Preview Newsletter
Ethicon Media Monitoring 12/10/2018
-
Mesh destroys 'intimacy in marriage' but Kiwi victim cannot sue
Dec 8, 2018 | Stuff.co.nz
By Cate Broughton
A woman, so damaged from vaginal mesh her husband was advised to wear two condoms to prevent being cut during sex, cannot sue the manufacturer because of ACC. -
Scotland’s other mesh scandal: Hernia patients reveal how their lives have been ruined by surgery
Dec 10, 2018 | The Sunday Post
By Marion Scott
Calls for action to help victims of Scotland’s second mesh scandal are escalating as the devastating toll emerges. -
Try talking the talk
Dec 8, 2018 | Newcastle Herald
By Joanne McCarthy
There weren’t many people in a court not so long ago – just some barristers, a nervous local government councillor waiting to be heard, a couple of court staff and me.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Mesh destroys 'intimacy in marriage' but Kiwi victim cannot sue
Dec 8, 2018 | Stuff.co.nz
By Cate Broughton
A woman, so damaged from vaginal mesh her husband was advised to wear two condoms to prevent being cut during sex, cannot sue the manufacturer because of ACC.
Jan*, 58, says the mesh has all but destroyed the intimacy in her marriage.
"It's affected me a lot because if my husband and I go to have relations it's always … I'm thinking am I hurting him?
"At one stage the doctor suggested we use double condoms and you know we're in our 50s and we're not interested in doing that."
Internationally, other cases have emerged of women suffering catastrophic injuries from surgical mesh including "a permanently destroyed vagina"
Jan joined about 20 Kiwi women to sue the manufacturer, Ethicon, owned by Johnson & Johnson in the US in 2014.
"I had no confidence that anyone in New Zealand could remove it and my hope was that I would get enough money to go to the US and have it removed."
But the Kiwi women's claims were dismissed by US district judge Joseph Goodwin following a challenge by Ethicon, mainly on the basis that they were eligible for cover by ACC.
"I am really pissed off that New Zealand taxpayers, ACC, district health boards … are paying for what I consider a faulty product," said Jan.
MESH REMOVAL
Jan, who was implanted with a mesh device in 2010 to treat Stress Urinary Incontinence (SUI), had part of the mesh cut out of her urethra last year.
However, she suspects the remaining mesh is eroding because of worsening pain.
Her doctor, one of 21 gynaecologists deemed to meet recent Australian standards for the procedure, did not put in a treatment injury claim to ACC as he did not believe anything was wrong.
After a recent request by the Ministry of Health to ensure tighter credentialing requirements, 21 surgeons in nine district health boards and an unknown number in private hospitals are performing mesh procedures for SUI.
Information provided to advocacy group Mesh Down Under by the ministry confirmed just two surgeons are qualified to fully remove mesh devices.
PAIN MAKES SEX VIRTUALLY IMPOSSIBLE
Caroline Evans was also among the women who tried to sue Ethicon. She had mesh procedures for SUI and pelvic organ prolapse in 2006 and 2009.
Both resulted in agonising pain, infection, disability and mental anguish.
For years doctors told Evans they didn't know why she had such severe pain and sex had become virtually impossible as a result.
Wellington gynaecologist Hanifa Koya removed some of the mesh but Evans paid $50,000 to travel to the US for high-risk surgery to remove the SUI "sling".
The surgery, which was successful, was made possible by Evan's mother who remortgaged her home to raise the money, a debt Evans was still repaying three years later.
Evans said her ACC claims were declined because the mesh damage did not meet their criteria for physical injuries.
ACC has spent $16.7 million on treatment and weekly compensation for surgical mesh injuries between 2005 to June this year. However, 22 per cent of claims for mesh injuries were declined.
Next year, Evans will take her fight for ACC cover to the district court.
Evans said it was wrong she could not sue the manufacturer. "I was angry, probably, angry that because we supposedly have a system that works – but it doesn't work – that makes it OK."
