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For patients suffering from a serious risk of pulmonary emboli or acute deep vein thrombosis, insertion of an inferior vena cava filter to prevent a blood clot from blocking blood flow to the lung can be life-saving. But that doesn't mean IVC filters are without risk.
The Food and Drug Administration has documented hundreds of adverse events regarding IVC filters, due mainly to leaving the devices in long after they are needed. So are IVC filters worth the risk?
In 2010, the FDA warned about the risk of adverse health effects connected with long term IVC filter use. The FDA noted 921 incidents involving IVC filters, from device migration and device fracture to perforation on the IVC itself. In 2014, the FDA updated its initial warnings and recommended that "implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed."
Then, a 2014 Journal of the American Medical Association study revealed that patients with IVC filters and full-dose anticoagulation were twice as likely to suffer a fatal pulmonary embolism as patients on anticoagulation alone. The study's findings did not support the use of IVC filters in patients that could be treated with anticoagulation.
Medical Device Liability
A person injured by a defective medical device could have a claim against the device manufacturer for product liability. A medical device could have a defect in design, manufacturing, or warning, and manufacturers or sellers of defective medical devices can be liable for any injuries caused by the defect.
Over one hundred lawsuits have been filed against two major IVC manufacturers, C.R. Bard and Cook Medical. The suits cover medical issues from additional procedures needed to remove the filters or broken pieces, to fatal organ damage.
If you have an IVC filter or have suffered an injury due to an IVC filter defect, you should consult with an experienced injury attorney near you.