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Ethicon Media Monitoring 7/4/2017
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Pa. Judge Urged To Move Mesh Cases After Justices' Rulings
Jul 3, 2017 | Law 360
By Matt Fair
After two recent U.S. Supreme Courtdecisions limiting the ability of trial courts to retain jurisdiction over claims from out-of-state plaintiffs, a Pennsylvania state judge was urged to dismiss a cluster of cases against Boston Scientific Corp. and a Johnson & Johnson unit from non-Pennsylvanians alleging injuries from faulty pelvic mesh products. -
Vaginal mesh risks downplayed by Johnson & Johnson, court told
Jul 4, 2017 | The Guardian
By Christopher Knaus
A pharmaceutical giant allegedly played down the risks of a vaginal medical device that has caused debilitating and irreparable pain to thousands of women after giving birth. -
Australian class-action case opens over pelvic mesh implants
Jul 4, 2017 | Associated Press (In ABC News)
By Kristen Gelineau
More than 700 Australian women in a class-action case against pharmaceutical giant Johnson & Johnson that started Tuesday argued that the company's vaginal mesh implants caused them devastating pain, ravaged their bodies and, in some cases, ruined their lives. -
These Women Have Taken Johnson & Johnson To Court Over Vaginal Mesh Implants
Jul 4, 2017 | Buzzfeed News
By Gina Rushton
Gai Thompson is one of more than 700 women taking Ethicon, a subsidiary of Johnson & Johnson, to court today in a class actionwhich will claim vaginal medical devices left women "suffering painful and life-altering complications". -
Hundreds of women join vaginal mesh lawsuit against Johnson & Johnson
Jul 4, 2017 | AAP (In Yahoo News)
More than 700 women suffering strong pain from vaginal mesh implants have launched a class action against global healthcare giant Johnson & Johnson in the Federal Court. -
“I would not want my wife to undergo this procedure”: pelvic mesh inventor
Jul 4, 2017 | Newcastle Herald
By Joanne McCarthy
A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today. -
Australian pelvic mesh victims launch their case against Johnson & Johnson
Jul 4, 2017 | Newcastle Herald
By Joanne McCarthy
Gai Thompson is in no doubt about the significance of the first day of a landmark Australian court case by more than 700 women against Johnson & Johnson that starts on Tuesday. -
Over 700 Aussie women seeking damages for vaginal mesh implants they say butchered their insides
Jul 4, 2017 | Now To Love
By Lorna Gray
The mesh devices have been used in supposedly routine pelvic floor procedures for over 8000 women. -
Damaged for life: Thousands of Australian women suffer devastating side effects in country’s ‘biggest medical scandal’
Jul 4, 2017 | news.com.au
By Megan Palin
A CONSULTANT who raised concerns about a controversial surgical mesh accused of butchering hundreds of Australian women told the manufacturers: “I would not like my wife to undergo this procedure ... not in my wife”, a court has heard. -
Vaginal mesh implants: Class action against Johnson and Johnson begins in Federal Court
Jul 4, 2017 | ABC Online
By Sophie Scott and Alison Branley
Women who say they have been injured by vaginal mesh implants used to treat pelvic-floor problems will claim hundreds of thousands of dollars in damages from makers Johnson and Johnson, the Federal Court in Sydney has heard. -
Thousands of women sue Johnson and Johnson over mesh implants
Jul 4, 2017 | Starts at 60
A class action against Johnson and Johnson has kicked off in Sydney today with more than 700 women claiming pharmaceutical giant’s vaginal mesh implant ruined their lives. -
Deeside AM backing for Connah’s Quay woman’s drive to warn others about controversial treatment
Jul 4, 2017 | Deeside
An AM is backing a constituent who has joined a national campaign after suffering agonising pain following a controversial treatment. -
NSW Health is investigating how a woman was photographed during intimate pelvic mesh surgery
Jul 4, 2017 | Newcastle Herald
By Joanne McCarthy
NSW Health Minister Brad Hazzard has ordered a review of pelvic mesh surgery by former University of Newcastle associate professor Richard Reid in 2013 after evidence a woman’s genitals were photographed for publication during pelvic mesh surgery, without her knowledge or permission.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Pa. Judge Urged To Move Mesh Cases After Justices' Rulings
Jul 3, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (July 3, 2017, 6:05 PM EDT) -- After two recent U.S. Supreme Courtdecisions limiting the ability of trial courts to retain jurisdiction over claims from out-of-state plaintiffs, a Pennsylvania state judge was urged to dismiss a cluster of cases against Boston Scientific Corp. and a Johnson & Johnson unit from non-Pennsylvanians alleging injuries from faulty pelvic mesh products.
BSC and Ethicon Inc. argued Friday that the justices’ recent decisions narrowing the scope of jurisdiction for plaintiffs looking to pursue claims in venues outside either where they were injured or where a defendant is headquartered meant that nearly 100 cases pending in the Philadelphia County Court of Common Pleas needed to be dismissed and refiled elsewhere.
