Preview Newsletter
Ethicon Media Monitoring 12/18/2017
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‘It’s the best Christmas present I could ever have hoped for’: Mesh victim gets life-changing surgery after Sunday Post report
Dec 17, 2017 | The Sunday Post
By Marion Scott
A mesh victim driven to the brink of suicide over fears she may lose two organs waiting for an expensive operation will now get treatment. -
Lawyer slams NHS Scotland and predicts mesh scandal will be as costly as thalidomide pay-outs
Dec 17, 2017 | HeraldScotland
By Andrew Whitaker
THE scandal of women crippled by mesh implant surgery in Scotland will have the same impact as the drug thalidomide, a human rights lawyer representing survivors has said. -
Grandma first spoke about surgical mesh five years ago; today, she is still suffering
Dec 18, 2017 | Sunday Star Times (In stuff.co.nz)
By Jonathan Milne
It's more than five years since we first started looking into reports of commonplace surgical mesh products causing extraordinary pain and damage to patients. -
Perth mum’s pelvic mesh implant caused ‘bladder erosion’
Dec 18, 2017 | PerthNow
By Jane Marwick
A PERTH woman says she flew to Sydney for surgery last month because her doctors did not believe her health problems were caused by pelvic mesh, instead asking her if she had been a bed-wetter as a child. -
Furious campaigners blast the 'weak' decision by the Government's health watchdog to recommend banning the scandal-hit vaginal mesh for only ONE procedure
Dec 15, 2017 | The Daily Mail
By Stephen Matthews
Furious campaigners have blasted the Government's 'weak' decision to recommend a ban on scandal-hit vaginal mesh implants for one procedure. -
Doctors told not to use vaginal mesh to treat prolapse due to 'serious' safety concerns
Dec 15, 2017 | ITV
Women who are suffering from vaginal prolapse should not be treated with mesh except in research contexts due to "serious" concerns over the procedure's safety, the NHS medical standards body has said. -
Health watchdog warns of ‘serious safety concerns’ with vaginal mesh
Dec 15, 2017 | Metro
By Tom Herbert
There are ‘serious safety concerns’ with using mesh to treat vaginal prolapse, the health watchdog has warned. -
UK watchdog says vaginal mesh to treat prolapse should be banned
Dec 18, 2017 | thejournal.ie.
Procedures using vaginal mesh implants have been carried out on women in Ireland since the late 90s and are still performed today. -
Vaginal mesh ops restricted to research only
Dec 15, 2017 | WebMD
By Peter Russell
New restrictions on vaginal mesh implants means they should not normally be offered as routine treatment inthe NHS in England, the health watchdog has announced. -
Don’t use vaginal mesh in routine prolapse operations, watchdog says
Dec 15, 2017 | iNews
By Heather Saul
The NHS health watchdog has recommended controversial vaginal mesh implants to treat prolapse should only be used only in the context of Government research. -
U.K.’s Health Watchdog Recommends Ban on Transvaginal Mesh
Dec 15, 2017 | Drugwatch
The U.K.’s National Institute for Health and Care Excellence has recommended a ban on transvaginal mesh for pelvic organ prolapse, according to guidance released Friday. -
The Biggest Pennsylvania Court Decisions In 2017
Dec 18, 2017 | Law 360
By Matt Fair
The Pennsylvania judiciary logged another busy year in 2017 as members of both the appellate and trial benches handled major cases, including a wholesale reshaping of environmental law in the state and a string of eye-popping verdicts in pharmaceutical product liability cases. -
Johnson & Johnson ordered to pay $15M in vaginal mesh case
Dec 15, 2017 | Philly.com
By Sam Wood
A Johnson & Johnson subsidiary was ordered Thursday to pay $15 million in damages to a New Jersey woman who was left in chronic pain after receiving defective transvaginal mesh implants. -
Jury awards $15M to woman for faulty mesh implant
Dec 15, 2017 | nj.com
By Anthony G. Attrino
A jury in Bergen County has awarded $15 million in damages to a woman who claims a faulty transvaginal mesh implant caused severe and chronic pain, her lawyer said Friday. -
Can new regulations help ensure manufacturers perform effective post-market surveillance?
Dec 15, 2017 | epm
By Stephanie Ward
In this online exclusive, Stephanie Ward, a quality assurance engineer at technology and product design firm Cambridge Design Partnership looks at the new European medical devices regulation in more detail and the impact these may have on manufacturers. -
Boston Scientific settles over 370 pelvic mesh lawsuits
Dec 18, 2017 | Mass Device
By Fink Densford
A federal judge in West Virginia this week dismissed approximately 378 recently settled lawsuits against Boston Scientific (NYSE:BSX) over supposed defective pelvic mesh implants, according to court documents released yesterday.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Dec 17, 2017 | The Sunday Post
By Marion Scott
A mesh victim driven to the brink of suicide over fears she may lose two organs waiting for an expensive operation will now get treatment.
The day after The Sunday Post revealed Claire Daisley could not face another year with debilitating bladder and bowel problems, health chiefs intervened.
Claire, fighting back tears of relief, said: “It wasn’t easy sharing deeply personal information so publicly but within hours of The Sunday Post telling my story, I was informed I’ll get my operation as a matter of urgency instead of waiting nine months or even longer.”
She is one of hundreds of women enduring crippling pain and life-changing health problems because of procedures involving trans-vaginal mesh, used to treat incontinence issues and prolapse.
They were assured the procedures were routine with little risk but are among the victims in what has become an escalating scandal around the world where women have been crippled by mesh.
Claire, 48, from Greenock, suffered horrific nerve damage after doctors at Inverclyde Hospital in 2011 used metal hooks in a “blind procedure” to insert a mesh implant to treat bladder problems after childbirth.
Afterwards, Claire suffered chronic pain, needed a wheelchair and developed an overactive bladder and bowel problems leaving her afraid to go out.
She said: “I couldn’t continue living this nightmare much longer. The pain was bad enough, but my bowel and bladder problems are now so acute, it’s difficult to go anywhere.
“Even after leaving us terribly injured, the NHS don’t provide victims with adequate incontinence supplies.”
Claire was given a shred of hope when a specialist said she was suitable for a procedure which could help.
Sacral nerve stimulation is similar to a tiny heart pacemaker being inserted to send electrical currents to the organs.
She said: “I was elated, then devastated to be told the waiting list could be more than a year because the treatment is so expensive.
“I didn’t have the strength to be stuck on a waiting list for up to a year.”
NHS body National Services Scotland revealed last week that recent increases in funding from £250,000 to £400,000 mean 20 bladder patients were treated last year. One centre in Glasgow deals with bladder patients, a further six across Scotland treat bowel patients.
Claire faced the stark choice of having her bladder and bowel removed and replaced with stoma bags.
Last month, she wrote to Scotland’s Chief Medical Officer Dr Catherine Calderwood, begging her for help.
Claire’s letter was acknowledged, but she heard nothing more.
On Monday, the day after we told her story, Dr Calderwood wrote to Clarie apologising for “the delay in responding”.
