170 Australians killed by faulty medical implant devices
A report published by the ABC has revealed that lax safety standards in medical implant devices are being overlooked by the Australian government regulator.
The consequences have been staggering. The ABC estimates that 83,000 people have died because of these dangerous devices – 170 of them in Australia. Over 1.7 million injuries have been reported, many serious, with more than 8,500 in Australia.
In Australia, medical implant devices are regulated by the Therapeutic Goods Administration (TGA).
About 90% of risky medical devices are evaluated by for-profit, private certifiers based in Europe, who are chosen by the medical device manufacturers.
Former TGA director Derrick Beech told the ABC that medical device manufacturers increasingly pick and choose certifiers based on their “speed of service”.
Only the most risky types of medical devices are automatically re-audited by the TGA. Otherwise, the TGA relies on these private European certifiers to confirm that these devices are safe.
Professor Derek Alderson, the president of the Royal College of Surgeons in the United Kingdom, has raised real concerns about the private European certifiers. He told the Guardian newspaper that: “In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence…This is a risk to patient safety and public confidence.”
Another concern arises because there is no central register of patients who have had had implant devices installed.
This means that, when a regulator like the TGA orders that a medical implant device be recalled, there is no way for medical bodies to track down patients and inform them of the need to remove the dangerous device already inside their body.
This means that patients can live for years with devices inside them without being notified of the serious risk.
In October a Senate inquiry recommended that a central registry be introduced for all high-risk medical implant devices. The Australian Government has said that it supports this recommendation in principle, and efforts to introduce a new legislative regime are continuing.
At Turner Freeman, we have lawyers who specialise in medical negligence claims who are able to advise you regarding your entitlements in this complex area of law. If you or someone you know has suffered as a result of a faulty medical implant device, we encourage you to call us on 13 43 63 to speak with one of our medical law experts.