Pharmaceutical

DePuy hip recalls expose flaws in U.S. health care system

The U.S. health care system, often celebrated domestically as the best in the world, is woefully inadequate when it comes to protecting consumers from dangerous and/or defective medical devices. The FDA, for instance, allows many medical devices to be fast-tracked through the approval process if the devices are substantially similar to already-approved devices. Then, if those devices fail and have to be recalled because they weren’t properly tested, no single registry exists that can readily tell officials how many Americans are affected and who those people are so that they can be contacted.

This is the story of DePuy’s recalled hip implants: the ASR XL Acetabular and ASR Hip Resurfacing Systems, which were surgically implanted in about 37,000 U.S. patients and nearly 60,000 more globally. Nobody knows how long it would have taken to discover the unsettling failure rate for these devices if it weren’t for artificial joint registries in the U.K. and Australia.

It was the National Joint Registry for England and Wales that uncovered the unusually high failure rates for the DePuy hip implants, at least officially: 12 percent of the ASR resurfacing device failed and 13 percent of the ASR total hip replacements needed to be replaced after just five years.

That data was also echoed down under by the Australian Orthopaedic Association’s Joint Replacement Registry, which showed that more than 5,000 Australians received DePuy’s defective prosthetic hips and needed have them replaced. Japan, Norway, Sweden, and other countries followed.

But the U.S. does not have a central registry for orthopedic prostheses, nor do any states that we know of. So while the FDA began receiving complaints about the DePuy hip implants as far back as 2008, it could not readily see the true extent of the problem. Surgeons continued to implant the defective devices in American patients until they were formally recalled in August of last year.

Meanwhile, thousands of Americans are now facing revision surgery to replace their DePuy hip implants – a procedure that gets trickier each time it is performed because there is less supportive bone and tissue to hold the implants in place. Many patients living with the defective devices face acute and constant pain, diminished ability to walk, and a range of symptoms indicative of metal poisoning caused by the implants’ frictional release of cobalt into the bloodstream.

The American Academy of Orthopaedic Surgeons (AAOS) has announced preliminary plans to establish an orthopedic joint registry in the United States, which doctors believe will help protect patients from defective implants by allowing doctors to research the performance of a device before implantation. The American Joint Replacement Registry is spearheaded by a number of orthopedic specialists and should be complete sometime this year. However, the privately run database will aggregate data from voluntary sources such as hospitals and may not represent the most comprehensive picture of problematic medical devices.