“Plaintiffs’ sole connection to the commonwealth is their lawyers’ choice to file suit in this court,” Ethicon said in its motion. “This is not enough for jurisdiction.”
The companies had previously sought to have claims from out-of-state plaintiffs, whose cases are part of a mass tort program aimed at coordinating litigation over alleged pelvic mesh injuries, dismissed for a lack of jurisdiction, but a judge rejected their bid in March 2015.
With the new Supreme Court precedent in hand, however, the companies are asking the judge to reconsider the decision.
The companies pointed to a ruling from the justices last month which found that Bristol Myers-Squibb Co. did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood-thinner Plavix.
The 8-to-1 opinion came just weeks after another ruling from the Supreme Court which found two out-of-state employees couldn’t sue BNSF Railway Co. in Montana given the company’s lack of a bona fide business presence in the state.
Ethicon argued in its motion Friday that its position as a New Jersey-based business meant that non-Pennsylvanians could not bring their claims in Philadelphia County.
BSC leveled the same argument in its motion, pointing to its incorporation in Delaware and its headquarters in Massachusetts.
“Plaintiff’s only allegation connecting Boston Scientific and Pennsylvania is Boston Scientific’s regular business conducted in the commonwealth,” the company argued. “Boston Scientific’s products, however, are sold and distributed nationwide, and only reach Pennsylvania through the stream of commerce. This is not sufficient to establish jurisdiction.”
Attorneys for the plaintiffs did not immediately return messages seeking comment Monday.
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP, and Julie Callsen of Tucker Ellis LLP.
Boston Scientific is represented by Joseph Blum and Erin Loucks of Shook Hardy & Bacon LLP.
The plaintiffs are represented by Shanin Specter, Lee Balefsky, Michelle Tiger and Christopher Gomez of Kline & Specter PC, and Clayton Clark of Clark Love & Houston.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Orlando Lorenzo.https://www.law360.com/articles/941004/pa-judge-urged-to-move-mesh-cases-after-justices-rulings
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Vaginal mesh risks downplayed by Johnson & Johnson, court told
Jul 4, 2017 | The Guardian
By Christopher Knaus
A pharmaceutical giant allegedly played down the risks of a vaginal medical device that has caused debilitating and irreparable pain to thousands of women after giving birth.
Instead it was “aggressively marketing” the products to surgeons as a cheap and easy way to boost their profits.
Up to 8,000 women in Australia and 100,000 worldwide are thought to have used the vaginal mesh and tape implants, which were produced by the Johnson & Johnson group as a low-cost way to treat prolapsed pelvic floors and urinary incontinence usually caused by complications after giving birth.
Vaginal mesh left me in agony. When will women’s health be taken seriously?Kath Sansom
Read more
On Tuesday, a trial involving 700 Australian patients against three Johnson & Johnson companies began in the federal court. Many of the women allege the devices ruined their lives.
They suffered irreparable, debilitating pain after the devices began to erode into surrounding tissue and organs, causing infections and complications. The mesh is unable to be removed. Even after further surgery, women continue to suffer chronic pain.
Johnson & Johnson allegedly failed to properly warn patients and surgeons of the risk, or test the devices adequately.
The trial has been described as one of the country’s largest product liability class actions, and Shine Lawyers, representing the applicants, described its commencement as an important step on the road to justice, accountability and recompense.
One woman involved in the case, Joanne Maninon, spoke outside of court on Tuesday. She said she wants to make sure no woman is ever subjected to the trauma inflicted by the devices again.
“It can’t go on,” Maninon said. “There’s too many women who have gone through the pain, the complications ... it’s lifelong,” she said.
“You can’t just have the mesh removed. You’re damaged for life.”
The case is expected to run for six months, and Tony Bannon SC began a four-day opening submission on Tuesday. He said Johnson & Johnson had aggressively marketed the lucrative benefits of the products to surgeons.
The risks of the surgery, Bannon alleged, were either minimised or not communicated to either surgeon or patient.
“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” Bannon told the court.
He said the company saw a “valuable market” to be gained through emphasising the speed and ease with which the devices could be installed.
It’s alleged the consultants engaged to trial the devices knew the risks.
Bannon cited an email exchange, involving French doctors enlisted for the trial, which appeared to show awareness of the dangers associated with surgery. One doctor wrote that he would “not like my wife to undergo this procedure”, and did not think he would be “alone” in that view.
The doctor is now earning royalties from their use, the court heard.
“That is one of the transvaginal mesh team members, one of the consultants. His view is that ‘I wouldn’t like my wife to undergo that, and I don’t think I’m alone’,” Bannon said.
He said the comment was known to Johnson and Johnson, but was not followed up.
The mesh is designed to cause inflammation upon its surgical insertion, to help fix it in place. But the inflammation did not subside as intended. The continuing inflammation allegedly caused the mesh to stiffen, meaning it did not have the flexibility the body requires.
Johnson & Johnson, which has also faced action in the United States, stopped selling the product. It claimed this was a commercial decision.
Bannon characterised it as an act designed to limit the number of women given the device, and therefore reduce its exposure to damages.
