June 25, 2012 — The U.S. Food and Drug Administration (FDA) has received 16,800 reports of adverse events associated with metal-on-metal hip implants from 2000-2011. Many of the reports were for the DePuy ASR hip implant, which was recalled after being linked to a 12% failure rate. Johnson & Johnson faces at least 6,000 lawsuits from people injured by the DePuy devices. There is also growing worldwide scrutiny over all metal-on-metal hip implants, after several studies published in 2012 found the devices linked to high rates of side effects compared to plastic or ceramic devices — including more incidents of revision surgery, failure, corrosion, metal poisoning (metallosis), pseudotumors, and more.
Revision surgery was the most commonly-reported adverse event for metal-on-metal hip implants, with 14,131 revision surgeries. Revision surgery involves removing, replacing, or fixing a defective hip implant. It is often very painful, and can cause chronic pain afterward. The FDA also received nearly 9,000 reports of pain after revision surgery.
When comparing metal-on-metal hip implants to plastic or ceramic devices, FDA staff said that the revision rate “is likely not lower.” Furthermore, there are two studies suggesting the revision rate is significantly higher. One study from England and Wales found that the five-year revision rate is 6.2% — triple the rate for plastic or ceramic devices.
The FDA will be meeting on June 27-28 to discuss the safety of metal-on-metal devices. They may recommend that patients undergo regular imaging and blood tests to check for signs of metal poisoning or early device failure. The FDA is also considering whether to require manufacturers of the devices to conduct more thorough safety studies.
Use of metal-on-metal hip implants peaked in 2006-2007, when about 30% of all hip implants were this design, but use has dropped to about 10% in recent years due to safety concerns. At the height of their popularity, manufacturers claimed that the long-lasting design was ideal for younger, healthier, more active patients. Instead, researchers have recently linked the devices to higher risks of side effects than plastic or ceramic designs. The problem is that the metal femoral ball and metal cup grind together, and can shed ionized particles of chromium and cobalt into the body. This could cause tissue damage or cause device failure.
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