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Ethicon Media Monitoring 8/14/2017
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Lamborghinis, ski trips used to market controversial mesh implant to surgeons, documents show
Aug 14, 2017 | ABC Online
By Sophie Scott and Alison Branley
Lamborghinis and ski trips to the Swiss Alps were among the incentives a pharmaceutical giant developed to market a surgical device that has ruined the lives of hundreds of Australian women. -
Vaginal mesh campaigners welcome 'major development'
Aug 11, 2017 | BBC
By Marie-Louise Connolly
At least one woman in Northern Ireland has been offered a surgical consultation in London, with a view to removing her vaginal mesh implant. -
'It’s like watching a car crash in slow motion': Leading surgeon reveals she feared 20 YEARS ago scandal-hit vaginal mesh procedure would cause problems for women but was ignored
Aug 11, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
A leading surgeon has launched a scathing attack on the scandal-hit vaginal mesh procedure that has destroyed the lives of thousands of women as being 'like a car crash in slow motion'. -
Arkansas Ethicon Hernia Mesh Failure Injury
Aug 11, 2017 | The Legal Examiner
By Shezad Malik
Arkansas Ethicon Hernia Mesh Failure Injury. Jennifer Stone, from Arkansas, recently filed a product liability and personal injury lawsuit against Johnson & Johnson and its Ethicon subsidiary claiming that problems with Ethicon Physiomesh hernia mesh patch caused her suffer multiple serious injuries. -
Pain from Surgical Mesh Complications Dropped Physiomesh Patient “To My Knees”
Aug 12, 2017 | Lawyers and Settlements
By Gordon Gibb
It might be argued that an 86-year-old individual shouldn’t be spending his twilight years suffering debilitating pain and surgical mesh complications from an allegedly defective surgical product.
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Lamborghinis, ski trips used to market controversial mesh implant to surgeons, documents show
Aug 14, 2017 | ABC Online
By Sophie Scott and Alison Branley
Lamborghinis and ski trips to the Swiss Alps were among the incentives a pharmaceutical giant developed to market a surgical device that has ruined the lives of hundreds of Australian women.Key points:Documents show Johnson and Johnson tried to sell mesh product to surgeons as a simple and high-earning procedureThe mesh devices have left at least 3,000 Australian women with serious side effectsPatients seeking full removal concerned by lack of Australian surgeons willing to do it
Documents obtained by the ABC show the extent to which Johnson and Johnson oversold its surgical mesh products, which are used to treat incontinence and prolapse after childbirth.
They paint a picture of a company that tried to sell surgeons a jet-setting lifestyle where they could insert four devices "before lunch" and notch up $10,000 in surgeries in a single morning.
The mesh devices have left at least 3,000 Australian women with serious side effectsincluding chronic pain, infections and inability to have sex, and are the subject of both a Senate inquiry and a class action.
New court documents released in the class action against Johnson and Johnson show that as early as 2009, concerns were raised inside the company that it was making "a huge mistake" by commercialising its latest brand of mesh, was "rushing to market", and opening up the use of the product to "unqualified surgeons".
Lawyers from Shine, who are representing the women in the class action, claim the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh.
The revelations have angered women such as Melbourne mother Shauna Cahill whose injuries from the mesh have left her in a wheelchair.
The 35-year-old has been in constant pain since having the product implanted just over a year ago.
"On a bad day my son will have to take me to the toilet," she said. "I feel like I've failed my kids. I feel like I've robbed them of their childhood."
She viewed some of the marketing materials tendered to the court and was horrified.
"If you read what's in that brochure, you'd definitely put your hand up and say, 'I'll have one of those', but that's not what I got," she said.
Sydney gynaecologist Professor Theirry Vancaillie has backed patients' concerns about the marketing of the mesh kits.
"There was a tendency to operate on more patients and on patients who may not have needed the insertion of the mesh," he said. "It's probably been a bit oversold."Company 'confident' of mesh safety
A spokeswoman for Johnson and Johnson said it could not comment on documents presented in the class action because it was still before the courts.
