Cook IVC Filters
Ohio Cook Inferior Vena Cava Filter Lawyers
Clark Perdue is investigating claims involving retrievable Cook IVC filters (inferior vena cava filters) manufactured by Cook Medical.
IVC filters are medical devices that are implanted in the inferior vena cava. These filters are designed to prevent deep vein thrombosis and pulmonary embolisms from forming, thereby preventing strokes and other potentially life-threatening conditions. Over 100,000 IVC filters have been implanted since the 1960’s. When the retrievable IVC filters are not removed, they can cause serious, even deadly side effects.
Cook Medical manufactures two IVC filters – the Gunther Tulip and Celect. The Gunther Tulip has been on the market since 1992. It has four “legs” and 12 filter wires that allow blood to flow through the vena cava while capturing blood clots in the top of the filter. The Celect IVC filter was approved by the FDA in 2008 with a 510(k) application. The filter can become embedded in the vena cava making removal of the filter difficult.
What is the problem with Cook IVC Filters?
IVC filters can provide protection against pulmonary embolisms. However, if the filter is not removed after the individual is no longer at risk for blood clots, it can become dangerous. Pieces of the filter can break off and migrate in the body or perforate the inferior vena cava. The U.S. Food and Drug Administration (“FDA”) received 921 reports of IVC filter failures between 2005 and 2010.
A New England Society for Vascular Surgery study reported that 31% of the IVC filters it studied fractured. Most of the broken shards migrated to the right ventricle of the heart. A study by Dr. Nicholson of York Hospital, found fractures in 25% of the IVC filters. Many very serious injuries can result from IVC filter failure – including, cardiac/pericardial tamponade, cardiac arrhythmia, hemorrhaging, perforations of blood vessels and organs, pain and even death. Research by the Society of Interventional Radiology indicated that in-hospital mortality rates were much higher for patients who received the IVC filters when compared to patients who did not receive the filters.
In response to the mounting research, the FDA began an investigation into the risks and benefits of the filters. Currently, the FDA recommends that IVC filters be removed as soon as the patient is no longer at risk for blood clots.
If you or a loved one has been harmed by a unsafe medical device, contact us for a free consultation.Clark, Perdue & List has extensive experience handling claims involving defective medical devices and pharmaceuticals. If you or a loved one has suffered injury as a result of a Cook IVC filter, contact the Ohio Cook IVC Filter attorneys at Clark, Perdue & List.
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