AUSTRALIA'S medical device watchdog was kept in the dark for nearly a decade about a pelvic mesh device's contribution to a woman's death in 2010 after accepting Johnson & Johnson advice the troubled Prolift device had not caused her death.
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The Therapeutic Goods Administration has issued a "please explain" to Johnson & Johnson after a landmark Federal Court decision for pelvic mesh victims against the company on November 21 revealed the initially "exonerated" Prolift device "was later said to have caused or contributed" to the Australian woman's death.
The TGA was unaware the device was implicated until Justice Anna Katzmann's judgment revealed the Australian case was one of five global Prolift-related deaths discussed by doctors at Johnson & Johnson subsidiary, Ethicon, in a June, 2010 report on "serious complications" associated with pelvic mesh devices.
None of the deaths were reported to authorities after Johnson & Johnson "exonerated" devices in four deaths outside Australia and left action on the Australian death to its local subsidiary. Johnson & Johnson's adverse event report to the TGA in February, 2010 said the woman's "pre-existing medical conditions" were a "main contributor" to her death, and not the Prolift device.
Johnson & Johnson did not lodge a second adverse event report and "the TGA was not aware that the post-mortem findings that were initially provided were in question" until Justice Katzmann's decision, a Federal Department of Health spokesperson said.
It is the second recorded pelvic mesh-related death in Australia after Queensland woman Alison Blake committed suicide in 2015 because of chronic pain and severe complications following surgery with an Australian-manufactured mesh device, but consumer health groups and mesh-injured women believe there could be more.
A leading campaigner for the child sexual abuse royal commission, Chrissie Foster, whose friend Joan Isaacs was sexually abused by a Catholic priest as a child and later experienced severe and permanent injuries after a Prolift device implant in 2011, has backed calls for a judicial inquiry into the pelvic mesh scandal as a way to investigate fundamental problems putting patients at risk in the health system.
"The public silence about the death of this woman shows manufacturers can say whatever they like to authorities and then cover up, just like the churches about child sexual abuse, and what's changed?" Mrs Foster said.
"It's hideous. It's shocking. This is a situation where women, like children, were being treated like second-class citizens in a world where the people selling these devices and the people implanting them all made money, and those who knew about a woman dying were able to cover it up."
Victorian Health Issues Centre chief executive Danny Vadasz said news of the woman's death was "the smoking gun that proves Australia's health safety regime has been hijacked by big pharma".
The TGA's reliance on mesh manufacturer reports "indicts the entire self-regulation framework that is supposed to protect public safety and welfare", Mr Vadasz said.
Consumer health groups called for an inquest into the woman's death and audit of deaths where mesh might have been implicated; a judicial inquiry into the regulatory process governing medical devices and a mesh manufacturer fund to compensate women similar to the James Hardie fund for asbestos victims.
"The damning findings of three royal commissions on aged care, mental health and disabilities, and now the lengthy and damning Johnson & Johnson class action judgment, reveals that vested commercial interests pose undue influence, and are a threat to, the health and wellbeing of Australians. It warrants a root and branch independent inquiry at the highest level," Mr Vadasz said.
Mrs Isaacs said it was more shocking to learn the TGA knew a woman died following pelvic mesh surgery and accepted Johnson & Johnson's account of what happened without investigating, than if it had not known at all.
"Johnson & Johnson knew long ago that the surgery I had was dangerous. Women had died. They knew an Australian woman had died more than a year before I had a Prolift implant but nothing happened. They lied. They're in a position of power, all of these people were in positions of power where they could and should have acted, but they're just immune," Mrs Isaacs said.
"How is that different from what happened when children were sexually abused for decades and people did nothing?"
In a statement on Tuesday Johnson & Johnson said the woman's death was reported to the TGA in 2010 because "the surgery in question involved a Prolift product", but "that does not necessarily mean the Prolift product was the cause, or a contributing factor".
"We believe that Johnson & Johnson Medical Pty Ltd has complied with all of its reporting obligations to the TGA," a company spokesperson said.
Companies and their representatives can face fines of $180,000 and 12 months' jail for failing to make adverse event reports but the TGA has not initiated one prosecution against pelvic mesh manufacturers.
This is despite thousands of women experiencing complications after pelvic mesh surgery ranging from mild to "catastrophic", and the TGA knowing by 2013 that its medical device adverse event reporting system, where manufacturers are the only mandatory reporters, captured possibly 10 per cent of device adverse events.
In January this year the Federal Department of Health released a study showing the true figure is more likely 0.5 per cent.
The Department of Health on Tuesday did not respond to a question about whether Johnson & Johnson could be prosecuted now for failing to report a Prolift-related death in 2010, but a spokesperson said the TGA had "requested further information from Johnson & Johnson which will be considered upon receipt".
Shine Lawyers has registered another 700 women seeking damages against Johnson & Johnson, taking the total to more than 2000, after Justice Katzmann found the company and its subsidiaries "oversold" nine pelvic mesh devices in Australia from 2001 as "safe and effective" to treat incontinence and prolapse while knowing they all carried serious and significant risks.
Shine has called for women implanted with Johnson & Johnson incontinence devices TVT, TVT-O, TVT Exact, TVT Abbrevo and TVT Secur, and prolapse devices Gynemesh PS, Prolift, Prolift+M and Prosima, to register in the class action.
In November Justice Katzmann said final orders for damages are unlikely before mid-February.
Shine has also called for women implanted with American Medical Systems pelvic mesh devices Perigee, Apogee, Elevate, SPARC, Monarc, MiniArc and RetroArc to register in a separate Federal Court class action. A Shine spokesperson said more than 850 Australian women have already registered.
Evidence to the Johnson & Johnson class action included internal Ethicon documents about deaths worldwide relating to the Prolift device. A woman died from "uncontrolled bleeding" before 2007 and another died in early 2010 following "injury to a big (blood) vessel" during surgery by a specialist with three years' experience implanting the Prolift device. There was no reference to reporting adverse events.
Three of the four women whose deaths were discussed by Ethicon doctors in June, 2010 were in their 60s, including an "otherwise healthy" woman who died on the same day she was implanted with the very large Prolift Total device, and a TVT pelvic mesh device for incontinence.
In a February, 2006 email tendered in the class action a Johnson & Johnson employee complained to another that a prominent Australian gynaecologist had "done probably six cases" using the Prolift device but was "still struggling with how to do the procedure".
