May 19, 2012

The government‘s failure to promote patient interests in the wake of what is unfolding as Australia’s worst orthopaedic debacle has triggered an outcry from patient and health groups.

After the disclosure this week that one in four Johnson & Johnson DePuy ASR hip implants had failed – affecting more than 1000 patients – the Health Department omitted mention of patient safety in its response, while advocating care in the treatment of product suppliers.

Asked when and how the authorities would introduce tighter safeguards on suspect devices, a spokeswoman said any decision needed to be soundly based ”and fair to all parties”.

Device suppliers would be given ”opportunity to respond to concerns about performance of particular devices”. No reference was made to patient interests in an original statement.

It was only after the department was asked why supplier interests were being given more attention than the patients that the spokeswoman said public health and welfare got prime consideration.

”The TGA does not favour the interests of sponsors over patients,” she said.

Bob Lugton, 68, a victim and patient advocate, said: ”The government’s only consideration should be for the patients’ safety.

”To suggest that safety is being compromised by thoughts of ‘fairness’ to any party other than the patient is immoral.”

He said the orthopaedic surgeon national registry showed more than 15,000 patients had received a prosthesis categorised as having a ”higher than anticipated failure rate”.

The Australian Orthopaedic Association’s national joint replacement registry shows in its latest available figures that more than 30 hip and knee implants were still being used in 2010 despite being shown in two previous years to have experienced a higher than average failure rate.

A campaigner for tougher regulation and a health fund chief, Michael Armitage, said the department’s handling of this matter was ”appalling”.

Dr Armitage, the chief executive of Private Healthcare Australia, said Health Minister Tanya Plibersek was ”condoning” the continued use of failure-prone prostheses by not taking urgent action to remove them.

The Health Department said an expert orthopaedic group had assessed the high-failure rate devices identified and still used. In all but one published case, the experts advised continued observation of such implants ”without taking regulatory action, due to uncertainty regarding the factors causing the increased revision rate”. Updated information would be referred to the experts in June.

The Australian Orthopaedic Association opposes publishing details of implant performance earlier, saying it creates ”unnecessary public alarm” by ”misinterpretation” of figures. But injured patients wish they had heard the ASR news earlier.

Diana of Beaumaris, whose partner, Harold, 84, only became aware last year of the widespread problems with his model hip implant, accuses the government and surgeons of ”disgusting inactivity” in failing to alert patients of the problems earlier.

Harold began experiencing pain and mobility problems about six months after his metal hip was fitted in 2007.