Stirling Griff (SA, Centre Alliance) Share this | Hansard source

My question is to Minister Scullion, representing the Minister for Health. I have a follow-up to my question last week regarding the international investigation into medical devices and Australia being effectively a dumping ground for products not permitted for use in the US. One product, a shoulder implant named PyroTITAN, was approved by the Australian TGA in 2011 and classified as low risk. There were several early failures and, two years later, the device was suspended. However, patients were not notified by the implant sponsor or treating surgeons of any of the failures. By way of contrast, every registered vehicle owner with a faulty Takata airbag received a recall notification so they could mitigate the health risks of an exploding airbag. Why hasn't the government mandated that patients must be notified when an implanted medical device is found to be faulty?