The Consumers Health Forum criticises Australia’s weak regulation of imported medical devices
“The revelation that 6,000 Australian women with faulty PIP breast implants have little legal redress because the Australian distributor of the product does not have the relevant insurance, demands firm action by the Federal Government,” said Carol Bennett, CEO of Consumers Health Forum.
Ms Bennett was speaking in response to the latest development in the faulty PIP breast implant saga which provides further disturbing evidence of the weakness of Australia’s regulation of imported medical devices.
“CHF strongly supports Senator Nick Xenophon’s move to introduce legislation that will require all sponsors or manufacturers of medical devices to hold product liability insurance as a condition of their approval for use in Australia. That would seem a minimum requirement that Australians would expect of the regulation of sensitive medical implants, Ms Bennett said.
According to Karen Carey, Chair of CHF, “yet again we are seeing a lack of vigorous response to faulty medical devices. Many thousands of Australians have suffered as a result of sub-standard regulation of not only the breast implants but also metal hip prostheses and heart valves. I know how damaging these failures can be. The growth in use and availability of implants of many kinds makes it imperative for the Therapeutic Goods Administration to have stronger oversight.
CHF has long argued that effective tracking of patients who have been fitted with medical implants is imperative in the event of product failure.
The medical profession also needs to take more responsibility. Their patients rely on them to advise on safe and effective implants. Patients expect the doctor to base implant decisions on reliable assessments. It is fortunate tests by the TGA and other international regulators have not found toxic chemicals in these PIP silicone implants. But these tests are after the event. The PIP experience puts the Government on notice to take stronger measures to prevent avoidable tragedies,” Ms Bennett said.