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