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Independent, Nick Xenophon, calls for reform of the TGA
22 November 2011. Independent Senator for South Australia Nick Xenophon has called for urgent reforms to the Therapeutic Goods Administration (TGA) and Department of Health and Ageing processes following a Senate Committee report just tabled. The report, from the Senate’s Community Affairs References Committee, inquired into the processes for the approval of medical devices, such as joint prostheses, in Australia. Senator Xenophon originally called for the inquiry in June this year, after shocking stories emerged in relation to the failure of the DePuy ASR hip replacements (DePuy is a subsidiary of Johnson & Johnson). Some 5,500 patients in Australia have been implanted with these devices, which were approved by the TGA. As a result of unacceptably high failure rates, many patients have required further surgery to have the devices removed. A significant number of patients have suffered from cobalt and chromium leaching from the devices, with associated toxicity issues. The report highlights major flaws in the way the TGA dealt with information detailing the problems with these devices. In one case, information provided to the TGA by the National Joint Replacement Registry in September 2008 flagging concerns about the devices was not considered by the TGA until December 2009, over a year after it had been received. The report also calls for major reforms to the regulatory processes that apply to the approval and post-market monitoring of medical devices in Australia, including: The introduction of mandatory reporting by medical practitioners to the TGA in relation to problems with medical devices; The urgent implementation of recommendations relating to increased regulation of medical devices, including post-market monitoring, and overall increased transparency in the operation of the TGA from the Health Technology Assessment Review and the Therapeutic Goods Administration Transparency Review; and The introduction of legislation requiring medical practitioners to disclose all financial or commercial interests (including gifts from medical device manufacturers and pharmaceutical companies) to their patients. Independent UK research indicates a failure rate for some of the DePuy devices in the order of 49 percent. In Australia, the revision rate for one DePuy device is currently 10.2 percent after five years, compared to 3.5 percent for other hip devices. "The risk is that many of these implanted devices are a ticking time bomb for many Australians," Nick said. "This report shows that the TGA has failed in their role of regulator when it comes to the DePuy hip replacements," Nick said. "It is now their responsibility to make sure history doesn’t repeat itself." While he supports the recommendations made by the committee, Senator Xenophon is concerned that they will not be adopted by the TGA within a suitable timeframe. "From the evidence the TGA gave to the committee, it’s unclear about whether they really understand their own failures," Nick said. "If they’re serious about providing the best possible health outcomes for Australia, they should implement these recommendations within the next year." "At the end of the day, many thousands of Australians have been implanted with a harmful device because of gaps in the TGA’s regulations," Nick said. "Many of them are now very ill, and their lives have been ruined. They deserve better."