It said it provided safe products through surgeon training, product safety requirements and the medical technology code of conduct.
"These products were developed in close consultation with specialist surgeons and are backed by clinical research," she said.
"We have confidence in the safety and efficacy of these mesh products, they are backed by scientific research."
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists said the appropriate marketing of devices was "critically important" but president Professor Steve Robson said it was "beyond the control of the college"
Patients seeking full mesh removal say they face resistanceWomen who are suffering severe side effects from the mesh said their pain was compounded when they couldn't find an Australian surgeon willing, or able, to fully remove the device.
Patient groups said many doctors were reluctant to fully remove meshes because of a mistaken perception it was sufficient or safer to only partially remove it.
Professor Vancaillie from the Women's Health Research Institute of Australia has just returned from the United States where he's learned to do full removals under US expert surgeon Dr Dionysios Veronikis.
"I believe that Dr Veronikis has shown that by removing mesh in a number of, several hundreds of cases, that he achieves better results in pain management," Dr Vancaillie said.
Patient groups are trying to get Dr Veronikis to visit Australia but said they had encountered resistance.
The college maintains there are surgeons in Australia with the required skills and all urogynaecologists are trained in the procedure.
"I'm not sure why some women have felt they need to go to America. There are a number of units around the country who have services specifically to deal with mesh and mesh complications," Professor Robson said.
'There's a lot of arrogance in this industry'
Perth mother Carolyn Chisholm, who founded the Australian Pelvic Mesh Support Group, said many surgeons in Australia had not done the procedure.
"I have done a poll and 70 per cent of women who've had a partial removal are worse off after their partial removal," she said.
"I think there's a lot of arrogance in this particular industry."
In the mean time, women in pain are waiting up to a year in the public hospital system for full or partial removals.
Ms Chisholm said some patients had been told they could have a full removal, only to experience the opposite.
"Then they go under the anaesthetic and they come out a few hours later and the surgeon says, 'I'm really sorry we only removed 2 centimetres of your mesh'."
The college said it was important to respect surgeons' judgement because they tried to minimise risk.
"It's very individual, it has to be something that is subject to assessment," Professor Robson said.'Just to make dinner, I stand there crying'
Mother of two Stella Channing said she would wait until Dr Veronikis came to Australia.
"My mesh is like a hammock and so standing up, it's like trampoline springs, it all pulls," she said. "Just to make dinner, I stand there crying."
The Perth woman said she was unhappy with the response of her original surgeon and a specialist pelvic pain centre, which was unable to help her.
"I went back to the implanting surgeon and he acted as if I was only the only one who had an issue with this mesh," she said.
"They don't know how to treat mesh-injured women, so I've actually stopped looking for help in Australia. It has shaken my faith in the medical community."
The Royal Australia and New Zealand College of Obstetricians and Gynaecologists said it was important to remember many women had good results from mesh and it was particularly effective for urinary incontinence.
"If women have … gone back to their surgeon and have not got a fair hearing, that's wrong, I'm extremely sorry," Professor Robson said.
He said the profession had learned lessons from the women's health scandal.
"I don't want people to get the sense that people were guinea pigs or experiments at all. People were trying to help a distressing problem."
Patients are calling for a moratorium on implanting the remaining products on the market, but surgeons said the mesh option should be available as a last resort.
http://www.abc.net.au/news/2017-08-14/surgical-mesh-maker-used-fast-cars-to-market-device-doctors/8796838
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Vaginal mesh campaigners welcome 'major development'
Aug 11, 2017 | BBC
By Marie-Louise Connolly
At least one woman in Northern Ireland has been offered a surgical consultation in London, with a view to removing her vaginal mesh implant.
The offer was made by the Belfast Health Trust.
It follows BBC reports that a number of women felt physically and mentally scarred after having the implants.
