Critics Say Recall of DePuy Hip Replacement System Comes "Way Too Late"

Warsaw, INA hip replacement system that was pulled from the market by its manufacturer last month due to early failures was fast-tracked for approval by the US Food and Drug Administration (FDA). The DePuy hip implant, also known as the ASR cup, was approved for use in 2005 by the FDA but "was cleared through a regulatory pathway that did not require it to undergo clinical trials," reports the 3/19/10 issue of the New York Times.

Just why the device was approved without clinical trials was not addressed. Another component of the ASR system, which is not a traditional hip replacement but involves a "resurfacing procedure" billed as an alternative to traditional hip replacement, is used elsewhere in the world, but was not FDA-approved for use in the US.

The ASR is a metal-on-metal device, a design which, according to the New York Times, is coming under increasing scrutiny due to the potential for generating large amounts of metal debris during normal wear and tear. Such debris can negatively impact soft tissue and evolve into a health issue for some patients.

Others have suggested that the shallow ASR hip replacement cup has a design flaw, an allegation the manufacturer disputes. The components also frequently need replacing far sooner than the expected 15-year life span.

On 4/3/10 the New York Times told the story of William R. Morris, whose artificial hip was failing so badly that he required hip revision surgery after only three years. Meanwhile, the FDA has heard about 300 complaints since 2008 from patients in the US who received the DePuy Orthopaedics product.

The New York Times reports that in early 2009 DePuy issued a brochure to doctors with regard to the importance of proper cup positioning for all hip implants. Since then the debate has centered on whether the problems patients encountered were due to a fault in the design or to improper insertion during surgery, or a combination of both.

Nonetheless, DePuy announced late last year that it planned to phase out the ASR worldwide by the end of 2010 due to slowing sales. There was no inference to a flaw or performance problem with the hip replacement system.

However, on March 6 DePuy issued a communiqué that referenced Australian data suggesting that the ASR delivered a higher-than-expected failure rate when used in traditional hip replacement involving certain types of patients. Identified amongst the groups that showed a higher risk for failure were women, people with weak bone structure and those of small stature.

The ASR was pulled from Australia in December 2009 and from the US last month.

Even patients with health insurance can face stiff co-payments for surgical procedures—and a hip replacement that fails prematurely and requires hip revision surgery often produces financial hardship for the patient. For those without adequate health insurance, the only recourse is often to suffer in silence and adjust to immobility.

Dr. Stephen Graves, the director of an implant database in Australia, said the data had shown for some time that the ASR had been failing early at a significantly higher rate than some competitors' devices.

Phasing out the product worldwide by the end of this year is simply "way too late," he said.