AMS (American Medical Systems,now Endo and J&J (Johnson & Johnson/JNJ) HARM Women FOR PROFIT in AU

Australian Medical Association president confirms AMA WA(Western Australia)’s role in pelvic mesh scandal

• Joanne McCarthy  AUGUST 22 2017 - 12:11PM

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The Australian Medical Association acted as exclusive distributor of an Australian-invented pelvic mesh device for women that helped spark a global pelvic mesh scandal after it was sold and registered for use in America in 2001.

The AMA's marketing of the Intravaginal Sling (IVS) Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse, despite women's reports of complications in Western Australian public hospital trials from as early as 1989, was "a long way from our proudest hour", said current AMA president Dr Michael Gannon.

Australian Medical Association national president Dr Michael Gannon confirmed the AMA promoted and distributed a pelvic mesh device for women that helped spark a global pelvic mesh scandal. 

"It is unfortunately the case that many women have been injured by these kinds of operations. To call this a tragedy is not overstating it at all," he said, after confirming a wholly-owned subsidiary of the AMA's Western Australian branch promoted and exclusively distributed the IVS device.

It was a controversial decision that "I'm sure they now regret", and which some Perth gynaecologists continued to be unhappy about more than 15 years later, he said.

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"I can only answer that in good faith the AMA WA thought it was a good product. History will not judge that decision kindly. It already has not judged that decision kindly," Dr Gannon said.

His comments come only months after the Royal Australian and New Zealand College of Obstetricians and Gynaecologists conceded there was "very little robust information" of the long term safety of some prolapse mesh devices, despite estimates more than 30,000 Australian women received them.

The IVS Tunneller's sale to Tyco Health and registration in America in April, 2001 was used by pharmaceutical giants, including Johnson & Johnson, to register their own prolapse devices by arguing they were "substantially the same" as IVS and subsequent devices, without producing independent evidence of safety. They were then cleared for use in Australia.

More than 700 Australian women alleging serious and permanent injuries after pelvic mesh surgery for incontinence and prolapse are suing Johnson & Johnson in a Federal Court case in Sydney.

An Australian Medical Association document describing the IVS Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse in women.

Another 300 Australian women are registered for a second class action against American Medical Systems (AMS), which developed pelvic mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, after AMS argued it was "substantially the same" as the Australian-invented IVS Tunneller.

Dr Gannon, a Western Australian obstetrician and gynaecologist, said he was aware of "hundreds of operations" by Perth specialists trying to "remedy the damage" caused by mesh devices including the IVS.

Australian Pelvic Mesh Support Group members fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia. 

"I have been personally involved in the care of women who have suffered greatly from bladder dysfunction, bowel dysfunction and sexual dysfunction because of some of these devices," he said.

It was a "regulatory failure that so many individual women were damaged".

"The TGA (Therapeutic Goods Administration) takes great care when it looks at new medicines entering the market, but I don't think they are resourced to take the same care with devices. We would like to see them use the same blowtorch on devices as applies to medicines," he said.

Perth woman Jeanette McKinnon, who said she "wanted to vomit" several weeks ago when a specialist confirmed she was implanted with at least two mesh devices at the Bentley public hospital in 2004 and 2005, allegedly without her knowledge or consent, was outraged when told of the AMA's involvement.

"I'm absolutely horrified. I'm so angry I'm shaking. That this has been allowed to go on, and the AMA's been involved. How dare they? We're human beings," Mrs McKinnon said.

The IVS Tunneller device was developed during experiments on 13 large dogs in 1987 by inventor Dr Peter Petros and other Royal Perth Hospital doctors.

A WA East Metropolitan Health Service spokesperson confirmed Royal Perth Hospital approved a research study in 1989 into the IVS device and procedure. It was granted standard clinical practice status by the hospital's ethics committee in 1993.

A Medical Journal of Australia report in July, 1994 acknowledged many doctors were critical of the procedure.

In February 2001, only two months before the IVS Tunneller was cleared for use in America as an incontinence and prolapse device, the Royal Australasian College of Surgeons found there was "no peer-reviewed, good quality evidence available to determine the safety and efficacy of the IVS procedure to treat women's incontinence". There was no assessment of its use to treat prolapse.

In a paper in 2003 called "Intravaginal Sling Distress", three Australian specialists, including Newcastle gynaecologist Alan Hewson and Brisbane gynaecologist Chris Maher, reported "disconcerting complications" in women after IVS surgery, including infections, pain syndromes and "symptoms debilitating to the patient's and partner's quality of life".

