Metal-on-Metal hip implant
FDA outlines concerns about metal-on-metal hip implant systems
The FDA issued a special report outlining its concerns about metal-on-metal hip implant systems, which lists “unique risks” associated with metal-on-metal hip implants, in addition to what the FDA considers general risks of all hip implant systems. Metal-on-metal hip implants feature a metal ball and socket construction at the hip joint.
According to the FDA report, “Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream.”
As a result of this particle release, the FDA notes some patients may experience adverse events, either at the hip implant site, such as pain, swelling and trouble walking, or general illnesses that may include effects on the heart, nervous system and thyroid gland.
In May 2011 the FDA contacted Johnson & Johnson, as well as 20 other medical device manufacturers, asking them to study the levels of certain metals in patients who have received metal-on-metal implants.
The request followed an August 2010 recall issued by Johnson & Johnson’s DePuy Orthopaedics subsidiary of its DePuy ASR Acetabular System, a metal-on-metal hip system. The recall affected about 93,000 people worldwide.
Sources:
FDA
Bloomberg News