Hundreds of thousands of Australians have medical devices contained within their bodies. Whether it is a cardiac stent, a pacemaker, a hip replacement, or some other implant. At present there is no guarantee if something goes wrong with these device.
The chairwoman of the Consumer Health Forum, Karen Carey has stated that the healthcare industry is one in which decisions are primarily profit based, but these decisions deeply affect peopleâ€™s lives.
According to Karen ” It is a scary environment when there is better product safety information when you buy a hairdryer, than when you buy a heart valve ”
In France a trial will shortly commence, with the founder of PIP silicone breast implants facing criminal charges regarding the malfunction of these devices which contained non-medical grade silicone. Around 6000 Australian women have had these implants and now face the anxiety of the possibility of the devices rupturing.
During the last 12 months, an Adelaide law firm representing 1300 of the women, has been working on a class action against the Australian distributors of these implants. This case has recently collapsed and will no longer proceed due to the discovery that the company concerned did not have adequate product liability insurance.
Independent Senator, Nick Xenophon has stated that the Therapeutic Goods Administration have failed in their duty of care to Australian women, even though the TGA claim that no toxic chemicals exist in the PIP implants which have an elevated risk of rupture.
Consumer Health Forum concur with the Senator, and say that the latest legal setback confirms the weakness of Australia’s regulation of imported 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”.
The medical profession also need to take more responsibility. Their patients rely on them to advise on safe and effective implants.
Later this month Senator Xenophon will introduce legislation to ensure that all manufacturers of medical devices and sponsors ( the companies that supply them for sale in Australia ) hold adequate product liability insurance before their products are approved for use in this country.