Preview Newsletter
Ethicon Media Monitoring 12/12/2017
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Doctors 'not told about full risk of vaginal mesh implants'
Dec 12, 2017 | The Guardian
By Nicola Slawson
One of the world’s largest pharmaceutical companies failed to update doctors on the full extent of risks posed by vaginal mesh implants, an investigation by Panorama has found. -
Mesh risks not passed on to doctors
Dec 11, 2017 | BBC
By Lucy Adams
One of the world's biggest medical companies failed to tell doctors and patients of the full extent of some of the risks posed by mesh implants. -
Vaginal mesh company ‘FAILED to tell doctors about all painful and chronic side effects’ of implant
Dec 11, 2017 | The Sun
By Andrea Downey
A GLOBAL vaginal mesh company failed to tell doctors about the risks of the implants, an investigation has found. -
Doctors were NOT told how dangerous vaginal mesh can be for thousands of women and only 31 females and SHEEP took part in a trial for one implant, reveals Panorama investigation
Dec 12, 2017 | Daily Mail
By Stephen Matthews
A company owned by a multi-billion pound pharmaceutical failed to fully inform doctors of how dangerous vaginal mesh can be, a BBC Panorama investigation has found. -
Doctors 'not told how dangerous vaginal mesh can be for women', BBC Panorama investigation reveals
Dec 12, 2017 | London Evening Standard
By Alexandra Richards
Doctors were not informed of potential health risks from vaginal mesh implants, a shocking Panorama investigation has revealed. -
Surgeon Tells Jury Complications Not Limited to J&J Mesh
Dec 11, 2017 | Law 360
By Daniel Siegal
The chief of female pelvic medicine at Hackensack University Medical Center told a New Jersey jury Monday that research and her own hundreds of surgeries reveal complications can arise from all methods of pelvic prolapse repair, not just Johnson & Johnson unit Ethicon’s Prolift... -
Surgical mesh ban a 'knee-jerk reaction' that may hurt women: Doctors
Dec 12, 2017 | Stuff
By Megan Gattey
Kiwi doctors have condemned Medsafe's move to restrict surgical mesh in gynaecological operations, citing potential implications for women with urinary incontinence (UI). -
Medsafe, doctors and ACC have failed patients - gynaecologist
Dec 12, 2017 | Radio New Zealand
A gynaecologist who has performed more than 75 surgeries to repair damage from surgical mesh says doctors, ACC and Medsafe have failed patients. -
Surgical expert hopes the surgical mesh crisis does not happen again
Dec 12, 2017 | Newstalk ZB
A medical expert says the benefits of surgical mesh in vaginal surgeries were never worth the risk. -
Victim 'overwhelmingly emotional' after decision to limit use of surgical mesh that left hundreds in 'awful chronic pain'
Dec 12, 2017 | TVNZ
Surgical mesh victim Carmel Berry told TVNZ1's Breakfast this morning she was "overwhelmingly emotional" when she heard the news. -
Surgical mesh victims welcome restrictions
Dec 12, 2017 | NZ City
Campaigners have welcomed the government's decision to limit the use of surgical mesh in certain operations, but say it should have been sooner. -
Artist Illustrates Children’s Book on Mesh
Dec 11, 2017 | Mesh Medical Device Newsdesk
See one of the most effective social media tools ever – Cambridgeshire artist, Michelle Deyna-Hayward illustrates while Sling the Mesh Kath Sansom’s words effectively tell the story in this chilling children’s tale as to how the women’s health disaster of transvaginal mesh happened. -
Children’s storybook tells the history of the vaginal mesh implant scandal thanks to Cambridgeshire artist
Dec 12, 2017 | Cambs Times
By Kath Sansom
Michelle Deyna-Hayward, created the original art work to provide a simple background to how the women’s health disaster happened. -
Regulation over vaginal mesh implants is inadequate
Dec 11, 2017 | Infosurhoy
By Denis Bedoya
A 65-year-old grandfather has slammed the controversial vaginal mesh procedure that has destroyed the life of his beloved wife and left her contemplating suicide. -
Endo Escapes Faulty Pelvic Mesh Suit on Appeal
Dec 11, 2017 | Law 360
By Rachel Graf
An Illinois appeals court on Friday tossed a suit accusing Endo Pharmaceuticals and its subsidiary American Medical Systems Inc. of manufacturing faulty pelvic mesh products, finding the suit doesn’t belong in an Illinois court. -
As Hernia Mesh Lawsuits Mount Nationwide, Study Calls for Improved Safety Labeling
Dec 11, 2017 | RX Injury Help
By Laurie Villanueva
As hernia mesh lawsuits continue to mount against Ethicon, Inc. and other device makers, researchers from the Washington University in St. Louis School of Medicine are calling for a standardized system of package labeling to better inform doctors of the risks associated with the implants.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Doctors 'not told about full risk of vaginal mesh implants'
Dec 12, 2017 | The Guardian
By Nicola Slawson
One of the world’s largest pharmaceutical companies failed to update doctors on the full extent of risks posed by vaginal mesh implants, an investigation by Panorama has found.
Known as trans-vaginal tape (TVT), the implant is a small mesh support that is used to treat urinary incontinence or prolapse occurring after childbirth. For the majority of women the procedure is quick and successful, however some patients have suffered debilitating complications such as severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.
As many as one in 15 women later require full or partial removal of the implant, with the latest figures showing that there have been more than 6,000 procedures to remove or partially remove mesh implants between 2006-07 and 2016-17, according to figures from NHS Digital and NHS Wales.
The BBC programme, which aired on Monday night, claimed that an in-house doctor of Ethicon, wholly owned by Johnson & Johnson, had not updated its information on complications caused by its Gynecare TVT mesh product.
The investigation also claimed that Ethicon launched a mesh implant product – the TVT-Secur implant – after testing it only in 31 women for five weeks, and in sheep. It was withdrawn in 2012 after six years on the market.