CATASTROPHIC INJURIES
US court evidence showing that medical device manufacturers knew surgical mesh could cause catastrophic injuries including "a permanently destroyed vagina" was provided to New Zealand politicians on a health select committee in 2014.
Lawyer Adam Slater, the lead litigator for the first pelvic mesh trial against Ethicon, a subsidiary of Johnson & Johnson wrote to the health select committee in 2014 to share information providing "a clear picture of the severe damage these devices cause to women".
Thousands of New Zealand women have been implanted with pelvic mesh devices to treat pelvic organ prolapse and SUI.
Among examples Slater provided the committee was a 2009 email from a urogynaecologist to an Ethicon product director for pelvic floor repair in which he described complications he was treating in one woman with a Prolift pelvic mesh device implanted by another doctor.
"She will likely lose any [sexual] function as her vaginal length is now 3cm and there is mesh extruding literally everywhere.
There is a large stone in the bladder from a bladder perforation with the anterior (mesh) arm ...this patient will have a permanently destroyed vagina, and I am only hoping to get her out of this without more morbidity."
In a 2005 email an Ethicon staff member advised the then medical director about urinary retention problems he and other doctors were seeing with patients following implantation, which they could not explain.
"But if this starts getting reported, it is going to scare the daylights out of the doctors."
Slater said there had been over 100,000 law suites against mesh manufacturers in the US alone.
The majority of women had settled with the companies but he still had several hundred cases pending.
One of his clients died before her case went to trial when infection from the mesh travelled to her lung.
Evidence presented in court for a class action trial by 1200 Australian women against Ethicon included an email from a consulting French doctor who invented a pelvic mesh device.
"I would not want my wife to undergo this procedure. And I don't think I'm alone in that."
The women were seeking damages in the hundreds of thousands of dollars, their lawyer Tony Bannon of Shine Lawyers told the court.
A verdict is expected early next year.
Jan joined about 20 Kiwi women to sue the manufacturer, Ethicon, owned by Johnson & Johnson in the US in 2014.
"I had no confidence that anyone in New Zealand could remove it and my hope was that I would get enough money to go to the US and have it removed."JASON DORDAY/STUFFJan says mesh has all but destroyed intimacy in her marriage. "If my husband and I go to have relations it's always … I'm thinking am I hurting him?
But the Kiwi women's claims were dismissed by US district judge Joseph Goodwin following a challenge by Ethicon, mainly on the basis that they were eligible for cover by ACC.
"I am really pissed off that New Zealand taxpayers, ACC, district health boards … are paying for what I consider a faulty product," said Jan.
MESH REMOVAL
Jan, who was implanted with a mesh device in 2010 to treat Stress Urinary Incontinence (SUI), had part of the mesh cut out of her urethra last year.
However, she suspects the remaining mesh is eroding because of worsening pain.
Her doctor, one of 21 gynaecologists deemed to meet recent Australian standards for the procedure, did not put in a treatment injury claim to ACC as he did not believe anything was wrong.
After a recent request by the Ministry of Health to ensure tighter credentialing requirements, 21 surgeons in nine district health boards and an unknown number in private hospitals are performing mesh procedures for SUI.
Information provided to advocacy group Mesh Down Under by the ministry confirmed just two surgeons are qualified to fully remove mesh devices. JASON DORDAY/STUFFJan joined a class action against manufacturer Ethicon in 2014 with the hope of winning enough money to pay for surgery in the US to have her mesh removed.
PAIN MAKES SEX VIRTUALLY IMPOSSIBLE
Caroline Evans was also among the women who tried to sue Ethicon. She had mesh procedures for SUI and pelvic organ prolapse in 2006 and 2009.
Both resulted in agonising pain, infection, disability and mental anguish.
For years doctors told Evans they didn't know why she had such severe pain and sex had become virtually impossible as a result.
