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FDA Requests J&J, Zimmer To Study Metal Levels In Hip Implant Patients

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A request by the FDA has been issued to 21 device makers of metal-on-metal hip implants, including Johnson & Johnson, Stryker Corp. and Zimmer Holdings Inc., asking for the companies to initiate studies that gauge the level of cobalt and chromium in patients’ blood for eight years following implanting a device.

FDA spokeswoman Karen Riley said in an email that the agency “is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

The FDA has created a website with information about metal on metal hip implants and cites reports that  “a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland. ”

The request also said that an increase in pain, tissue damage and revision surgery might be related to a levels of metal in the blood.

The ASR hip implant, which was recalled by Johnson & Johnson’s  DePuy Orthopaedics unit last years due to a high early failure rate, was a metal-on-metal hip implant. disclaimer: This article: FDA Requests J&J, Zimmer To Study Metal Levels In Hip Implant Patients was posted on Wednesday, May 11th, 2011 at 7:03 pm at and is filed under Medical Device Lawsuits.

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