A support group for women from Northern Ireland who have had the surgery has described the move as a major development.Vaginal mesh surgery advice issuedMesh led to 'excruciating pain'Hundreds suing NHS over vaginal implantsWhat's the issue with mesh implants?
In a statement, the Belfast Health Trust said it would treat each case individually but for those whose condition is more complex it would "refer, using the extra contractual referral guidance, to a clinical centre in London."
In June 2017, a group of women from across Northern Ireland went public with very personal accounts of how mesh implants had left them physically and mentally wrecked.'Constant pain'
The implants are used by surgeons to treat organ prolapse and urinary incontinence.
Law lecturer Mary McLaughlin said she had been left in constant physical pain since her operation in 2008.
"My bowel has stopped working, my bladder has stopped working - this means that all my social interactions have been curtailed and I only leave the house if I can," she said.
"You feel very lonely and you feel that people do not realise you are in pain."
Many of the women have criticised the health trusts for ignoring their complaints - but in a major development, Ms McLaughlin has heard that the Belfast Health Trust has agreed to send her to London to see a specialist.'Encouraged'
She said the past 10 months had been spent writing to consultants and the Belfast Health Trust, who she said passed her around like a parcel from one doctor to another.
"I have a back ground in law and public policy and I have found it incredibly difficult to move this to a transfer to the extra contractual referral," she said.
"It is a closed system, the patient is excluded, we do not see the documents that are submitted and the trust has stonewalled me on several occasions."
Susan McLarnon, from the support group Meshed Up NI, said the group had been "encouraged" by the news. There are now 250 people in the support group.
"We hope that this now sets a precedent for other women - there are three others waiting on confirmation to also go to England," she said.
http://www.bbc.com/news/uk-northern-ireland-40898220
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Aug 11, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
· Suzy Elneil, of University College London Hospital, is trained to remove mesh
· She is one of just a handful of surgeons that have the ability to do so in England
· Her comments follow the emergence of the scandal-hit surgery in recent months
· Hundreds of British women have been left suicidal as a result of being ignored
A leading surgeon has launched a scathing attack on the scandal-hit vaginal mesh procedure that has destroyed the lives of thousands of women as being 'like a car crash in slow motion'.
Suzy Elneil, based at University College London Hospital, is one of just a handful of urogynaecologists trained to remove the brittle devices which so often erode into tiny fragments inside women.
But Dr Elneil has revealed to MailOnline she first became concerned that problems would emerge in women given the surgery 20 years ago. However, it's become clear that her claims were ignored.
Her comments have been provoked following the emergence of the widespread damage this controversial surgery has caused in recent months. Some have compared it to the thalidomide scandal and accused NHS officials of attempting to to cover it up.
Calls for a public inquiry have been growing since it became news that at least 800 affected women are suing the health service and device manufacturers - but just two weeks ago Government officials rejected calls for a ban.
Tireless fights by campaigners have asked for the surgery, which has left hundreds of British women suicidal because of their life-changing complications, to be halted until a thorough safety review is undertaken.
Dr Elneil raised concerns about the operation when she first saw the procedure, which sees a piece of plastic placed into a delicate area, being performed 'blindly' in 1997. She was with her mentor at the time.
She told MailOnline: 'Both of us were unsure about the procedure as it worried us that it was blind in nature, and it involved inserting a piece of polypropylene or plastic using sharp large needles into a rather complex anatomical space.
'It felt like the nature of the woman’s tissue, the nature of the mesh, the anatomical complexity and the blind approach were not issues meant to be considered. We were fearful as we suspected there would be many complications in the future.
'There is no doubt that we felt as if one was watching a car crash in slow motion taking place in the pelvis. Having removed multiple meshes used for both prolapse and incontinence, it feels that that fear was realised.'
Dr Elneil was invited to join a Government inquiry into the usage of surgical mesh but was dropped from the committee 18 months ago. The report, released two weeks ago, was met with backlash from outraged women.
Upon investigation, officials confirmed that many more women have complained of injuries than previously suggested and called for a helpline to support victims. But it did not look at the safety of the mesh and rejects calls for a ban.