She added: “I am very sorry that you did not receive a reply to your email.
“I was alerted to the fact that you had sent a further email by the Sunday Post article yesterday and chased this up today.”
Dr Calderwood told Claire she had been in touch with her specialist and added: “He is arranging for your urgent admission and will be in touch.
“I hope that the treatment will be of some help for your very distressing symptoms.”
Claire said: “I know I’ll always be in pain and unable to walk properly again, but I pray this operation will allow me to regain some semblance of the life I once had.
“I’ve been told it could help both organs, one or neither of them. But at least I’ve been given a chance instead of none.”
Campaigners have accused the NHS of using mesh implants to save just £200 on traditional surgery despite it not being properly tested.
Scottish ministers, who had ordered the suspension of mesh, have since been accused of whitewashing concerns in a review of the procedure, which campaigners claim was heavily swayed by doctors who support its use.
Mesh implant manufacturers have already paid out more than £3 billion to US patients and NHS Scotland faces its largest ever legal action with almost 500 women suing.
Olive McIlroy, of Scottish Mesh Survivors, said: “It’s unforgivable the NHS destroyed the lives of hundreds women for the sake of a few pounds. We’re relieved Claire will now get the help she needs.”
https://www.sundaypost.com/fp/mesh-victim-gets-life-changing-surgery-after-sunday-post-report/
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Lawyer slams NHS Scotland and predicts mesh scandal will be as costly as thalidomide pay-outs
Dec 17, 2017 | HeraldScotland
By Andrew Whitaker
THE scandal of women crippled by mesh implant surgery in Scotland will have the same impact as the drug thalidomide, a human rights lawyer representing survivors has said.
Patrick McGuire warned of a “ticking time bomb" in the bodies of female patients who have had the controversial procedure.
He also said a failure to enforce a suspension on mesh implant surgery was "sticking two fingers up" to the Scottish Parliament.
McGuire, who is representing 500 affected women, predicted the scandal would have the same impact as that of the drug thalidomide which caused thousands of birth defects in children and led to millions of pounds in damages for victims.
The women he represents are now seeking damages from Scotland's NHSafter they suffered painful and crippling complications. A hearing of the action was heard in the Court of Session earlier this month and is likely to be called again next year.
Tens of thousands of Scottish women had the implants to treat prolapse and bladder problems. In 2014 they were suspended by the Scottish Governmentafter a number of women suffered severe pain and trauma. However some health boards still permit them.
McGuire, a partner at Thompsons Solicitors, warned that a failure to impose an outright ban would exacerbate the number of compensation claims and a surge in law suits as more patients develop medical complications – with the legal consequences similar to those of the thalidomide scandal decades ago.
Last night, mesh victims and Thalidomide justice campaigners said there were striking similarities between the two scandals.
Thalidomide was used in the late 1950s and early 1960s to combat morning sickness but led to 10,000 babies being born without limbs. The UK manufacturers Distillers Biochemicals Limited (now Diageo) paid out a total of £28 million during the 1970s to the families of those affected.
McGuire said he expected the mesh scandal to reach similar heights. "There are hundreds of claims, but they are the tip of a very large iceberg."
He said success for the 500 initial challenges could open the floodgates for tens of thousands more.
"Most significantly they [the NHS in Scotland] are continuing to use this treatment. To do this after the procedure was suspended is sticking two fingers up at the Scottish Parliament which took that decision."
McGuire also criticised the Scottish Government's claim that it could not introduce an outright ban on mesh implants. Ministers have said the power rests with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
McGuire said: "I'm afraid this is Ministers doing a medical Pontius Pilate. It's a glaring irresponsibility."
Thalidomide survivors also said mesh victims were being denied justice in the same way they were decades ago.
On of them, Steve Sinclair, from Selkirk in the Borders, claimed the mesh victims were being ignored. "Mesh survivors are facing a similar sort of misrepresentation as thalidomide survivors did," he said.
Liz Buckle, who lives on the Isle of Lismore, Argyll, also a victim of the drug, added: "There are parallels with the thalidomide scandal. In common to both, there seems to be a collective process of denial from within the medical and political establishment, which is allowing the mesh products to be used without a proper level of regulatory monitoring or 'duty of care'.
"This also happened with thalidomide, it was openly marketed as a 'safe, wonder-drug'."
Holyrood's health committee convenor Neil Findlay called on the Scottish Government to use its powers over public service procurement to ban mesh implants. He said: "They should immediately clear the shelves of this product."
Former health secretary Alex Neil said the UK Medicines and Healthcare products Regulatory Agency (MHRA) should be held to account over the use of the implants.
He said: "If the NHS is sued successfully, it in turn should sue MHRA over what has become an international scandal. I fully understand why women are so angry and want to sue. But the real culprits should be pursued."
In response, John Wilkinson, MHRA Director of Devices, said: "The decision to use mesh should be made between a patient and clinician, recognising the risks and benefits in the context of the distressing conditions being treated."
On Friday the UK health watchdog Nice recommended that mesh implants be restricted to research purposes only.
Catherine Calderwood, the Scottish Government's chief medical officer, said those restrictions would apply in Scotland.
She said: “In Scotland we asked NHS Scotland health boards to suspend the use of mesh in 2014 due to clinical concerns. That suspension will remain in place until we are satisfied all necessary procedures, approvals, and restrictions are in place."
New Zealand has now become the first major country in the world to ban all vaginal mesh procedures.
In the United States, mesh survivors are winning tens of millions of dollars in compensation pay outs.
Survivor Ella Ebaugh, 51,was awarded $57 million in a lawsuit against Johnson & Johnson as the first person in America to speak out about the severe pain she suffered from a faulty implant.
Patrick McGuire said he expected a sharp rise of claims in Scotland in the coming years.
He said: "Many women are currently suffering in silence. The symptoms are horrible and a larger number of women could start to suffer the same devastating health problems.
"There could then be mass litigation."
Elaine Holmes, a member of the Scottish Mesh Survivors campaign, said she is contacted weekly by women in excruciating pain from the implants.
Holmes, from Newtown Mearns, suffers severe complications following her own mesh surgery.
Speaking to the Sunday Herald, she said: "When we first handed in a petition to parliament in 2014, two victims of thalidomide in the public gallery said to us that this was huge and bigger than thalidomide.
"At first I thought it couldn't be, but the scale of what we've been through has been grossly underestimated and all these women have been duped. We're getting contacted every week by women so this could be on the scale of thalidomide."
Earlier this year, Holmes and fellow Mesh survivor Olive McIlroy said they were "dismayed and disgusted" at the publication of an independent report into the risks or mesh implants and use which they claim has been "watered down".
McIlroy and Holmes, who resigned from the mesh implants review group, said they felt "utterly betrayed" by the publication.
http://www.heraldscotland.com/news/15777844.Lawyer_slams_NHS_Scotland_and_predicts_mesh_scandal_will_be_as_costly_as_thalidomide_pay_outs/
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Grandma first spoke about surgical mesh five years ago; today, she is still suffering
Dec 18, 2017 | Sunday Star Times (In stuff.co.nz)
By Jonathan Milne
OPINION: It's more than five years since we first started looking into reports of commonplace surgical mesh products causing extraordinary pain and damage to patients.
