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/

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

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

Pelvic Surgical Mesh Scandal: FDA Wrongly Cleared Predicate Device

Dr Peter Petros said he warned women about the 'very frightening' symptoms of his procedure 

Joanne McCarthy  FiDA highlight

15 Mar 2017, 5 a.m.

A DOCTOR whose invention is at the centre of a global medical scandal told a court in 2004 that women could experience “very frightening” symptoms after a pelvic surgical procedure he developed, but that was “how the operation works”.

“Even though it’s not harmful to the patient it can be quite frightening, that suddenly they get this thick yellow discharge that can be very smelly and it can be very frightening to a patient. So I make sure that I tell them about it,” Dr Peter Petros told a Western Australian court after a woman took civil action against him following mesh surgery using nylon tape.

Judge Roger Macknay awarded the woman more than $136,000 after finding Dr Petros “undoubtedly” failed to warn her of risks associated with Dr Petros’s intravaginal slingplasty (IVS) procedure, based on his “integral theory” to treat urinary incontinence.

The woman, 45 when she had the surgery in 1997, suffered “significant” injury which had a “substantial” effect on her life, with symptoms continuing over the long term, Judge Macknay found.

Dr Petros’s mesh delivery device through a woman’s vagina, the IVS tunneller, which was later developed by a subsidiary of Tyco Healthcare and incorrectly cleared for use in America in 2001 for both urinary incontinence and prolapse in women after childbirth, became the “predicate case” which major medical device companies used to “clear” and market multiple other pelvic mesh devices for prolapse.

Investigation: Dr Peter Petros

Global legal cases brought by women alleging serious injuries after pelvic mesh surgery are estimated to cost $20 billion.

In a paper in 2012 Dr Petros distanced himself from the global mesh scandal, saying his “early experimental studies” had been “wrongly” used as “an intellectual cornerstone to justify the use of mesh in prolapse surgery”.

During the 2004 Western Australian court case Dr Petros denied being “somewhat blinded” to possible risks associated with his (IVS) surgical procedure.

“Can you accept as a possibility that because of your personal and financial stake in this procedure that you may perhaps be somewhat blinded as to the adverse elements associated with it? You see it as your baby and you can’t see any bad elements?” the woman’s barrister, Geoffrey Hancy, put to Dr Petros.

Dr Petros replied: “Absolutely not. The role of the scientist is to seek the truth, whether it’s good or bad. That’s the way it is.”

The court was told Dr Petros received a royalty of about $15 per instrument for the IVS tunneller and he performed about 400 operations a year. 

Judge Macknay found Dr Petros had “a proprietary attitude towards the IVS procedure, as well as great pride in events associated with its development”.

In his dealings with the woman Dr Petros “was concerned to extol what he perceived to be the many advantages of the IVS procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and the risks”.

“The defendant did not, it would seem, and apparently still does not, believe there was or is any real detriment associated with ‘his’ procedure,” Judge Macknay said.

Dr Petros “lacked to some extent a complete understanding of the obligation owed by a medical practitioner to a patient who was contemplating surgery”, and was “at times argumentative, anxious to debate, unwilling to answer questions as put, anxious to display his knowledge”, the judge found.

Specialists who gave evidence said the IVS procedure had no independent studies to support it in 1997 and the majority of specialists who performed surgery to treat incontinence did not use the procedure.

By 2003 Newcastle obstetrician/gynaecologist Dr Alan Hewson and his Brisbane colleague Dr Chris Maher said the IVS procedure “cannot be recommended” after treating women dealing with complications after its use, and because of the lack of independent evidence of its safety and efficacy.    

Dr Petros’s name no longer appears on the Australian Health Practitioner Regulation Agency register. He did not respond to questions from the Newcastle Herald about whether he had retired in November. 

The NSW Health Care Complaints Commission advised the Herald it has finalised an investigation of complaints against him and has referred the case to “the Director of Proceedings for the consideration of appropriate disciplinary action”.

http://www.theherald.com.au/story/4524242/doctor-denies-being-blind-to-mesh-risk/?cs=305

Australian Pelvic Surgical Mesh Scandal Widens

Difficulty issues remain about mesh surgery for women.

