Unsafe High-risk Medical Devices on the Market

Photo: Hip joint

Reparative surgery is required at least four
times as often as traditional hip replacement
surgery; © panthermedia.net/Linda Gilliland

"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 Doctor Rita F. Redberg of the University of Califonia, San Francisco.

Researchers of UCSF reveal 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 scientists 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 are 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."

Hospitals in United States 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 replacement surgeries.

"Some patients' mobility will decline to the point of needing walkers or wheelchairs to get around and other serious events up to and including death can occur from subsequent operations," Redberg said. "And that is just for the metal-on-metal implants."

MEDICA.de; Source: University of California - San Francisco