Could DePuy Hip Recall Stem From Study?

Some medical experts are wondering whether a DePuy hip recall is finally on the horizon after the Food and Drug Administration announced in May of 2011 that they were going to compel orthopedic device manufacturers to conduct post-market studies on all 145 metal-on-metal hip replacement devices in use across the country that have been approved by the Food and Drug Administration.

Australia and the United Kingdom have both taken steps towards protecting consumers from the potential side effects and DePuy hip complications associated with the hip replacement systems, particularly the metal-on-metal ASR hip replacement system. Australia has gone so far as to ban the device, while the United Kingdom’s British Orthopaedic Association issued a “medical device warning” that advised and informed patients of the complications possible with the hip replacement system, and will mandate post-surgery monitoring for a select number of patients. This monitoring will include blood testing for a type of metal poisoning, called metallosis, associated with metal-on-metal hip replacement systems, and imaging that will detect possible hip implant dislocation.

An Australian study found that nearly 15 percent of patients of DePuy metal-on-metal hip replacement systems experienced hip replacement failure severe enough to necessitate hip revision surgery within five years of receiving the device, and the number only increases as more years go by. DePuy hip revision surgery is a complicated, dangerous, painful, and expensive second surgery intended to fix problems associated with hip implant failure, but some patients cannot afford it, and it is much more difficult to perform than the initial surgery due to scar tissue and inflammation.

There is some question as to whether the devices in question, including the DePuy ASR system and the similar DePuy Pinnacle – which comes in metal-on-metal and ceramic-on-ceramic forms – are faulty by design, or if there is an innate problem with metal-on-metal hip replacement systems, which can grate on one another and allow particles of metal to flake off into a patient’s bloodstream. This is known as DePuy metal poisoning.

The United States Government Accountability Office testified at an April 2011 Congressional hearing that the Food and Drug Administration pre- and post-marketing safety protocols were inadequate for these devices.

Many patients have already filed lawsuits against DePuy Orthopedics, and more will likely join as time goes on.