DePuy’s now notorious metal-on-metal artificial hip, known as the ASR, was marketed as the next great thing in orthopedics, but actually was a recycled old design that ignored warnings from industry insiders that the all-metal construction was subject to dangerous flaking of metal fragments inside the patient’s body.
That’s the conclusion of a new takeout on the artificial hip saga from the New York Times’ Barry Meier, who has written extensively on the DePuy debacle and other defective products in the medical device world.
The article also discusses a disturbing loophole in FDA regulations that allowed products like the DePuy ASR onto the market with little testing, because the manufacturer could argue that they were close enough to an old design that they should be grandfathered into approval.