It was a woman named Heather Anderson who first stepped up to tell her story. Few others were talking. The mesh was implanted to deal with hernia, pelvic organ prolapse and stress urinary incontinence. These are the kinds of health complications that affect many people, yet are difficult to talk about.
Anderson had been in pain for eight years since the mesh was implanted to repair a hernia in her lower abdomen. She said it was like a cheese grater cutting through her internal organs.
When journalist Chloe Johnson first told Anderson's story in August 2012, her concerns were dismissed by surgeons, health regulators and ACC.
Emboldened by Anderson's bravery, more and more women and men came forward, and we kept telling their stories.
I remember talking with West Coaster Heather Mehrtens, who had lost her husband Geoffrey to mesh complications. For months she tried to seek answers from medical authorities; eventually she told her story publicly in the hope of drawing attention to the problems. "These are human beings, people that we love that we don't want hurt to come to, these are people who we don't want to die," Heather Mehrtens said.
I remember mum-of-two Alison Lee telling me of the pain she suffered, a nightmare that wouldn't end. "I haven't been able to walk properly since the surgery," the 38-year-old said. "Yeah, I'm pretty much screwed."
Then in June this year, I spoke with Sheree Freer, whose mother Karyn died following surgery to remove mesh. The family was calling for an inquiry into mesh complications.
This week, MedSafe announced it was banning the use of surgical mesh in pelvic organ prolapse, and the use of some types of mesh for stress urinary incontinence
On its own, this is not an answer to the problem, but it is long overdue recognition by health authorities that there is a problem.
Thankfully, there has been a gradual decline in the number of mesh implants in gynaecological surgery even before this week's ban.
It should be noted that mesh provides an effective solution for many hernia, which constitute the vast majority of mesh operations. But the numbers of ACC claims for hernia injuries are growing – surgeons must be careful that this is not the next battlefield.
The support group Mesh Downunder is calling for a register of the thousands of pieces of mesh implanted every year, so surgeons can understand how and when the procedures are going wrong. Top Canadian surgeon Robert Bendavid is poised to come here to train New Zealand surgeons in removing the mesh. And Auckland University's gynaecology professor Cindy Farquhar is hoping to lead a comprehensive study of what happened in the hundreds of reported cases of mesh complications.
There is hope – for some men and women.
This weekend I talked with Heather Anderson, more than five years after she first told her story.
Since 2012, her pain has only got worse. "If I strain myself now, I can't breathe, I can't eat."
The foul 6-by-3-inch piece of mech is still embedded above her abdomen, still ripping through the flesh. She say the public hospital will not remove the mesh, because the private hospital that implanted it has lost her surgery notes. And she was in court just last month, still fighting ACC for compensation.
The 67-year-old Aucklander has grandchildren aged 9, 7 and 5. "I can't picks the kids up," she grieves. "I can't do anything with them. I look like death warmed up."
But amid her pain, the Medsafe decision provides a ray of light. It was vindication that the mesh problem was not in her head. And, she said, it provided hope that other people would not suffer the same.
https://www.stuff.co.nz/national/health/99926728/grandma-first-spoke-about-surgical-mesh-five-years-ago-today-she-is-still-suffering
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Perth mum’s pelvic mesh implant caused ‘bladder erosion’
Dec 18, 2017 | PerthNow
By Jane Marwick
A PERTH woman says she flew to Sydney for surgery last month because her doctors did not believe her health problems were caused by pelvic mesh, instead asking her if she had been a bed-wetter as a child.
Katrina Strange, 44, said she chose an interstate surgeon because of his empathy and experience in full mesh removal.
On the day 42-year-old Christina Brajcic died in Canada from mesh-related sepsis following the removal of her implant, Ms Strange arrived in Sydney to have the same type of device, implanted in 2005 to treat mild urinary stress incontinence, taken out.
The four-hour procedure to remove the 20cm chunk of mesh, which had fused to her flesh and eroded her bladder, cost $14,000.
Ms Strange’s husband, Craig White, who worked FIFO to pay his wife’s $90,000 medical bill, said his wife’s illness had hit the family emotionally and financially.
“It angers me that the doctors seem to be ignoring women’s problems after implanting them with mesh,” he said, while calling on surgeons to stop using mesh and return instead to native tissue repair.
Ms Strange told of her horror when her Perth doctors put her urinary urge incontinence down to an over-active bladder, denied that mesh could be causing her problems and asked her if she had a history of bed-wetting as a child.
“I was gobsmacked. I didn’t have a history of bladder problems as a child. I was not a bed-wetter,” Ms Strange said, adding that the doctor had told her she did not have any bladder erosion.
Ms Strange “felt lighter” the moment she awoke from her operation. Her Sydney surgeon found her implant had caused bladder erosion and had stuck to her pubic bone, which she believes caused excruciating hip and leg pain.
At a Senate hearing in Perth in August, women detailed how consultants had mocked and humiliated them while dismissing negative stories about mesh as “media hype”.
Ms Strange said her mesh implant had made her sick for years. At one stage, her pain was so bad she was convinced she had cancer and wrote a will.
She welcomed the banning of some pelvic mesh by the Therapeutic Goods Administration, but said it should ban all polypropylene meshes.
Hers was still on the market and was considered the “gold standard”.
In 2010, US Professor of obstetrics and gynaecology Lewis Wall wrote “powerful commercial interests are reshaping the field of pelvic surgery”.
He singled out the “development of operation-specific ‘kits’ for surgical use, which ... hold the promise of quick, easy, standardised operations, higher surgical volumes and increased profits for both the surgeon and the device manufacturer”.
Ms Strange, who only discovered in May her chronic pain and illness were mesh-related after media reports surfaced, urged women to do their own research. She hoped her Perth doctors would read her story.
“We are both extremely happy and we can now plan for our future,” she said.
https://www.perthnow.com.au/news/health/perth-mums-pelvic-mesh-implant-caused-bladder-erosion-ng-b88693075z
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Dec 15, 2017 | The Daily Mail
By Stephen Matthews
· Health watchdogs released their final guidance on vaginal mesh this morning
· Nice announced that mesh should only be used for research in treating prolapse
· Campaigners argue they ignored repeated calls to also ban it for incontinence
· The scandal, which has left some women suicidal, is dubbed akin to thalidomide
Furious campaigners have blasted the Government's 'weak' decision to recommend a ban on scandal-hit vaginal mesh implants for one procedure.
Health officials announced the controversial surgery should only be banned for prolapse - when organs fall out of place, and not incontinence.
Outraged victims warn this leaves the door open for thousands of other women to suffer life-changing complications from the 'barbaric' devices.
Nice, which advises the NHS, announced this morning that mesh, made of brittle plastic, should 'only be used in the context of research' for prolapse.
But Sling The Mesh, backed by nearly 5,000 women, claim they have ignored the repeated calls to ban the surgery for incontinence.
