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Artificial Hip Recall Reveals Loophole in Medical Implant System, Part One

Over the last year, health care product manufacturer Johnson & Johnson has come under scrutiny after multiple allegations of injuries caused by various products. On this blog alone, we have written about the harm reportedly caused by the birth control patch and children's over-the-counter cold medicines, both of which have given rise to products liability litigation. Recently, a new controversy has risen after claims that an artificial replacement hip manufactured by DePuy Orthopaedics, a unit of Johnson & Johnson, was not only failing, but causing serious and lasting harm to patients.

According to hundreds of reports from around the world, DePuy's Articular Surface Replacement hip, or A.S.R., began causing intense and unexplainable pain in some of the over 90,000 patients who received the hip implants soon after surgery. When surgeons went to replace the implants, they discovered masses of dead tissue near patients' thighs. Although many patients opted for a different hip replacement in place of the A.S.R., they were left dealing with lasting and lifelong pain due to bone, muscle and nerve damage. In some cases, that damage complicated the replacement operation.

The problem escaped widespread publicity as many surgeons simply attributed the problems to their own surgical mistakes. The symptoms of the DePuy issues are often reported by patients who suffer from edge-loading, which occurs when a hip joint ball rubs against an improperly positioned hip cop, causing debris from the hip to chisel off and enter the bloodstream. As a result, elevated levels of cobalt and chromium ions are found in patients' blood. Yet after numerous reports of pain from patients with DePuy implants, surgeons tested the blood of patients who had the implants but were not reporting pain, and found such elevated levels. This indicated that the implant, and not the surgeon, was the problem.

As surgeons throughout the world began to remove the defective products from their patients' bodies, they learned that the debris that had been chipped from the hip implants was irreversibly destroying nearby muscle and bone. Many sought out a way to notify other physicians and patients of the problem, but were unable to do so due to the lack of an independent monitoring system for tracking implant failures in the U.S.

We will continue this post later this week with a look at the implant system loophole that allowed the wide use of DePuy's product.

Source: New York Times, "The Implants Loophole", Barry Meier, 16 December 2010

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