Instead, it said hospitals should ensure that surgeons be trained to implant it; at the moment any gynaecologist can perform the procedure. Campaigners reacted with fury at the findings.
English health officials have yet to acknowledge the risks of the brittle implants which can shrink, twist and curl at the edges and cause nerve damage. Currently, the NHS and MHRA state only 1 to 3 per cent will experience complications such as pain.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with officials accepting that up to 40 per cent of women may experience injury.
Fights by campaigners have helped gather momentum for a public inquiry into the implants, with MPs now beginning to ask questions about the safety of mesh and calling for further investigations over the devices.
Earlier this week, MailOnline revealed how the NHS has ignored damning studies that show the damage controversial vaginal mesh procedures cause to be much higher than the health service is willing to admit.
Published in various journals, the alarming evidence which revealed pain, erosion and perforation to strike up to 40 per cent of women, prompted doctors in three US states to suspend the practice and saw them call for a review into its safety.
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence and which did not require specialist training to implant. More than 10,000 women a year have the mesh procedure.
At least 800 women are suing the NHS and device manufacturers over the use of vaginal mesh implants.
http://www.dailymail.co.uk/health/article-4781500/Leading-surgeons-blast-scandal-hit-vaginal-mesh-procedure.html
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Arkansas Ethicon Hernia Mesh Failure Injury
Aug 11, 2017 | The Legal Examiner
By Shezad Malik
Shezad Malikis an attorney with Shezad Malik Law Firm
Arkansas Ethicon Hernia Mesh Failure Injury. Jennifer Stone, from Arkansas, recently filed a product liability and personal injury lawsuit against Johnson & Johnson and its Ethicon subsidiary claiming that problems with Ethicon Physiomesh hernia mesh patch caused her suffer multiple serious injuries.
Stone filed her claim in the U.S. District Court for the Eastern District of Arkansas, alleging that the hernia mesh multi-layer coating is defective and an unreasonably dangerous design. According to Stone this sandwich design lead to a severe inflammatory response, fluid build up known as a seroma, movement of the patch and damage to abdominal tissue.
Stone received an Ethicon Physiomesh Composite mesh for a hernia repair surgery in 2011. Over the next few years, she developed severe bacterial infections and breakdown of the mesh requiring invasive surgery to fix.
Ethicon Physiomesh Hernia Mesh “Voluntary Recall”
After worldwide reports over the similar side effects from the Ethicon Physiomesh, Ethicon announced a voluntary recall in June 2016. But, in the United States, Ethicon removed the hernia mesh implants under the radar and labeled it as a “market withdrawal.”
What is the problem with the Ethicon Physiomesh?
Ethicon released its Physiomesh products in 2010, utilizing the U.S. Food & Drug Administration’s (FDA) 510(K) program. This “fast track” loophole allows a medical device to come to market without any human clinical trials, as long as a manufacturer can show that it is “substantially equivalent” to another product previously approved by the agency.
Ethicon Physiomesh claims a unique design with five distinct layers, that supposedly improves function. Ethicon Physiomesh has a sandwich design, with two layers of polyglecaprone-25, and two layers of polydioxanone film. The coating was applied to the polypropylene mesh to reduce adhesion, inflammation and help the mesh fix into the body.
According to experts, the design is defective in that the sandwich design and the Physiomesh coating blocks fluid to escape, causing seroma formation, infections, and other side effects.
Ethicon Physiomesh Hernia Mesh Multidistrict Litigation
The U.S. Judicial Panel on Multidistrict Litigation (JPML) recently approved Multidistrict Litigation or MDL to coordinate pretrial proceedings and centralizing all cases before U.S. District Judge Richard Story in the Northern District of Georgia.
