September 28, 2012 — Researchers have good news for people who have been implanted with a metal-on-metal hip implant.
An early study has found no increased risk of cancer seven years after implantation. The researchers cautioned that more studies need to be conducted, because some cancers take longer than seven years to develop.
The risk of cancer has been a serious concern, because metal-on-metal hip implants are known to shed toxic metal debris into a patient’s body. Some of these metal ions are highly soluble, and travel in the bloodstream throughout the body.
The researchers who conducted the study analyzed data from the United Kingdom National Joint Registry (NJR), a database of joint implants, performance of the implant, and patient outcomes. Some early epidemiological studies suggested that metal-on-metal hip implants could increase the risk of melanoma, prostate, and kidney cancers.
The NJR found no evidence of an increased risk of cancer, but they said the devices should continue to be tracked. The agency said:
“Due to the age of the NJR we could only assess the risk for the first seven years after hip replacement and are happy to report that we could not identify an increased risk of developing cancer. We must, however, point out that many cancers have prolonged latency after initial exposure to carcinogens and thus long-term follow up is needed to provide a definitive answer.”
The United States currently lacks an efficient tracking mechanism for medical devices. The U.S. Food and Drug Administration (FDA) requires device manufacturers to report injury reports, and the FDA also has its own injury reporting database. But because the database is voluntary, many injuries are never reported, and experts estimate that the FDA only catches 10% of the actual adverse events that occur.
The FDA has asked hip implant manufacturers to conduct additional safety studies to get a better idea how often they fail and the risk of side effects. These studies will not be complete for several years.
Several types of metal-on-metal hip implants have been recalled after researchers found high rates of corrosion, metal debris, and failure. DePuy has recalled the ASR hip implant, and Stryker recently recalled the ABG II and Rejuvenate hip implants. The metal-on-metal “ball and socket” design could shed particles of chromium and cobalt into the body, which can cause inflammation, tissue damage, bone loss, growth of soft-tissue pseudo-tumors, and other complications that may require revision surgery. Since these recalls, the popularity of metal-on-metal hip implants has declined dramatically, in favor of plastic and ceramic hip implants.
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