January 18, 2013 — The U.S. Food and Drug Administration (FDA) has published a new Safety Communication to warn that metal-on-metal hip implants are associated with soft-tissue damage and toxic metal poisoning. The agency has also submitted a proposal that would require manufacturers to submit a pre-market approval application (PMA). Currently, manufacturers of metal-on-metal hip implants are allowed to submit a 510(k) application whenever they introduce a new implant, which allows them to avoid conducting new safety studies. In the wake of several high-profile recalls, thousands of injuries, and a growing litigation, many have called on the FDA to regulate these device more strictly.
Hip deterioration is common ailment that occurs with age. It can lead to pain, stiffness, or difficulty walking, which is why many people choose to undergo hip replacement or hip resurfacing procedures. One type of implant is a metal-on-metal design, in which the “ball and socket” are both made from metal.
According to the FDA:
“Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants. … Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.”
Metal-on-metal hip implants have the added risk of metallosis. As the metal parts grind together, toxic particles of cobalt and chromium can shed into tissues around the hip. These can inflame nearby tissues and cause bone loss, tissue death, and failure of the hip implant.
In the Safety Communication, the FDA recommended that doctors should discuss the potential risks and benefits of a metal-on-metal hip implant with their patient. According to recent studies, the 5-year failure rate of these devices is significantly higher than for plastic and ceramic designs, but the metal-on-metal design does not provide significant advantages. It was originally intended as a longer-lasting implant for younger, more active patients. However, recent studies have found that highly active patients are more likely to suffer complications with a metal-on-metal implant.
Another risk is that metal debris can leak into a patient’s bloodstream and accumulate in the body, with unknown long-term complications. Currently, the FDA does not recommend routine blood-testing unless the patient is having problems with their hip implant. Several other countries, including Australia and the United Kingdom, do recommend routine blood tests.
The FDA provided a list of patients who would be considered “high-risk” for complications of a metal-on-metal hip implant:
- Patients with bilateral implants
- Patients with resurfacing systems with small femoral heads (44mm or smaller)
- Female patients
- Patients receiving high doses of corticosteroids
- Patients with evidence of renal insufficiency
- Patients with suppressed immune systems
- Patients with suboptimal alignment of device components
- Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
- Patients who are severely overweight
- Patients with high levels of physical activity.
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