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Wednesday, September 1, 2010

J & J Initiates Recall of Hip Replacements

Finally responding to concerns that had been voiced by doctors, industry experts, and the FDA and other regulatory agencies, Johnson & Johnson last week initiated a recall of hip implants manufactured by its DePuy division. The recall was initiated because data compiled by the National Joint Registry (NJR) of England and Wales showed that the joint replacements caused higher-than-expected rates for revision surgery.

The two affected products are the ASR XL Acetabular system and the ASR Hip Resurfacing System. The ASR Hip Resurfacing system replaces the socket in the hip with a metal cup and places a metal cap over the ball of the femur. The ASR XL system has three components. A shaft or stem is placed inside the femur. The stem is connected to a ball. This ball is inserted into the metal cup.

The recall comes only after the company had decided to phase out the implant in 2010 due to slowing sales. In December 2009, the device was withdrawn from the market in Australia as a defective medical device, after the director of that country's implant database, Dr. Steven Graves, pointed out that it had a higher failure rate than competitor's devices. In response to the withdrawal, Dr. Graves said, "It's way too late." However, DePuy did not initiate a worldwide recall at that time. Instead, it waited until the NJR data confirmed what the Australian data showed. The NJR data showed that 12-13% of the implants failed within five years, instead of lasting fifteen years as they are supposed to.

Early failure is not the only problem with the ASR implants. They belong to a class of implants that are described as metal-on-metal implants because both components in the joint are metal. Following implantation, the action of the joints can lead them to wear quickly, shedding metal fragments. These fragments can touch off inflammatory reactions, cause extreme pain, and lead to a loss of both soft tissue and bone around the implant. When this occurs, patients may suffer lasting pain and other complications even after the implant is replaced. In fact, one study showed that more than half of people who underwent revision surgery for metal-on-metal implants had to undergo at least one re-revision surgery. Some doctors have also raised the potential of long-term toxicity of these heavy metal fragments that make their way into the blood stream (including chromium and cobalt, which are known to be toxic).

Metal-on-metal implants in general and the ASR in particular are an example of doctors and industry experts rushing in to use a device that seems like a great idea before examining the full range of consequences, putting thousands of people's lives at risk in a great gamble. If you or a loved one lost and suffered serious injury as a result of the ASR implant, you may be able to receive compensation. The Cochran Firm stands ready not only to fight for you, but to send a definitive message to doctors and manufacturers that gambling with health of patients is unacceptable. Please contact us today for a free case evaluation.

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posted by Benjamin A. Irwin at 8:10 AM

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