Wellington gynaecologist Hanifa Koya removed some of the mesh but Evans paid $50,000 to travel to the US for high-risk surgery to remove the SUI "sling".
The surgery, which was successful, was made possible by Evan's mother who remortgaged her home to raise the money, a debt Evans was still repaying three years later.
Evans said her ACC claims were declined because the mesh damage did not meet their criteria for physical injuries.
ACC has spent $16.7 million on treatment and weekly compensation for surgical mesh injuries between 2005 to June this year. However, 22 per cent of claims for mesh injuries were declined.
Next year, Evans will take her fight for ACC cover to the district court.
Evans said it was wrong she could not sue the manufacturer. "I was angry, probably, angry that because we supposedly have a system that works – but it doesn't work – that makes it OK."JASON DORDAY/STUFFJan says she is "really pissed off that New Zealand taxpayers, ACC, district health boards … are paying for what I consider a faulty product".
CATASTROPHIC INJURIES
US court evidence showing that medical device manufacturers knew surgical mesh could cause catastrophic injuries including "a permanently destroyed vagina" was provided to New Zealand politicians on a health select committee in 2014.
Lawyer Adam Slater, the lead litigator for the first pelvic mesh trial against Ethicon, a subsidiary of Johnson & Johnson wrote to the health select committee in 2014 to share information providing "a clear picture of the severe damage these devices cause to women".
Thousands of New Zealand women have been implanted with pelvic mesh devices to treat pelvic organ prolapse and SUI.
Among examples Slater provided the committee was a 2009 email from a urogynaecologist to an Ethicon product director for pelvic floor repair in which he described complications he was treating in one woman with a Prolift pelvic mesh device implanted by another doctor.
"She will likely lose any [sexual] function as her vaginal length is now 3cm and there is mesh extruding literally everywhere.
There is a large stone in the bladder from a bladder perforation with the anterior (mesh) arm ...this patient will have a permanently destroyed vagina, and I am only hoping to get her out of this without more morbidity."
In a 2005 email an Ethicon staff member advised the then medical director about urinary retention problems he and other doctors were seeing with patients following implantation, which they could not explain.
"But if this starts getting reported, it is going to scare the daylights out of the doctors."
Slater said there had been over 100,000 law suites against mesh manufacturers in the US alone.
The majority of women had settled with the companies but he still had several hundred cases pending.
One of his clients died before her case went to trial when infection from the mesh travelled to her lung.
Evidence presented in court for a class action trial by 1200 Australian women against Ethicon included an email from a consulting French doctor who invented a pelvic mesh device.
"I would not want my wife to undergo this procedure. And I don't think I'm alone in that."
The women were seeking damages in the hundreds of thousands of dollars, their lawyer Tony Bannon of Shine Lawyers told the court.
A verdict is expected early next year.
SUPPLIEDFrom left Charlotte Korte, Carmel Berry and Patricia Sullivan, founders of Mesh Down Under a support and advocacy group for people injured by surgical mesh.
https://www.stuff.co.nz/national/health/109061370/mesh-destroys-intimacy-in-marriage-but-kiwi-victim-cannot-sue
-
Scotland’s other mesh scandal: Hernia patients reveal how their lives have been ruined by surgery
Dec 10, 2018 | The Sunday Post
By Marion Scott
Calls for action to help victims of Scotland’s second mesh scandal are escalating as the devastating toll emerges.
Mesh used to treat prolapse and incontinence has already been exposed as causing devastating injuries to thousands of women around the world, including hundreds in Scotland. But up to 30% of the almost 10,000 hernia mesh patients in Scotland each year may also face complications.
Some patients have told how their hernia surgery has left them crippled with pain and unable to work or walk.
MSP Neil Findlay said Health Secretary Jeane Freeman needs to take charge of the situation, unlike her predecessor Shona Robison, who he says failed to take effective action to halt the use of transvaginal mesh.