JOANNE McCARTHY  FiDA Highlight

13 Mar 2016, 4 p.m.

THE woman on the end of the phone line said hello and gave her name, and then the sobbing started. For at least a minute she tried to talk but the sobbing overwhelmed her. She regained some control and apologised: “I’m sorry, I’m so sorry, I’ve just had no one to talk to”.

Then the sobbing resumed as she gasped: “I’m rotting from the inside.”

The woman is in her 50s. In 2012 she had surgery to treat prolapse – where a woman’s uterus bulges into the vagina, typically after pregnancy – and her gynaecologist, who has worked in the Hunter, the Central Coast, Sydney and other parts of NSW, spoke about the benefits of using mesh as an internal sling to pull her organs back into place.

He recommended “natural” mesh made of pig intestines, and surgery through the vagina rather than the abdomen.

In a paper for other doctors in 2007 the gynaecologist praised the “natural” mesh over earlier biological prolapse treatments which, he said, women’s immune systems came to regard as “dead tissue” subject to “a strong foreign body reaction”.

In the 2007 paper the doctor declared a conflict of interest – he was being funded by the pig intestine mesh manufacturer to conduct a trial of the mesh’s use in women’s bodies.

The woman said she knew nothing of that.

The pain after surgery started immediately. It worsened with time. Then the “horrible smell” started, the rounds of antibiotics to treat infections, and comments from the gynaecologist that it was “just the healing process”.

After nine months she had a nervous breakdown.

In chronic pain, unable to have sex, isolated, emotionally shattered and coming to terms with the shocking knowledge there was little surgically that could be done to relieve the pain or remove the mesh, she hinted at suicidal thoughts.

“I felt like I was treated like a guinea pig,” she said, and sobbed.

“Why is this allowed to happen?”

It only made it worse to hear there are many other women like her.

What has become a global mesh catastrophe for possibly more than 100,000 women who sought prolapse treatment over a decade – which could become one of the biggest medico-legal cases in history - started with a United States Food and Drug Administration (FDA) decision in 2001.

The FDA approved a prolapse mesh device for surgery through a woman’s vagina based on it being “substantially equivalent” to an existing device for surgical incontinence treatment.

Any differences between the devices “do not raise new questions of safety and efficacy”, the FDA stated, so a new prolapse mesh kit device was approved without the rigorous pre-market testing required of new devices or Class III high risk devices. 

The decision, which provided a treatment option for gynaecologists in a difficult area where up to 50 per cent of women seek help for prolapse and incontinence problems over their lifetimes, and up to 19 per cent of American women receive surgical treatment, opened a door and manufacturers responded.

Within a few years up to 40 companies had more than 60 surgical mesh kits for prolapse patients on the American market stating they were “substantially equivalent” to other mesh products, and all reliant on the 2001 FDA approval. They included biological or “natural” mesh products as well as polypropylene plastic devices for vaginal access, or transvaginal, surgery.

By 2012 there were 47 prolapse and incontinence devices on the Australian market.

The only problem was the FDA’s decision process was flawed, said leading Australian urogynaecologist and Queensland University Associate Professor Chris Maher in a paper in 2013 headed The Transvaginal Mesh Decade.

The device approved in 2001 was subject to high complication and infection rates when used to treat prolapse, and was modified and gained a new clearance seven years later.

But the genie was out of the bottle.

The first mesh kits with tools to insert the mesh through incisions in a woman’s vagina were on the market in America in 2004. By 2010 more than 300,000 mesh kits a year were being used for prolapse surgery.

But by that stage adverse event reports were also being logged, with a five-fold increase in adverse reports to the FDA between 2005-2007 and 2008-2010.

The adverse events included mesh erosion and extrusion into the vagina and urinary tract, bleeding and infections, organ perforation, severe and chronic pain, nerve entrapment and urinary problems.

By 2013 a Newcastle specialist complained to the Australian Therapeutic Goods Administration (TGA) about the lack of “rigorous constraints” controlling new medical devices, when compared to drugs, after a woman nearly died of excessive blood loss linked to mesh implant surgery.

The specialist warned the TGA an approved suture device was unsafe after a woman suffered a severe haemorrhage during a trial. The woman complained to the Health Care Complaints Commission about the specialist, saying the operation “went dramatically wrong”.