Both are common problems for women after childbirth.
Kath Sansom, founder of Sling The Mesh, told MailOnline: 'The guidance does not go far enough. It's ludicrous that patients haven't been listened to on this.
The move comes amid mounting pressure for the complete ban of vaginal mesh implants, which have left thousands of women on the brink of suicide.
It also comes after the death of a prominent vaginal mesh campaigner who died from sepsis, reportedly triggered by her controversial implant.
Christina Brajcic, 42, from Ontario, Canada, passed away in November following a four-year battle with persistent infections - as a result of her mesh.
Ms Sansom added: 'Our Government ministers are not listening. It's time for them to stop burying their heads in the sand and suspend its use.'
She wants a retrospective audit to determine 'the true scale of the disaster' and work out how many women have been fitted with the 'barbaric' implants.
Sling The Mesh has almost quadrupled in members in recent months. Nearly 5,000 people, mostly sufferers, now support the cause to ban vaginal mesh.
It is believed that of the women in the group who have been given vaginal mesh, three quarters were fitted with the device to treat their incontinence.
Vaginal mesh has been subject of various legal proceedings across the world, with figures suggesting more than 100,000 are suing manufacturers of the devices.
Tiresome fights by campaigners, backed by MailOnline, has since led to Australian health officials making a similar move for prolapse operations.
Watchdogs in the country banned the use of vaginal mesh implants for prolapse earlier this month after a review found 'the benefits do not outweigh the risks'.
The Nice verdict comes after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
The drugs rationing body issued draft guidance in November that recommended the 'gold standard' implants should not be routinely offered for treating organ prolapse.
It also follows the landmark news from New Zealand that all forms of pelvic mesh would be banned - becoming the first major country to do so.
Officials in the country announced earlier this week that they would remove the controversial implants from supply and limit the use of surgical mesh products.
The scandal came to light in April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some saying the scandal could be akin to thalidomide.
At the time, 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
Mesh, introduced 20 years ago and dubbed 'gold-standard', was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
Because it did not require specialist training to implant, victims of the procedure have since begged for tougher regulations to conduct such surgery.
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 injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike 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.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
More than 10,000 women a year are fitted with mesh. But only 4,800 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.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million in September to a woman fitted with the implant.
Ella Ebaugh, 51, from Philadelphia, was awarded the eight-figure sum after a jury found the company to be negligent and its product defective.
http://www.dailymail.co.uk/health/article-5182463/Furious-vaginal-mesh-campaigners-blast-weak-decision.html
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Doctors told not to use vaginal mesh to treat prolapse due to 'serious' safety concerns
Dec 15, 2017 | ITV
Women who are suffering from vaginal prolapse should not be treated with mesh except in research contexts due to "serious" concerns over the procedure's safety, the NHS medical standards body has said.
The newly-released guidance from the National Institute for Clinical Excellence (NICE) effectively bans the use of mesh for prolapse in normal circumstances - though it is still recommended to treat other conditions.
The new ruling comes after a growing campaign from women who say they suffered serious pain and illness caused by the mesh and were not fully informed of the potential risks.
Mesh implants support damaged tissue and muscles to treat incontinence and prolapse, conditions which often occur following childbirth.
Some women say they have suffered crippling long-term pain after the operations, with some surveys suggesting that as many as one in ten women may suffer complications after the procedure.
The latest guidance from NICE said there are "serious, but well-recognised safety concerns" over the use of mesh to replace weakened tissue in the case of vaginal prolapse.
It also warned there was "inadequate" evidence over its long-term effects, both in terms of the amount of data available and its quality.
The guidance is the last of eight different rulings on the use of mesh for women suffering either stress urinary incontinence (SUI), or pelvic organ prolapse (POP).
The body says that mesh is still recommended as a standard treatment for two medical scenarios.
It can also be offered to treat five other conditions, but is subject to "special measures" which require enhanced patient consent due to a lack of comprehensive research supporting its use.
http://www.itv.com/news/2017-12-15/doctors-told-not-to-use-vaginal-mesh-to-treat-prolapse-due-to-serious-safety-concerns/
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Health watchdog warns of ‘serious safety concerns’ with vaginal mesh
Dec 15, 2017 | Metro
By Tom Herbert
There are ‘serious safety concerns’ with using mesh to treat vaginal prolapse, the health watchdog has warned.
The National Institute for Clinical Excellence (NICE) has raised concerns over vaginal mesh, saying ‘long-term efficacy is inadequate in quality’.
Guidance states mesh should be used for research purposes only, while other findings revealed it ‘showed no added benefit of using mesh compared with native tissue repair’.
The report says: ‘Current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows there are serious but well-recognised safety concerns. ‘Evidence of long-term efficacy is inadequate in quality and quantity.
Therefore, this procedure should only be used in the context of research.’
It adds: ‘When complications occur, these can be serious and have life-changing consequences.’
The recommendations come amid a growing campaign from women who have reported pain so intense they considered suicide, while others said they were unable to have sex after the operation.
Mesh, made out of polypropylene plastic, is used to strengthen the vaginal wall and treat incontinence and prolapse, which can happen after childbirth.
More than 92,000 women in the UK received the implants between April 2007 and March 2015. Around 1 in 11 are believed to have suffered complications.
This is the last of eight different rulings on the use of mesh for women who suffer stress urinary incontinence or pelvic organ prolapse.
Mesh is still recommend as standard treatment for two different scenarios and can also be offered to treat five other conditions.
http://metro.co.uk/2017/12/15/health-watchdog-warns-of-serious-safety-concerns-with-vaginal-mesh-7162330/
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UK watchdog says vaginal mesh to treat prolapse should be banned
Dec 18, 2017 | thejournal.ie.
Procedures using vaginal mesh implants have been carried out on women in Ireland since the late 90s and are still performed today.
THE UK’S HEALTH watchdog has recommended restricting the use of vaginal mesh implants for treating pelvic organ prolapse.
There has been global scrutiny surrounding transvaginal mesh devices, which are used in surgeries to treat two conditions women can develop following natural childbirth: stress urinary incontinence and pelvic organ prolapse. These procedures have been carried out on women in Ireland since the late 90s and are still performed today.
Health Minister Simon Harris recently asked the Chief Medical Officer to compile a report on the use of transvaginal mesh implants in Ireland, after complications suffered by a number of Irish women were highlighted by TheJournal.ie.
These complications include migration of the mesh, which can then protrude through the vagina, chronic pain, and recurrent urinary tract infections.
In guidelines issued today, the UK’s National Institute for Health and Care Excellence (Nice) said these procedures should only now be used for research purposes. It said current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows “there are serious but well-recognised safety concerns”.
Nice said all adverse events involving the medical devices (including the mesh) used in this procedure should be reported to the UK’s Medicines and Healthcare products Regulatory Agency.
“Further research should include details of patient selection, long-term outcomes including complications, type of mesh used and method of fixation, and quality of life.”
Vaginal mesh in Ireland
Last year in Ireland, 728 patients had a procedure for pelvic prolapse. The HSE has said it does not separate data for each operation to treat prolapse, so it is unclear how many of these involved the use of mesh.
