By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP
HOUSTON—On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced it is voluntarily recalling two types of hip implants due to high early failure rates.
The recall affects the ASR™ XL Acetabular System, which is used for total hip replacements, and the DePuy ASR™ Hip Resurfacing system, which is used in a newer kind of bone-conserving procedure. To date, more than 93,000 of the devices have been implanted worldwide.
DePuy said that it was issuing the recall after new data from a British joint replacement registry showed about 1 in 8, or around 12 percent, of those who received the implants needed corrective procedures, called revision surgeries, within five years. Typically, the devices are supposed to last 15 years before requiring any corrective revision.
DePuy’s hip replacement system—a metal-on-metal implant—has been linked to metal poisoning or metallosis, which, according to the Journal of Bone & Joint Surgery, is "aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris." Design problems with the devices cause the metal components to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions and bone loss.
Symptoms of metallosis from metal-on-metal hip replacement devices can include pain, inflammation, tumors and difficulty walking. Specialized blood tests can be used to detect levels of toxic metals in patients experiencing these symptoms. In some cases, patients with DePuy implants have been found with 100 times the normal levels chromium and cobalt in their bodies.
Metal-on-metal devices gained popularity in recent years among orthopedic surgeons and patients who believed they would be more durable than those made of other materials, such as ceramics. But it soon became apparent that many of the devices were deteriorating quickly, shedding metallic debris that was readily absorbed into the bloodstream.
The New York Times reported in March that it was "not clear whether some makers’ devices are more prone to the debris problem than others. But some experts argue that some manufacturers, in a rush to meet the demand for metal-on-metal devices, marketed some poorly designed implants and that some doctors fail to properly implant even well-designed ones."
But it appears that DePuy’s ASR devices are more prone to debris problems than other brands. The first lawsuit filed in the United States against DePuy over the defective ASR hip implants was in March 2009—almost 18 months before the device was recalled. In fact, the Food & Drug Administration (FDA) had received over 500 complaints about the devices through the years leading up to the recall, but no action was taken as a result.
Countless patients are now left to struggle with the serious side effects of receiving a faulty hip implant, including pain, inflammation, metallosis, and costly revision surgery to correct these problems. And while DePuy’s recall notice stated that, "DePuy intends to cover reasonable and customary costs of testing and treatment if you need services, including revision surgery if it is necessary," the company did not elaborate on what it perceives is "reasonable" or mention compensation for injury, such as the damages to overall physical and mental health, pain and mental anguish, disfigurement and scarring, or future medical expenses.
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