FDA Warning: Bard IVC Filter

 

The FDA issued a statement that it had received 921 adverse event reports concerning IVC filters in August 2010. In IVC (inferior vena cava) filter is used to prevent blood clots in the main vessel that carries blood from the legs and lower body to the heart.

Some of the FDA adverse event reports included cases where the filters migrated to other body parts, most notably the heart (328), cases where parts of the device broke off (146), cases where the device perforated the IVC (70), and cases where the IVC filters fractured )56).

IVC filters are used in patients who are unable to take anticoagulant medications or in patients for whom anticoagulants have proven ineffective.

The main goal of the FDA warning was to make sure doctors remove the IVC filter as soon as the risk of a blood clot in the lungs (pulmonary embolism) has passed.

In addition to the IVC filter problems reported by the FDA, long0term risks associated with IVC filters include:

 

  • Perforation of the IVC

  • Filter embolization (where parts of the filter detach and travel in the body)

  • Lower deep limb thrombosis

  • Migration of the filters to different parts of the body, including vital organs

  • IVC filter fracture

The FDA is currently conducting more studies to analyze the risk of IVC filter complications as compared to the benefits these potentially dangerous medical devices provide. The FDA may update its recommendations in light of the results of these studies.

Contact a Dangerous Medical Device Lawyer

If you or someone you love has suffered as a result of problems with an IVC filter made by Bard or another company, you may be able to collect significant compensation in a medical product liability lawsuit. Contact a dangerous medical device lawyer today to learn more about your options in a free legal consultation.

 

 

Dec. 22, 2011 | Tags: Bard IVC Filter, FDA

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