For those with hip injuries, a prosthetic limb can mean the difference between immobility and independence. If the prosthetic hip is a metal-on-metal device, however, patients may find themselves with more health problems than they bargained for.
In order to ensure that metal-on-metal hip implants are safe, the Food and Drug Administration (FDA) has ordered about twenty prosthetic device manufacturers to conduct surveillance and testing on their products. The agency is specifically interested in the effects of the metal particles that the devices can shed — which are believed to possibly cause damage to a patient's bones, muscles and nerves.
In addition, the FDA is requiring these companies to get blood samples from patients with their prosthetic devices, so that an analysis can be done to determine the amount of metals that are present in the patients' bloodstream.
Problems With DePuy Hip Replacements
The FDA's concerns were precipitated by problems associated with products manufactured by DePuy Orthopedics, a subsidiary of Johnson & Johnson. According to the New York Times, the company recalled its ASR XL Acetabular hip system when researchers discovered that 13 percent of customers that received the device required revision surgery within five years of it being implanted — an amount that is considered "unusually high."
DePuy Orthopedics has also faced legal problems because of its metal-on-metal prosthetic devices. The company has been sued by patients in 19 states and has been named in over 100 federal lawsuits because of injuries that patients have suffered after receiving the company's hip system.
Based on the results of company tests, the FDA may reclassify metal-on-metal prosthetics. This would require manufacturers to thoroughly test their products prior to receiving approval from the government to sell them.
