FDA Asks Hip Makers Johnson & Johnson, Zimmer for Patient Data on Metal Levels in Blood

The U.S. Food and Drug Administration asked Johnson & Johnson (JNJ), which is already facing more than 1,000 lawsuits over hip replacements, to study whether its implants raise the level of metal in patients’ blood to dangerous levels.

The FDA on May 6 sent the request to J&J and 20 other device makers, including Biomet Inc., Stryker Corp. (SYK) and Zimmer Holdings Inc. (ZMH), asking them to conduct so-called postmarket surveillance of the hip replacements.

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

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