are considered to be the gold standard for the treatment of stress urinary incontinence by many doctors.
‘Pelvic mesh devices have helped millions of women suffering from stress urinary incontinence and pelvic organ prolapse.’
Professor Keith Willett, medical director for Acute Care at NHS England, said: ‘There’s no doubt there has been significant progress to improve information, care and support for women affected by SUI and POP.’
http://gearsofbiz.com/womens-lives-have-been-ruined-by-vaginal-mesh-nhs-implant/4929
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Damning studies showing complication rates of vaginal mesh
Aug 10, 2017 | Gears Of Biz
By Victoria Ritter
The NHS has been accused of ignoring damning studies that show the damage controversial vaginal mesh procedures cause is much higher than the health service is willing to admit.
Published in various journals, the alarming evidence prompted doctors in three US states to suspend the controversial practice – used to treat incontinence – and saw them call for a review into its safety.
The studies, handed exclusively to MailOnline following our calls to review the safety of mesh implants, revealed pain, erosion and perforation from the surgery can strike up to 40 per cent of women. Others suggest it could be as high as 75 per cent.
But English health officials have yet to acknowledge the risks of the brittle implants which can break into tiny fragments and cause nerve damage. Currently, the NHS and MHRA state only 1 to 3 per cent will experience complications such as pain.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with officials accepting that up to 40 per cent of women may experience injury.
Outraged women have consistently argued for UK health bodies to adopt a similar stance as thousands of British women have been left suicidal and unable to have sex as a result of the controversial procedure.
Tireless fights by campaigners have helped gather momentum for a public inquiry into the implants, with MPs now beginning to ask questions about the safety of mesh and calling for further investigations over the devices.
Its usage has been suspended in Scotland since 2014 pending a safety review, but hundreds of women are still believed to be having the surgery. And just last month the English MHRA insisted the mesh was safe.
Kath Sansom, founder of Sling The Mesh, a campaign dedicated to reviewing the usage of mesh, has backed our calls for addressing the problem.
She told MailOnline: ‘I wish the NHS would wake up to the number of women suffering.
‘I don’t know why they are unwilling to accept the higher complication rates that have seen the surgery suspended in three US states and Scotland.
‘However, it could have something to do with a large number of studies that have received funding from manufacturers of the controversial implants.
‘I really wish they were willing to acknowledge the results of various studies and accept the true risks to the procedure, for the thousands of affected women.
‘It’s clear to see that US doctors have acknowledged the results of multiple studies suggesting much higher complication rates.’
Her concerns come just days after we revealed that having mesh implants fitted had destroyed the lives of two women.
The scandal came to light earlier this year, but its true extent is yet to be uncovered – though mounting pressure is being placed on health officials to address concerns.
Senior doctors have already called for a public inquiry into the use of vaginal mesh surgery in Britain, saying it could be akin to the thalidomide scandal.
An editorial published in European Urology five years ago suggested adverse effects strike nearly half of women who are fitted with the implant.
Author Dr Firouz Daneshgari, of the Department of Urology, Case Western Reserve University, slammed the alarming rates.
He said: ‘By any modern industrial standards of quality, a 30–40 per cent rate of adverse events is simply unacceptable.
‘Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?
‘Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.’
Reporting in the journal Nature in 2015, nine leading researchers concluded the risk to be more in the region of 15 per cent.
Research led by Loyola University Chicago in November 2012 showed adverse episodes occur in up to 42 per cent of women.
A mother-of-five who had a vaginal mesh implant fitted for mild stress incontinence now has to rush to the toilet and has even wet herself on several occasions as a result of the procedure.
Julie Gilsennan, 41, from Liverpool, had an implant fitted on February 1 as she would experience leaking if she coughed, sneezed or lifted something heavy, which was impractical given her job as a paramedic.
Although she can now sneeze without leaking, Ms Gilsennan has been left with an overactive bladder that makes her desperate for the toilet within 20 minutes of drinking.
Previously highly active, Ms Gilsennan even ran 5km the day before having the implant fitted, yet she now struggles to move as she suffers unbearable pain.
The agony has even forced her to quit her highly-challenging career as a paramedic in order to work from home alone.
Ms Gilsennan was told she would need up to six weeks off work after having the mesh fitted, however, she has been unable to return to work as a paramedic and instead works from home processing complaints to the ambulance service.
She said: ‘I loved my job, I did it for 12 years. I miss being out on the road with colleagues and talking to people. Now I’m trapped inside my house.
‘I’m in immense pain permanently. It’s like a cheese wire, glass pain in my groin.