“At the end of the day, apart from being an ethical decision, I suppose that’s a commercial decision as well,” he said.
The tape product is still being sold by Johnson & Johnson. The trial continues on Tuesday.
https://www.theguardian.com/australia-news/2017/jul/04/vaginal-mesh-risks-downplayed-by-johnson-johnson-court-told
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Australian class-action case opens over pelvic mesh implants
Jul 4, 2017 | Associated Press (In ABC News)
By Kristen Gelineau
More than 700 Australian women in a class-action case against pharmaceutical giant Johnson & Johnson that started Tuesday argued that the company's vaginal mesh implants caused them devastating pain, ravaged their bodies and, in some cases, ruined their lives.
Patients across the United States, United Kingdom and Canada have filed tens of thousands of lawsuits against Johnson & Johnson and other pelvic mesh manufacturers over the devices, which are used to treat urinary incontinence and repair pelvic organ prolapse, a condition often caused by childbirth in which organs shift out of place. Women who have sued the manufacturers say the mesh caused them chronic and often debilitating pain, infections, loss of sexual function and incontinence. In 2014, Irish medical device maker Endo International said it would pay $830 million to settle more than 20,000 personal injury lawsuits related to its vaginal mesh implants.
The Australian trial that began Tuesday is expected to last six months. The lawsuit argues the U.S.-based company was negligent for not properly warning doctors and patients about the risks associated with the devices. The lawsuit also contends that the products were not fit for the purposes for which they were designed, and the testing prior to the devices being sold was inadequate.
Gai Thompson, one of the claimants in the lawsuit, said she has suffered pain every day since she received the implant.
"No amount of compensation, money, could ever replace what we've lost with our lives, with our families, our health, our emotional health," Thompson told reporters outside court. "My prayer is that this mesh would be banned and that no woman would suffer what we suffer."
Attorney Jan Saddler of Shine Lawyers, the firm representing the women, said the major problem with the devices is that they erode into surrounding tissue and organs, causing a chronic inflammatory response. Virtually all the women involved in the lawsuit suffer chronic pain, and many have experienced relationship problems due to their inability to have sex, Saddler said.
"Many women are no longer able to have any sort of sexual relationship, or if they are able to have a sexual relationship, there is a lot of pain associated with that," Saddler said. "Women have been also unable to really enjoy proper fulfilling relationships not only with their partners, but with their children, with their friends. ... Women have found it very difficult to work in the way they used to work. So it's had really debilitating impacts."
Johnson & Johnson says it has sold over 100,000 mesh products in Australia. The lawsuit singles out nine separate devices; of those, the company has taken five off the market. None of the devices have been subject to a recall by Australian regulators. In the U.S., the Food and Drug Administration last year reclassified all pelvic mesh implants as "high risk" instead of moderate, making them subject to extra regulatory requirements. But the agency has not recalled the devices.
In a statement, Johnson & Johnson said the use of mesh to treat pelvic organ prolapse and urinary incontinence has successfully helped millions of women worldwide, and said the majority of women who undergo the surgery have had a positive result.
"These pelvic mesh products have been developed in close consultation with specialist surgeons and are backed by years of clinical research," the company said. "We have always complied fully with local regulatory requirements when providing the products in Australia, and have acted ethically and responsibly in the research, development and supply of the products."
Thompson said she wants the company to be held accountable for the suffering she and so many other women say the mesh has caused.
"For so many years, we've been told that there's nothing wrong with us, that symptoms are either in our head or it's not because of the mesh. But there are so many women who have the same complications," Thompson said. "The mesh destroys lives — it destroys you physically and emotionally."
http://abcnews.go.com/Health/wireStory/australian-class-action-case-filed-pelvic-mesh-implants-48428845
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These Women Have Taken Johnson & Johnson To Court Over Vaginal Mesh Implants
Jul 4, 2017 | Buzzfeed News
By Gina Rushton
Gai Thompson is one of more than 700 women taking Ethicon, a subsidiary of Johnson & Johnson, to court today in a class actionwhich will claim vaginal medical devices left women "suffering painful and life-altering complications".
"I have literally been praying for nine years that this would come to light and that there would be accountability," Thompson told reporters as she stood out the front of the Federal Court in Sydney, alongside fellow class action members on the first day of the trial on Tuesday.
BuzzFeed News reported in May that women had claimed the vaginal implants have impacted negatively on their health, happiness, sex lives and financial wellbeing.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse - when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth - or urinary incontinence.
In the former case the mesh - which is polypropylene, non-absorbable and acts as a permanent implant - is inserted under the urethra (the tube that empties urine from the bladder).
"No amount of compensation, money, could ever replace what we have lost with our lives, with our families, our health, our emotional health, our physical health," Thompson said outside the court.
"My prayer is that this mesh would be banned and no more women suffer with what we suffered and what we continue to suffer.
"For so many years we have been told that there is nothing wrong with us, that the symptoms are either in our head or it isn't because of the mesh."
