FDA Issues Safety and Guidance update for Metal-on-Metal Hip ImplantsJan 21, 2013
Federal health officials provided wide-ranging updated safety information and recommended courses of treatment for the numerous metal-on-metal hip implants that have been linked to scores of complications for their recipients.
Tens of thousands of people in the U.S. have experienced complications caused by their defective metal-on-metal hip implant after receiving them in either a total hip replacement surgery or a hip resurfacing procedure. More than 500,000 people in the U.S. have received a metal-on-metal hip implant in the last decade.
In the last two years, the Food and Drug Administration has issued several updates on reports of complications caused by defective metal-on-metal hip implants. In an update issued last week, the FDA says the new information is “based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.”
The information provides guidance for people considering a total hip replacement or a hip resurfacing procedure. It also advises surgeons and physicians on how best to treat patients relying on these implants or considering them in the future. Some patients may be more prone to the dangerous side effects of a metal-on-metal hip implant, namely the risk of metal poisoning, metallosis, caused by the implant’s metal component parts rubbing together and releasing small metallic particles in the recipient’s bloodstream and surrounding areas of the body.
Metal poisoning among metal-on-metal hip implant recipients has been reported to cause organ and tissue damage and this can lead to other problems faced by many wearers of hip implants, such as a total device failure or pain and loosening of the hip implant. This results in many recipients of these devices undergoing costly and painful revision surgeries or being forced to undergo another replacement surgery.
In its updated guidance, the agency said it “does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.”
In the agency’s updates to physicians treating patients who are considering a metal-on-metal hip implant, they should only opt for these devices if their benefit-risk profile indicates that the device is a good match for that patient. Age, sex, weight, diagnosis, and activity level are all factors a doctor should consider when planning a hip replacement for a specific patient.
In addition, recipients of these devices should be monitored regularly for potentially dangerous levels of metallic ions in the body. The FDA identifies patients with bilateral implants, resurfacing recipients that require small femoral heads, females, patients already taking high doses of corticosteroids, renal insufficiency, suppressed immune systems, and other conditions as those most likely to experience more complications than benefit from a metal-on-metal hip implant.