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Many Need Revision Surgery
Getting a hip replacement once is bad enough for most people. What could be worse? Hundreds of patients with ASR hip replacements, constructed by the DePuy Orthopaedics unit of Johnson & Johnson, have had to undergo complicated revision surgery to correct ASR hip failure. Two ASR hip replacements, the ASR XL Acetabular System and the ASR Hip Resurfacing System, were recalled in late August due to the high rate of revision surgeries, more than two years after the FDA started receiving complaints from patients.

Approximately 93,000 hip replacement devices were implanted nationwide. According to a recent study, nearly one in eight DePuy devices failed within five years requiring patients to undergo revision surgery. The DePuy devices are so dangerous because they are in a category of implants which can cause high levels of metal ion release, resulting in inflammation and tissue damage in certain patients.

Johnson & Johnson’s Response
While acknowledging that the devices were problematic and recalling them, DePuy has said that the majority of hip replacements using the ASR devices had been successful. Nevertheless, the company has advised patients who have had hip replacements with the recalled products to see their surgeons. These patients have also been advised to have annual monitoring. “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall,” said David Floyd, President of DePuy.

The Fallout
Despite DePuy’s willingness to take responsibility for the recalled products, the true fallout remains to be seen. As mentioned earlier, the FDA received around 400 complaints since 2008, from patients who received the implants in the United States. In fact, the ASR hip replacement recall from the Australian market occurred in December 2009. The recall didn’t occur in the United States until late August 2010. The question remains why DePuy waited as long as it did to recall the hip replacement products. The number of people impacted by the faulty implants and the extent of those people’s injuries also is yet to be determined.

What is clear is that significant changes need to be made. Dr. Joshua J. Jacobs, the chairman of orthopedic surgery at Rush University Medical Center in Chicago, said that the recall highlighted the importance of having a national registry for joint implants that can serve as an early warning system for product problems. That would be one step in the right direction for the DePuy unit of Johnson & Johnson, but it is possible larger scale changes need to be made companywide, in light of the previous recalls of liquid Tylenol children’s products and Acuvue contact lenses. Johnson & Johnson has to improve its product safety and that improvement needs to start immediately.

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