Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, August 22, 2017

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

  • Joanne McCarthy  AUGUST 22 2017 - 12:11PM

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.

"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.

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