June 26, 2012 — Tomorrow, a U.S. Food and Drug Administration (FDA) committee will convene to discuss the future of metal-on-metal hip implants. Around half a million Americans are currently implanted with the devices. Though the design’s popularity has decreased in recent years amid several recalls and negative scientific studies, the devices continue to be implanted. Evidence is growing that the device could actually be more dangerous than plastic or ceramic devices.
If the FDA decides to require manufacturers to conduct new safety studies, answers could be years away. A well-controlled safety study might take eight years to fully assess the risks and benefits of the metal-on-metal design.
Most other countries have systems for monitoring people with new medical devices, but the U.S. does not. The FDA is currently attempting to gather data from these international sources to determine whether certain patients have a higher risk of complications.
The FDA will also likely discuss whether to recommend routing blood tests, imaging, or laboratory tests for people who currently have the metal-on-metal hip implants. British health authorities have already recommended routing blood tests to check for elevated metal ion levels in the bloodstream. Several British researchers are calling for the devices to be banned, after their study linked the metal-on-metal design to a tripled risk of failure compared to plastic or ceramic devices. These researchers found that 6% of metal-on-metal hip implants failed within five years.
About a decade ago, metal-on-metal hip implants were fast-tracked through the FDA approval process through the 510(k) loophole. This allows “similar” medical devices to be approved without conducting any scientific safety studies. The manufacturers claimed that the metal-on-metal design was “similar” to plastic and ceramic hip replacements that had been on the market since the 1950s. They claimed that the metal design would last longer and be more durable, making it the ideal choice for younger, physically active hip implant recipients.
After more than 500,00 Americans were implanted with metal-on-metal hip implants, independent researchers began finding that the devices were linked to more side effects than plastic or ceramic devices, and they tended to fail earlier. The grinding metal parts could potentially shed toxic metal particles of chromium and cobalt into the patient’s body, causing metal poisoning (metallosis), non-cancerous pseudotumors, tissue damage, pain, swelling, and other serious side effects.
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