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FDA Probing Safety of Metal-on-Metal Hip Implants
Date:6/27/2012

By Steven Reinberg
HealthDay Reporter

TUESDAY, June 26 (HealthDay News) -- While thousands of Americans have benefited from hip replacements over the years, problems with metal-on-metal implants can lead to troubles requiring surgery to replace defective devices, experts say.

Specifically, experts say, tiny fragments of metal can shear off from these joints, causing chronic pain or infection and raising levels of metals in the bloodstream. Experts estimate that more than 500,000 Americans have received a metal-on-metal hip joint, mostly between 2003 and 2010.

Worry over the failure rate of the implants, and the speed at which they were initially approved for the U.S. market, has led to a special two-day session, beginning Wednesday, by experts at the U.S. Food and Drug Administration.

"Data from recent studies and from FDA's own review show some patients experiencing complications, including the need for additional surgeries, which could be attributed to metal-on-metal hip implant devices," said FDA spokeswoman Michelle Bolek.

Since 1999, almost 17,000 problems with these devices have been reported to the FDA. Of these, more than 12,000 were reported last year alone.

According to the agency, the problems with metal-on-metal implants are about the same as those seen with polyethylene and ceramic implants, except for the specific risks caused by the metal itself.

But others say that when it comes to complications, metal-on-metal implants are in a class of their own. Writing earlier this month in the New England Journal of Medicine, Dr. Joshua Rising of the Pew Charitable Trusts, and colleagues said that "there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials; indeed, one type of metal-on-metal hip has a failure rate of nearly 50 percent at 6 years."

Responding to these concerns, the FDA panel is considering the risks an
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