Off-Label Use of Biliary Stents

An analysis performed by the Medical Device Safety Institute and published in the January 2008 American Journal of Therapeutics notes that in four years alone, from 2003 to 2006, more than one million patients suffering from clogged arteries and veins in their legs and torsos received biliary stents that had not been tested for that use. 

The FDA had approved these devices to help drain digestive fluids from the bile ducts in cancer patients.  However, the biliary stents have been used off-label to help alleviate the symptoms of clogged arteries and veins.  The FDA has received hundreds of complaints regarding problems with the device, nearly 90% during use in this off-label manner.  Extensive off-label use of a medical device can undermine the regulatory process and unnecessarily expose patients to untested products.