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C.R. Bard is one of the nation’s largest medical device manufacturers, but the company is now facing lawsuits over many of its inferior vena cava filters (IVC filters), including the G2 Express and G2X IVC filters.
IVC filters are umbrella-shaped medical devices with legs intended to prevent blood clots from moving from the lower extremities of the body into the heart or lungs. These devices were only designed to be implanted temporarily, but complications from the device have made removal impossible for some patients.
In 2008, Bard received approval for the G2 Express and G2X IVC filters, intended to replace earlier filters that were prone to migration, fracture, and perforation. However, the G2 Express and G2X filters have shown to be just as dangerous as their predecessors.
After hundreds of reports of complications associated with IVC filters, the FDA released a safety statement in August 2010 advising that these temporary medical devices should be removed immediately after the threat of blood clots has subsided. Five years later, the FDA followed up with a clarification on its recommendation, specifying that IVC filters be removed within 29-54 days after implantation because the risk of device failure greatly increases with time.
In 2015, the FDA sent Bard a warning letter that stated the company failed to establish and maintain procedures for reviewing and evaluating complaints regarding several of its filters, including the G2X filter.
The FDA warnings came too late for thousands of patients who had already suffered adverse events from the implantation of the G2 Express and G2X IVC filters. Bard had a responsibility to inform patients of any risks associated with their IVC filters, but the medical device manufacturer failed to do so.
If you or someone you love suffered complications or death from a G2 Express or G2X IVC Filter, you may be unsure what to do next, but you should know that you are not alone. The defective medical device attorneys at Raizner Slania have extensive experience investigating legal claims related to IVC Filters and we can review your potential claim. Contact an IVC filter lawyer at Raizner Slania today for a free and confidential consultation about your concerns.