"Until further data on the safety and efficacy of the IVS procedures is available they cannot be recommended," they concluded.

A 2010 Melbourne Mercy Hospital for Women review of 10 years of pelvic mesh surgery found the IVS device had significantly higher rates of pain, mesh erosion and infection complication rates than eight other devices reviewed.

Dr Petros did not respond to Newcastle Herald questions.

In a paper in 2012 Dr Petros said his "early experimental studies" had been "wrongly" used as "an intellectual cornerstone to justify the use of mesh in prolapse surgery".

In the paper he distanced himself from the global mesh scandal, saying complications were related to "large sheet" mesh adopted by some companies, and not the small tapes advocated by him which preserved "vaginal elasticity".

In a submission to a Senate inquiry into pelvic mesh devices, which will hold its second public hearing in Perth on Friday, Dr Petros referenced his 1990 paper produced after trialling the Intravaginal Sling procedure on "13 female mongrel dogs", in association with Royal Perth Hospital and the University of Western Australia.

-  Newcastle Herald

http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html

Australian Inquiry: Pelvic Mesh Causes Catastrophic Harm

A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries

Joanne McCarthy

4 Aug 2017, 5:30 a.m.

Determined: Women pelvic mesh victims leave the Federal Court in Sydney as a six-month class action against pelvic mesh manufacturer Johnson & Johnson takes place. A Senate inquiry is considering how mesh was cleared for use in Australia.

AUSTRALIA’S peak health care commission has told a Senate inquiry that up to 3000 Australian women have been left with injuries ranging from very serious to catastrophic after pelvic mesh surgery that is no longer recommended as a front line treatment.

The Australian Commission on Safety and Quality in Health Care was highly critical of specialist training, information to women about pelvic mesh risks, the treatment of women after serious mesh complications and the failure of doctors to respond when they sought help.

“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue,” commission chief executive, Adjunct Professor Debora Picone told the inquiry during a public hearing in Melbourne.

Commission clinical director Dr Robert Herkes said 40 women interviewed during consultations in four Australian cities had complications that were “undoubtedly overwhelming those women’s lives”.

“The bulk of the women were separated or divorced. Only one woman held down a job. For those women the complications were catastrophic,” Dr Herkes said.

Many of the women did not know they had been implanted with mesh devices until they searched for explanations for complications including chronic infections, disabling pain, erosion of the mesh into other organs and an inability to have sex.

“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue.

- Associate Professor Debora Picone

”

“We’ve been extremely concerned by the issues raised by the women we’ve talked with about the informed consent process, and particularly the informed consent process in relation to mesh surgery to treat prolapse,” Professor Picone said.

“In fact some of the conversations we’ve had with women, informed consent has really been absent. There’s no question about that in our minds.”

She described “so-called patient information leaflets” about pelvic mesh surgery as “hopelessly inadequate”, and said the commission felt very strongly that “major steps” needed to be taken on credentialing of doctors who implant mesh devices.

The Senate inquiry into pelvic mesh was called after Australian Pelvic Mesh Support Group founder Caz Chisholm and other members spoke with Victorian Senator Derryn Hinch. He campaigned for an inquiry into “one of the greatest scandals against women in Australian history”.

It is hearing evidence from women who received mesh implants through the vagina for prolapse treatment – now not recommended as a front line treatment after complication rates of at least 10 per cent – and mesh for incontinence, with lower complication rates and recognised evidence of safety and efficacy.

At the first hearing day two doctors who gave evidence conceded they should have declared they were to appear as expert witnesses for Johnson & Johnson in the company’s defence of a class action brought by more than 700 women after mesh surgery for incontinence and prolapse treatment.

Dr Anna Rosamilia told the inquiry she “should have disclosed” that she would be giving evidence for the company after appearing as a representative of Monash Health at the inquiry.

“I wasn’t aware that I needed to,” she said.

Dr Peter Dwyer, who will also give evidence for Johnson & Johnson, told the inquiry most of these companies have got strict ethical protocols that they stick to, before conceding he was an expert witness for the company.

Dr Dwyer told the inquiry that specialist training on mesh surgery was “falling between the gaps a bit”.

“If they’re placed in the wrong place… I mean, patients have died from these devices. They’ve got to be placed correctly,” he said.

Mesh manufacturers, which have been training doctors, should not be left to train them, he said.

Medical colleges had been “very happy to pass this on to special interest groups to manage these problems”, he said.