The Labour MSP warned the government “must get in front of the situation.”
Mr Findlay said: “There are five times the number of hernia mesh patients as transvaginal mesh patients, and if the government does not act now and take a grip of this situation we are facing a major health crisis.
“The risks and dangers of that type of mesh were exposed in Scotland thanks to the bravery of victims willing to speak out. But still it took the government almost six years to act over transvaginal mesh which is now recognised as the worst global health scandal of modern times.
“We cannot have a repeat of that fiasco when so many more lives are affected.”
A 10th of people will develop a hernia, when part of an organ pushes through the muscle or tissue holding it in place, and the most common treatment is for surgeons to push bulging material back into the body and cover it with surgical mesh.
Surgeons admit the use of mesh can cause complications but say non-mesh treatments can also be problematic and what is important is that patients are fully informed and properly advised.
Last week, former Chief Petty Officer David Foulkes, 56, told The Sunday Post how he had a testicle removed after a hernia operation left him crippled in pain.
He said: “We all need to speak up because doctors are in denial.”
Politicians are calling for hernia mesh to be suspended to fall in line with the suspension of bladder and pelvic organ prolapse mesh that has left hundreds of thousands of women injured around the world.
Health Secretary Freeman has warned of her “dismay” over the lack of action by regulators and promised she will act.
But Mr Findlay’s call for a hernia mesh suspension and a safety inquiry, backed by former Health Secretary Alex Neil, will be repeated in Parliament next week as he asks why surgeons are in denial over the risks.
Patients are being forced to use their savings to seek medical attention in England, with surgeons south of the border offering complete removal of devices.
He said: “It is unacceptable that Scottish patients are having to seek help elsewhere. I will be asking Jeane Freeman what she is going to do to ensure patients here are getting the very best treatment available.”
Graham Robertson , 52, a former mountaineer and Duke of Edinburgh Award leader has been left in agony by surgery to repair a hernia and is struggling to cope with his ruined health.
Graham, from Bridge of Weir, Renfrewshire, said: “My life has been destroyed by what I was told was a ‘gold standard’ procedure that was supposedly so simple, I didn’t even need an overnight stay to repair the hernia in my groin.
“Within weeks, I was on some of the most powerful painkillers that can be prescribed, and the nightmare has never ended.
“Now I’ve lost my job, I can’t do any of the everyday things I used to take for granted.”
He is the latest man to reveal they are also victims of plastic mesh used by surgeons to treat hernia after thousands of women around the world were revealed as victims of transvaginal mesh used to treat prolapse and bladder problems.
Graham used to run his own furniture firm, and reckons years of heavy lifting caused his hernia.
Graham said: “I’ve seen several surgeons in a desperate bid to see if anyone can help me with the agonising pain. But they just keep saying every procedure can have complications, and I’m just one of the ‘unlucky’ ones. Nobody warned me before my operation, and nobody wants to take responsibility.”
He has been warned that further surgery could have further, devastating, side effects. “I had no idea my whole life could be ruined by mesh. I can’t even pick up my one year old grandson and give him a cuddle,” he said.
Graham said the pain from the mesh inside his body is like “being strangled from the inside” and he has been so low, he has been suicidal.
He said: “You feel so low and worthless. I’ve had many times when I’ve even considered what’s the point of trying to struggle on with what is left of my life in constant pain?
“Then I look at my family and I know I couldn’t do that to them. I’ve been all kinds of antidepressants but they don’t touch how bad I feel. There are thousands struggling in silence.
“I understand that hospitals use it because they think it’s a quicker, cheaper fix. It might save the NHS a few pennies, but when things go wrong, patients’ lives are destroyed. Once you’re mesh injured, it’s impossible to be put back together.”
Before he received a mesh repair for a groin hernia, mechanic John McFadden bagged 90 Munros across Scotland.
Now he struggles to bend down and has suffered five years of intolerable pain.
