IT would be interesting to know why a federal Department of Health report about the failure of its medical device adverse event reporting scheme ended up published in the European Medical Journal in January.
Europe is such a long way away.
Wouldn't it be in the public interest for a government department to let people in Australia know what's going on, by releasing such a report to an Australian publication? There are plenty of outlets willing to do so.
Certainly when the Newcastle Herald became aware of the report's findings - that the department estimated only 0.5 per cent of medical device "adverse events" were recorded on the Therapeutic Goods Administrations adverse events system - we wrote an article and published it today.
The public is entitled to know that the system the medical device regulator relies on to provide data about the safety and efficacy of devices leaves the regulator in the dark. This is despite device manufacturers being the only mandatory reporters of device "adverse events", at risk of criminal or civil penalty proceedings if they don't report.
We say "at risk", but it's not much of a risk given the TGA has confirmed - after questions from the Herald - that it has only initiated criminal action against four medical device manufacturers in the past decade. And we haven't forgetten the two infringement notices it's also sent.
In the notorious case of pelvic mesh devices for women after childbirth complications, the TGA has not taken any criminal or civil penalty proceedings against manufacturers. It's been left up to women to take civil action against manufacturers by way of class actions.
What is clear to the Herald after a number of years of reporting on Australia's central role in the global pelvic mesh device scandal, is the enormous cost on the community when manufacturer and doctor-led "innovations" in technology go wrong.
There is the toll on human lives. People die when medical devices fail because they've been cleared for use without rigorous evidence and recognised human trial processes. They lose their jobs. They lose their homes and marriages.
But medical devices allowed on the market, under a system that requires faith in manufacturers to have proven their claims, cost Australian taxpayers many millions of dollars both before and after they fail.
When devices are registered by the TGA they're subsidised to varying degrees, either through private health insurance or public benefits. That costs many millions of dollars each year. When things go wrong and patients require years, or a lifetime, of treatment and support, it is the patient and health system who pay.
The Department of Health report makes clear the system we have is not up to the task of keeping tabs on device failures. It's Australians, not Europeans, who should have been told.