FDA Panel Sees Little Reason to Use Metal-on-Metal Hip Implants

June 29, 2012 — An advisory panel to the U.S. Food and Drug Administration (FDA) met earlier this week to discuss possible recommendations regarding metal-on-metal hip implants. Although they did not raise the issue of recalling the devices, experts saw little reason to continue using the device instead of ceramic or plastic implants. Recent studies from Europe have linked metal-on-metal hip implants to corrosion, metal toxicity, premature failure, and other serious side effects.

The metal-on-metal design was developed about 10 years ago, as an alternative to plastic or ceramic designs that have been in use for more than 50 years. Although the metal hips were initially marketed as a longer-lasting, more durable hip replacement, recent studies have found just the opposite — approximately 6% of metal-on-metal hip implants fail within the first five years, compared to less than 2% of ceramic or plastic devices.

The FDA advisory panel convened in response to nearly 17,000 adverse event reports, several critical studies published in 2012, and regulatory action from health officials in the U.K.

The chairman of the 18-member panel, Dr. William Rohr of Mendocino Coast District Hospital, said “I do not use metal-on-metal hips, and I can see no reason to do so.”

The experts agreed that people who experience problems with their metal-on-metal hip implant (such as pain, swelling, changes in their gait, etc.) should undergo X-rays and blood tests to check for elevated chromium or cobalt levels. Some experts were concerned that these tests are not always accurate, can be difficult to interpret, and there are no commercially available diagnostic kits for chromium or cobalt. Furthermore, the panel recommended annual X-rays for all people who have metal-on-metal hip implants.

The group’s recommendations fall short of those issued by health regulators in the U.K. earlier this year, who advised all people with metal-on-metal hip implants to undergo yearly blood tests and X-rays.

The FDA has previously suggested that they need more time to decide whether they should make any new recommendations. There are approximately 100 different types of metal-on-metal hip implants made by 31 different manufacturers. Furthermore, some research suggests that certain groups of people may have higher risks than others — women and people who are overweight, for example. Earlier this year, the FDA asked the manufacturers to conduct additional safety studies, but the results of those studies could be nearly a decade away.

Most metal-on-metal hip implants were approved via the FDA’s 510(k) approval process, which allows manufacturers of new devices to avoid conducting safety studies if their device is “substantially similar” to devices that the FDA has already approved. Manufacturers and the FDA agreed that metal-on-metal hip implants were “similar” enough to plastic and ceramic devices that no safety studies were required.

It was only after half a million Americans were implanted with the devices that researchers began warning about the serious risks of metal-on-metal hip implants. The metal parts grind together, and they can shed toxic particles of chromium and cobalt into the bloodstream. This increases the risk of pain, swelling, dislocation of the hip joint, and damage to tissues, muscle, and bone. One study found an increased risk of pseudotumors, which are non-cancerous growths of soft tissue. Another study found that the implants corrode more quickly and severely than plastic or ceramic devices. Yet another study found that metal-on-metal hip implants are three times more likely to fail within their first five years compared to plastic or ceramic devices.

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