Depuy FDA Metal on Metal Hip Devices

FDA Examines Metal Hip Devices

Metal hip replacements implanted in a half-million Americans may be failing earlier than expected, but it could be years before U.S. health regulators have a clear picture of the problem.

The Food and Drug Administration holds a two-day meeting starting Wednesday to scrutinize the safety of metal-on-metal hip implants, following years of patient reports of pain and swelling that sometimes requires removal of the devices, and thousands of patient lawsuits. It is a challenging but familiar predicament for the FDA: reviewing the safety of a device that was expected to be superior, but which may actually be more dangerous than what came before.

For decades, nearly all orthopedic implants were made from plastic or ceramic. But in the last 10 years, some surgeons began to favor implants made with metal stems and sockets. Laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered by surgeons in the U.K. appears to show just the opposite.

In March, British experts at the world’s largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, citing an analysis showing they have to be replaced more often than other implants.

Hip replacements are supposed to last between 10 and 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years. That compared with just 2 percent of people who had ceramic or plastic joints. Both types of devices are prescribed for people suffering hip pain and limited movement due to arthritis or injury.

British regulators now recommend that people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies as the components rub against each other.

The FDA has not made any recommendations of its own for the estimated 500,000 American patients with the devices. FDA scientists say they want to consider all available information before making their recommendations — not just the data from the U.K.

On Wednesday and Thursday, the FDA will ask a panel of experts to recommend the best practices for monitoring patients with the devices. Panelists will consider blood tests, medical imaging and laboratory tests.

Unlike other countries, the U.S. has no national registry to track the performance of implants over time. The FDA received 16,800 negative event reports involving metal hips between 2000 and 2011, but regulators stress that number is not very useful. Many doctors do not report problems to the FDA, and the volume of reports is influenced by news reports on safety issues.

 

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