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A call to prevent unsafe high-risk medical devices from reaching the marketplace
Date:1/22/2013

Technological advancements in medicine have allowed patients suffering from musculoskeletal conditions such as hip and knee pain to regain mobility and live relatively pain-free. But some "high risk" surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.

"This could be potentially very dangerous. Many Americans patients and even physicians - are not aware of how many devices in this country are on the market without having clinical data of safety and effectiveness," said Rita F Redberg, MD, MSc, professor of medicine and director of the UCSF Women's Cardiovascular Services.

UCSF and the Australian Joint Registry published this month a perspective in the New England Journal of Medicine that reveals the complex history of how metal-on-metal hip implants reached the marketplace. The implants are categorized by the FDA as high-risk devices, yet have been allowed into the marketplace without first testing them. They failed at a dangerously high rate, often requiring reparative surgery at least four times as often as traditional hip replacement surgery.

The perspective's authors are calling for changes in how the FDA approves metal-on-metal hip replacement devices and other high-risk devices for the marketplace.

"If those hip implants are recalled, besides the problem of having to remove them because they're very painful, they can release chromium ions into the blood stream which pose an unknown risk," Redberg said. "Patients would also undergo significant disability having a second, third or fourth hip operation."

U.S. hospitals perform 48 million medical procedures each year, according to the U.S. Centers for Disease Control and Prevention. Of that number, roughly 676,000 patients undergo total knee replacement surgeries and 327,000 undergo total hip replacemen
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Contact: Leland Kim
leland.kim@ucsf.edu
415-502-6397
University of California - San Francisco
Source:Eurekalert  

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