In response to a question from Mr Hinch about mesh company representatives being present in operating theatres while women are being implanted with mesh devices via the vagina, Dr Dwyer said “on occasion the rep does come into the operating theatre”.

“It’s not unusual for them to come into theatre at times. As long as they’re not directing the operation or interfering in other ways,” Dr Dwyer said.

The inquiry will hold another public hearing in Perth on August 25.
http://www.theherald.com.au/story/4832324/peak-health-body-scathing-on-mesh-history/

American Healthcare Giant J&J Stonewalling in Australia: Transvaginal Mesh

Exposed: how Johnson & Johnson cut its risk in vaginal mesh lawsuit.

July 20, 2017  FiDA highlight

* The world’s biggest healthcare group has quietly cut its exposure to victims in its vaginal mesh class-action lawsuit.

* Seven Johnson and Johnson subsidiaries are in breach of the Corporations Act.

* With no explanation, J&J and its auditor PwC reduced accounting disclosures and transparency.

The 700 women suing Johnson and Johnson for faulty vaginal mesh implants will not be pleased to hear that the healthcare giant has quietly reduced its exposure to medical negligence lawsuits.

Buried in Johnson and Johnson’s disclosures to the corporate regulator is a letter from the group’s lawyers King & Wood Malleson to the corporate regulator which shows a Deed of Cross Guarantee between seven of the group’s subsidiaries has lapsed. By allowing the Deed to lapse, the company has effectively reduced the pool of assets which creditors can access in a legal claim.

Previously, this Deed had ensured that the seven Johnson and Johnson companies had, until this year, guaranteed each others’ debts. This no longer appears to be the case. In the event therefore of a successful class action lawsuit, a claim potentially worth hundreds of millions of dollars, the 700 women may have less access to the assets of the world’s biggest healthcare company.

The company, whose market value in the US is $US370 billion, refused to respond to questions for this story. Communications director Meshlin Khouri claimed, “We are endeavouring to respond to your questions in the timeframe that you’ve requested …”.

We extended the timeframe and Khouri failed to respond to all questions. Gavin Fox-Smith, managing director of Johnson and Johnson Medical Australia/NZ was approached for comment but also declined to respond.

Johnson and Johnson is being sued in a class action lawsuit in the Federal Court. The plaintiffs claim faulty pelvic implants have caused them debilitating pain and that Johnson and Johnson failed to properly test the devices. The case is expected to run for six months. It follows a successful class lawsuit last year in which a $250 million settlement was struck with victims of faulty Johnson and Johnson hip implants.

An analysis of ten years of Johnson and Johnson financial statements shows a swathe of irregularities. Unlike its Big Pharma peers Abbvie and Gilead, Johnson and Johnson pays a reasonable amount of tax. Over ten years, the company racked up $12 billion in revenues and paid $238 million in income tax. In comparison to aggressive transfer pricing culprits Gilead and Abbvie, Johnson and Johnson showed gross margins of 40 per cent in Australia over the period; an indication that it is not pillaging the Australian tax base quite as aggressively as its peers.

However, enshrining the trend towards increasingly shoddy accounting and poor financial disclosure by multinational companies and their Big Four auditors – PwC, Deloitte, KPMG and EY – the financial statements of Johnson and Johnson are littered with faults.

For a start, its seven subsidiaries which had been covered by the aforementioned Deed of Guarantee, have failed to file accounts and are now two and a half months late. We can safely assume that the Australian Securities & Investments Commission (ASIC) has failed to fine the company for these myriad breaches.

Without any explanation by its directors or by its auditor PwC, Johnson and Johnson quietly changed from lodging General Purpose financial statements to the inadequate and skimpy Special Purpose variety in 2009.

Here is a company therefore which deems there are no other “users” of its financial statements than its parent company in New Jersey. Here is a company, the world’s largest healthcare group, an institution which has attracted billions of dollars in taxpayer support from Australia’s Pharmaceutical Benefits Scheme, but which deems that no other party apart from its parent company could be interested in its financial statements.

That is, directors and their auditors at PwC deem the victims of Johnson and Johnson lawsuits, the company’s staff, its creditors and the taxpaying public which subsidises the PBS – none of these stakeholders are deemed to have any interest in its financial statements.

PwC, which cooly picked up $6.6 million over the decade for audit and tax advice can’t even get its numbers straight. According to its “Auditors’ Remuneration” note, PwC earned $1.07 billion in audit fees over the past two years, rather than $1.07 million.

