Study looks at off-label use of bili...(a closer look. The authors determine...),Health

The authors determined that biliary stent implants among PVD patients increased 21.4 percent, from 227,145 in 2003 to 275,795 in 2006; approximately 1 million biliary stents were implanted off-label in the peripheral vasculature in total. Additionally, using the publicly available MAUDE (Manufacturer and User Facility Device Experience) database -- a compilation of serious adverse events and malfunctions associated with medical devices that have been reported to the FDA -- the authors reviewed all reports involving biliary stents between 2003 and 2006. During this time period, 1,036 confirmed biliary-stent malfunctions were reported, 81.2 percent of which occurred during off-label use. Malfunctions were most often due to premature stent dislodgement, premature deployment or failure of the catheter/delivery system.

In addition, notes Maisel, 87.9 percent of the 561 adverse events associated with biliary stent use during the study period occurred during off-label use, with retained product, additional catheter procedures or surgery being the most common adverse events. Thirteen patient deaths were reported during off-label use. Like the malfunctions, we found that many more adverse events occurring during the use of biliary stents in peripheral blood vessels than when they were used in a biliary or gastrointestinal location, he adds.

Our analysis raises several important issues, says Maisel. The frequent off-label use of biliary stents for treatment of peripheral vascular disease implies an unmet clinical need in the management of these patients. With the aging of the U.S. population, the number of patients with vascular disease can be expected to grow. Efforts should be directed at improving the evaluation of devices used to treat peripheral vascular disease in order to better identify those patients that will most benefit from this promising therapy.

'/>"/>