The UK watchdog’s guidelines do not make any recommendations in relation to mesh devices used to treat the other condition treated with mesh – stress urinary incontinence. The most common procedure involves the use of what is called a mid-urethral sling, which supports the bladder.
Previous studies have shown that there is a higher success rate and lower complication rate for these procedures than there is for mesh operations to treat prolapse. Experts have said this is because operations to treat prolapse require the use of a larger amount of the polypropylene mesh.
However, campaigners are calling for an all-out ban on the use of these devices until further study has been completed.
In November, a Canadian mesh campaigner died, having suffered serious complications after a procedure to treat stress urinary incontinence. 42-year-old Chrissy Brajcic, from Ontario had her implant removed, but her pain had continued and she suffered regular infections.
She became resistant to antibiotics and was hospitalised in October this year suffering from sepsis. Brajcic died on 29 November.
‘The pain frightens me’
The Irish women who have experienced issues with mesh devices also had procedures to address stress urinary incontinence, rather than prolapse.
Janet Roche, 48, had her implant removed this year after seven years of chronic pain following her surgery.
However, she said she is still experiencing pain and has been told she will probably have chronic pain for the rest of her life.
“It’s constant pain medication, morning and night. Sometimes a sleeping tablet is the only thing that will work when it gets really bad. The pain frightens the life out of me, she told TheJournal.ie.
“I’ve gone from being a participant in the family to someone who is just being looked after.”
The Health Products Regulatory Authority (HPRA) has received six incident reports in relation to these devices and is asking women who have suffered complications to report it to them, which they can do through this form.
https://www.thejournal.ie/vaginal-mesh-4-3753070-Dec2017/
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Vaginal mesh ops restricted to research only
Dec 15, 2017 | WebMD
By Peter Russell
New restrictions on vaginal mesh implants means they should not normally be offered as routine treatment inthe NHS in England, the health watchdog has announced.
The decision comes after many women reported severe pain and disability after having the devices fitted.
In new guidance, the National Institute for Health and Care Excellence (NICE) says the use of meshes to repair vaginal wall prolapse should be restricted to research purposes.
Vaginal mesh implants are used for a variety of conditions, including urinary incontinence and pelvic organ prolapse after childbirth.
The meshes are made by different manufactures from a plastic called polypropylene. They have been used to support organs such as the vagina,womb, bladder, or urethra which may have been weakened while giving birth.
Pelvic painIn April this year, the BBC reported that more than 800 women in the UK are taking legal action against the NHS and the makers of vaginal mesh implants.
Some women have reported that the devices have perforated the lining of the vagina, leaving them in permanent pain, unable to walk or have sex.
One woman, Margie Maguire, 41, told the Victoria Derbyshire programme: "I havechronic pelvic pain on a daily basis and I'm on 9 different medications when I have a pain attack. These can last from 2 to 6 hours at a time and is like having a heart attack."
Another woman described how the mesh had cut its way through the wall of her vagina "like a cheese-wire".
'Insufficient evidence'According to NICE, current evidence on the safety and effectiveness of vaginal meshes is "insufficient in quality and quantity".
It says that in future, one procedure should only be carried out as part of a research study and that 5 procedures should only be offered with special measures in place for patient consent. A further 2 procedures are recommended for use with standard arrangements for consent.
The guidance also stresses the need for clinicians to be properly trained to undertake procedures involving vaginal meshes and for the reporting of side-effects.
In April, the MHRA released figures showing there were 733 adverse incidents in the UK for stress urinary incontinence and 346 for pelvic organ prolapse between 2012 and 2016.
A review earlier this year in Scotland concluded that vaginal meshes should not be routinely offered to women with stress urinary incontinence or pelvic organ prolapse.
https://www.webmd.boots.com/women/news/20171215/vaginal-mesh-operations-restrictions
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Don’t use vaginal mesh in routine prolapse operations, watchdog says
Dec 15, 2017 | iNews
By Heather Saul
The NHS health watchdog has recommended controversial vaginal mesh implants to treat prolapse should only be used only in the context of Government research.
Advice published today by the National Institute for Clinical Excellence (NICE) recommends the mesh is not used to treat prolapse in routine operations.
Vaginal mesh is an implant used to treat pelvic organ prolapse and stress urinary incontinence. It is made from the same material used to make drinks bottles and inserted into the vagina where it becomes embedded in the surrounding tissues.
Advice published today by the National Institute for Clinical Excellence (NICE) recommends the mesh is not used to treat prolapse in routine operations.
Nice said this guidance does not constitute a ban on the use of the procedure and their recommendation does not cover mesh as a treatment for stress urinary incontinence. The NHS is not legally compelled to act on it.
According to NHS data, over 92,000 women in England have had vaginal mesh implants fitted. A number of women say they have suffered debilitating pain as a long-term complications, others say they have been left unable to walk or have sex.
Recommendations published today state:
1: Current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows there are serious but well-recognised safety concerns. Evidence of long-term efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.
2: All adverse events involving the medical devices (including the mesh) used in this procedure should be reported to the Medicines and Healthcare products Regulatory Agency.
3: Further research should include details of patient selection, long-term outcomes including complications, type of mesh used and method of fixation, and quality of life.
Sir Andrew Dillon, NICE chief executive said: “Our updated advice on surgical procedures using mesh is based on the latest evidence available, which has been considered in the light of the serious concerns expressed by individual patients and patient groups.
“We emphasise the importance of patient consent and data collection and we are confident that our advice will give patients and health professionals the right information to make treatment decisions.”New Zealand takes action
On Tuesday, New Zealand became the first country to effectively ban vaginal mesh for the repair of prolapse and stress urinary incontinence.
UK regulator the MHRA says that mesh implants are effective for the majority of women and puts the complication rate of vaginal mesh implants at between 1-3 per cent. Campaigners say this figure could actually be as high as 10 per cent.
A spokesperson said: “Patient safety is our highest priority and we recognise some women do develop serious complications which can be very significant for the affected women. We also know many women derive benefit from these surgical procedures for what can be extremely debilitating conditions.
“We continue to work closely with NHS England, National Institute for Health and Care Excellence (NICE) and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications.
“We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card scheme.”
https://inews.co.uk/news/health/vaginal-mesh-prolapse-implants-used-research-health-watchdog/
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U.K.’s Health Watchdog Recommends Ban on Transvaginal Mesh
Dec 15, 2017 | Drugwatch
The U.K.’s National Institute for Health and Care Excellence has recommended a ban on transvaginal mesh for pelvic organ prolapse, according to guidance released Friday.
“The evidence for long term efficacy is inadequate in quality and quantity,” the health watchdog said in its official guidance. “Therefore, the procedure should only be used in the context of research.”
In its decision, the agency also weighed the concern over device complications voiced by patients and patient groups.
The National Health Service — England’s national health care system — does not have to act on recommendations, but experts say the recommendations will result in a de facto ban.
