AMA says pelvic mesh support ‘not our proudest hour’ Decision: 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.
Promotion: An Australian Medical Association document describing the IVS Tunneller device as an “Australian medical design breakthrough” to treat incontinence and prolapse in women.
Legal: Women implanted with pelvic mesh devices leave a Federal Court class action suit against Johnson & Johnson.
Crusader: Australian Pelvic Mesh Support Group founder Caz Chisholm fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia. The inquiry will sit in Perth on Friday.
Devices: A sample of pelvic mesh devices marketed for use in women to treat incontinence and prolapse.
Angry: Australian Pelvic Mesh Support Group members fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia.
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facebookSHAREtwitterTWEETemailwhatsappTHE Australian Medical Association acted as exclusive distributor of an Australian-invented pelvic mesh device for women that helped spark aglobal pelvic mesh scandal afterit 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.
“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 aboutmore 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.
An Australian Medical Association document describing the IVS Tunneller device as an “Australian medical design breakthrough” to treat incontinence and prolapse in women.
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 than30,000 Australian women received them.
The IVS Tunneller’s sale to Tyco Health andregistration in America in April, 2001 was used by pharmaceutical giants, including Johnson & Johnson, to registertheir own prolapse devicesby arguing they were “substantially the same” as IVS and subsequentdevices, without producingindependent evidence of safety. They were then cleared for use in Australia.
Australian Medical Association president Dr Michael GannonI’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.
Pelvic mesh victim Jeanette McKinnonMedical Journal of Australiareport inJuly, 1994 acknowledgedmany 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 IVSprocedures 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 2012Dr 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.
The Herald, Newcastle