Shine Lawyers, representing the women, has said there could be upwards of 8,000 Australians who have been implanted with one of the nine devices and suffered complications that may be entitled to join the action.
In the statement of claim, supplied to BuzzFeed News, patients have listed a raft of symptoms and complications they say they have suffered following the insertion of nine different Ethicon mesh devices.These include: chronic and constant vaginal pain, visceral pain with bowel movements, dyspareunia (pain during sex), vaginal bleeding, the granulation of vaginal tissue, pain through the glutes, inflammatory reactions, "offensive discharge", incontinence, leg weakness and haemorrhages.
Shine Lawyers special counsel Rebecca Jancauskas said her clients had suffered "painful and life-altering complications".
"It is such a private pain and women have been suffering in silence for years," Jancauskas told BuzzFeed News.
"Yet it is one of the biggest product liability class actions that this country has seen, if not the biggest, based on the number of people affected."
"The evidence will demonstrate that before launching each of their mesh products, Johnson & Johnson did not pause to investigate via appropriate clinical trials, the true nature and consequences of these permanent implantations in the female anatomy," Shine's barrister Tony Bannon SC told the court, in an opening submission that will run for the rest of the week.
"Even if [the implants] can be removed, the ongoing pain and disability will continue."
Johnson & Johnson's lawyers will present their opening submissions on Monday July 10.
Johnson & Johnson said the company's pelvic mesh products had been developed in "close consultation with specialist surgeons" and were "backed by years of clinical research".
"We have always complied fully with local regulatory requirements when providing the products in Australia, and have acted ethically and responsibly in the research, development and supply of the products," the company said in a statement provided to BuzzFeed News on Tuesday.
"We have sold over 100,000 mesh products in the Australian market. We have been notified of fewer than 200 total product events."
In a document filed to the Federal Court, Johnson & Johnson has outlined its defence to the case.
In its submission to a federal Senate inquiry, the company said the use of implantable mesh was supported by clinical research and was often the preferred option to treat pelvic conditions, including incontinence and pelvic organ prolapse.
The Senate inquiry will hear from doctors and women who say they have been affected by the implants, and will also examine the Therapeutic Goods Administration's "knowledge of women suffering from health problems after having transvaginal mesh implants".
Submissions to the inquiry closed last month and the committee will report in November this year.
https://www.buzzfeed.com/ginarushton/these-women-have-taken-johnson-johnson-to-court-over?utm_term=.rfRnaKe31#.xbDbk3RqW
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Hundreds of women join vaginal mesh lawsuit against Johnson & Johnson
Jul 4, 2017 | AAP (In Yahoo News)
More than 700 women suffering strong pain from vaginal mesh implants have launched a class action against global healthcare giant Johnson & Johnson in the Federal Court.
The implants are thought to have been used to treat pelvic floor damage on about 8000 Australian women who have suffered life-altering complications after surgery, Rebecca Jancauskas from Shine Lawyers said on Tuesday.
She said the mesh was designed to repair pelvic floors, but side effects have been devastating.
"The complications that Australian women are suffering include the mesh or tape eroding through, and into, surrounding tissue and organs, as well as incontinence, infection and chronic pain," she said.
"Many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives," she said.
Some of the implants can still be bought, Ms Jancauskas said.
"This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives," she said.
The Australian class action comes after more than 100,000 women started legal action in the US and similar moves were taken in the UK and Canada.
Shine is due to open its case in the Federal Court in Sydney on Tuesday, with Johnson & Johnson's lawyers to present their arguments next Monday.
Hearings are expected to run for about six months.
https://au.news.yahoo.com/a/36259078/vaginal-mesh-lawsuit-to-commence/#page1
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“I would not want my wife to undergo this procedure”: pelvic mesh inventor
Jul 4, 2017 | Newcastle Herald
By Joanne McCarthy
A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.
Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.
The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.
Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".
Mr Bannon told the court the comments' message was "those of us who were in the know".
"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.
The landmark case, which has attracted international media attention, is expected to take six months.
Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.
"Their enjoyment of life has been seriously compromised,” he said.
"Their lives have been dramatically altered for the worse.”
Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.
The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.
The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.
They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.
Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.
They were more likely "mid-career doctors" who saw their practices as businesses.
The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.
The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".
Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.
He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.
The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.
One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.
Ms Manion was visibly upset through some of the evidence.
The hearing continues.
http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/
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Australian pelvic mesh victims launch their case against Johnson & Johnson
Jul 4, 2017 | Newcastle Herald
By Joanne McCarthy
Gai Thompson is in no doubt about the significance of the first day of a landmark Australian court case by more than 700 women against Johnson & Johnson that starts on Tuesday.
“But at the end of the day we’re not going to get our lives back,” Mrs Thompson said. “No amount of money will make up for what we’ve suffered.”
Shine Lawyers will launch one of Australia’s largest product liability class actions against Johnson & Johnson and allege its pelvic mesh implants have left thousands of women suffering painful and life-altering complications.
At least 16 Hunter women are registered as claimants.
