THERE is no doubt multinational medical device and drug company Johnson & Johnson reported the death of an Australian woman following pelvic mesh surgery to the medical device watchdog in February, 2010.
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There is also no doubt the Therapeutic Goods Administration accepted what Johnson & Johnson told it about the woman's death - that the Johnson & Johnson Prolift mesh device had not caused or contributed to the woman's death - and filed the report.
It did not investigate further. It did not challenge Johnson & Johnson. It did not take the kind of action the public probably expects a watchdog - particularly one described by government as Australia's medical device 'specialist safety regulator' - would take after advice a woman had died under these circumstances.
It just accepted what a very large corporation making tens of millions of dollars a year from aggressively marketing its pelvic mesh devices around the world told it.
And that's nowhere near good enough.
The Prolift device was sold in Australia from 2005 after the TGA cleared it for use without requiring any independent evidence that it would do what Johnson & Johnson said it would do, and that it was safe to be implanted in women's bodies to remain for the rest of their lives.
As it turns out, and as Federal Court Justice Anna Katzmann made crystal clear in her 1500-page report on November 21, the Prolift dramatically failed on safety and efficacy. And Johnson & Johnson knew that. It made claims in 2005, which the TGA didn't dispute or challenge, that Prolift was "specially designed for placement through the vagina to support (prolapsed) pelvic organs".
As one of Johnson & Johnson's own documents showed, the mesh in Prolift was not "specifically designed" for such a purpose but "pulled.. out of our existing bag of tricks".
By 2008 the TGA's American counterpart, the Food and Drug Administration, warned American doctors that while complications from pelvic mesh devices for incontinence and prolapse were rare, they could have "serious consequences".
By February, 2010 when Johnson & Johnson reported the Australian woman's death after Prolift surgery the device had been on the market for five years. Yet the company had not provided a post-market clinical evaluation report of the device to the TGA.
Whether the TGA pursued Johnson & Johnson to account for the level of complications, Justice Katzmann doesn't say. But by 2012 women were dismissed when they complained and the TGA was telling politicians it had only recorded 45 adverse events across all pelvic mesh devices.
The health system is broken when public trust is betrayed. Calls for a judicial inquiry might be brushed away by governments, but so were calls for child sexual abuse and banking royal commissions.
Issue: 39,471.
