FDA, companies to study metal-on-metal implant effects
  • Mon, 07/02/2012 - 4:06pm

The FDA recently asked a panel of experts to recommend guidelines for monitoring over 500,000 patients with metal-on-metal hip replacements.

According to the Associated Press, “The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.”

Thursday, the panel suggested that all metal-on-metal hip replacement patients should undergo yearly X-rays. Those patients who are suffering pain should also undergo blood tests for metallosis, or blood poisoning, since metal-on-metal hip replacements have been known to shed particles in the blood stream.

These recommendations are more lax than other countries, including the U.K., who already advised that all patients get yearly blood tests.

The AP reports that arthritis or injury sends nearly 400,000 Americans to the hospital for hip replacement, or arthroplasty, each year. In 2008, metal-on-metal systems accounted for 40 percent of those operations. By 2010, that number declined 13 percent thanks to recalls like Johnson & Johnson’s recall of 93,000 defective devices.

The FDA has not requested metal-on-metal hip implants be removed from the market. Instead, it hopes that monitoring patients will determine why women and the obese are more prone to problems with them.

“With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market,” according to the AP.

Some are critical of this decision.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said National Research Center for Women & Families president Diana Zuckerman during the panel’s open forum session. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."

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About the Contributor

Kaitlin Gill
Cleveland
I report on news regarding product safety concerns for individuals and families.

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