Most Biliary Stent Injuries Due to Off-Label Use

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Most Biliary Stent Injuries Due to Off-Label Use

January 22nd, 2008 joshua

The New York Times is reporting many of the problems related to biliary stents derive from the alternative use of the medical device.

From 2003 through 2006, doctors have been using the stent, most commonly used to open bile ducts in patients, on clogged arteries in the torso and legs. More than a million patients have received a biliary stent to treat a clogged artery, an off-label use of the device.

Of those million-plus, nearly 600 have reported problems with the stent, but experts in the report believe many more hiccups with the device are not being reported by either doctors or the device maker for fear of lawsuit.

The Times reports there is little testing on the use of biliary stents to treat clogged arteries. The biggest problem for the makers of biliary stents is that their labeled use is not generating enough money – only $36 million last year.

The Food and Drug Administration urged medical professionals last year to not market the use of biliary stents for circulatory system complications and encouraged more study on alternative uses.

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