John, from Lennoxtown, said: “When I went to get the hernia repair, nobody explained there could be complications and I certainly wasn’t told about mesh or given any alternative.
“Today, I’m a shell of the man I once was. If I didn’t work in our family business I’d be unemployable because I’m always having to rest up or take time off because of the pain.
“Mesh has destroyed my life,” said John, 39.
John has spent the last five years being prescribed the strongest painkillers available, and has lost count of the specialists he has seen.
He said: “Nobody wanted to believe mesh was the problem until one specialist actually admitted that it was and the reason they use mesh is that it’s quicker and cheaper and less experienced surgeons can carry out the procedures.”
Just over a year ago John finally persuaded his consultant to remove the mesh. He said: “I’m still in agony and suspect there’s mesh still left inside me. I’m thinking about having a private ultra-sound scan in England.
“If surgeons here can’t remove mesh, they shouldn’t be putting it in.
“Scotland needs the ultra-sound equipment to see where mesh is inside patients, and we need surgeons with the skills to remove mesh implants without causing further nerve damage.”
A mum has had to spend thousands getting hernia mesh removed in London after being warned surgery in Scotland could leave her with major nerve damage.
Lesley Hughes, 54, from Edinburgh, feared she would end up crippled in a wheelchair after a “routine” hernia repair to her groin a year ago.
The Edinburgh City Council worker said: “Within a few weeks of getting hernia mesh, I was in so much pain and became so ill there were times when my body shut down and I had to use a wheelchair.
“I couldn’t understand what was wrong with me because I’d been assured there was only a slight risk of pain afterwards, and the operation itself had appeared to have gone well.
“But as the weeks went on, and I kept trying to get back to work and having to take time off again, I realised something was seriously wrong.
“I was in terrible pain, I felt ill all the time, I was totally exhausted, and at one stage I simply couldn’t move.”
Lesley went to see a top Scottish hernia surgeon and was told that the mesh could be removed but she could face major nerve damage as a result.
Not only that, she would have to wait till at least next year for any NHS help as no appointments were available.
The mum of two did her own research and finally found a surgeon in London who could remove all of the mesh without the same risk of nerve damage.
After talks with her family, Lesley decided to raise the £7,500 for the operation.
She said: “I couldn’t take the risk of having to wait. After the surgery, I was assured removal had gone very well and I’d escaped nerve damage which was a huge relief compared to the prognosis I had been offered in Scotland.
“Almost a month down the line and I feel I’ve had the ‘monster’ removed from my body.”
Lesley is backing the call to suspend hernia mesh use.
She said: “I’ve had a lucky escape, but what about the others who haven’t?”
https://www.sundaypost.com/fp/scotlands-other-mesh-scandal-hernia-patients-reveal-how-their-lives-have-been-ruined-by-surgery/
-
Dec 8, 2018 | Newcastle Herald
By Joanne McCarthy
There weren’t many people in a court not so long ago – just some barristers, a nervous local government councillor waiting to be heard, a couple of court staff and me.
The male barrister looked to be in his 60s. He was quite affable and had one of those plummy, deep, resonant but pleasant voices that plays well in court. Those kinds of voices suggest intelligence, a person comfortable with debating issues, and authority. They also suggest a comfortable background and, it must be said, quite probably a private school boys-only education, with lots of rugby, boater hats, high expectations and a keen sense of the importance of having good connections for life after school.
The female barrister had a similar kind of voice. I’d watched her in court before that day. She was quick-witted, no-nonsense, clinical in her questioning and firm but fair with witnesses.
I was there because of the councillor. He had challenged his council on matters that he felt he had a responsibility to challenge. The council responded in a heavy-handed fashion.
We were waiting for something when the barristers started talking about a matter that was in the news that day. The female barrister laughed about not being able to believe what was in the news, her colleague responded with his own disparaging comments, and they had a great time making the kind of generalised negative comments about “the media” that wouldn’t be out of place at a Donald Trump rally.