The federal multidistrict litigation currently houses over 100 Physiomesh injury claims.
http://fortworth.legalexaminer.com/medical-devices-implants/arkansas-ethicon-hernia-mesh-failure-injury/
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Pain from Surgical Mesh Complications Dropped Physiomesh Patient “To My Knees”
Aug 12, 2017 | Lawyers and Settlements
By Gordon Gibb
Dartmouth, NS It might be argued that an 86-year-old individual shouldn’t be spending his twilight years suffering debilitating pain and surgical mesh complications from an allegedly defective surgical product. But such is the fate of a Canadian man who alleges that Ethicon Physiomesh, which has been recalled by Health Canada, is responsible for his suffering.
According to a report from the Canadian Broadcasting Corporation (CBC 06/05/17) in Dartmouth, Nova Scotia Eric Hagen went into Dartmouth General Hospital for a hernia repair procedure in 2012. According to court records Ethicon Physiomesh was used. The aforementioned mesh had been introduced in the US and Canada about two years prior, in 2010.
“The surgeon, she told me that she used the mesh,” Mr. Hagen said, in comments to the CBC, because at the time, “this is a new thing.” Hagen had suffered an abdominal hernia and the mesh was used in the repair. All seemed well until this past March, when Hagen was standing outside his home leisurely chatting with a neighbor.
“All at once it just hit me, and I was to my knees,” he said.
That was in March. Then, in late May it flared up again. “I can’t describe it today in words how much it hurt,” he told the CBC. “I didn’t think anything could hurt that much.”
Hagen tells CBC that he historically has led an active life, taking care of his own home and helping his neighbors as much as he can. Now, he’s afraid he won’t be able to undertake for himself, let alone help others.
“Right now, I can’t look after myself,” he told the CBC.
At this juncture Hagen’s only intent in speaking out is to raise awareness. However, efforts are underway to certify a surgical mesh lawsuit as a class action on behalf of all patients in Canada who allege harm from Ethicon Physiomesh. A spokesperson with the sponsoring law firm, based in London Ontario, alleges that Physiomesh once implanted has the capacity to pull apart and / or move away from its initial insertion point within the abdomen, impacting nearby organs and other tissue – while no longer managing the hernia.
The mesh is inserted laparoscopically, by way of a small incision, and then deployed within the abdomen. Laparoscopic surgery is intended to reduce blood loss and speed healing.
And there are those who liked working with the product, including Dr. Alex Mitchell, head of surgery at Dartmouth General Hospital. “In truth I liked it,” Mitchell told the CBC. “It was easy to use. It was relatively easy to put in. The results were pretty good, the patient legitimately was comfortable.”
It should be noted that Mitchell was not the operating surgeon who performed the procedure on Hagen. However, while Hagen may have been comfortable and problem-free for five years, he isn’t now. And while at present he has no intention of joining a surgical mesh side effects lawsuit, there are plenty of others who are considering the option – especially in light of the fact Ethicon Physiomesh was voluntarily withdrawn by the manufacturer in the US, and recalled in Canada.
Ethicon is a subsidiary of pharmaceutical giant Johnson & Johnson. In early May of last year, Ethicon triggered a voluntary withdrawal of Ethicon Physiomesh from the US market after it discovered that Physiomesh was responsible for more surgical mesh complications and revision surgeries than competing products, the manufacturer said in an emailed statement to CBC News.Health Canada, the federal regulator and the Canadian equivalent to the US Food and Drug Administration (FDA), recalled Ethicon Physiomesh later that month, in May 2016.
According to those conversant with the Canadian hernia patch lawsuit, it is estimated that some 30,000 patients in Canada have received the Ethicon Physiomesh in the six years it was on the market. The estimate is based on US data.
Dr. Alex Mitchell, the surgeon from Dartmouth, advocates that Physiomesh patients should not subject themselves to undue concern, especially if their hernia mesh is continuing to perform well without pain or surgical mesh complications. However, he told the CBC, any pain or ongoing symptoms originating from the site of the hernia repair should be duly reported to a family doctor.
“They should be alerted,” he said.https://www.lawyersandsettlements.com/articles/mesh-complications/surgical-mesh-lawsuit-hernia-6-22503.html
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