Panorama obtained emails from inside Ethicon, including one from the company’s associate medical director in 2008 who wrote to managers concerned that the information provided by Ethicon to surgeons about the Gynecare TVT mesh had not been updated since 2005.
She said “post-market knowledge” had provided much more information than was given to doctors and recommended updating the “potential adverse reactions” section of the implant’s instruction for use (IFU) document.
However, in January 2009 she wrote again to say this update had not been done and the document still referred to several complications as “transitory”, adding: “From what I see each day, these patient experiences are not ‘transitory’ at all.”
Ethicon admit they did not remove the word “transitory” at the time, however the company’s latest IFUs, updated in 2015, do make clear some effects may be permanent.
A spokeswoman for Ethicon told the programme: “The risks associated with the use of a permanent mesh implant were properly identified in Ethicon’s instructions for use.”
She added: “While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day-to-day lives. All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.”
Earlier in December, medical experts from University of Oxford warned that women have been exposed to unnecessary harm due to poor regulation for vaginal mesh products.
Prof Carl Heneghan, at Oxford’s Centre for Evidence-Based Medicine, who also featured on the Panorama programme, told the Guardian: “Many women have been subjected to great harm because regulatory loopholes allowed mesh devices to be made available in large numbers with no evidence in humans. It is now clear that regulation is not fit for purpose for the riskiest of devices, those that are implanted in the body.
“We now know that women who received mesh implants have been part of a global experiment that in many cases has gone badly wrong.”
https://www.theguardian.com/society/2017/dec/12/doctors-not-told-full-risk-vaginal-mesh-implants-bbc-panorama
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Mesh risks not passed on to doctors
Dec 11, 2017 | BBC
By Lucy Adams
One of the world's biggest medical companies failed to tell doctors and patients of the full extent of some of the risks posed by mesh implants.
A BBC Panorama investigation has seen documents that show one of Ethicon's own in-house doctors warned it had not updated information on complications.
Ethicon is wholly owned by pharmaceutical giant Johnson & Johnson.
It said doctors were informed of the risks and that the company cared deeply about patient safety.
Over the past 20 years, more than 100,000 women across the UK have had transvaginal mesh implants, which are used to treat prolapse and incontinence, often after childbirth.Chronic pain
The vast majority of women suffer no side effects but others have reported chronic and debilitating pain, with some being left unable to walk.
The plastic meshes, which are made of polypropylene - the same material used to make certain drinks bottles - are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed.
The Panorama investigation obtained insider emails that show Ethicon was warned repeatedly by one of their own in-house doctors, about the risks of mesh.
Post-market knowledge
In 2008, Ethicon's associate medical director wrote to managers at the company with her concerns about the fact the information provided by Ethicon to surgeons had not been updated since 2005.
She said "post-market knowledge" of the products had provided much more information than was given to doctors.
The associate medical director recommended updating the "potential adverse reactions" section of the Instructions for Use (IFUs) for all types of TVTs (tension-free vaginal tape) it had on the market at the time.
In January 2009, she wrote again to say the information for doctors had not been updated and still referred to several complications as "transitory".
"From what I see each day, these patient experiences are not 'transitory' at all," she wrote.
Constant pain
Claire Daisley, from Greenock, is 48.
She struggles to walk after a simple operation to treat a weakened bladder.
She is in constant pain.
Claire had the mesh surgically removed but it can be difficult to take out and after the operation her pain got worse.
She now faces having her bowel removed.
"I don't want to be here any more," she said.
"That's how far it's taken me because sometimes you don't know if you can take the next day."
She is one of 501 women in Scotland now taking legal action.
Dr Wael Agur, a consultant urogynaecologist, told Panorama that the information for use leaflet was vital for doctors.
"It's so important for me as a surgeon to understand full the risks of a medical device I'm about to implant during a surgical procedure and my first resource would be the instructions for use," he said.
"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."
A spokeswoman for Ethicon said: "The risks associated with the use of a permanent mesh implant were properly identified in Ethicon's Instructions for Use (IFUs)."
Clinical testing
Documents seen by Panorama also show that the clinical testing of the vaginal tape TVT Secur before it was put on the market only included trials in sheep and five weeks' monitoring in 31 women.
Carl Heneghan, professor of evidence-based medicine at Oxford University, said: "It's just unacceptable and outrageous.
"It just blatantly says we don't care about patients. We don't care about safety, we just want to get out and start making money."
Ethicon said that it empathised with those women who had suffered complications but said the company had always had the best interests of patients at heart.
The firm said that all pelvic floor surgery came with a risk and that millions of women had benefited from having treatment for incontinence and prolapse.
Millions of women around the world have had transvaginal mesh implants.
For the vast majority, the surgery has been a success but thousands of women have suffered devastating consequences as a result of mesh surgery.
In some cases the damage is irreversible.
More than 100,000 women around the world are now suing the manufacturers, including Ethicon.
That includes more than 1,000 women in the UK - many of whom are also taking legal action against the NHS who they will claim failed to inform them of the potential risks.
Figures compiled for Panorama show that more than 6,000 women in the UK have had mesh surgery removals in the past decade.
BBC Panorama's The operation that ruined my life can be seen on the BBC iplayer.
http://www.bbc.com/news/uk-scotland-42307953
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Vaginal mesh company ‘FAILED to tell doctors about all painful and chronic side effects’ of implant
Dec 11, 2017 | The Sun
By Andrea Downey
A GLOBAL vaginal mesh company failed to tell doctors about the risks of the implants, an investigation has found.
The BBC Panorama investigation found Ethicon, owned by Johnson & Johnson, had failed to mention the implants had caused chronic pain in some women.
It also found that the mesh, marketed under the brand name Gynecare TVT (trans-vaginal tape) in the UK, had only been tested on 31 women and in sheep before being prescribed to patients.
Pelvic mesh implants have been used to treat prolapse and incontinence in women since the late 1990s.
The vast majority of women who have the implants suffer no side effects but some women have reported chronic and debilitating pain, with some being left unable to walk.
And last week Chrissy Brajcic, 42, died after a four year battle with sepsis allegedly brought about by a TVT implant.
The investigation found that in 2009 an associate medical director at Ethicon warned that the information about the side effects in the instructions for use leaflet included with the implants were not sufficient.
At the time it said the side effects were “transitory” but a number of women have complained that their complications are permanent.
The associate medical director wrote in an email: “From what I see each day, these patient experiences are not ‘transitory’ at all.”
Ethicon did not update the information until 2015 but still did not warn that complications could be permanent.
Instead the company decided the wording in the leaflet, including the word “transitory”, was “appropriate for the intended users – trained pelvic floor surgeons” after a review of the complaints.
They said: “The risks associated with the use of a permanent mesh implant were properly identified in Ethicon’s instructions for use and in the professional education materials provided to physicians.”
Dr Wael Agur, a consultant urogynaecologist, told BBC Panorama that the information for use leaflet is vital for doctors.
“It’s so important for me as a surgeon to understand full the risks of a medical device I’m about to implant during a surgical procedure and my first resource would be the instructions for use,” he said.
“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.”
The net-like implant is used to treat incontinence or prolapse, conditions often caused by childbirth.
The 20-minute non-invasive procedure works by inserting the mesh tape through the vagina and placing it around the urethra to support it like a hammock.
Ethicon launched its TVT-Secur product in 2006 after testing it on 31 women for only five weeks.
In 2012 it was withdrawn from the market.
Ella Ebaugh, from Pennsylvania, was fitted with the device in 2007 to cure incontinence.
She suffered from chronic pain which left her needing a walking stick and mobility scooter to get around.
She sued Ethicon and was awarded $57m (£43m) in September this year.
“The pain that I have I will have to live with for the rest of my life. There’s nothing they can do to help me,” she said.
“If I was told that I would need a wheelchair to get around, if I was told that I was going to live with permanent disabilities for the rest of my life, I wouldn’t have had a surgery for a simple stress urinary incontinence problem.”
Ethicon is appealing the verdict.
The company told Panorama: “While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives.
“All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.
“Regarding the discontinuation of the TVT-Secur, in 2012, Ethicon announced a business decision, for reasons unrelated to the safety or efficacy of the products, to discontinue the global commercialisation of some of our pelvic mesh products around the world.”
More than 92,000 women in England had implants between 2007 and 2015.
One in 11 is believed to have problems.
There have been more than 6,000 surgeries to remove vaginal mesh implants on the NHS between 2006/7 and 2016/17 in England and Wales.
Dr Linda Cardozo, from the Royal College of Obstetricians and Gynaecologists, said: “You cannot operate without complications occurring in a small minority of cases.
“You are never aware of complications that may occur years later and that doesn’t just occur with these tapes and meshes.”
https://www.thesun.co.uk/news/5111565/vaginal-mesh-company-failed-tell-doctors-painful-chronic-side-effects/
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Dec 12, 2017 | Daily Mail
By Stephen Matthews
A company owned by a multi-billion pound pharmaceutical failed to fully inform doctors of how dangerous vaginal mesh can be, a BBC Panorama investigation has found.
The programme, airing tonight, will also reveal how an implant made by Ethicon was only tested on 31 women and in sheep before being used in patients.
The company, owned by Johnson and Johnson, sells its scandal-hit products in the UK under the brand name Gynecare TVT.
An investigation reveals how a director at the company asked for the wording to be changing in the safety leaflets for mesh implants to recognise the dangers - but her request was ignored.
It comes amid mounting pressure for the ban of controversial vaginal mesh implants, which have left thousands of women on the brink of suicide.
The revelation follows the death of a prominent vaginal mesh campaigner, who reportedly died from sepsis triggered by her implant.
Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections - as a result of her mesh.
Her death last week followed landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
It is expected that the NHS will follow the guidance from Nice, the Government's healthcare adviser - despite not being obliged to do so.
The 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.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found 'the benefits do not outweigh the risks'.
http://www.dailymail.co.uk/health/article-5166733/Doctors-werent-properly-informed-vaginal-mesh.html
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Doctors 'not told how dangerous vaginal mesh can be for women', BBC Panorama investigation reveals
Dec 12, 2017 | London Evening Standard
By Alexandra Richards
Doctors were not informed of potential health risks from vaginal mesh implants, a shocking Panorama investigation has revealed.
The BBC programme, which is due to air on Monday, will claim to show how the distributor of vaginal mesh in the UK, Ethicon, did not tell doctors about the full extent of the risks surrounding the its mesh.
The vaginal implant – known as trans-vaginal tape (TVT) – is a small mesh support used to treat urinary incontinence or prolapse occurring after childbirth.
Risks linked to the implant are nerve damage, chronic pain and organ erosion and ,in some cases, sepsis.
Ethicon, owned by Johnson and Johnson, produced Gynecare TVT mesh.
The Panorama investigation reveals that one of Ethicon’s implants called the TVT-Secur implant, which was launched in 2006, was only tested on 31 women and sheep before being used in patients. It was later withdrawn from the market in 2012.
The investigation comes only a week after the death of Chrissy Brajcic, the first woman to have died from sepsis allegedly caused by mesh complications.
The vaginal mesh treatment involves implanting the netted mesh made from polypropylene into the vaginal wall. Over 10,000 women per year use the treatment in the UK.
The Panorama investigation comes amongst mounting pressure for vaginal mesh implants to be banned in the UK after many women suffered complications as a result of having it inserted into their body.
There has been growing concern that the side effects of having the mesh implanted can be more dangerous than previously believed.
Mounting evidence over the severe side effects and insufficient trialling has resulted in it being dubbed “the biggest scandal since Thalidomide,” referring to the morning sickness drug used in the 50s which caused birth defects.
Hundreds of thousands of women in the UK, US and Australia are currently involved in lawsuits against mesh producers with at least 800 in the UK suing the NHS.
Ethicon is also the subject of multiple class action law suits.
The company provides “instructions for use” leaflets with all its mesh products which have been designed to explain to doctors how to insert the mesh implants. The leaflets are also supposed to explain the risks associated with the surgery to help doctors explain the “adverse reactions” that some patients might develop after the surgery.
In the Panorama investigation, it will be revealed that in 2009, an associate medical director at Ethicon warned that the side effects detailed in the leaflets were insufficient as they described the side effects as “transitory”.
However many women have experienced lasting side effects after the surgery.
In an email sent in January 2009, the associate medical director suggested that the wording be changed in the leaflets, writing: “From what I see each day, these patient experiences are not ‘transitory’ at all.”
However, Panorama reveals that the instruction leaflets were not updated at the time. The most recent leaflets, which were updated in 2015, do outline that some effects may be permanent but use insufficient risk assessment data to do so.
Dr Wael Agur, a consultant urogynaecologist, told Panorama: “It’s so important for me as a surgeon to understand the full risks of a medical device I’m about to implant ... and my first resource would be the IFU.
“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.”
Figures collected by Panorama revealed that NHS Digital and NHS Wales has implanted more than 130,000 women with mesh devices in the last decade.
In that same amount of time there have been 6,000 procedures to remove the implant.
In reality figures could be much higher as they do not include women who have had the mesh removed privately.
The Standard has reached out to Ethicon for further comment.
BBC Panorama: The Operation That Ruined My Life airs today on BBC One at 7.30pm
https://www.standard.co.uk/front/doctors-not-told-how-dangerous-vaginal-mesh-can-be-for-women-bbc-panorama-investigation-reveals-a3716846.html
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Surgeon Tells Jury Complications Not Limited to J&J Mesh
Dec 11, 2017 | Law 360
By Daniel Siegal
The chief of female pelvic medicine at Hackensack University Medical Center told a New Jersey jury Monday that research and her own hundreds of surgeries reveal complications can arise from all methods of pelvic prolapse repair, not just Johnson & Johnson unit Ethicon’s Prolift, which a woman alleges is responsible for debilitating pain.
At the outset of the third of week of the trial before Bergen County Superior Court Judge Rachelle Harz in Hackensack, Ethicon called to the stand female pelvic health and reconstructive surgery specialist Dr. Deborah Fromer.
Plaintiff Elizabeth Hrymoc has alleged that the Prolift she had implanted to treat a pelvic prolapse left her with chronic pain and the inability to have sex without pain.
Fromer testified that over her career, she performed surgeries on hundreds of women with pelvic prolapse, and used a variety of techniques, including “native tissue repairs” using the body’s own material, other techniques that predated the Prolift, and the Prolift itself.
Fromer said the concerns for doctors before the Prolift came on the market were that women might see their prolapse reoccur, might have chronic pain and especially might have painful intercourse as a complication.
She said these were the same worries surgeons had today, even with mesh products, but that she has had “good results” with her Prolift patients, saying she’d had patients who experienced none of the above issues.
Fromer said she also had Prolift patients who had complications, but also said there was no surgical option available in 2008 — the year Hrymoc had her operation — that could prevent the risk of chronic pain or painful intercourse.
Hrymoc, whose husband Tad Hrymoc also is a plaintiff, is among the thousands of women nationwide who have filed suits alleging Ethicon and J&J failed to fully disclose risks associated with its Gynecare Prolift pelvic floor support mesh product, which was on the market from 2005 through 2012.
The Hrymocs’ suit is just the second pelvic mesh suit against Ethicon to go to trial in New Jersey, where the company is headquartered. The trial comes nearly a year after the New Jersey Supreme Court declined to review a jury’s $11.1 million award to the plaintiff in the first pelvic mesh trial.
Hrymoc said she had the Prolift implanted in 2008 to treat a pelvic prolapse, but that it contained a design defect and that the defendants knew it was risky but kept this information from consumers.
Hrymoc, who was 62 when she had the mesh implanted, says she has suffered vaginal pain and pain when having sex since then.
She is also alleging that the defendants failed to warn of the risks associated with a second J&J medical device, Trans Vaginal Tape, known as TVT, that was implanted to treat her stress urinary incontinence. The plaintiffs are seeking punitive damages.
The Hrymocs are represented by Adam Slater and David Mazie of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Judith Wahrenberger of Ruprecht Hart Weeks & Ricciardulli LLP, Philip Combs of Thomas Combs & Spann PLLC and William Gage of Butler Snow LLP.
The case is Elizabeth Hrymoc et al. v. Ethicon et al., case number L-13696-14, in the Superior Court of the New Jersey, County of Bergen.
-- Additional reporting by Bill Wichert. Editing by Nicole Bleier.https://www.law360.com/articles/993554/surgeon-tells-jury-complications-not-limited-to-j-j-mesh
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Surgical mesh ban a 'knee-jerk reaction' that may hurt women: Doctors
Dec 12, 2017 | Stuff
By Megan Gattey
Kiwi doctors have condemned Medsafe's move to restrict surgical mesh in gynaecological operations, citing potential implications for women with urinary incontinence (UI).
Gynaecologist Dr Hanifa Koya said New Zealand "cannot have a knee-jerk reaction, or blanket rule, and remove all the meshes".
"Australia has not removed the incontinence slings, and we should not either," she said.
"The Therapeutic Goods Administration had already undertaken a robust process to confirm the benefits and risks, and that is why Australia did not withdraw the [mid-urethral] incontinence slings. "
Koya has worked on more than 75 complex cases requiring pelvic mesh removal since 2005, and has been advising against mesh surgery for years.
She supported a ban on mesh for pelvic organ prolapse, but believed mesh slings were still appropriate to implant in women with UI when carried out by competent surgeons.
"A device itself is not the only problem, but rather the regulation, training, oversight, and competence of surgeons," Koya said.
The alternatives to UI slings in New Zealand – the Rectus Sheath Sling and Burch Colposuspension – also posed significant risks to health, she said.
Koya said Medsafe's decision had also robbed women of an important choice. "The retropubic vaginal sling should remain a choice for women."
Urologists, urogynaecologists, and gynaecologists needed to be approached by Medsafe for a robust discussion about the use of mesh products for UI treatment, Koya said.
"These specialists have been doing these procedures for many, many years and can provide evidence."
PRODUCTS AFFECTED BY BAN:
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* Xenform Soft Tissue Repair Matrix
* Advantage
* Lynx
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* Coloplast – 9 modelsEndotherapeutics NZ
* TOA Sling
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* Ophira MinislingJohnson & Johnson Medical NZ
* GYNEMESH PS soft mesh
* Gynecare TVT Device
* Gynecare TVT W/Abdominal
* Gynecare TVT Obturator
* TVT Abbrevo
* TVT Exact Retropubic systemhttps://www.stuff.co.nz/national/health/99762302/Surgical-mesh-ban-a-knee-jerk-reaction-that-may-hurt-women-Doctors
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Medsafe, doctors and ACC have failed patients - gynaecologist
Dec 12, 2017 | Radio New Zealand
A gynaecologist who has performed more than 75 surgeries to repair damage from surgical mesh says doctors, ACC and Medsafe have failed patients.
ACC has paid out more than $13m in injury claims in the past decade and Medsafe yesterday announced mesh implants will no longer be used for pelvic organ prolapse or urinary incontinence because of the risks.
Last month Australia banned the implants for use in pelvic organ prolapse.
Some of the injuries include the mesh eroding in the body and binding with other tissue.
It will still be used for other surgeries, including hernia repair.
But Dr Hanifa Koya told Nine to Noon she has mixed feelings about the partial ban and that the blame doesn't just lie with the products.
She said surgeons need to be more competent.
"People decided, knee jerk reaction again, that ... we must use something like the meshes," said Dr Koya.
"There was no data ... no training ... the companies trained and people trained each other."
She said people should also be told by ACC who the doctors who have harmed patients with mesh are so they can make the best decision about whether or not to have the surgery.
"So Medsafe has, in my books, failed and we [doctors] have also failed the patients," she said.
"We now need to sit down and ask ourselves the question, 'Where are we going?'"
The gynaecologist is calling for more regulations and a registry for how the mesh is used.
"It will be an extremely important step and long overdue," she said.
Dr Koya said when major adverse effects are found with a particular product it should be pulled out immediately whereas products with significant problems should be put on hold.Ministry backs tougher laws on surgical devices
The Ministry of Health wants stronger legislation on medical devices in the wake of a ban on surgical mesh.
Stewart Jessamine, from Ministry of Health, said there was no legal requirement at present for a medical device to go through an approval process in New Zealand before being used.
Medical devices could be assessed and approved by international regulators on the basis of relatively small clinical trials, said Dr Jessamine, the ministry's director of protection, regulation and assurance.
The ministry was not happy with that situation and there were plans to strengthen the legislation.
"There is a bill being developed ... which will introduce regulatory regime for medical devices that will require evidence of their safety and their quality and their effectiveness.
"In New Zealand ... legislation does not allow us to assess and approve [these products] before they exit the market.
"If we wish to remove a product from the market we have to have sufficient evidence to warrant the removal ... and that requires clinical trials.
"New Zealand was one of the first countries in the world to look into surgical mesh and the problems associated with it but we've always required ... a large scale clinical trial."Advocate says partial ban long overdue
Mesh Down Under co-founder Carmel Berry said Medsafe's decision was a complete about face, but one she welcomed, having pushed for it since 2014.
"[It is a] huge vindication ... or validation that what we've been saying all along was in fact true."
"It should not have taken health officials this long, she said.
"We really believed that we'd given Medsafe and the Ministry of Health enough evidence to make this decision a long time ago."
Dr Jessamine said there had not been enough data to assess whether the benefits of the mesh outweighed the risks.
Officials have spent the past couple of weeks considering new Australian researchthat was released last month.
"There's no doubt that for women who've had these surgeries this has been a tragedy at a personal level in up to 10 to 12 percent of people who've had mesh used in this way."
Dr Jessamine said there were major lessons for regulators.
"With surgical devices you do need more research before they come into common use."
Ms Berry said the fight was not over yet. She still wants a registry of all mesh surgery and research into this "unfortunate experiment".
https://www.radionz.co.nz/news/national/345971/medsafe-doctors-and-acc-have-failed-patients-gynaecologist
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Surgical expert hopes the surgical mesh crisis does not happen again
Dec 12, 2017 | Newstalk ZB
A medical expert says the benefits of surgical mesh in vaginal surgeries were never worth the risk.
Medsafe has restricted supply of the product for transvaginal surgeries, after hundreds of patients with the mesh were left in constant pain.International Urogynaecological Association president Lynsey Hayward said the mesh was supposed to give extra support, but as she told Rachel Smalley, the mesh was simply too strong.
"If you can imagine you've broken your arm and you put your arm into a plaster cast, over months and years that muscle with wither away."
Hayward spoke to Newstalk ZB earlier and said that overall the technology is still useful.
She said there are other types of mesh that work well.
"The complication rates are low and they have been proven to be, particularly in terms of strength for urinary incontinence, the best treatment that we have to date when you compare all treatments."
She said the issue can be traced back to a Food and Drug Administration policy in the US.
The policy allowed for the mesh to be approved without rigorous testing, as it was seen as similar to other surgical meshes.
Hayward hopes that lessons are learnt from the use of surgical mesh.
"The biomechanics, so the understanding about what stresses and strains occur, weren't understood either. This has been a very big learning curve and I would hope it would not happen again."
http://www.newstalkzb.co.nz/on-air/early-edition/audio/lynsey-hayward-i-would-hope-it-would-not-happen-again/
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Dec 12, 2017 | TVNZ
Surgical mesh victim Carmel Berry told TVNZ1's Breakfast this morning she was "overwhelmingly emotional" when she heard the news.
"Out of the blue it's happened. I'm just so happy people like me and other victims of this disaster have been vindicated," Ms Berry said.
Surgical mesh is commonly used after birth where it is implanted to reinforce vaginal wall, or implanted for hernia repair.
Currently, ACC have 892 people who have taken out claims for surgical mesh, MedSafe have 142 people report adverse events and in Ms Berry's support group there were 516 victims.
Ms Berry said sufferers were living in "awful chronic pain", which was not covered by ACC.
She said it was time for government to take over responsibility of looking after these people.
Associate Minister of Health Julie Ann Genter and Medsafe announced yesterday surgical mesh products for urogynaecological (transvaginal) surgeries would be limited.
"Hundreds of women in New Zealand have seen their health and lives compromised because of surgical mesh and I gladly welcome changes to restrict usage," Ms Genter said.
"This will prevent further harm to women being caused by surgical mesh."
The changes would allow Medsafe to limit the supply of surgical mesh and require suppliers to provide safety information about it.
"As in Australia, surgical mesh will still be able to be used for other surgical conditions such as hernia repair in New Zealand," Medsafe said.
The Accident Compensation Corporation receives hundreds of claims each year over injuries related to treatments involving the mesh.
Mesh Down Under co-founder Carmel Berry told Radio NZ Medsafe's decision was one she welcomed but it had taken too long to get there.
"I should not have taken health officials this long. We really believed that we'd given Medsafe and the Ministry of Health enough evidence to make this decision a long time ago," she said.
The decision was influence by new research about surgical mesh complications published in Australia that New Zealand health officials have been reviewing.
She said the five year campaign to rid surgical mesh from use had been "a battle".
https://www.tvnz.co.nz/one-news/new-zealand/victim-overwhelmingly-emotional-after-decision-limit-use-surgical-mesh-left-hundreds-in-awful-chronic-pain
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Surgical mesh victims welcome restrictions
Dec 12, 2017 | NZ City
Campaigners have welcomed the government's decision to limit the use of surgical mesh in certain operations, but say it should have been sooner.
Associate Minister of Health Julie Ann Genter and Medsafe announced on Monday that surgical mesh products for urogynaecological (transvaginal) surgeries would be limited.
"Hundreds of women in New Zealand have seen their health and lives compromised because of surgical mesh and I gladly welcome changes to restrict usage," Ms Genter said.
"This will prevent further harm to women being caused by surgical mesh."
The changes would allow Medsafe to limit the supply of surgical mesh and require suppliers to provide safety information about it.
"As in Australia, surgical mesh will still be able to be used for other surgical conditions such as hernia repair in New Zealand," Medsafe said.
The Accident Compensation Corporation receives hundreds of claims each year over injuries related to treatments involving the mesh.
Mesh Down Under co-founder Carmel Berry told Radio NZ Medsafe's decision was one she welcomed but it had taken too long to get there.
"I should not have taken health officials this long. We really believed that we'd given Medsafe and the Ministry of Health enough evidence to make this decision a long time ago," she said.
The decision was influence by new research about surgical mesh complications published in Australia that New Zealand health officials have been reviewing.
http://home.nzcity.co.nz/news/article.aspx?id=260809
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Artist Illustrates Children’s Book on Mesh
Dec 11, 2017 | Mesh Medical Device Newsdesk
See one of the most effective social media tools ever – Cambridgeshire artist, Michelle Deyna-Hayward illustrates while Sling the Mesh Kath Sansom’s words effectively tell the story in this chilling children’s tale as to how the women’s health disaster of transvaginal mesh happened.
Camb Times reports on the effort here.
In this six minute storybook, the artists tells the tale of how the rest of the world follows the U.S. Food and Drug Administration’s lead in requiring no clinical trial clearance for market, unlike the stricter requirements for drugs.
Fast-track is how the FDA’s approval system for medical devices is known, the 510(k) approval process.
“Substantial equivalence” is all that is required for a manufacturer to gain clearance to market- that, a few thousand dollars, and an exchange of paperwork.
No wonder artist Deyna-Hayward illustrates women to look like a guinea pig.
Please enjoy this creative storytelling tool.
https://www.meshmedicaldevicenewsdesk.com/artist-illustrates-childrens-book-mesh/
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Dec 12, 2017 | Cambs Times
By Kath Sansom
Michelle Deyna-Hayward, created the original art work to provide a simple background to how the women’s health disaster happened.
The video comes amid growing calls from around the world for better regulation of medical devices.
This includes a damning assessment of the tragedy by Oxford University professor, Carl Heneghan, who said that inadequate regulation for vaginal mesh products has exposed women to unnecessary harm.
Michelle’s six minute storybook tells how mesh was approved in a piggy back approval system, where manufacturers do not have to carry out clinical trials.
Instead, they get approval under something called Substantial Equivalence, or the 510K route in America.
Michelle said: “When I first realised there were few patient safety checks I was shocked.”
She got involved as she lives in the same Fenland market town where Sling The Mesh founder, Kath Sansom, lives.
Working together the pair created the words and Michelle added the images.
“I didn’t even know what a TVT was,”Michelle said. “I heard Kath’s story while waiting for a hernia operation using mesh. I cancelled.
“I made enquiries and realised it was the same plastic material implant. I had to do something to help men and women who hadn’t had the heads-up I had.
“My painting of a guinea pig wearing frilly pants, seen in the video, shows women were, and still are, the human guinea pigs.”
Professor Carl Heneghan at Oxford University’s Centre for Evidence Based Medicine and colleagues argue that regulatory failings have enabled new mesh devices to be brought to market with inadequate evidence.
He says more than 100,000 women around the world are suing manufacturers after developing serious complications.
Professor Heneghan and his team traced marketing clearance for 61 mesh devices which show no new clinical trials at the time of approval.
His team argue that evidence consistently points to a lack of long term data.
And when longer term evidence did emerge, he said, it identified serious concerns.
Evidence from large trials did not emerge until 20 years after the first products were introduced and 12 years after the call for longer term studies, professor Heneghan said.
“In our view, to be considered safe and approved for widespread use, long term implantable devices should have been evaluated in studies with follow-up of at least five years,” he added.
http://www.cambstimes.co.uk/news/ambridgeshire-artist-michelle-deyna-hayward-sling-the-mesh-march-1-5316722
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Regulation over vaginal mesh implants is inadequate
Dec 11, 2017 | Infosurhoy
By Denis Bedoya
A 65-year-old grandfather has slammed the controversial vaginal mesh procedure that has destroyed the life of his beloved wife and left her contemplating suicide.
John Sharman, from Reading, revealed Lynne’s heartbreaking account of the scandal-hit surgery, which left her in unbearable pain and unable to have sex, following the emergence of hundreds of similar stories.
He decided to tell MailOnline of her painstaking ordeal from a man’s point-of-view, which is often forgotten amid the scores of outraged women who have spoken, in an attempt to raise awareness about the topic which, up until now, has been swept under the carpet.
The father-of-three he has sometimes thought about leaving Mrs Sharman, who he has been married to for 43 years, due to the effect the mesh has had on their marriage.
Mr Sharman, who met his wife at a chess club, told MailOnline: ‘It does impact your relationship and now I’m more of her carer than I am her lover and a husband.
‘She has been left in constant pain which has totally altered our sex life, social life and the way we operate and what we do.’
It comes as a leading expert has warned there are inadequate regulation for vaginal mesh products which has exposed women to unnecessary harms.
Carl Heneghan, professor of evidence-based medicine at Oxford University, has previously described the mesh scandal as akin to thalidomide.
Professor Heneghan has now launched a fresh attack on mesh, asking for them to be given temporary licences that restrict them solely to use in clinical trials – and not in humans.
Writing in the BMJ Open Professor Heneghan and colleagues argue the implants can’t be considered safe as they didn’t undergo scrutiny in scientific studies with a follow-up of at least five years.
The implants, which can shrink, twist, curl and cut through internal tissue, have left women on the brink of suicide, unable to work and even walk.
Mr Sharman added:’It’s something she will have for the rest of her life, there is no possibility of getting a pain-free life back. That’s so frustrating.
‘Sometimes I wonder whether if it’s worth staying together, you can’t help it because our relationship has changed.
‘It has to change because your wife isn’t the same one that you married.
‘We’ve been together for long enough that I care enough about her, but you can never say never. But at the moment it isn’t an issue.
He revealed how the couple’s sex life has been scuppered, going from twice a week to barely engaging in any activity beneath the sheets.
The issue arose when he felt something in the way as they had intercourse a few years ago. He could see it was hurting her.
Since then, Mr Sharman constantly worries about causing her pain.
He said: ‘Even if she isn’t in pain I’m always worried about hurting her if we try.
‘Your sex life goes out of the window. Both of us in terms of libido have totally gone.’
‘It [the mesh]probably means you don’t have fun anymore at all. You’ve got to look after your wife.’
Mrs Sharman, 61, had the vaginal mesh surgery at Berkshire Independent Hospital in 2011 due to her mild incontinence – triggered by childbirth.
Pain almost immediately followed.
But she was not given any warnings about any possible life-long side effects other than it might perforate her bladder.
The former counsellor, who had three children, then had it partially removed at the John Radcliffe Hospital, Oxford, a year later.
It followed a year of tireless pleas to the surgeon who put in the implant, who was unable to determine what was causing her pain.
A full removal followed a year later, but the delay in removing the mesh has left her plagued by a lifetime of pain.
Mr Sharman said: ‘She has contemplated it [suicide], I guess if she hadn’t been a teenage counsellor then she might have had the inclination to do so.
‘If she hadn’t recognised in herself how to deal with it and if I hadn’t been behind her then she might have gone through with it.’
The pain has impacted on Mrs Sharman’s ability to be a grandmother, meaning she often struggles to cuddle her five grandchildren.
Mr Sharman said: ‘It’s difficult to tell a four-year-old that nanny can no longer pick them up and give them a cuddle anymore because she isn’t capable.’
He said attempting to pick the youngsters up will have a detrimental effect on her, leaving her to spend the next day in bed recovering.
The couple have long campaigned for an end to vaginal mesh procedures, such as this one which has made Mrs Sharman reliant on painkillers.
Mr Sharman added: ‘I know of nobody who has had a successful removal who hasn’t been left with some form of pain, which is normally quite chronic.
‘We are applauding all of the actions going on at the moment. It’s really appalling, but hopefully we’re getting somewhere.’
The couple purchased a narrowboat a few years ago. It’s easier for Mrs Sharman to walk around in and gives them both an interest.
Figures suggest more than 100,000 women around the world are suing mesh manufacturers after developing serious complications from the brittle implants.
Tiresome fights by campaigners, backed by MailOnline, has since led to Australian and English health officials calling for a ban to some of the procedures.
Professor Heneghan’s latest comments add fuel to the fire as outraged sufferers seek a House of Commons debate over the safety of vaginal mesh.
The comments follow the death of a ‘courageous’ vaginal mesh campaigner who passed away from sepsis triggered by her implant, it was reported.
Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections – as a result of her mesh.
During her final few months, she posted an array of videos detailing her struggle with the scandal-hit devices on her Facebook page.
Ms Brajcic’s death followed landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
It is expected that the NHS will follow the guidance from Nice, the Government’s healthcare adviser – despite not being obligated to do so.
The 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.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found ‘the benefits do not outweigh the risks’.
However, vaginal mesh remains a viable option for surgeons operating on women suffering from incontinence in both countries.
