Sunday, October 21, 2012

Dangerous implants 'a time bomb'

EXCLUSIVE by Sue Dunlevy
October 20, 201212:00AM
HUNDREDS of thousands of Australians have been fitted with hip and knee replacements, breast implants and other devices that could be ticking health time bombs, with 300 deaths and more than 2300 serious injuries linked to prostheses in the past decade. 
Many of these devices have never been subject to clinical trials before they are inserted into human bodies.

The nation's medical device regulator, the Therapeutic Goods Administration, relies on the manufacturer to tell it if there are any adverse events after they go on sale.

But if they are found to be faulty there is no way for the government's medical watchdog to identify which patients have used them and warn them of the problem.

Often the doctors who use the devices have played a part in developing them, with a financial incentive to use them as they earn royalties. One overseas company has been fined for providing doctors with financial inducements to use its products.
The Department of Health has revealed it manages the recall of around 500 medical devices every year and there has been a 100 per cent increase in recalls in the past five years.

Failures with these devices are forcing thousands of Australians to undergo repeat surgery. Last year, there were 4646 revisions of hip replacements, or 89 each week. More than 570 of these related to the DePuy hip, which was recalled by its manufacturer in 2009 after evidence it began to deteriorate inside many patients, flooding their bodies with metal chemicals.

Mother-of-two Therese Wood has endured two operations to remove her faulty DePuy hip, while others have undergone five operations.

Despite problems soon after she got a DePuy hip in 2007, it was not until two years later that tests found she had extraordinarily high cobalt levels - seven times the rate of someone who worked in the cobalt industry.

She underwent surgery in 2010 and again just this month to have the stem of the hip - which had been cemented in place - removed.

"I am angry," she said.

"What a dreadful thing that a company could issue a product when they knew it was failing at a high rate in 2005 in the United Kingdom.

"It has hurt my life tremendously."

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