‘I also have constant pain across my hips as if I have arthritis. I can’t return to work as a paramedic.’
However, the scientists wrote in the America Journal of Obstetrics and Gynaecology that mesh was still acceptable to use.
Of women suffering problems from vaginal mesh, a study published in the same journal showed 77 per cent to have severe effects.
Different types of mesh implants include:
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence.
Because it did not require specialist training to implant, outraged women have since begged for tougher regulations to conduct such surgery.
More than 10,000 women a year have the procedure. But only 7,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more – but they have been kept silent.
A three-year investigation by NHS England confirmed many more women have complained of injuries than previously suggested.
But it steered away from looking at the safety of mesh, and stopped short of demanding a register of all implant operations.
Professor Keith Willett, of NHS England, said: ‘There’s no doubt there has been significant progress to improve information, care and support for women affected by stress urinary incontinence and pelvic organ prolapse.’
John Wilkinson, Director of Devices at MHRA, said: ‘We are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.
‘What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.’
According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.
Yet, a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.
Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.
Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.
Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life.
According to Kath Samson, head of the Sling The Mesh campaign, surgeons often refuse to accept vaginal mesh implants are causing recipient’s pain, and are not obligated to report such complications anyway.
She said: ‘Less than 40 per cent of surgeons report vaginal mesh implant side effects.
‘In last 10 years, 126,000 mesh and tape implants have been fitted in England alone.
‘In that period around 7,800 women have gone into hospital with a mesh complication, but the number reported to the MHRA is just over 1,000.
‘Many more women would have experienced pain but never gone to hospital.’
http://gearsofbiz.com/damning-studies-showing-complication-rates-of-vaginal-mesh/5047
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Georgia Widow Blames Physiomesh for Husband’s Death
Aug 10, 2017 | The Legal Examiner
By Roopal Luhana
⦁ Roopal Luhana is an attorney with Chaffin Luhana LLP
The Ethicon Physiomesh multidistrict litigation continues to grow in the Northern District of Georgia. All federally filed cases were transferred there in June 2017, with District Judge Richard R. Story overseeing the pre-trial proceedings.
On June 21, 2017, a Georgia woman filed a Physiomesh lawsuit against defendants Ethicon and Johnson & Johnson (J&J). She filed on behalf of her deceased husband and is the representative of his estate. She claims that her husband suffered complications associated with a Physiomesh hernia repair and that he deteriorated so badly he passed away. She seeks both compensatory and punitive damages.Plaintiff Suffers Numerous Complications After Physiomesh Implantation
According to the plaintiff’s complaint, her husband was implanted with Ethicon’s Physiomesh on June 26, 2015, to repair an incarcerated ventral hernia. This is a type of hernia that occurs in the abdominal area, in which the tissues are strangulated and lacking a blood supply. The condition is considered serious and usually requires immediate surgery.
A few days later, on July 9, 2015, the decedent went back to the doctor because of severe abdominal pain and worsening edema. He had to go back into surgery on July 22, 2015, to repair the hernia and to treat a possible incarcerated small bowel. Unfortunately, this was only the first of numerous surgeries.
On July 30, he was again admitted with hematoma and a related infection, and on November 1, 2015, he underwent surgery to debride the abdominal wound. Then on November 4, doctors found that the implanted Physiomesh was infected and had not incorporated into his tissues. The Physiomesh was removed, and doctors put a biologic form of mesh in its place.
The plaintiff continued to have problems and had to be treated again on November 11, 2015.Plaintiff Blames Physiomesh for Husband’s Death
Months later, in April 2016, the decedent was examined again and doctors reported that his abdominal wound had not improved. On May 10, 2016, he was diagnosed as in serious condition and referred to the Emory Hospital in Atlanta, Georgia. The complications continued, and on January 31. 2017, the decedent passed away of septic shock, respiratory failure, and acute renal failure.
The plaintiff blames Physiomesh for starting all the problems her husband suffered from, noting that the product was defectively designed and was not safe for hernia repair. She blames the product’s multi-layer design for encouraging infection and swelling, and for leading to her husband’s subsequent infections and other complications.
She adds that neither her husband nor his doctors were properly informed by the defendants of the defective and dangerous nature of Physiomesh. Because the product failed to perform as expected, her husband suffered serious injuries, had to go through multiple surgeries, and ended up with worse problems than he had to begin with.
In May 2016, Ethicon issued an urgent field safety notice advising doctors to stop using Physiomesh because of higher than expected reports of recurrence and reoperation rates.
http://newyork.legalexaminer.com/medical-devices-implants/georgia-widow-blames-physiomesh-for-husbands-death/
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