Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.
Australia was the first country to withdraw DePuy’s ASR implants from use in December 2009. The defective metal-on-metal hip replacement devices were not recalled in the U.S. and elsewhere until August 2010.As we’ve reported previously, DePuy’s worldwide recall of the ASR Hip Resurfacing System and ASR Acetabular System was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the metal-on-metal hip replacement devices had to undergo revision surgery within five years. A total of 93,000 implants were sold worldwide, including 37,000 ASR Acetabular System implants in the U.S.
According to TheAge.com, data from Australia’s national joint registry indicates that both ASR hip implant devices have a cumulative failure rate of 25 per cent over seven years – about five times higher than average. DePuy Orthopaedics, a division of Johnson & Johnson, says it has spent $45 million (Australian dollars) to reimburse the costs of affected patients there.
The DePuy ASR hip implant debacle has prompted Australian health regulators to crack down on all makes of the devices. Like regulators in other countries, the Australian Health Department is investigating the problems associated with metal-on-metal hip replacement devices, and their emission of toxic heavy metal residues into the bloodstream. The Department also plans to be more active in banning suspect implants after experts assess performance on the basis of national records on joint replacements, TheAge.com said.
DePuy ASR Hip Implant Recall Fallout
The U.S. Food & Drug Administration (FDA) also began studying all-metal hip implants shortly after the DePuy ASR hip implant recall. An agency advisory panel is scheduled to take up metal-on-metal hip implants during a two-day meeting scheduled for June 27th and 28th.
Meanwhile, regulators in Canada and the U.K. have issued advisories to doctors regarding metal-on-metal hip replacement devices. In both countries, doctors have been advised to monitor some patients after surgery via imaging and blood tests to ensure their hips aren’t shedding poisoning metal debris into surrounding tissue or their blood stream.
Since the DePuy ASR hip implant recall, thousands of people have filed suit against Johnson & Johnson and DePuy Orthopaedics. More than 4,200 lawsuits are pending against the companies in a federal multidistrict litigation now underway in the U.S. District Court for the District of Northern Ohio. Bellwether trials in that litigation are expected to start early next year. Another 2,000 lawsuits are also pending in state courts. Two DePuy ASR hip implant trials are set to start in Nevada and Maryland later this year.