August 9th, 2010

FDA Issues Warning About Inferior Vena Cava Filters

The FDA has issued an initial communication informing health professionals that it is evaluating reports of adverse events with the long-term use of inferior vena cava (IVC) filters. The FDA “recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.”

Simultaneous with the FDA announcement, the Archives of Internal Medicine published online a paper by William Nicholson and colleagues reporting a high rate of fracture and embolization, “with potentially life-threatening sequelae,” in the Bard Recovery and Bard G2 filters. In an accompanying commentary, Rita Redberg writes that “remarkably, these filters, which are placed inside the IVC, were considered Class II by the FDA—the same risk category of mercury thermometers—and received approval without any clinical data of safety and effectiveness identified in their 510(k) clearances.” She proposes that “high-risk devices must go through the appropriate approval process adequately supported by reliable data. Manufacturers should not be routinely permitted to circumvent the PMA process for high-risk devices by means of 510(k) clearances.”

Comments are closed.