Moreover the accounts are larded with completely spurious information about accounting policies relating to items which don’t exist. All this mirrors a systemic failure: a failure of the Australian Accounting Standards Board (AASB) a failure of successive governments and their Ministers for Finance, a failure of accounting peak bodies, a failure of ASIC to police the sector and above all a failure of the global accounting firms to which all these governments, agencies and peak bodies kow-tow.

If the government really had the backbone to fix this problem it could instruct ASIC to issue a guidance note requiring all foreign multinational companies to lodge General Purpose financial statements. This damaging failure of accountants to be accountable could be fixed in a week. Instead, the world’s largest companies operating in Australia, jagging billions in taxpayer subsidies, file inadequate financial statements which allow them to hide critical information and avoid tax.

michaelwest.com.au has been sponsored by GetUp! and the Tax Justice Network to conduct an investigation into the financial statements and tax affairs of 20 multinational companies. 

https://www.michaelwest.com.au/exposed-how-johnson-johnson-cut-its-risk-in-vaginal-mesh-lawsuit/

Pelvic Surgical Mesh: "Living in Hell"

Western Australian pelvic mesh victims criticise government response to scandal

Joanne McCarthy

21 Jul 2017, 1 p.m. FiDA highlight

• Women call on WA Health Minister to order investigation into mesh surgery research

Women allege they were used as guinea pigs in pelvic mesh trials in WA public and private hospitals

SUE Turner and Jeanette McKinnon are the Western Australian women implanted with pelvic mesh devices in public hospitals who refuse to be regarded as unfortunate statistics.

They have made submissions to a Federal Parliament Senate inquiry into pelvic mesh – with a public hearing in Perth on August 25 – listing serious, permanent and life-altering consequences of their surgeries more than a decade ago.

They want answers from WA Health Minister Roger Cook about mesh research allegedly conducted in public hospitals, and whether they are included in mesh trials for which they say they did not consent.

They are scathing of Mr Cook’s commitment to “make some enquiries” about the alleged mesh research trials, in response to questions from Fairfax Media, and have called for a full investigation into whether women were used as “mesh guinea pigs” in public health facilities.  

“Something awful happened to me in 2004 and 2005 after I had mesh put into me. My world’s just so small now,” said Mrs McKinnon, who was 46 in 2004 when she was implanted with an Australian-developed pelvic mesh device at Bentley Hospital.

“It’s like living in hell. I’m dying a very slow and agonising death.”

Victorian Senator Derryn Hinch in February successfully argued for a Senate inquiry into how some pelvic mesh devices for women’s incontinence and prolapse problems after childbirth were cleared for use in Australia over the past two decades. He compared pelvic mesh products to Thalidomide, the drug that led to birth defects in babies in the 1960s.

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(Video on link.) Senator Derryn Hinch calls for a Senate inquiry into pelvic mesh.

The aggressive marketing of many mesh devices in Australia from 2003, without sufficient evidence of their safety and efficacy, led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” Senator Hinch said in a speech to Parliament.

Nearly 200 Western Australian women have responded to a survey conducted by Victorian consumer health advocacy group, Health Issues Centre, for a submission to the inquiry representing the experiences of more than 2200 Australian women implanted with pelvic mesh devices.

More than 700 women are part of a current class action against major pelvic mesh manufacturer, Johnson & Johnson, in the Federal Court in Sydney.

Sue Turner, of Perth, has sought legal advice about a class action against an Australian manufacturing company, after she was implanted with an Australian-developed pelvic mesh device at Armadale Hospital in 2007.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial.

- Sue Turner, who had pelvic mesh surgery in 2007.

”

“I had a prolapse. I just trusted the doctor and our health system when he told me it would be a pretty easy fix,” Mrs Turner said.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial. If I was told there was a risk that if things went wrong I would never have a sex life again, or live a life of sometimes unendurable pain, or be left with mesh and anchors in my body that have moved and embedded into tissue very close to major blood vessels and nerves, I would never have consented. But I wasn’t told.”

In a statement to Fairfax Media Mr Cook said he would ask the Department of Health to “make some enquiries into the research undertaken, and the cases where the implants have been used”, after two senior Western Australian doctors released a series of papers from 2005 about trials in Western Australian public and private hospitals, including Armadale Hospital, using the Australian-developed pelvic mesh device.

In a statement by a WA Health Department unit, Fairfax Media was advised there are no records of research approvals for trials involving surgery on women at public hospitals using the Australian-developed pelvic mesh device.

