A recent article by the New York Times reveals a flawed medical implant system that is under intense scrutiny after the recall of 93,000 DePuy A.S.R. hip replacement implants. Originally promoted as a breakthrough in design that would last patients at least 15 years, the device is failing worldwide at unusually high rates after just a few years. Some patients have had to undergo painful operations to replace the device with another artificial hip. Other suffered permanent disabilities to bones, muscles, and nerves because of tiny metallic particles shed by the faulty device.
The article points to a medical loophole that was exposed by the A.S.R. hip failures. Unlike new drugs, which undergo a series of clinical trials before gaining approval from federal officials, critical implants can be sold without such testing if they resemble another implant that is already approved and used on patients. This allows producers to bundle a component from an unapproved implant into an existing design and sell the device with minimal testing.
Only one version of the DePuy device was approved for sale in the United States, but it used parts of another unapproved device. Current rules do not require producers to notify federal officials when they bundle together approved and unapproved device components. And, until recently, doctors and regulators remained largely unaware of the problem because there is no independent monitoring system in this country that tracks implant failures.
The faulty DePuy device is just one of a number of Johnson & Johnson products that have been recalled for defects or manufacturing flaws. Although the FDA recently proposed rules that would require more rigorous testing for implanted devices, the industry is questioning the need for even broader changes.