The U.S. Food and Drug Administration is soliciting advice from scientific and medical experts outside the FDA to evaluate recent information on the metal-on-metal hip implant devices in order that “the agency can continue to make reliable safety recommendations,” said Dr. William Maisel, deputy director of science of FDA’s Center for Devices and Radiological Health.[1]
Prosthetic hip joint implants are frequently recommended by orthopedic surgeons in patients with hip bone and joint problems often caused by arthritic conditions, fractures and years of constant use. In the best case, the goals of a hip implant are to minimize hip pain, provide greater leg strength, allow for easier movement and improve daily quality of life and comfort when performing normal daily tasks and low-impact activities.
Last May, the FDA issued an order to hip implant device manufacturers to collect additional safety data on the metal-on-metal implants. The failure rate of the metal-on-metal hip implants has been found to be higher than that of hip implants using other materials (such as ceramic or plastic systems), according to an article published by Reuters in The Chicago Tribune, March 29, 2012.[2] Approximately 6 percent of people with metal-on-metal hip implants require a replacement after five years.[3] Hip replacement surgery has become an inevitable expectation to many older Americans; and about 270,000 hip replacements are performed annually in the U.S., according to the British Medical Journal.[4]
The FDA’s expert panel will examine not only failure rates of hip implants but will evaluate results of metal ion testing, imaging methods used, risk factors among patients, and negative results of the procedures using metal-on-metal hip replacement devices.
[1] “FDA Seeks More Advice on Metal Hip Implants”, Reuters, The Chicago Tribune, Health Section, March 29, 2012; http://www.chicagotribune.com/health/sns-rt-us-usa-fda-hipsbre82s0xu-20120329,0,6310992.story
[2] Op. Cit.
[3] Ibid.
[4] Ibid.
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