DePuy Hip Replacement: Do Patients Serve as Guinea Pigs?

New York, NYIn the waning weeks of 2010, writer Barry Meier in The New York Times looked at the troubles surrounding DePuy Hip Replacement, and what role a loophole in the FDA (US Food and Drug Administration) approval process for prosthetic medical devices may have played in the heartbreak and frustration that many a DePuy client has been experiencing at the hands of their new hip.

Hip implants are designed to last 15 years at the minimum, under normal use. However, patients having received the DePuy ASR or Articular Surface Replacement have been finding that in many cases their DePuy hip is failing after just a few years—sometimes within a matter of months.

Meier reported in The New York Times in December that surgeons faced with the task of performing revision surgery and replacing the hip joint were finding masses of dead tissue near the thighs of some patients.

A DePuy lawsuit filed in the US District Court for the Northern District of California takes defendants DePuy and Johnson & Johnson to task for allegedly waiting for more than two years following advisements of problems with its ASR hip implant devices before issuing a recall.

Specifically, the lawsuit notes that since 2007/2008 the FDA received in excess of 400 complaints involving US patients having received the troubled device, with more than 90 percent of those patients in need of revision surgery—at considerable expense—in order to replace the failed devices.

And yet the defendants did not undertake a Hip Replacement Recall until August 26, 2010.

Meier points to the FDA approval process for medical devices as a potential factor in the plaque-ridden DePuy ASR hip issue. The approval process holds that so long as a medical device is substantially similar to one already on the market, the new device or component is acceptable even in the absence of the kind of testing that would otherwise be required with a brand-new device featuring a unique design.

Manufacturers cite the loophole as a means to rapidly undertake small changes in a device in order to improve it. However, as Meier points out, it also allows manufacturers the capacity to "bundle" an unapproved component into an existing design, and do it with minimal testing.

Dr. Sidney Wolfe, FDA critic and director of the Health Research Group for Public Citizen, sees it this way: "You are basically testing these devices in an uncontrolled way on a large number of people."

The allegation is that the troubled DePuy Hip Replacement grew from such circumstances.