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Complications with Bard G2 and Recovery IVC Filters

Posted on February 28th, 2011 by Robert D. Rowland

The U.S. Food and Drug Administration has issued a safety alert regarding the risk presented by long term use of interior vena cava (IVC) filters. An IVC filter is inserted in the interior vena cava, which is the large vein in the abdomen that returns blood from the lower body to the heart. A filter is used to catch blood clots before they can reach a patient’s heart and lungs. The filter is used for people who are not candidates for clot reduction through medication like blood thinners. Typical filter candidates are people with a history of blood clots in their legs, including those diagnosed with deep vein thrombosis (DVT), trauma victims, recent surgery patients or patients who have immobilizing conditions.

The risks presented by these filters include device migration, embolization (detachment of the device) perforation of the IVC and filter fracture. One particular manufacturer of the IVC filter, Bard Peripheral Vascular, has experienced a very high failure rate. The Bard Recovery Filter has a 25% failure rate while the Bard G2 filter has a reported 12% failure rate. It has been estimated that more than 7,000 Americans are currently walking about with a fractured G2 filter, which could cause rapid heart beat, fluid build up and even sudden death.

The most disturbing aspect of this story is that IVC filters are Class II medical devices. This means that the FDA has put these filters into the same risk category as mercury thermometers. More importantly, this means that these filters were approved without any clinical data showing they were effective or safe! Bard circumvented FDA approval procedures by using a 510(k) clearance for its Recovery (approved in 2002) and G2 (approved in 2005) filters.

Our firm is currently investigating claims involving injuries or potential injuries from these filters. If you or someone you know has received a Bard IVC Filter, we would like to help.