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Patients reveal agony of toxic hip implants

By Quentin McDermott and Karen Michelmore; Updated Mon May 16, 2011 10:52am AEST

DePuy issued a worldwide recall of the articular surface (ASR) hip replacement in 2010. (www.depuy-recall-hip.com) The articular surface replacement (ASR) hip was made and marketed by DePuy Orthopaedics. (www.sxc.hu: asterisc21, file photo)

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A medical scandal that has resulted in hundreds of patients being poisoned and seriously disabled may soon lead to changes in the way medical devices are approved for use in Australia.

The full story of the failed devices – described by an English researcher as “perhaps the biggest disaster in the history of orthopaedics” – is told for the first time on television on tonight’s Four Corners program. There are calls for an inquiry into the regulation of Australia’s $4 billion medical devices industry following the recall of the faulty hip that left hundreds of Australians in unbearable pain.

The articular surface replacement (ASR) hip was made and marketed by DePuy Orthopaedics, a subsidiary of the Johnson & Johnson healthcare empire.

DePuy issued a worldwide recall of the hip in 2010 and voluntarily withdrew it from Australia in 2009, but not before 93,000 patients worldwide, 5,500 of them Australians, had been implanted with the faulty hip.

Patients from Queensland and South Australia tell Four Corners they have suffered terribly from the side-effects of the hips failing.

An increasing number of patients who had the hip implanted are having to undergo painful and complex revision surgery to remove the faulty hip.

Many, in addition, have experienced severe illness away from the hip, which some doctors and medical researchers attribute to metal poisoning from the joint.

Hundreds of Australians who had the faulty hip implanted are now joining class actions against DePuy Orthopaedics and Johnson & Johnson.

High levels of cobalt and chromium, two of the metals used in the manufacture of the joints, have been found in the blood of many patients whose DePuy ASR hips have failed.

Brisbane man Bob Lugton says the cobalt from his faulty hip had eaten away his thigh bone.

Mr Lugton says the surgeon who removed the faulty joint told him that “my flesh had turned a grey black around the hip area”.

“The bone, he said, looked like a sewer pipe and was full of a sludgy grey material,” he said.

Mr Lugton also complained of tinnitus and problems with his sight, which he now attributes to cobalt poisoning.

One Adelaide woman who had a cobalt reading 50 times the acceptable limit told Four Corners she had years of inexplicable serious illness before the faulty joint was taken out.

Despite growing concern in Australia and overseas, the Australian Orthopaedic Association (AOA) is reluctant to accept there may be a real problem of cobalt toxicity in patients with hips that have failed.

Toxic effect

AOA vice president Graham Mercer says the issue of cobalt toxicity is still only anecdotal.

“We are open-minded as to whether there may be an issue with cobalt toxicity in the future, but at the moment there’s not the scientific evidence to support that,” he said.

“There’s a lot of media hype about it and I think the media hype really at this stage hasn’t got the scientific background or evidence to actually support an issue with it.”

But Four Corners presents evidence that pathology labs are recording much higher levels of cobalt than previously, and that this carries with it the potential for a range of toxic effects in the worst-affected patients, including blindness, deafness, seizures, cognitive problems and heart failure.

“We’re talking serious toxicity in a large number of patients that have received faulty hip joints,” a specialist chemical pathologist said.

So-called metal-on-metal hip replacements are coming under increasing scrutiny around the world following last year’s global recall of the DePuy ASR metal hip joint.

Hundreds of thousands of metal-on-metal joints have been used on patients around the world.

US regulator the Food and Drug Administration (FDA) wrote to manufacturers of metal-on-metal hip prostheses on May 6, demanding they study patients who have received their devices amid concerns the joints may be leeching potentially toxic metal ions.

Approval process

South Australian Senator Nick Xenophon, Four Corners reveals, will soon call for a senate inquiry into the approval process for medical devices like the ASR, which was not required to undergo clinical trials as part of its assessment.

The Therapeutic Goods Administration (TGA) approves devices for use in Australia, and the DePuy ASR was approved for use here on the basis of European certification by the British Standards Institute.

It was never separately tested by the TGA and the resurfacing version of the device – which was approved for use in Australia by the TGA – was never approved for use in the US by the FDA.

TGA spokesman Dr Rohan Hammett says there are about 1 million individual medical devices available on the Australian market.

“It’s not possible to individually test a million medical devices, but we need those devices to improve our lifespan, to provide treatment, to take away the pain that patients who walk around with osteoarthritis in their hips suffer from every day,” he said.

Senator Xenophon says there needs to be legislative reform.

“The system isn’t working as it should. It’s not protecting patients, and there is a lack of transparency in the current system in terms of the way the TGA acts,” he said.

“I think the TGA has let down Australian patients with some of their actions and it’s about time that changed.”

The TGA says it is moving to reclassify joint prostheses to allow a greater level of oversight before a joint is approved.

Too little, too late

The Four Corners investigation explores the circumstances leading up to last year’s global recall of the DePuy ASR hip joint.

Experts overseas and in Australia say for years they warned DePuy and Johnson & Johnson the device was failing.

About one in 10 of the 35,000 hip implants in Australia in 2009 used metal-on-metal devices, according to AOA figures.

The TGA says it is monitoring the issue of metal-on-metal devices closely through the National Joint Replacement Registry (NJRR), which collects data on failed implants.

NJRR spokesman Stephen Graves says the registry “has been identifying for the last two years that metal-on-metal, as a group, has a higher risk of revision”.

But despite criticism that in the case of the DePuy ASR it did too little too late, the TGA says it is proud of its record.

“Australia led the world in removing this device from the marketplace,” Dr Hammett said.

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