The Food and Drug Administration recently announced it would be meeting with a panel of orthopedic experts to more fully explore the growing body of evidence showing that metal-on-metal hip devices have a higher failure rate than other similar devices, typically made of plastic or ceramic.
The FDA’s chief scientist for medical devices, William Maisel, has said, “The FDA has been aware of some of these problems for three years and has made recommendations in the past, but I think what you’ll see coming out of these meetings are more specific recommendations for follow-up care.” Dr. Maisel was quick to say that the agency would not announcing any new recommendations right away, but would instead need time to fully investigate its options.
The problem is a significant one for Americans given that some 285,000 hip replacement surgeries are performed each year. Nearly half a million people in the United States have all metal hip implant devices. The reason the devices were used in the first place is because it was thought that metal-on-metal hip implants lasted longer than those made from other materials. The all-metal devices were given primarily to younger, more active patients. The most recent date from 2006 suggests that a whopping 32% of all hip replacement surgeries involved metal-on-metal devices.
This view of the all-metal devices has shifted in recent years as doctors have reported increasing problems with the devices. Metal debris can break off when the pieces rub against each other. The debris can then spread and cause severe pain and even tissue damage. The most extreme reactions involve pieces that get in the bloodstream and cause problems in the heart, kidneys, nerves and even thyroids. Such splintering also frequently necessitates further revision surgeries, a painful and expensive process. Though there are certainly some people that experience no problems with the devices, there is data that shows that all-metal devices require revision surgeries three to four times more often than devices made of other material.
Some say that the devices have lost their value. Initially they were used because the plastic and ceramic versions were breaking down too quickly. Scientists point out that medical plastic has improved substantially in recent years and is plenty strong enough to last without degradation.
Dr. Maisel says that there are currently no plans to stop doctors from implanting the devices in the first place. “Doctors can still use them,” but down the road there could be changes. For now, the FDA is focused on improving care for patients who have already had the devices implanted.
The FDA is considering a variety of recommendations for patients including blood tests to test for metal levels and imaging scans of the joint and surround tissues. One problem with all these recommendations is that they happen after the fact. Even excellent post-op care often does not show symptoms until after the damage has been done.
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