Inferior Vena Cava (IVC) filters designed to prevent dangerous blood clots may break off and travel through the body, severely damaging the heart and lungs.
Inferior Vena Cava Medical Device
Inferior Vena Cava (IVC) filters are implanted in the heart and intended to prevent blood clots from forming, preventing stroke and other dangerous conditions. However, several studies have shown that these filters can break off into shards which can pose a deadly threat to the same patient they were supposed to protect.
IVC Filter Device Defects
IVC filters, including the Bard Recovery filter, the Bard G2 filter, and the Bard G2 Express filter which have been implanted in the inferior vena cava region of the heart during surgery have not maintained their integrity over time. According to a study by the New England Society for Vascular Surgery, 31% of most IVC filters fractured over time. Another study undertaken at York Hospital found that 25% of its patient sample suffered IVC filter splintering; most of these splinters traveled to an end organ, such as the heart, lungs, or hepatic vein.
Originally brought into use during the 1960s, these devices were not designed for permanent placement. They would be retrieved once the patient was deemed to be out of danger of blood clot or pulmonary embolism. At some point, however, the manufacturer, Bard, allegedly petitioned for the device to be approved as a permanent implant.
The FDA issued a warning letter to C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively referred to as "Bard") for eight violations of federal law relating to the safety of its Inferior Vena Cava (IVC) filter product line. Among the number of violations, Bard illegally sold adulterated and misbranded IVC Filters and failing to report complications and adverse events. The letter further cites Bard with violations for withholding critical information from the FDA and public. These violations concern the following products:
- Recovery Filter
- G2 Filter
- G2X Filter
- G2 Express Filter
- Meridian Filter
- Denali Filter
Several other manufacturers make IVC filters with similar risks, including Bard, Cook, Argon, and B. Braun.
PA & NJ Unsafe Medical Device Attorneys
If you or someone you love has suffered as a result of an Inferior Vena Cava filter, please contact our experienced mass tort legal team for a free consultation at 1-215-462-3330 or by using our online contact form.