Following up on the experience and decisions of the United Kingdom, the FDA seems to agree that they are dangerous, and is poised to recommend new guidelines on medical monitoring of the 500,000+ Americans with metal-on-metal hip implants. These metal hip implants, once touted for safety and efficacy by the manufacturers, are now known to cause early breakdown, to release metal particles into the body and bloodstream, and to have an overwhelmingly high failure rate (one study suggests 6.2% over five years). The FDA has received 17,000 reports of metal hip problems, and in 2009 one-third of all total hip replacements were metal in the U.S.
Sadly, the FDA probably won’t issue a metal hip recall, leaving the medical device to die a natural death as word of the dangers permeates the medical community, and as the manufacturers put those products to pasture. Any actual recall at this point would be more philosophical–most orthopedic surgeons are well aware of the dangers, and it is unlikely that many of them are implanting these devices. Manufacturers affected by these studies include Johnson & Johnson, which manufactures metal hip implants through DePuy Orthopaedics.
Monitoring patients is important–not only can the implants fail, requiring painful revision surgeries, but the metal particles can cause metallosis, which is poisoning of the body. This metal poisoning may be linked to the development of tumors, inflammation, destroyed tissue and even necrosis. Blood tests may be necessary to determine whether a patient has hip-implant caused metallosis.
If you have been injured by a Johnson & Johnson metal hip implant, contact our product liability lawyers at 443.850.4426, or online for a free consultation. We can help you determine what company manufactured your implant, and whether it is the cause of your injuries.