May 15, 2011

FDA Orders More Data on Metal Hip Implants

Metal-on-metal hip implants are used in about one-third of the 250,000 hip replacement surgeries performed each year according to a recent New York Times report.  In early May 2011, the FDA issued 145 orders to 21 manufacturers of metal-on-metal hip implants ordering post-market surveillance studies due to serious safety concerns.   The concerns include higher-than-normal revision surgery rates, increased risk of tissue necrosis surrounding the implants, and dangerous increased levels of metal ion levels (cobalt, chromium) in the bloodstream of persons implanted with metal-on-metal hip implants.  Metallic debris generated from metal-on-metal hip implants can cause damage to the bone and surrounding tissue which can cause the implant to loosen and lead to severe pain.  A recent editorial in a medical journal for orthopedic surgeons, The Journal of Arthroplasty, urged doctors to use the metal-on-metal devices only with “great caution, if at all.”

Click here to read FDA's Information for Patients with Metal Hip Implants

Click here to read about the May 2011 FDA order to manufacturers

Click here to read more about metal-on-metal hip implants


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