US Food and Drug Administration and Off-Label Use of Metal Expandable Biliary Stents within the Peripheral Vasculature—Update

Abstract

In the past, some medical device manufacturers were obtaining marketing clearance for metallic stents indicated for biliary use; however, these devices were being promoted and used in the peripheral vasculature, creating a patient safety problem. The US Food and Drug Administration (FDA) acted in 2006–2008 to help decrease off-label use of metal expandable biliary stents. This communication describes the early and continued efforts of the FDA to address safety concerns relating to off-label use of metal expandable biliary stents and the status of this issue. An analysis of Medical Device Reporting (MDR) data from January 1, 2005, through December 31, 2018, was conducted to determine the percentage of MDR reports associated with off-label use. The percentage was approximately 90% in 2001–2006 and decreased to < 40% a decade later. In reports associated with off-label use, these devices are still associated with death and serious injury; however, the percentage of injury MDR reports associated with off-label device use has trended down since 2007. Whereas 92%–95% of reported serious injuries were with off-label placement in 2005–2007, 43%–79% of injuries were with off-label placement in 2008–2018. Collaborative efforts among the FDA, manufacturers, and physicians appear to have made progress in addressing this issue.