Half the women are alleging serious injury after pelvic surgery for incontinence using five varieties of Johnson & Johnson’s TVT implants and the other half are seeking damages after they were implanted with the company’s Total Prolift and Total Gynemesh devices following prolapse after childbirth.
Shine Lawyers special counsel Rebecca Jancauskas said the class action was “a significant case in the judicial landscape” that was expected to run for six months.
“Our case is that the TVT implants cause complications that are not experienced with alternative treatments for stress incontinence,” Ms Jancauskas said.
The case will hear evidence that warnings and product information did not adequately identify complications or the difficulty of rectifying them.
“Australian women have had their lives changed forever by these products. Many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives.
“In many cases they are even unable to be intimate with their partners. It has had truly devastating consequences,” Ms Jancauskas said.
Shine barrister Tony Bannon, SC, will present opening submissions from Tuesday to Friday and Johnson & Johnson will respond with an opening submission on Monday.
In June the Royal Australian and New Zealand College of Obstetricians and Gynaecologists controversially backed traditional midurethral “slings” such as the Johnson & Johnson TVT in a position statement after years of controversy about pelvic mesh surgery.
It conceded failure can lead to “intractable” and permanent complications for women and have “severe effects” on quality of life.
Mrs Thompson was implanted with the Johnson & Johnson Prolift device in February, 2008.
Her life from that date had become “a living nightmare”, she said.
“People just do not understand what you have to live with and there’s nothing you can do.”
http://www.theherald.com.au/story/4768360/700-women-set-for-battle/
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Over 700 Aussie women seeking damages for vaginal mesh implants they say butchered their insides
Jul 4, 2017 | Now To Love
By Lorna Gray
The mesh devices have been used in supposedly routine pelvic floor procedures for over 8000 women.
A legal battle involving hundreds of Australian women has commenced in Sydney’s Federal Court today. More than 700 women have joined the class action against Johnson & Johnson Medical Australia and subsidiary companies Ethicon Inc and Ethicon Sarl, over their vaginal mesh implants used in supposedly routine pelvic floor surgery.
The women are seeking damages for “life-altering complications” caused by the implants. Shockingly, the mesh is being blamed for internal organ injuries as well as incontinence and chronic pain, which has left some women unable to have sex .
"The complications that Australian women are suffering include the mesh or tape eroding through, and into, surrounding tissue and organs, as well as incontinence, infection and chronic pain,” legal representative Rebecca Jancauskas from Shine Lawyers said today.
"Many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives."
"This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives."
Jancauskas said it’s thought the implants have been used to treat the pelvic floors of a whopping 8,000 Australian women.
Senator Derryn Hinch described it as “the biggest medical scandal for Australian women since thalidomide,” earlier this year.
Take 5 magazine spoke to Lynda Garlinge , 65, who says she had a mesh implant fitted without her consent after incontinence issues. She says “nearly a decade of my life was destroyed by pain.”
“It was supposed stop any leaks, but it turned out the mesh could cause life-ruining side effects like intense pain, infections, bleeding and painful sex, not to mention even worse incontinence and constipation,” she told the publication.
The Australian class action comes after more than 100,000 women started legal action in the US. The UK and Canada has also seen similar moves.
Hearings are expected to run for about six months.
More as we get it.
http://www.nowtolove.com.au/news/latest-news/700-aussie-women-seeking-damages-vaginal-mesh-implants-38898
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Jul 4, 2017 | news.com.au
By Megan Palin
A CONSULTANT who raised concerns about a controversial surgical mesh accused of butchering hundreds of Australian women told the manufacturers: “I would not like my wife to undergo this procedure ... not in my wife”, a court has heard.
Shine’s class action barrister Tony Bannon, SC, read the excerpt from an email that was allegedly sent by Total Transvaginal Mesh (TVM) French consultant Bernard Jacquetin to Johnson & Johnson personnel. Dr Bernard was enlisted to conduct clinical trials for the implants. Mr Bannon said there was “no feedback” but that the doctor is now earning royalties from their use.
“That is one of the transvaginal mesh team members, one of the consultants. His view is that ‘I wouldn’t like my wife to undergo that, and I don’t think I’m alone’,” Bannon said.
Hundreds of Australian women who allege pelvic mesh implants have left them with catastrophic injuries to their internal organs have today taken the manufacturers to court for damages.
More than 700 women have joined the class action against Johnson & Johnson Medical Australia and subsidiary companies Ethicon Inc and Ethicon Sarl to seek hundreds of millions in compensation, as the case gets underway in Sydney’s Federal Court today.
They claim the surgical mesh approved by Australia’s medicine watchdog has disfigured and disabled them, caused chronic pain and destroyed their sex lives.
It will also be alleged that the implants were not fit for their purpose, were not of merchantable quality, were not safe and that the companies were negligent for rushing the devices onto the market without clinical testing. Instead, the mesh was “aggressively market(ed)” to surgeons as a cheap and easy way to boost their profits, the court heard.
The controversial mesh implants have been used to treat urogynaecological issues typically caused by child birth in thousands of Australian women since 2000.
