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Questions raised over medical device regulation

Updated November 07, 2011 23:05:00 ABC News

Senate report into an orthopaedic medical scandal prompts questions over the regulation of Australia’s medical devices industry.

John Taylor  Source: 7.30 | Duration: 5min 42sec



LEIGH SALES, PRESENTER: In Canberra the Senate will soon release a much-awaited report into one of the greatest medical scandals to confront orthopaedics in Australia. At the centre of it is a faulty hip implant made by a subsidiary of Johnson & Johnson. It leeched metal and caused severe pain in many patients and was withdrawn from Australia in 2009 and then the world.

Thousands of Australians were hurt and the case raises many questions about the regulation of Australia’s multibillion-dollar medical devices industry.

John Taylor reports, and a warning: this story contains pictures of medical procedures.

STUART CAIN, NURSE: I’ve been told it’s the last I can ever have because of the damage that’s been done to my leg.

NICK XENOPHON, INDEPENDENT SENATOR: There are Australians who will die needlessly as a result of the regulatory failure. And that is something that is in my view nothing short of a scandal.

JOHN TAYLOR, REPORTER: Last year, more than 80,000 Australians had a joint replacement. With an ageing population, that figure could well double in the next decade.

The surgery is life changing, but for 42-year-old nurse Stuart Cain, it’s been for the worse.

STUART CAIN: We’ve made provisions in our life to cope with the fact that I may not be able to walk.

JOHN TAYLOR: In 2007, years of rugby and too many scrums had taken their toll and he had a total hip replacement. It was known as an ASR, made by a subsidiary of Johnson & Johnson and not long released in Australia. For 12 months, everything was fine, but then came pain, bad sleep, anaemia and a limp.

STUART CAIN: The physical symptoms that I was experiencing were everything from fatigue and headaches, loss of toenails. I also suffered a lot through memory and recall.

JOHN TAYLOR: Unknowingly his hip replacement was to blame. It was leeching dangerously high levels of cobalt, poisoning his blood. Only in November 2010 was it removed.

STUART CAIN: There was metal debris from the acetabulum cup, and that metal debris spread into my hip joint. I was told around the top of my femoral bone that had already been removed to fit the prosthesis, that there was metal debris around there at the entrance to where the prosthesis entered my femur.

JOHN TAYLOR: There are two types of ASR hips, and from 2006, orthopaedic surgeons in Australia began to be concerned about the high need for corrections in ASR patients. The statistics got steadily worse until in 2009, the manufacturer, not the Therapeutic Goods Administration, removed it from Australia. But by then, about 5,500 Australians had ASR implants.

GRAHAM MERCER, AUST. ORTHOPAEDIC ASSOC.: I think there are some questions there that need to be answered as to the speed of the response.

JOHN TAYLOR: Dr Graham Mercer from the Australian Orthopaedic Association says the ASR case highlights problems with the way joint replacements come onto the market. While regulations have progressively changed since 2006, he’s hoping for legislation requiring earlier testing of devices.

GRAHAM MERCER: What we’ve been pushing for is a minimum two years of pre-market surveillance before a prosthesis is introduced into the market. So there’s two years of clinical testing which can be undertaken in a randomised style in an ethically approved study.

JOHN TAYLOR: Spurred on by the ASR case, since June, a Senate committee has been examining the regulatory standards for the approval of medical devices in Australia.

NICK XENOPHON: The evidence I’ve heard from the committee indicates that there must be some deep systemic changes. Not only does this cost our medical system hundreds of millions of dollars each year – not just the public system, but the private system as well – but there are enormous consequences to individuals.

ANTHONY BISHOP, JOHNSON & JOHNSON MEDICAL (Senate committee, July): Clearly this recall has had an enormous impact upon patients, their loved ones and their health care professionals.

JOHN TAYLOR: Johnson & Johnson has paid out more than $21 million to ASR patients, but is also facing class actions.

Stuart Cain is among those going to the courts. He only became aware of concerns about his hip when it was withdrawn from Australia. And even though his has now been removed, he says another, different hip replacement failed because of continuing ASR issues with a titanium rod snapping from his femur.

STUART CAIN: It’s now come to my attention unfortunately in the last week that I still have a toxic cobalt level as a result of a blood test just this week. I’ve been told that within my surgery that there was a rather large deposit of metal within my bone, but also still within my hip area.

JOHN TAYLOR: The 42-year-old now has a third artificial hip. If it fails, he’s facing life in a wheelchair.

STUART CAIN: Whilst I’m not questioning that I wasn’t well looked after, I was put at risk and I was certainly put in a position where I wasn’t safe.

LEIGH SALES: John Taylor reporting.