“The recommendations by [the National Institute for Health and Care Excellence] are highly significant, as I think they will make us all re-evaluate the way we use mesh,” mesh expert and former National Institute board member Dr. Sohier Elneil told U.K.’s Sky News.
In the U.K., about 14,500 women undergo mesh surgery to treat incontinence or pelvic organ prolapse, according to a 2012 Department of Health report.
That number is 38 times greater in the U.S., where 100,000 women undergo prolapse surgeries with mesh and 208,000 women undergo incontinence surgeries transvaginally with mesh, according to the FDA’s latest available figures.
So far, the U.S. Food and Drug Administration has not considered a ban in the U.S. nor has it commented on transvaginal mesh bans in other countries.Mesh Patient Advocate: U.K. Ban Doesn’t Go Far Enough
The U.K. agency’s recommendation follows recent bans on pelvic mesh in Australia and New Zealand.
Like Australia’s ban, the U.K.’s proposed ban focuses on mesh used to treat pelvic organ prolapse. That leaves mesh used to treat stress urinary incontinence on the market.
About 13,000 U.K. mesh surgeries a year apply to incontinence while only 1,500 are for prolapse, the U.K.’s Department of Health revealed in its 2012 report.
The founder of Sling the Mesh, a U.K. advocacy group for mesh-injured people, told the press the ban does not go far enough.
“By restricting the use of vaginal prolapse mesh to research only, it’s effectively a backdoor ban,” Kath Sansom told U.K.’s Sky News. “But it needs to go further to include the hundreds of women who suffer every day from mesh used to treat stress incontinence. They need to be taken seriously.”
New Zealand announced earlier this week that it would ban mesh for all urogynecological uses, including incontinence. It is the first country to announce a total ban on transvaginal mesh.
“As a consequence of the Australian [Therapeutic Goods Administration] review of surgical mesh for urogynaecological use, and subsequent regulatory action, there is a case for Medsafe to question the safety of certain devices,” Medsafe, New Zealand’s heath agency, said.BBC Panorama: Manufacturers Failed to Warn Doctors
Controversy surrounding transvaginal mesh implants increased this week after a recent BBC Panorama investigation revealed Johnson & Johnson’s Ethicon — one of the largest manufacturers of mesh — did not properly warn doctors about the risks of transvaginal mesh.
BBC Panorama’s investigation put a spotlight on conflicts of interest, weak clinical trials and a poor regulatory system for vaginal mesh in the U.K. The report aired just days before the announcement of the U.K. ban recommendation.
Ethicon, the maker of Gynecare TVT mesh (sold in the U.K. and the U.S.), did not properly inform doctors of the risks, according to BBC Panorama.
The company admitted it did not update its instructions for use for three Gynecare TVT implants with risk data until 2015. Still, the 2015 instructions contain insufficient risk data, Panorama found.
“I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the [instructions for use] so I fully understand these and communicate them,” urogynecologist Wael Agur told Panorama.
The investigation also revealed Ethicon tested one device, the TVT-Secur implant, only in sheep and 31 women for five weeks before selling it in 2006. The company pulled it from the market in 2012.
The J&J subsidiary is one of several mesh manufacturers facing lawsuits in several countries over allegations that transvaginal mesh implants are defective in design and caused serious complications, such as pelvic pain and organ damage. This includes about 28,000 federal cases in the U.S.
https://www.drugwatch.com/2017/12/15/uk-health-watchdog-recommends-ban-transvaginal-mesh/
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The Biggest Pennsylvania Court Decisions In 2017
Dec 18, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (December 15, 2017, 1:46 PM EST) -- The Pennsylvania judiciary logged another busy year in 2017 as members of both the appellate and trial benches handled major cases, including a wholesale reshaping of environmental law in the state and a string of eye-popping verdicts in pharmaceutical product liability cases.
The state’s Supreme Court, which is enjoying a period of stability following years of scandal and turnover that has seen four new justices assuming the bench since last January, had issued about 80 rulings as of mid-December, including rulings in more than 50 noncriminal cases.
These have run the gamut from a major medical malpractice ruling placing new obligations on physicians, to a decision breathing new life into the state’s so-called Environmental Rights Amendment, to less headline-grabbing cases including disputes over professional licensure and adoption and guardianship matters.
“[Something] that has struck me about the Supreme Court’s work this year is the diversity of cases it has accepted and decided,” said John Hare, chair of the appellate group at Marshall Dennehey Warner Coleman & Goggin PC. “They really run the gamut of the court’s jurisdiction and have required the justices to delve into a lot of areas that do not get much attention.”
Meanwhile, the Philadelphia County Court of Common Pleas continued to make news throughout the year as it saw several major verdicts in pharmaceutical product liability cases and a massive $227 million settlement in a case over a fatal building collapse.
Here, Law360 takes a look at some of the biggest cases to come out of Pennsylvania in 2017.
Shinal v. Toms
A Pennsylvania Supreme Court ruling handed down in June imposed new obligations on health care providers as the justices concluded that only doctors, and not their assistants, could obtain informed consent of patients for medical procedures.
“This will be a material factor in a lot of cases where the question of informed consent may not have been seriously raised in the past,” said Cozen O’Connor attorney Tom Wilkinson.
The justices revived a medical malpractice case after ruling 4-3 that a jury, which ultimately sided with the defense in the case, had been improperly allowed to consider evidence that qualified members of a brain surgeon's staff had provided information to a patient about the risks of a procedure she opted to undergo.
Instead, the court ruled, a physician's duty to obtain informed consent was "nondelegable."
Wilkinson said it remained to be seen whether lower courts, which will be tasked with applying the ruling, would be willing to carve out exceptions to the rule.
“The hospitals, obviously, make the case that it’s impractical under certain circumstances, as we will see whether what sounds like a bright-line rule might become a bit more flexible and whether there will be some exceptions that develop due to emergent circumstances,” he said.
The case is Megan Shinal et al. v. Steven Toms, case number 31 MAP 2016, in the Pennsylvania Supreme Court.
Pennsylvania Environmental Defense Foundation v. Commonwealth of Pennsylvania
After years of uncertainty following a plurality decision by the Pennsylvania Supreme Court invoking the so-called Environmental Rights Amendment of the state constitution, the justices handed down a 5-1 ruling in June breathing new life into the provision.
The ruling found that legislators had violated their responsibilities as trustees of public natural resources under Article 1, Section 27 of the Pennsylvania Constitution by transferring some $335 million in revenue from the leasing of state forestland for natural gas drilling out of an account reserved for conservation activities.
On a broader scale, however, Saul Ewing Arnstein & Lehr LLP partner Joel Burcat said the ruling represented a wholesale restating of the government’s obligations — from local zoning and planning boards to state permitting agencies — to address the environmental impacts of its actions.
“I don’t think we can understate the importance of the ruling,” he said. “What the Supreme Court did in this case was to completely rewrite Pennsylvania constitutional law with respect to the Environmental Rights Amendment.”
Bruce Merenstein, chair of the appellate group at Schnader Harrison Segal & Lewis LLP, said the case was all but certain to spawn litigation in courts across the state over whether the government was meeting its obligations under the amendment, especially in an era of waning enforcement from federal regulators under the Trump administration.