Medical reviews claim up to one in eight suffer complications including scarring, infection, bleeding, organ perforation, incontinence and recurrent prolapse. Several patients claim the mesh has eroded their organs and fused others together.
Primary school teacher Jan Hawkins, 60, said she was forced to retire after she developed severe complications from a pelvic mesh implant she had inserted in 2007.
“It’s like sandpaper inside you that every now and then rears its ugly head and pokes through organs and walls, which affects nerves and how they function,” Ms Hawkins told news.com.au.
“It’s a terrible thing that rubs and creates a cheese grater effect.”
Ms Hawkins, from Terrigal on the NSW Central Coast, said she felt discomfort immediately following the surgical procedure and was soon “filled with horror”.
“I had some ghastly tests that showed the mesh had buckled and folded,” she said.
“Everything had prolapsed and I had terrible troubles with the bowel.
“Everything was in a real mess and ulcers had started forming.”
With full medical cover and “all of the extras” it still cost her a total of about $20,000 to have one of only about two doctors in Australia who can remove the implants carry out the procedure in 2013.
“The doctor that removed the mesh said it was about the size of an iPhone screen and that he had to remove the whole back wall of the vagina,” Ms Hawkins said.
“I was black and blue down to my knees ... there was blood transfused ... it was big.”
It couldn’t be completely removed so parts of the mesh and its hooks remain inside the mother-of-three’s body, continuing to cause her pain and other medical complications.
“I lived on pain killers for a while because of ongoing leg problems where I can’t stand for long as a result of aching that is quite severe,” she said.
“I feel so reconstructed, sometimes you don’t feel like you can function on a normal level, and daily functions aren’t normal.”
But Ms Hawkins said she was “one of the lucky ones”. In most cases, the mesh can’t be removed.
“It’s designed to hook into the tissues so they grow in and around it so getting rid of it is often impossible,” she said.
Shine class action lawyer Rebecca Jancauskas told news.com.au that the pelvic mesh implants had changed the lives of many Australian women forever.
“The complications that Australian women are suffering include the mesh or tape eroding through, and into, surrounding tissue and organs, as well as incontinence, infection and chronic pain,” Ms Jancauskas said.
“Many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives.
“In many cases they are even unable to be intimate with their partners. It has had truly devastating consequences.”
She estimated that up to 10,000 women could be affected by complications.
None of the products have been recalled and some remain on the market today, according to Ms Jancauskas.
“This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives,” she said.
Outside court, complainant Gai Thompson told reporters she has suffered pain every single day since she had the mesh implanted in her.
“No amount of compensation money could ever replace what we’ve lost with our lives, with our families, our health, our emotional health, our physical health,” Ms Thompson said.
“They can’t just make products and put them in women, destroy their lives and say ‘I can do that’ — and that’s what they’ve done.
“(Johnson & Johnson need to be held) accountable and responsible.”
Fellow claimant Jo Mannion told reporters she hoped the case would bring her some closure after years of pain.
The landmark class action is one of the largest medical civil cases in Australia. The action could dwarf the $250 million settlement Johnson & Johnson paid out last year over its DePuy hip implant that left hundreds of patients poisoned and seriously disabled. It has been set down for six months.
Earlier this year, Senator Derryn Hinch described it as “the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs”.
“It has to be halted until it is proven safe because there are too many cases where this is crippling people for life,” Mr Hinch said in February.
A Senate inquiry into transvaginal mesh devices will hear from women across the country who were left with injuries.
Another 300 Australian women are registered for a second class action against American Medical Systems, which developed mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, and relied on the Australian-developed device for clearance. News.com.au understands other Australian women have filed lawsuits against individual doctors.
Australia’s Therapeutic Goods Administration still allows surgeons to implant the mesh despite bans, warnings and withdrawals in other countries and more than 120,000 pending lawsuits in the US. However, some of the implants have been discontinued.
http://www.news.com.au/lifestyle/health/health-problems/damaged-for-life-thousands-of-australian-women-suffer-devastating-side-effects-in-countrys-biggest-medical-scandal/news-story/54744a31c01dfef9a032e4754298a5a8
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Vaginal mesh implants: Class action against Johnson and Johnson begins in Federal Court
Jul 4, 2017 | ABC Online
By Sophie Scott and Alison Branley
Women who say they have been injured by vaginal mesh implants used to treat pelvic-floor problems will claim hundreds of thousands of dollars in damages from makers Johnson and Johnson, the Federal Court in Sydney has heard.
A class action involving more than 700 women has begun, with legal representatives for the women claiming the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh.
If the case is successful, it could lead to payouts totalling hundreds of millions of dollars to affected women.
Barrister Tony Bannon SC said there was a "tidal wave" of aggressive marketing to surgeons and patients that suggested implanting the mesh was a "quick and easy operation".
He told the court the "suffering of the applicants would demonstrate [the] true risks of the … mesh".
"These are risks none of the applicants would have run if they had been properly advised," he said.