It annoyed me intensely.
I felt like jumping up and asking how long they thought judges or barristers would remain safe in a country without an independent media. You only have to look around the world right now to know that just calling a country a democracy doesn’t mean the rule of law, or even basic human rights, necessarily follow.
I wanted to ask them how, exactly, they thought a democracy minus the media would operate; whether their dismissal of “the media” was as broad-brush as it came across, or whether it allowed a sliding scale of credibility for different media outlets, or forms of media. And the list went on.
I did enjoy one aspect of that day. A judge criticised a legal firm for the very large costs it sought to reclaim for the council matter, and knocked the bill down to size by a factor of tens of thousands of dollars.
Defamation is exercising the minds of many journalists, media outlets and some within the law right now, with a NSW-led review of Australia’s defamation laws considering whether unreasonable limits are placed on “the publication and discussion of matters of public interest”.
These are the kinds of cases where media outlets take on governments, corporations and powerful people whose actions are not in the public interest, and where the media is often needed to prod or shame governments or regulators to respond.
Recent high-profile defamation court cases have shown how costly, complicated and fraught they can be, how technical the arguments, and how inappropriate a forum in which to test matters of sex, power and gender as society struggles to deal with changing attitudes.
Then there is the way the threat of defamation is used by powerful people to silence critics – often average Australians – by the dodgy to scare off questioners, and by thugs and bullies to intimidate people.
I have in front of me letters sent by a pelvic mesh manufacturer to a woman patient who complained to authorities after catastrophic injuries when she was implanted with a device. The letter doesn’t use the word “defamation”, but it carries a threat.
“We are concerned about you disseminating incorrect information about the device. We are concerned about the harm that causes to our company,” the letter said.
The manufacturer wrote letters to doctors as well, and to the Newcastle Herald when I began writing about pelvic mesh. It was a little more liberal with the word defamation in those letters, warning about the risk of “legal proceedings” against the doctors and this newspaper if we made “damaging and defamatory statements”.
It was acting “to protect its reputation”.
Its device is one of many that are no longer available in Australia because they failed to meet safety and efficacy standards, and failed women.
Writing about some of the doctors who used the mesh devices also carried risks. It was in the public interest to report on a matter that is now acknowledged as a global scandal, but doctors with big egos and questions to answer don’t hesitate to remind you they have a lawyer.
I have other documents showing defamation threats made to people who dared raise allegations of child sexual abuse to churches, schools and other institutions over decades. They include two women who reported serious allegations about a teacher to the Catholic Education Office in the 1980s.
They were told they had “better watch yourselves because you could be prosecuted for continuing to make allegations”.
The teacher was eventually charged with child sex offences. The women were horrified to discover years later that the Catholic Education Office that threatened them with “prosecution” for making allegations had employed the teacher, despite knowing he had already been convicted of child sexual offences.
I know of many cases where threats of defamation were used by people in local government in attempts – some successful – to shut down people asking the kinds of questions that needed to be asked.
A lawyer in an article about the chilling effect of Australia’s defamation laws on public interest journalism said there was a sense that some judges “don’t get what journalists do”.
I tend to agree. The discussion by the two barristers in the court that day was so blinkered, so dumb, that it was almost shocking. But if you’re a powerful person, and articulate, and have the means to stand up for yourself when things go wrong, you can lack a sense of what it’s like to be at the end of the food chain, where having your rights trampled can be almost a daily event.
You only have to look at major inquiries launched in Australia over the past few years – the banking royal commission, the child sexual abuse royal commission, the NSW Independent Commission Against Corruption inquiries that snared politicians from both major parties – to see the consequences of public interest journalism in action. And each involved walking the tightrope of defamation laws during the fight to get those inquiries established.
https://www.theherald.com.au/story/5796380/try-talking-the-talk/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested