Saturday, January 26, 2013

Evidence Supporting Ban of Metal-on-Metal Hips Grows, as FDA Issues New Guidelines

Public Health Watchdog

Overview: Metal-on-metal hip implants have been a growing health concern since 2010, when Johnson & Johnson recalled DePuy ASR hip implants due to a high failure rate. Since then, researchers have found that the high revision rate and the release of metals is a problem common to all metal-on-metal hip implants. The evidence against metal-on-metal is compelling, so much so in fact that some experts feel that the devices should no longer be sold. Recent information released by the U.S. Food and Drug Administration (FDA) only lends further support to this notion.
  • The FDA has issued new guidelines for patients with metal-on-metal hip implants
  • Metal-on-metal hip implants are known to release metal ions and cause complications such as soft tissue reactions
  • In March, the Lancet published a study showing that metal hip implants fail more often compared to other types of hip replacements; the authors call for an end to their use
Product & Manufacturer

Johnson & Johnson/ DePuy OrthopaedicsBiometSmith NephewZimmerWright Medical Technology
ASR (recalled)M2a MagnumOxiniumDuromCONSERVE Hip Systems
Pinnacle Birmingham BHR Profemur

Side Effects & Complications
  • High failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Pain at the implant, sometimes spreading to the groin and back
  • Osteolysis (bone loss)
  • Fluid collections/solid masses around the hip joint

Some Calling for a Ban on Metal-on-Metal Hips
Recently, the FDA proposed stricter regulations for metal-on-metal hip implants that would force manufacturers to conduct safety test before selling them. Currently, the implants go through 510(k), a route that approves devices without safety tests so long as they are “substantially equivalent” to previous devices. Some experts, however, feel that metal-on-metal hip implants should be sold at all. In fact, these sentiments were expressed among experts last summer at an FDA advisory panel meeting convened to discuss the implants. In March 2012, the Lancet published a study showing that metal-on-metal hip implants fail at a rate of 6 percent in five years compared to 2 percent for ceramic and plastic devices

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