Mr Bannon said each applicant continued to suffer significant, unbearable pain.
He quoted an internal email from French doctor Bernard Jacquetin, running a clinical trial for the manufacturer, who allegedly wrote: "I wouldn't like my wife to undergo this procedure."I've been praying this would come to light: claimant
Outside court, two of the lead claimants in the case said it was a momentous day.
Gai Thompson said she had been waiting for this moment.
"I've literally been praying for nine years that this would come to light, that there would be accountability for what has happened to us," she said.
"No amount of compensation, money, can ever replace what we've lost with our lives with our families, our health, our emotional health.
"For so many years we've been told there's nothing wrong with us, that symptoms are either in our head or it's not because of the mesh.
"I don't think people understand [there's not] one day from the time it's been put in that we haven't had pain — not one day."
The women, including another claimant Joanne Boone, want the mesh banned.
"I had my mesh removed overseas so I've been through a lot of trauma and recovery that has just been, probably even harder since I've had the mesh removed," she said.
"I want to see it banned. It can't go on. There's too many women that are injured."
Many products are still approved for use and available for surgeons to implant.
The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.
Women in the case said it had left them with further complications ranging from severe pain to inability to have intercourse.
Surgeons maintain the products have been clinically tested and have helped many women.Company rejects claims
Johnson and Johnson has sold more than 100,000 mesh and tape implants but said that did not equate to the number of women affected.
In its submission to a federal Senate inquiry, the company said the use of implantable mesh was supported by clinical research and was often the preferred option to treat pelvic conditions, including incontinence and pelvic organ prolapse.
It was "not able to detail the total number of women that have had transvaginal mesh implants, the number who have experienced adverse side-effects nor the number who have made attempts to have transvaginal mesh removed [in Australia or elsewhere]".
http://www.abc.net.au/news/2017-07-04/class-action-vaginal-mesh-implants-johnson-and-johnson/8674106
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Thousands of women sue Johnson and Johnson over mesh implants
Jul 4, 2017 | Starts at 60
A class action against Johnson and Johnson has kicked off in Sydney today with more than 700 women claiming pharmaceutical giant’s vaginal mesh implant ruined their lives.
The women are suing for damages after suffering long-term pain as a result of the implant, which is meant to help with incontinence and prolapse caused by childbirth.
Johnson and Johnson says the mesh is supported by research, but thousands of women have come forward claiming they’ve been left with “painful and life-altering complications”, reports the ABC.
Shine Lawyers, the firm behind the class action, claims as many as 8,000 Australian women may have been impacted by mesh and tape implants.
In their opening submissions, barrister Tony Bannon SC said patients had suffered unbearable pain because of the implant.
He is also expected to present testimonial evidence from a number of women who say their marriages and careers were destroyed as a result of their pain.
Some women have said they were unable to have intercourse because of the pain.
The mesh implant is now the subject of a Senate inquiry with Independent Senator Derryn Hinch calling for doctors, pharmaceutical companies and the Therapeutic Goods Association to face consequences.
Johnson and Johnson is standing by the product though, saying it is supported by medical research and that thousands of women are successfully living with the implant.
In its submission to the federal Senate inquiry the company said it was “not able to detail the total number of women that have had transvaginal mesh implants, the number who have experienced adverse side effects nor the number who have made attempts to have transvaginal mesh removed (in Australia or elsewhere)”.
https://startsat60.com/health/thousands-of-women-sue-johnson-and-johnson-over-mesh-implants
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Deeside AM backing for Connah’s Quay woman’s drive to warn others about controversial treatment
Jul 4, 2017 | Deeside
An AM is backing a constituent who has joined a national campaign after suffering agonising pain following a controversial treatment.
Maxine Cooper has joined the Sling the Mesh campaign after a procedure she underwent in 2010 to cure stress incontinence caused by childbirth left her with life-changing side effects.
After researching her problems online Maxine came across the Sling the Mesh campaign run by journalist and fellow-sufferer Kath Sansom.
She realised that thousands of women have been affected after having either Tension-Free Vaginal Tape (TVT) or Tension-Free Vaginal Tape Obturator (TVTO) procedures to cure incontinence or prolapse.
The traditional operation for these conditions takes three to four hours whereas TVT and TVTO insertion takes 15-20 minutes and is performed ‘blind’ as opposed to through incision or keyhole methods.
Maxine, 54, from Connah’s Quay, wants to share her story in a bid to make other women aware and to stop the procedure being carried out.
She had TVTO inserted in June 2010 after physiotherapy hadn’t worked and started noticing problems three years ago. Maxine is unable to be intimate with a partner because of bleeding and pain, suffers haemorrhaging, stomach pains and pain down the right side of her body all the way from her shoulder blade.
She is in such severe pain that she has been prescribed strong painkillers and has been unable to go to her work at the Youth Justice Service – which is also causing stress and worry.
Maxine said;
After three years of suffering I realised the mesh could be causing all my problems. I think they want to save money by performing TVT and TVTO, but they’re not because this is causing so many complications.
