IVC FilterThe Food and Drug Administration (FDA) issued warnings about the safety of retrievable inferior vena cava (IVC) filters as early as 2010 and as recent as July 2015. Hundreds of lawsuits have been filed on behalf of patients who have been harmed by IVC filters.
Medical device companies marketed retrievable IVC filters for patients at risk of developing pulmonary embolism who were not candidates for blood thinning medications. The small cage-like devices are inserted into the main vessel that returns blood from the lower half of the body to the heart (the inferior vena cava) and were designed to filter and trap blood clots allowing them to dissipate in place preventing clots from reaching the lungs.
Warnings from 2010 and 2014 included cautions of device fracture, punctured veins, perforated organs and migration to other areas of the body causing embolism, as well as the inability to remove. The FDA cautioned doctors to remove the IVC filters as soon as risk of blood clot has passed, within the 29th and 54th day after insertion. The warnings in July 2015 were specific to the manufacturer Bard and included marketing a device without approval and failure to report adverse events or device malfunctions to the FDA.
The FDA states on its website that it began receiving hundreds of reports of adverse events from retrievable IVC filters as early as 2005. According to the FDA, filter fracture, perforations, embolism, lower limb deep vein thrombosis (DVT) and migration “may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE [pulmonary embolism] has subsided.” At least one medical study has reported that because less than ten percent of retrievable filters are successfully removed, most are becoming permanent filters despite the risks of leaving the filters in place longterm.
Martin & Jones attorneys are investigating potential claims on behalf of patients harmed by IVC filters. If you or a family member have been harmed by an IVC filter, please call our attorneys at 800-662-1234 for a free consultation or contact us online.