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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Friday, July 7, 2017

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

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

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