Over 2,000 women have joined the sling the mesh campaign. I want to get TVT and TVTO banned and to raise awareness. If it wasn’t for the internet I wouldn’t have found Sling the Mesh and other women with the same symptoms as me.
After seeing a gynaecologist Maxine has been referred for a scan and further explorations, which she will have this week.
Whereas surgeons can insert the mesh after a day’s training, only a handful of surgeons can remove the mesh. In cases where it is used to fix prolapse it can be almost or totally impossible as the mesh has fused with organs.
This affects thousands and thousands of women across the UK and has left some in wheelchairs.
How bad is it going to get and how far does it have to go before this procedure gets banned?
Too many women are suffering, they all have the same symptoms – it speaks volumes. It’s barbaric. -Maxine Cooper
Maxine is hopeful after securing a much-sought-after appointment with Sohier Elneil, a consultant in urogynaecology and uroneurology.
The consultant has spoken out about her concerns over the procedure and performs 20-30 TVT and TVTO removals a month.
After a campaign in Scotland, the procedure was suspended in 2014, but reinstated in 2017 following a controversial report in which it was deemed safe.
Maxine’s local Assembly Member Carl Sargeant is backing her calls to Welsh Health Cabinet Secretary Vaughan Gething to hold an urgent review of mesh procedures in Wales.
Another problem the campaign is encountering is a lack of awareness among GPs which can lead to symptoms being ascribed to other conditions, making it hard to evidence the extent of the problem.Carl Sargeant said:
I’ll be asking the health secretary to look into this as anecdotal evidence shows this is a massive problem. Many women are having this procedure without a clear explanation of the risks and are finding their lives drastically changed for the worse.
I hope there will be a review into this, and in the meantime I support Maxine in raising awareness so that other women don’t suffer like she has. I admire her bravery and will back her campaign all the way.
http://www.deeside.com/deeside-backing-connahs-quay-womans-drive-warn-others-controversial-treatment/
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NSW Health is investigating how a woman was photographed during intimate pelvic mesh surgery
Jul 4, 2017 | Newcastle Herald
By Joanne McCarthy
NSW Health Minister Brad Hazzard has ordered a review of pelvic mesh surgery by former University of Newcastle associate professor Richard Reid in 2013 after evidence a woman’s genitals were photographed for publication during pelvic mesh surgery, without her knowledge or permission.
The move comes a day after a second patient of Dr Reid’s said a male pelvic mesh company representative watched her intimate pelvic mesh surgery at Sydney Private Hospital in 2013, without her knowledge or permission.
Mr Hazzard instructed the ministry of health on Monday to review pelvic mesh surgery at the hospital by Dr Reid and Dr Peter Petros using the Tissue Fixation System (TFS) device invented by Dr Petros, after questions from the Newcastle Herald.
It comes after Victorian Health Minister Jill Hennessy ordered an investigation into TFS surgery involving Dr Reid, Dr Petros and Victorian gynaecologist Dr Max Haverfield at a Melbourne public hospital in 2010 and 2013 after Herald questions.
It also comes as a landmark Australian legal class action for damages by more than 700 women against pelvic mesh manufacturer Johnson & Johnson starts in Sydney on Tuesday.
A spokeswoman for Mr Hazzard said the review ordered on Monday could lead to legislative changes about photography in operating theatres.
“The Minister has asked for legal advice on whether or not it is lawful for a surgeon or clinician or any other person in the operating theatre to take photographs of a person who is under the effect of an anaesthetic and who has not given permission for the photographs to be taken,” the spokeswoman said.
“The Minister is of the view that there should be a presumption against photography which is not associated with the appropriate care or treatment of the individual patient and will consider whether any further legislative change needs to be made.”
The review will also include whether there were any adverse events related to TFS surgery at Sydney Private Hospital involving Dr Reid and Dr Petros, and if any adverse events were reported to relevant authorities as required under the hospital’s reporting obligations.
A NSW Health spokesperson said the review would include an audit of the hospital’s reporting practices.
Asked what was in place, if anything, to protect patients in NSW hospitals from being photographed or filmed while under anaesthetic, the spokesperson said NSW Health was “not aware photographs were being taken of this type of surgery” and “what has been outlined by the Newcastle Herald seems entirely inappropriate”.
“This will now form part of the current review,” the spokesperson said.
The review will also consider what action can be taken when someone is photographed without their consent.
Catherine Henry Lawyers senior solicitor Jane Bulter said the Newcastle firm was seeing an increasing number of women who experienced serious complications after pelvic mesh surgery.
“There is increasing awareness in the community of the mesh issue and we’re seeing more and more cases,” Mrs Bulter said.
“Unfortunately some of these cases are outside the time limitation period because the women have been told there’s nothing wrong with them and they’ve had surgery after surgery in repairs.
“We’d urge women to contact a lawyer soon if they believe they have experienced injury because of pelvic mesh surgery. We would also ask governments to look at doing something about the time limitation period as it affects these cases.
http://www.theherald.com.au/story/4765416/hazzard-orders-mesh-photography-review/
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