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Toriseva Law and Karon & Dalimonte LLP: Archives of Internal Medicine Article Faults Manufacturers of IVC Filters
Date:11/9/2010

BOSTON, Nov. 09, 2010 /PRNewswire-USNewswire/ -- The following was released today by the legal offices of Toriseva Law and Karon & Dalimonte LLP:

An article published by the American Medical Association Archives of Internal Medicine on November 7, 2010 (http://archinte.ama-assn.org/cgi/reprint/2010.323v1.pdf) suggests that while the G2 filter may have been approved by the FDA, there was no clinical data provided prior to approval.

Editor's note: Inferior Vena Cava (IVC) filters are used in cases where patients are at risk of pulmonary embolism (also referred to as PE, or blood clotting within the lungs) when anticoagulants cannot be used or may be deemed ineffective.

Moreover, only about 5% to 10% of adverse events are reported as part of the voluntary reporting system for adverse event reports made to the FDA.  Because this system is voluntary, it is widely believed that the number of actual adverse events is much higher.  Extrapolating the data, the authors of the study suggest that more than 7,000 Americans may currently have a fractured G2 filter implanted with the potential of embolization to the IVC filter. The article also notes that only 7% of the devices have been removed and that this number will likely rise over time.

In a recent safety alert, the U.S. Food and Drug Administration (FDA) urged physicians and clinicians who have implanted temporary IVC filters to consider removing them immediately after the threat of PE has passed. In some cases, the devices have been allowed to remain in the body temporarily after the symptoms of PE had disappeared. In recent years, the FDA has received 921 reports involving failure of IVC filters, 328 of which involved device migration and 146 of which caused embolizations (or detachment of the device components) as w
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SOURCE Karon & Dalimonte LLP; Toriseva Law
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