When a global car manufacturer discovers a faulty part in one of their cars owners across the world are notified of the risk. A register is in place that keeps track of what parts are in which model of car. So why is it not the same for all Australian recipients of medical implants?
Thousands of high-risk medical devices are implanted into Australians every year. Incredibly, there is no compulsory register for most medical devices to track recipients and products in the event of fault. In recent times, two examples spring to mind which resulted in painful, tragic circumstances for Australian women; the Poly Implant Prosthese (PIP) breast implants which were recalled in 2010 and vaginal mesh implants which are currently facing a class action.
Unfortunately the vaginal mesh implant product failure is another example of a Category III high-risk medical device failing. The class action against the manufacturer has again brought to light issues with the supply of high-risk implantable medical devices that were exposed when the sub-standard Poly Implant Prosthese (PIP) breast implants were recalled in 2010. Namely, that there needs to be a national registry for all implantable devices classified as high risk, so that in the event of fault all patients can be notified of the risk to their health.
It is an inexcusable flaw that our laws currently do not require a compulsory registry. Australian Medical Association President Dr Michael Gannon recently echoed this need. Without a registry, there is no way of determining how many women received a defective product and also no way to contact these women when the defects became known. For some women the only way to determine if they received the defective device was to undergo further surgery to have the device removed.
Even more disappointing, this is not the first time that a registry has been raised. Following the discovery that the French-imported PIP breast implants were faulty, a parliamentary enquiry was undertaken in relation to issues of insurance as well as the absence of a breast implant registry (which does exist for knee/hip replacements). The enquiry found many women had no way of finding out what brand implants they had inserted and if they were at risk. The Government also had no means to assess the extent of the issue. The enquiry’s findings were published in May 2012 (full report here), giving 13 recommendations, including a national opt-out Breast Implant Registry be established as a priority.
A non-compulsory opt-out Breast Implant Registry was established, so the question becomes, why did the message not reach the suppliers of other high-risk medical devices? Was it really necessary to have a further parliamentary enquiry to make essentially the same recommendations? Could this not have been dealt with back in 2012 so that we could have avoided a repeat of the pain and tragedy now being experienced by vaginal mesh implant victims?
Given this is the second high-risk implantable medical device to cause problems for patients in a short number of years, it is clear that long-overdue legislative changes must be made to establish a compulsory registry for all implantable devices to assist patients, medical providers and the government in managing these issues if and when they should arise again. Failure to do so is a negligent invitation to repeat history for a third time.