Mrs Turner and Perth-based Australian Pelvic Mesh Support Group founder Caz Chisholm were angered by Mr Cook’s statements that the “WA Government understands the concern this has caused for some patients”, but “there have been very few complaints received by WA Health and the Health and Disability Complaints Office”.

“What are we? Guinea pigs?” Mrs Turner said.

“I want this stuff out of my body but my doctor’s told me the surgery could be life-threatening. This isn’t about numbers. It’s about how our health system allowed these devices onto the market, and how these doctors were allowed to do this surgery in public hospitals without telling us of the risks.”

Ms Chisholm said the lack of complaints was a consequence of women being told for years that their chronic problems, including often debilitating pain, repeated serious infections, and erosion of mesh into organs including the bladder and bowel, were not linked to mesh surgery, or not being told they were implanted with mesh.

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause.

- Australian Pelvic Mesh Support Group founder Caz Chisholm

”

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause. It is only because of recent media attention about stories of women's pain and complications that women are realising their own complications are identical to the media stories,” Ms Chisholm said.

“The minister says there have been very few complaints by women, but what about the doctors treating the women? Obviously doctors aren’t reporting complications either, and are they supposed to?”

Mrs McKinnon has spent more than a decade on antibiotics.

“I came out of hospital not very well in 2004 and had my first urinary tract infection shortly after that. Then it was one urinary tract infection after another. If I come off the antibiotics I get a urinary tract infection,” she said.

She had another four major surgeries over the following year to relieve the pain and address mesh erosion into organs. 

In 2009 Mrs McKinnon was diagnosed with the auto immune condition lupus, requiring steroid treatment.

“I was normal, healthy and fit before I had that surgery. I’m only 59 and I feel like a 100-year-old. I thought all these years it was just me. It’s just the nightmare that you live.”

In a statement in June the Royal Australian College of Obstetricians and Gynaecologists said the majority of women treated with mesh for incontinence or prolapse had “a good long-term result” but “in a small number of cases the complications have been very serious”.

In a submission to the Senate inquiry Victoria’s Health Issues Centre chief executive Danny Vadasz has criticised mesh debate “framed in terms of the good outcomes of the many outweighing the unfortunate experiences of a few”.

“Our health system is built on values such as equity and a universal duty of care, not on a cost/benefit analysis that accepts the unavoidability of collateral damage,” he said, in a Health Issues Centre submission arguing Australian regulators have been “asleep at the wheel” on pelvic mesh.

Do you know more? Email jmccarthy@fairfaxmedia.com.au

http://www.theherald.com.au/story/4804268/its-like-living-in-hell/

Gasp!: Surgeon/Designer Calls His Own Pelvic Mesh Device Garbage

“I would not want my wife to undergo this procedure”: pelvic mesh inventor

Joanne McCarthy

4 Jul 2017, 12:04 p.m  FiDA highlight

LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: 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/?cs=305

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.

Court told how Johnson & Johnson conducted 'tidal wave of promotion'

By Hannah Sinclair

Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.

“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.

Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.

“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.

“This is about accountability and ensuring this never happens again.”

The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.

Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."

The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.

Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."

The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.

More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.

Some of the products involved in the suit are still available to purchase.

“There’s too many women who are injured,” implant victim Joanne Maninon said.

“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.”

Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.

A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.

“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.

“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.

“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.

http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.

“I would not want my wife to undergo this procedure”: pelvic mesh inventor

Joanne McCarthy

4 Jul 2017, 12:04 p.m

LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: 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/?cs=305

Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?

“I was rotting from the inside”: The vaginal surgery secretly destroying mothers’ lives.

MICHELLE ANDREWS

April 28, 2017  FiDA highlight

• 
  

Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.

But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.

“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.

“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”

"I had necrotic flesh in there." (Image supplied)

"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."

From there, Kim's condition spiralled.

"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."

Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".

"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."

The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.

The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".

By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.

By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.

Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".

While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.

The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.

"I felt like I was rotting from the inside," she describes.

By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.

The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.

"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.

"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."

The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.

Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.

To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.

There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)

While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.

"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."

Kim also lives with a level of anxiety she likens to post traumatic stress disorder.

"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."

If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.

When Kim found someone who had experienced what she had online, she was overwhelmed.

"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.

"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."

"I want everyone to know about it." (Image supplied)

Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".

It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.

Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.

But the aim is to do more than just have the mesh banned - it's to get justice.

"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."

And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.

If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state: 

Victoria; New South Wales/ACT; Queensland; South Australia; Western Australia; Tasmania; Northern Territory.

 http://www.mamamia.com.au/transvaginal-mesh-implants/