FDA Warns of Major Problems for C.R. Bard’s Blood Clot IVC Filters

Yesterday, the FDA issued a safety alert for Bard Recovery and Bard G2 filters, inferior vena cava (IVC) filters, manufactured by C.R. Bard. These filters are small devices that are implanted in to the inferior vena cava, the main blood vessel that returns blood from the lower half of the body, to prevent pulmonary embolism. The filters prevent blood clots from reaching the lungs where they would become fatal. Over the last five years, there have been 921 adverse event reports involving IVC filters – 328 cases where the device migrated in the body, 146 cases involving a detachment of a device component, 70 cases involving perforation, and 56 cases where the filter fractured. According to the FDA, many of these events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of a blood clot or pulmonary embolism has subsided.

The biggest concern is that these retrievable filters, which are intended for short-term placement, are not removed after a patient’s risk for a blood clot subsides. Accordingly, the FDA is warning physicians to remove these filters as soon as protection from blood clots is no longer necessary – before they can break inside the patient and cause life-threatening harm.
Researchers in a clinical trial examined the safety of these IVC filters, by following 80 patients who had received a Bard Recovery or Bard G2 filter at York Hospital in York, Pennsylvania between 2004-2009. Seven (7) of the twenty-eight (28) patients who received the Bard Recovery Filter, exactly twenty-five percent (25%), experienced a filter fracture. Six (6) of the fifty-two (52) patients or twelve percent (12%) who received the Bard G2 filter experienced a filter fracture.

If you or someone in your family has been injured by a Bard Recovery Filter or a Bard G2 filter becoming dislodged – please contact the attorneys at Pogust Braslow & Millrood as soon as possible for a free evaluation of your case.