“In light of the new administration in Washington and the stories you’re seeing about the lack of environmental enforcement, you’re going to see more and more litigation in Pennsylvania state court,” he said.
The case is Pennsylvania Environmental Defense Foundation v. Commonwealth of Pennsylvania et al., case number 10 MAP 2015, before the Pennsylvania Supreme Court.
Professional Ethics Cases
A pair of rulings from the justices earlier this year helped to clarify what Merenstein said were the “sometimes confusing” questions over the scope of the Supreme Court’s authority to police the conduct of Pennsylvania attorneys.
“In both cases, a divided Supreme Court rejected challenges by lawyers to the state Legislature’s efforts to regulate attorney conduct,” Merenstein said.
The first decision — Villani v. Seibert — dispatched a constitutional challenge to the so-called Dragonetti Act, a decades-old law which allows for civil claims against attorneys for pursuing knowingly frivolous litigation.
The ruling overturned a suburban Philadelphia trial judge's conclusion that the Dragonetti Act was an unconstitutional encroachment of the judiciary's power to set rules governing the practice of law, and affirmed a private right of action allowing lawyers to be placed on the hook for pursuing claims without probable cause.
The second case — Yocum v. Commonwealth of Pennsylvania — rejected a constitutional challenge to a statute barring former employees with the Pennsylvania Gaming Control Board, including attorneys, from working with gambling facilities for two years after leaving the agency.
The justices rejected arguments that the statute, as applied to attorneys, ran afoul of the judiciary's power to regulate the practice of law under the Pennsylvania Constitution.
The cases are Jean Louise Villani etc. v. John Seibert Jr. et al. and Frederick Seibert Jr. et al. v. Jean Louise Villani, case number 66 MAP 2016, and Susan Yocum v. Commonwealth of Pennsylvania et al., case number 74 MM 2015, both before the Pennsylvania Supreme Court.
Philadelphia Building Collapse Settlement
Philadelphia’s robust plaintiffs’ bar made major headlines in February as it inked a $227 million settlement — the largest personal injury settlement in the state’s history — to end claims against the Salvation Army and others over a building collapse that caused seven deaths and left a dozen others injured.
The litigation stemmed from the uncontrolled collapse of a four-story building undergoing demolition on Market Street, one of the city’s most active commercial corridors, which sent an unbraced wall falling onto an adjacent Salvation Army store where the victims — employees and shoppers — were located.
The settlement came after a five-month trial — the longest in the city’s history — that found the Salvation Army, the owner of the collapsed building, and an architect overseeing the demolition project liable for the tragedy.
“It shows that the deep pockets of some defendants, either with or without insurance, can serve to multiply the value of these cases,” Wilkinson said.
Kline & Specter PC attorney Chip Becker, whose firm represented one of the victims in the case, said that the case, in addition to providing significant economic relief, also helped to drive important public policy changes based on revelations of lax oversight by the city.
“Not only was the collapse terrible, but what was revealed about how the city was handling and not handling the licensing and inspection of these projects was very profound,” he said. “I think the trial has prompted the city to increase its oversight over demolition.”
The case is Angelo Harmon etc. et al., v. The Salvation Army et al., case number 130700720, in the Court of Common Pleas of Philadelphia County.
Product Liability Verdicts
The Philadelphia County courts also hosted a string of trials against pharmaceutical companies and medical device manufacturers in the last year that resulted in several sizable awards for plaintiffs.
Major verdicts returned by Philadelphia juries in 2017 included a $57 million award in September against Johnson & Johnson unit Ethcon Inc. in a case over injuries from a pair of pelvic mesh products a woman received to treat symptoms of urinary stress incontinence.
Another major verdict came down earlier this month as a jury credited claims that Janssen Pharmaceuticals Inc. — another J&J subsidiary — and a Bayer AG subsidiary had provided inadequate warnings about the risk of bleeding associated with the anticoagulant medication Xarelto.
That verdict came with a $27.8 million damage award in favor of the plaintiff.
Wilkinson said that the number of cases moving forward to trial in the city — often as part of mass tort programs meant to consolidate hundreds of cases, from plaintiffs across the country, all dealing with a single product — was a testament to the quality of judges overseeing them and to top-notch administrative practices.
“The First Judicial District has become more proactive and prompt in case management,” he said. “Cases do not languish and the court is willing, if the numbers justify it, to coordinate like cases into mass tort programs.”
In addition to the $57 million verdict returned against Ethicon, the company faced a $20 million damage award in another mesh case in April, and a $2.2 million verdict in May.
The cases are Ella Ebaugh et al. v. Ethicon Inc. et al., case number 130700866, Beltz v. Ethicon Women’s Health and Urology et al., case number 130603835, Engleman v. Gynecare et al., case number 140305384, and Hartman v. Janssen Pharmaceuticals Inc. et al., case number 160503416, all in the Court of Common Pleas of Philadelphia County, Pennsylvania.
-- Additional reporting by Dan Packel. Editing by Rebecca Flanagan and Kelly Duncan.https://www.law360.com/articles/994950/the-biggest-pennsylvania-court-decisions-in-2017
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Johnson & Johnson ordered to pay $15M in vaginal mesh case
Dec 15, 2017 | Philly.com
By Sam Wood
A Johnson & Johnson subsidiary was ordered Thursday to pay $15 million in damages to a New Jersey woman who was left in chronic pain after receiving defective transvaginal mesh implants.
The case, heard in Bergen County Superior Court, was one of 9,000 pending cases involving Ethicon pelvic mesh devices. In September, a Philadelphia jury awarded $57 million to a Pennsylvania woman who required three operations to remove the implants which left her chronically incontinent. The company is appealing that verdict.
The jury found that Ethicon failed to provide adequate warning about the risks associated with the polypropylene mesh, which plaintiff Elizabeth Hrymoc, now 71, had implanted in 2008 to treat pelvic organ prolapse.
“Unfortunately, her injuries are permanent,” said Hrymoc’s attorney Adam Slater, of Mazie, Slater, Katz and Freeman. “One of the fundamental and horrific defects with this device is the inability to successfully treat complications, and Elizabeth is a clear illustration of what happened to countless other women.”
A spokeswoman for J&J was not immediately available for comment.
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Jury awards $15M to woman for faulty mesh implant
Dec 15, 2017 | nj.com
By Anthony G. Attrino
A jury in Bergen County has awarded $15 million in damages to a woman who claims a faulty transvaginal mesh implant caused severe and chronic pain, her lawyer said Friday.
Elizabeth Hrymoc of South River sued Johnson & Johnson after one of two pelvic mesh devices she received in 2008 caused her chronic discomfort and pain, her attorney Adam Slater claimed in the lawsuit.
The device was sold to Johnson & Johnson under the brand name Prolift and was designed by Ethicon. Johnson & Johnson no longer sells the Prolift device, Slater said.
The jury awarded $4 million to Hrymoc for her injuries, $1 million to her husband, Tadeusz Hrymoc, and $10 million in punitive damages, Slater said.
