May 8, 2012 — Health Canada, the largest federal health advocacy agency in Canada, is warning doctors and patients about the risks of metal-on-metal hip implants. After several metal hip implants were recalled last year, the safety of these devices has been under renewed scrutiny. Health Canada is warning the public to be aware of the symptoms of trouble with the implants, so they can seek immediate treatment.
The problem with the metal-on-metal hip implant design is that the metal parts of the device grind together whenever a person moves, and over time, this can cause tiny particles of metal to leak into the body. A recent study found that the metal-on-metal hip replacements corroded more quickly and severely compared to metal-on-plastic devices. Other studies have also found significantly higher rates of failure and complications, compared with metal-on-plastic or ceramic designs.
Health Canada estimates that approximately 10% of all hip implant recipients have received a metal-on-metal device. The agency is now advising that patients who receive these devices should be monitored for at least five years following surgery.
The patients should also be on the lookout for the first symptoms of a complication: pain and swelling in the groin, hip, leg, or joint area. Patients should also seek medical attention if they notice a change in their gait, a limp, decreased walking ability, or a limited range of motion. These symptoms can be the first sign that the device is damaging tissues in the hip area, which increases the risk that the device will fail.
Health Canada is advising patients who have side effects with the device to undergo blood serum tests to check for elevated levels of chromium or cobalt in the bloodstream. When the metal-on-metal parts grind together, these metal ions can leach into nearby tissues and circulate in the bloodstream. In severe cases, this can lead to metallosis, metal poisoning, or cobalt poisoning.
Because metal-on-metal hip implants do not have a long history of use, there is little information about the long-term side effects of this device. The manufacturers of these products gained FDA approval in the United States because they based the design on existing implants that had already gained FDA approval. The devices were marketed toward younger, healthier, more active hip implant recipients. By the time experts became aware that the metal-on-metal design might actually have higher risks of side effects compared to other hip implants, hundreds of thousands of people had already been implanted with the devices.
Health Canada is warning that the people who seem most likely to be affected are women, physically active patients, obese patients, and those who received hip implants in both hips.
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