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

My question is to Senator Scullion, representing the Minister for Health. This week the ABC and Fairfax started issuing a series of reports called 'The Implant Files' as part of a collective effort by the International Consortium of Investigative Journalists. It uncovered concerning information about the lax domestic and international regulation of medical devices and the devastating impact of this on Australian patients. We've all learned that the US FDA has allowed 4,600 medical devices to be approved for export only. These are devices that it refuses to approve for use in Americans but that are exported for use in Australia and other countries without having any mandatory postmarket surveillance. Why does the TGA in Australia allow devices that the US FDA has not approved for its domestic use to be imported and implanted in Australian patients?