Hrymoc is one of thousands of New Jersey women who have sued Johnson & Johnson over the mesh implants, which were supposed to help fix bladder leakage or bulges in pelvic organs. Many of the cases have been consolidated in Bergen County Superior Court.
http://www.nj.com/bergen/index.ssf/2017/12/jury_awards_15m_to_woman_for_faulty_mesh_implant.html
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Can new regulations help ensure manufacturers perform effective post-market surveillance?
Dec 15, 2017 | epm
By Stephanie Ward
In this online exclusive, Stephanie Ward, a quality assurance engineer at technology and product design firm Cambridge Design Partnership looks at the new European medical devices regulation in more detail and the impact these may have on manufacturers.
As the complications of vaginal mesh implants make headlines again, the need for patients to be reassured by the medical device regulations is more important than ever. With routes to markets and manufacturer responsibility in the spotlight, can the European Medical Devices Regulation (MDR) help ensure manufacturers are not overlooking their products – and the patients they treat – once they are on the market?
The words ‘post-market surveillance’ (PMS) appear 129 times in the new European MDR. This repetition is not accidental. The requirements for manufacturers to ‘actively and systematically’ gather, record and analyse relevant data for the lifetime of each device they market is work most companies had not been conducting effectively – and the European Commission wants that to change.
PMS is the proactive activities carried out by manufacturers to establish, implement and keep up to date a systematic procedure to collect and review experiences of their devices on the market. The purpose is to identify any need to apply corrective or preventive actions.
The MDR significantly increases the role of PMS, requiring a ‘post-market surveillance system’ to be an ‘integral’ part of a company’s quality management system.
And, in my opinion, PMS is integral to ensuring a successfully marketed device – but, more than that, a device that is effective and de-risked as far as possible for the benefit of patients.
What can manufacturers do to establish an effective PMS system?
The MDR specifies that the manufacturer must plan, establish, document, implement, maintain and update a PMS system. The manufacturer is required to produce a PMS plan, specific to each of its products. This is key to the beginning of a successful, non-intrusive PMS system that can contribute to the development and long-term stability of a manufacturer’s device.
The plan must outline how to collect information from sources such as:information from vigilance, including trend reportingrecords referring to non-serious incidents and data on any undesirable side effectsinformation from specialist or technical literature, databases and/or registersinformation from feedback and complaints, provided by users, distributors and importerspublicly available information on similar medical devices
A company can use existing processes, or implement new ones, to achieve the above. These could be:complaints proceduresvigilance procedureschecking of competent authority websites for information on adverse events or recalls of similar devicespost-market clinical follow-up (PMCF) studiessetting up key-word alerts on search enginessocial mediafeedback from users (via email/website/surveys)
The data gathered is to be used in ensuring the quality, performance and safety of the device beyond the original pre-market data obtained. The manufacturer must produce a periodic safety update report (PSUR), which summarises the results and conclusions of its PMS, demonstrating continued safe and effective use. For high-risk devices, these are to be produced yearly and reviewed by the notified bodies for evaluation and reporting to the competent authorities. Any trends towards a significant increase in the frequency or severity of incidents could see actions being required to be carried out by the manufacturer — or ultimately the device being removed from the market.
The consequences
Speedy reaction to the possibility of adverse incidents will ensure any potential risk to public health is minimised, and a well-designed system to enable this is key.
Slow and reactive response to post-market data can be costly — in more ways than one.
The recent media coverage of the vaginal mesh implants has shown what slow follow-up from manufacturers can lead to. The mesh had been predicated onto the market as the same material had been used for hernia repairs. It is estimated that up to 10,000 women within the UK receive the implant a year, along with thousands more around the world. For some, the implant has caused pain after the device began to erode into the surrounding tissue and organs, also causing infections and other complications. The mesh cannot be removed simply, with many additional complications coming from attempted corrective surgery. Currently in the US, UK and Australia, hundreds of thousands of women are involved in lawsuits against the mesh producers. One manufacturer – Johnson & Johnson’s Ethicon — has since stopped selling the product.
This is not the only case of devices being recalled after thousands of patients have been exposed to the device before any adverse incidents have been realised.
The PIP breast implants scandal in 2012 showed regulators the issues with the vigilance and post-market clinical feedback systems in place at the time. The fraudulent change of the silicone grade in the implants — from the medical grade original approved for the market — went unnoticed until it was realised that the implants had double the rupture rate of other implants, but only after an estimated 400,000 women had the implants.
In 2010, St Jude Medical stopped selling its Riata defibrillation leads after the silicone coating insulating the electrical conductor wires within the leads was found to erode prematurely — sometimes leading to a malfunction of the life-saving device. Also in 2010, DePuy removed its metal-on-metal hip implants from the market after the rate of failure of these implants was determined to be greater than the polyethylene acetabular hip implant.
Will new regulations help?
The European MDR has been written with the knowledge of these previous complications. Surgical meshes, breast implants and joint replacements are now classified as Class III devices — the highest risk classification there is.
But what about other devices? Do we have to wait for a device to go wrong before regulations catch up?
The MDR has attempted to prevent any repeat events by requiring PMS for all classes of medical devices. With the oversight of the notified bodies, the competent authorities and the European Commission, updates to the instructions for use (the main port of call for users to find information on side effects), the manufacturing process, labelling and even the design itself are likely to be seen on a more frequent basis.
And, due to the requirement of a PMS plan being included in the device documentation pre-approval, manufacturers are required to design a system that answers how they are going to proactively collect data and ensure the continued benefit of the device over any risk. Visibility of this can only help to reassure the public that the industry has a ‘patient first’ outlook.
https://www.epmmagazine.com/opinion/can-new-regulations-help-manufacturers/
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Boston Scientific settles over 370 pelvic mesh lawsuits
Dec 18, 2017 | Mass Device
By Fink Densford
A federal judge in West Virginia this week dismissed approximately 378 recently settled lawsuits against Boston Scientific (NYSE:BSX) over supposed defective pelvic mesh implants, according to court documents released yesterday.
Pelvic mesh implants are used to treat pelvic organ prolapse and female stress urinary incontinence, and have been the source of a number of lawsuits which claim the devices have caused lasting damage to the individuals they are implanted in.
The Marlborough, Mass.-based company and the plaintiffs filed joint motions looking to dismiss the cases with prejudice on Wednesday, according to court documents, bringing an end to cases that had been in process for nearly 5 years.
No details were released as to the amounts offered in the settlements, and Boston Scientific has not yet provided any comment on the settled cases.
Boston Scientific has seen a mixed bag in terms of pelvic mesh suits over the past year.
In October, a federal appeals court upheld a plaintiff’s $27 million win over Boston Scientific in a product liability lawsuit brought over its Pinnacle pelvic mesh. But in May, a federal appeals court upheld a win for Boston Scientific in a product liability lawsuit brought over its Uphold pelvic mesh.
http://www.massdevice.com/boston-scientific-settles-370-pelvic-mesh-lawsuits/
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