The FDA Releases a Public Health Statement on Metal-on-Metal Hip Implants

RED BANK, N.J., Feb. 17, 2011 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) posted a public health communication this week about metal-on-metal hip components to notify the public of the concerns on the use of metal-on-metal hip components used in total hip arthroplasty (THA). The information on the F.D.A. website, notifies people of […]

RED BANK, N.J., Feb. 17, 2011 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) posted a public health communication this week about metal-on-metal hip components to notify the public of the concerns on the use of metal-on-metal hip components used in total hip arthroplasty (THA).

The information on the F.D.A. website, notifies people of the symptoms which include “hip/groin pain, local swelling, numbness or changes in your ability to walk.”

According to the site, “Metal-on-metal hip implants, like other types of hip implants, are known to have adverse events including infection and joint dislocation. There are some case reports of the metal particles causing a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant and failure of the device, as well as some of the symptoms described above. In addition, some metal ions from the implant may enter into the bloodstream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart and thyroid gland.”

The statement comes months after DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a recall on their ASR line of hip replacement devices which were metal-on-metal hip components.  After hundreds of patients complained to the F.D.A., stemming back to 2008, the F.D.A. finally released a statement to the public.

Anyone who has received a hip replacement in the U.S. after July 2003 may have received a DePuy ASR device that contains defects.

 

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