In his paper Associate Professor Maher outlined how mesh devices remained on the market for a decade, with sometimes catastrophic results for many women.

“These products were aggressively marketed to clinicians by the manufacturers on the basis of FDA clearance,” he said.

Manufacturers, and not Australian, British and American colleges of obstetrics and gynaecology, trained doctors to use the new mesh products to treat prolapse.

It was not until 2011, after thousands of adverse event reports and the start of serious litigation by patients, that the FDA determined serious adverse events with mesh were “not rare”, and could be “life-altering” for some women.

In October 2012 the Australian TGA website noted it had only received 63 adverse event notices, the majority from device manufacturers, despite many thousands of devices being implanted.

The TGA met with the Urogynaecological Society of Australia where the society reinforced its view “the issues were about the use of these meshes  rather than the meshes themselves”.

In his paper Associate Professor Maher noted at least three members of an international gynaecological association that commented about prolapse mesh devices after the 2011 FDA statement received royalties from device manufacturers.

By January 2014 the FDA warned manufacturers it proposed to upgrade mesh products for vaginal-entry prolapse surgery to Class III high risk category, requiring manufacturers to provide clinical data supporting device safety, and post-surgical data demonstrating safety and efficacy.

But by that stage civil suits in the US – and the threat of many more to come – coincided with manufacturers withdrawing devices from the market.

In a significant case American woman Linda Gross was awarded $11.1 million against Johnson & Johnson after prolapse mesh surgery in February 2013 led to 18 subsequent operations. An appeal by the company is currently being heard in the New Jersey Appeals Court.

Mesh activist Jane Akre said more than 100,000 women had filed lawsuits against companies, with Philadelphia woman Patricia Hammons, 65, the most recent successful mesh device plaintiff who was awarded $12.5 million against a Johnson & Johnson subsidiary in December.

Akre said device manufacturers, doctors and regulators had catastrophically failed many women.

Devices entering the market without the clinical assessment required for drugs meant “patients became the post-market clinical trial subjects and many suffered devastating and permanent injuries”.

“The woman at the other end of the pelvis was not even thought of,” Akre said.

Transvaginal mesh legal suits are expected to reach more than $20 billion.

In an internationally-respected Cochrane Review of studies of mesh devices in February, Associate Professor Maher found the quality of evidence ranged from very low to moderate.

In a Cochrane editorial in February titled No implementation without evaluation: the case of mesh in vaginal prolapse surgery, University of Auckland Professor of Obstetrics and Gynaecology Cindy Farquhar said the transvaginal mesh decade was a warning to doctors who had to “learn from the lessons of the mesh experience”.

“New interventions should always be subject to rigorous evaluation through randomised controlled trials, and adoption of new interventions must be accompanied by specific training in their use. Future studies should report adverse events carefully and include reporting pain and quality of life. Our patients deserve better studies and, in the absence of evidence, better advice.”

Port Stephens MP, health lawyer and member of NSW Parliament’s committee on the Health Care Complaints Commission, Kate Washington, said the mesh debacle was consistent with “the dismissive nature of the medical fraternity to women who’ve had significant injury following birth”, including many who suffered with prolapse.

“This dismissive attitude to what are really serious problems for women is really embedded in the medical profession.”

The low number of formal complaints from women to Australia’s Therapeutic Goods Administration about mesh devices was not surprising, she said.

“This is a hidden issue. The women involved are vulnerable, embarrassed and mortified by what’s happened to them in terms of the injuries they’ve sustained, and the fact that it’s hidden has allowed practices like this to flourish.”

Associate Professor Maher said while regulators in Australia and America had failed to monitor and influence clinician behaviour relating to transvaginal mesh, litigation lawyers and publicity had brought about change.

“This scenario is completely unsatisfactory for all pelvic floor clinicians who have failed to demand a satisfactory level of evidence regarding the safety and efficacy of a product prior to its utilization,” he said.

“It is vital that we review the events that allowed the women we are trained to serve to be exposed to unknown risk during the surgical treatment of prolapse.”

In 2012 in response to rising concerns about mesh the Australian TGA said it was not possible to know “all the possible complications that may develop” when a new medical device is approved for use.

http://www.theherald.com.au/story/3778936/women-pay-the-price-for-a-most-private-medical-disaster/

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