Design problems of certain inferior vena cava (IVC) filters have caused many individuals all throughout the nation to suffer severe complications and injuries when the small medical devices fractured or broke inside the body. Inferior Vena Cava (IVC) filters, or blood clot filters, are small devices designed to catch blood clots that may break free inside the deep veins of the body and travel toward the lungs. The spider-like filters are implanted in patients who are at risk for a pulmonary embolism, when they are unable to take anticoagulants or when those medications have failed. A pulmonary embolism can occur when blood clots travel through the bloodstream and become lodged near the lung. This can cause a sudden blockage of the artery that brings blood into the lungs, causing serious and potentially fatal injuries.
In August 2010, the FDA issued a warning to doctors, alerting them about the risk of problems with retrievable IVC filters, such as those manufactured by Cook and C.R. Bard. The FDA informed and advised doctors that they should remove the filters once the danger of the clot has passed, or else the filters could break free and travel through the body of the patient. Along with the FDA warning, a clinical study was published online by the Archives of Internal Medicine that highlights the high failure rate of C.R. Bard’s Bard Recovery and Bard G2 IVC filters. Researchers found that the Bard IVC filter problems appear to be both commonplace and severe, and at times produce deadly results.
The FDA issued an updated safety statement in May of 2014, indicating that patients could possibly face an increased risk of problems with IVC filters the longer the filters remain in place. The FDA went on to advise doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation. Improper warnings labels and instructions were the cause of many doctors not being aware of the importance of removing the IVC filters. In addition, design problems with certain IVC filters could increase the risk of IVC filter failures, including fractures of the device, perforation of the vena cava or other injuries.
In April 2015, a study published in the Journal of the American Medical Association (JAMA) found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism. The researchers found that filter recipients were twice as likely to have a blood clot travel to their lungs than those on blood thinners. The FDA issued a warning letter to Bard in July 2015 for illegally marketing a device used to remove the Recovery IVC filter, as well as for problems with its Denali IVC filter.
COOK CELECT AND COOK GUNTHER TULIP IVC FILTERS: A study was published in the April 2012 issue of CardioVascular and Interventional Radiology which found that all Cook Celect and Gunther Tulip filters showed some degree of vena cava perforation after just 71 days. The researchers found that full perforation of at least one component all the way through the IVC wall occurred in 86% of all cases. The filters were found to have tiled in 40% of cases. Like the FDA, the researchers called for the removal of IVC filters as early as clinically indicated. They also called on doctors to take a close look at IVC filters during follow-up imaging scans. Researchers from the University of Colorado revealed in March 2015 that rates of IVC filter perforations were significantly higher with the Cook Celect than with competing IVC filters.
LAWSUITS OVER IVC FILTER FRACTURES: If an IVC filter fractures in a patient’s body the filter, or parts of it, can migrate causing internal injuries including:
- Perforation of the heart
- Perforation of the lungs
- Hemorrhagic pericardial effusion (blood around the heart)
- Cardiac tamponade (disruption of the heart caused by excess fluid)
- Ventricular tachycardia (accelerated heartbeat)
- Puncturing of the vena cava
In many cases, the problems require emergency treatment for the blood clot filter removal, which may result in open heart surgery in some cases. Through an IVC filter lawsuit, individuals who have experienced a fracture, failure or migration of their device may be able to obtain compensation from the manufacturer as a result of the allegedly negligent and defective design of these products.
If you or a family member has had a problem due to a defective IVC Filter please fill out our Jones Brown Law Defective Medical Device Questionnaire HERE.
Jones Brown Law is currently accepting clients that have been affected by the Cook IVC Filter lawsuits, Bard Recovery IVC Filter lawsuits and Bard G2 IVC Filter lawsuits for individuals nationwide. Jones Brown Law has an experienced defective drug and defective medical device team of attorneys that are ready to help you and your loved ones that have been affected by these IVC filters
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