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 scope 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 after years of patient reports of pain and swelling that sometimes require removal of the devices. 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 previous solutions.
For decades nearly all orthopedic implants were made from plastic or ceramic. But in the past 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 Britain appear 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 that found they have to be replaced more often than other implants. Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after fewer than five years. That compared with just 2 percent of people who had ceramic or plastic joints.
British regulators also 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.
U.S. regulators have not made any similar recommendations for the estimated 500,000 American patients who have received the devices.
FDA scientists say they want to consider all available information before making their recommendations — not just the data from Britain.
“Why look at a single registry when there’s data from around the world?” said Dr. William Maisel, FDA’s chief scientist for medical devices, in an interview. “This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made.”
Dr. Maisel said the FDA is working to combine data from foreign countries and the U.S. to determine which groups of patients and implants are most problematic. 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.
But some U.S. orthopedic specialists say they have already reached their own conclusions about metal hips.
“In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective,” said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.
The FDA’s deliberative approach to handling the hip implant issue is in some ways a necessity. Unlike other countries, the U.S. has no national registry to track the performance of implants over time.
The FDA has received 16,800 “event reports” about 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.