Bard Inferior Vena Cava (IVC) Filters

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Bard IVC Filter, FDA Warning

FDA Warnings about Problems with IVC Filters

In August 2010, the U.S. Food and Drug Administration (FDA) issued a statement that it had received 921 adverse event reports involving IVC (inferior vena cava) filters. The inferior vena cava is the main vessel that carries blood from the legs and rest of the lower body back to the heart.

The filters are cage-like devices that are surgically implanted into the IVC to trap blood clots traveling from the lower body and keep them from flowing into the lungs.

Some of the adverse events reports included:

328 cases in which the filters migrated to other parts of the body (most often to the heart)
146 cases of what was called embolization, where parts of the device came off
70 patients in whom the filters perforated the IVC
56 cases when the filters fractured

The devices are used in patients who cannot take anticoagulants to prevent blood clots or in patients in whom anticoagulants are ineffective.

The FDA's main concern was alerting doctors to remove the devices once the risk of a pulmonary embolism (blood clot traveling to the lungs) had passed.

Long term risks and problems with IVC filters include (but are not limited to):

Lower limb deep vein thrombosis (or the formation of blood clots in the legs)
Fracture of the filters
Migration of the filters to different parts of the body, sometimes inserting themselves into organs
Filter embolization (in which parts of the filter break off and travel to other parts of the body)
Perforation of the IVC

The FDA said it was conducting studies to analyze the risks versus the advantages of IVC filter transplantation over time once they were implanted and would update its recommendations at some future date when it had completed its analyses.

The agency encouraged all physicians who were treating patients with IVC filters to consider the risks and benefits to each patient of removing the filters as soon as they were no longer needed to protect them against the possibility of pulmonary embolisms.

If you or someone you love has experienced problems with an IVC filter, our Bard IVC filter attorneys might be able to help you. Contact us today for help.

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