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, it was reported that at least 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, outraged women 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.infosurhoy.com/cocoon/saii/xhtml/en_GB/health/regulation-over-vaginal-mesh-implants-is-inadequate/
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Endo Escapes Faulty Pelvic Mesh Suit on Appeal
Dec 11, 2017 | Law 360
By Rachel Graf
An Illinois appeals court on Friday tossed a suit accusing Endo Pharmaceuticals and its subsidiary American Medical Systems Inc. of manufacturing faulty pelvic mesh products, finding the suit doesn’t belong in an Illinois court.
Judge Vincent J. Lopinot remanded the case with directions to dismiss because the two remaining plaintiffs who did not settle their claims are not Illinois residents and the alleged misconduct did not occur in Illinois. Baltimore County would be a better location for the case, since it is where the plaintiffs, Paula and Earl Conway of Essex, Maryland, and “nearly all” of the witnesses live, and is where the mesh was implanted, the court said.
“The weight of the public and private interest factors greatly favors Baltimore County as the more convenient forum for the Conways’ cause of action,” the court said.
Five years ago, 75 plaintiffs from 23 states alleged AMS and Endo made and sold pelvic mesh products that caused health problems after they were surgically implanted, saying at the time that St. Clair County was the proper venue because it’s where the company promoted the pelvic mesh and where one of the plaintiffs received an implantation, according to the filing.
All but two of the plaintiffs, the Conways, have since settled their claims. AMS subsequently sought to dismiss the case, arguing Paula Conway’s implantation occurred in Baltimore County and the majority of witnesses live in the area, but the lower court denied the motion.
The appeals court reversed the decision Friday, noting that AMS’s July 2016 dismissal bid was timely with relation to when the other plaintiffs concluded their settlement negotiations.
“Simply stated, the present case was not the same case that it was before 73 of the 75 plaintiffs had agreed to dismiss their claims, and AMS’s motion was not ripe for filing until the parties’ settlement negotiations had concluded,” the court said.
The court reasoned that it wouldn’t necessarily be inconvenient for either party for the case to be litigated in St. Clair County, but “relative ease of access to the sources of testimonial, documentary and real evidence” makes Baltimore County preferable. None of the witnesses are from Illinois, the court noted.
“Turning to the public interest factors, the interest in having local controversies decided locally and the unfairness of imposing jury duty upon residents of a county with no connection to the litigation both weigh in favor of a transfer to Baltimore County,” the court added.
The only link St. Clair County has to the case currently is that there are attorneys for both parties nearby, according to the filing.
An Endo representative didn’t respond Monday to a request for comment.
Counsel information for the parties was not available Monday.
The case is Shawn McIver et al. v. American Medical Systems Inc. et al., case number 5-17-0011, in the Appellate Court of Illinois, Fifth District.
--Editing by Breda Lund.https://www.law360.com/articles/993488/endo-escapes-faulty-pelvic-mesh-suit-on-appeal
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As Hernia Mesh Lawsuits Mount Nationwide, Study Calls for Improved Safety Labeling
Dec 11, 2017 | RX Injury Help
By Laurie Villanueva
As hernia mesh lawsuits continue to mount against Ethicon, Inc. and other device makers, researchers from the Washington University in St. Louis School of Medicine are calling for a standardized system of package labeling to better inform doctors of the risks associated with the implants.
Their study, published online last month in the Journal of the American College of Surgeons, analyzed labeling guidelines and 510(k) requirements across a range of common hernia mesh products regulated by the U.S. Food & Drug Administration (FDA). They also conducted a literature review to understand recommended guidelines for mesh products.
“We found that food labels undergo critical scrutiny and detailed specifications, yet medical devices are not subjected to similar guidelines,” the study authors wrote.
The paper noted that:
· Only 33% of the hernia mesh labels investigated gave doctors information on composition of the device.
· Only 31% of Instructions for Use (IFU) provided information regarding the mechanics of the mesh.
· Only 11% of IFU’s noted mesh thickness.
· Mechanics and pore size lacked consistent descriptive terms.
“While standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines. There is an extreme underreporting and lack of consistency of clinically important mesh properties,” the study authors concluded. “Standardized packaging labels will provide accessibility of these properties and aim to bring standardized terminology into practice. With an increase in access to important properties, this can facilitate intraoperative decision making on a case-by-case basis.”
Ethicon Physiomesh Litigation
The majority of hernia mesh lawsuits currently pending in U.S. courts involve Ethicon’s Physiomesh products and C-Qur devices marketed by Atrium Medical Corp.
Ethicon’s Physiomesh implants are made from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the mesh is then covered with an absorbable film coating intended to help the patch incorporate into the body and reduce inflammation. However, plaintiffs claim that this configuration actually prevents incorporation and increase the odds that a patient will experience serious complications, including hernia recurrence and the need for revision surgery.
In May 2016, Ethicon announced a worldwide market withdrawal of its Physiomesh Flexible Composite Mesh product, after unpublished data from two European hernia registries suggested that these devices were associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
Earlier this year, all federally-filed Physiomesh lawsuits were centralized in a multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia. More than 300 cases were pending in that litigation as of November 15, 2017.
Atrium C-Qur Hernia Mesh Lawsuits
Hernia mesh lawsuits involving Atrium’s C-Qur implants have been centralized in the U.S. District Court, District of New Hampshire, where more than two dozen cases were pending as of November 15th.
C-Qur hernia mesh is constructed with an Omega-3 barrier coating, which Atrium claims will reduce the risk of adhesion formation between the mesh and the intestines and allow for better fixation of the device to the abdominal wall. However, plaintiffs allege that this configuration actually encourages an inflammatory response that promotes the formation of bowel adhesions, impedes proper abdominal wall fixation, and causes additional severe complications.
Laurie Villanueva is an attorney with Bernstein Liebhard LLP RX Injury Help
https://www.rxinjuryhelp.com/news/2017/12/11/as-hernia-mesh-lawsuits-mount-nationwide-study-calls-for-improved-safety-labeling/
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