THREE multinational companies grievously failed at least 1350 women implanted with pelvic mesh devices in Australia since 1999.
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But as Federal Court Justice Anna Katzmann's devastating decision on Thursday makes clear, it's the broader health system that has profoundly betrayed them.
The case against Johnson & Johnson and related companies Ethicon Inc and Ethicon Sarl is a line in the sand of sorts, delivering a comprehensive win to women patients left with severe, permanent, "life-altering" and sometimes "catastrophic" injuries after pelvic mesh surgery.
But as emphatic as the women's victory is, it's not an end when it comes to the fallout from the tragedy of the pelvic mesh scandal, even in this case. The three companies have 21 days to lodge an appeal against the decision. And given their history of appealing similar comprehensive decisions in other countries, they are expected to do so.
And it's certainly not an end to legal action by Australian women against other pelvic mesh companies.
Shine Lawyers, which successfully represented women in the Johnson & Johnson case, has a second large class action representing 850 women against multinational mesh manufacturer American Medical Systems, which had mesh devices on the Australian market from 2004. That case is still working its way through the Federal Court.
A second Australian legal firm is assessing a potential class action against an Australian-invented and manufactured device.
An unknown number of women have already settled compensation claims against doctors following pelvic mesh surgery since the late 1980s, and more are pursuing cases. The vast majority of those cases will never be known to the public because they're settled by doctors' insurance groups and come under confidentiality agreements. But I know of at least one case where a woman ran up a legal bill of well more than $500,000 before agreeing to a settlement.
Australia's medical device approval system, overseen by device regulator the Therapeutic Goods Administration, didn't require the companies to provide proof the devices did what the companies said they would do.
It's worth noting here that at the height of what's become known as the pelvic mesh era - from about 1999 to roughly 2014 - more than 100 different mesh devices were cleared for use in Australia under a system Justice Katzmann confirmed on Thursday was "largely self-regulating".
That "largely self-regulating" system allowed Ethicon Inc and Ethicon Sarl to have nine devices cleared for use in Australia, to be implanted in women via their vaginas, without clinical trials confirming they were safe to use and would do a better job than traditional methods of repairing prolapse and incontinence issues after childbirth.
Ethicon Inc and Ethicon Sarl knew all too well their devices caused serious injuries to women, including acute and chronic pain, chronic infections and mesh erosion into other parts of the body. The companies knew it was sometimes impossible to remove the devices. They knew one of the worst devices could lead to women being "handicapped".
They went ahead anyway, and Australian taxpayers were required to subsidise the devices' use as soon as they were approved. Just one pelvic mesh device kit I'm aware of cost more than $800. We will never know the figure for sure, but it's believed at least 150,000 pelvic mesh devices have been sold in this country.
Australia's medical device approval system, overseen by device regulator the Therapeutic Goods Administration, didn't require the companies to provide proof the devices did what the companies said they would do. The devices were cleared for sale in the European Union, the companies confirmed that, and it wasn't long before doctors were being directly targeted to implant them.
As we learnt on day one of the class action hearing back in July, 2017, Johnson & Johnson had a kind of obstetrician/gynaecologist in mind - the "practice-driven physician" - who would find the devices attractive because they would speed up surgery, increase fees and allow doctors to "really enjoy life".
The marketing described doctors being able to implant one Johnson & Johnson device, the TVT-0, in eight minutes.
"You know I use your products because I can do more procedures in less time with better reimbursement," the "practice-driven physician" is described saying.
"Just got back from a week in St Moritz. I picked up the Lamborghini on Friday. I'm finally going to invest in that sailboat this summer so we can cruise to the Caribbean. My practice is now at the level of efficiency where I can take some time away to really enjoy life."
Women who walked into doctors' surgeries didn't know about the failed regulatory process or the significant risk of injuries. Their doctors almost certainly didn't tell them about the mesh manufacturer-sponsored conferences where devices were spruiked. The women were told the marketing guff that companies like Johnson & Johnson produced.
In product brochures for devices like the "gold standard" TVT for incontinence, women were told they might experience "some mild pain" up to 48 hours after surgery that could be controlled by "simple pain relief".
"It was not until 2015, by which time TVT had been on the market for over 16 years ... that (the companies) warned of the risk of chronic pain, and then only at the behest of the TGA," Justice Katzmann said.
Women have been profoundly betrayed by Australia's health system. On Thursday there were no cheers as Justice Katzmann read out her damning indictment of Johnson & Johnson. There was just a silence, even at the end.
The health system failed to respond to the women's complaints. It disrespected them. It still does. There was a silence because the women know nothing has happened to prevent another tragedy from occurring. There is no transparency where it's vitally needed and no accountability, and when things go wrong it is individuals up against multinationals and doctors' insurers boasting of more than $1 billion in assets. Women trusted that system and are left to endure the consequences.
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