Tuesday, September 27, 2011

Three years to recall problem implants

Reprint of an article posted in the Sydney (Australia) Morning Herald earilier today.

Mark Metherell September 28, 2011   

AFTER evidence emerged of the high failure rate of an artificial hip, it took three years for the recall of the product. This resulted in an estimated 5000 Australian patients having to undergo repeat operations.

An orthopaedic expert, Stephen Graves, told a Senate committee yesterday of his concerns about the time it took for the Therapeutic Goods Administration to act on national evidence of the high failure rate of the device, which first surfaced in 2006. Solicitors acting on behalf of people affected by the allegedly faulty hip implants filed an action against the orthopaedics manufacturer DePuy in the Federal Court yesterday seeking compensation for harm.

The claimants are also seeking punitive damages on the basis that the company, owned by the medical giant Johnson & Johnson, allowed the products to remain on the market despite sufficient evidence showing the devices were causing harm.

As many as one in eight people who received the implant required it to be replaced within five years, a number much higher than other hip replacements, the solicitors said.

Anthony Bishop, the Australian head of Johnson & Johnson, appeared before the Senate committee yesterday and offered the company's regrets.

He said the company had reimbursed more than $21 million in claims to more than 3500 patients in Australia who had registered with the company's claim processor.

Mr Bishop said on legal grounds the company would not answer questions about its response to earlier advice of the product's failure and why it took so long to withdraw it.

Australia was the first country to withdraw two DePuy hip implants in December 2009. Europe followed last August. Professor Graves, who heads the National Joint Replacement Registry, told the Herald yesterday outside the hearing that about 5000 patients with the implants had undergone repeat surgery.

He told the committee that the registry first picked up a 50 per cent higher rate in repeat surgery involving the DePuy product in 2006 and while not sure it reflected faults in the product, mentioned it to the TGA.

In 2007 the higher failure rates were confirmed and again related to the TGA, which established an expert advisory group, which after a series of further reviews recommended withdrawal in December 2009.

Rohan Hammett, the national manager of the TGA, later told the hearing that between 2006 and 2008 the orthopaedic expert advisory group - established to advise the TGA on the issue - had recommended more training of surgeons using the product because of its technical complexity.

Dr Hammett said the matter had been further complicated when a second but technically different DePuy hip implant was also found to have problems.

The Consumer Health Forum chief executive, Carol Bennett, said: ''In many cases it is not until devices are on the market that failures become apparent. Consumers want to know that when a device is failing at unacceptable levels, action will be taken promptly to contact and assist those who are already using the device and to prevent the use of the device where necessary.''

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