In the midst of growing concerns about the alleged risk of complications from inferior vena cava (IVC) filters, which are designed to reduce the risk of blood clots, pulmonary embolism and deep vein thrombosis, a new study warns that retrievable IVC filters may actually increase the risk of blood clots and deep vein thrombosis when they are left in place for an extended period of time. Hundreds of IVC filter lawsuits have already been brought against C.R. Bard, Cook Medical, and other manufacturers of retrievable blood clot filters for injuries to patients, and as researchers continue to investigate the potential risks of IVC filters, it is ultimately expected that several thousand product liability lawsuits will be filed against IVC filter manufacturing companies.
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IVC filters are cage-like devices implanted in the inferior vena cava to capture and trap blood clots that may break free within the body, preventing them from traveling to the heart and lungs and causing a pulmonary embolism or other serious complications. In recent years, new designs have been developed that allow the filter to be removed from the inferior vena cava once the risk of pulmonary embolism has subsided. However, IVC filter side effects have been tied to thousands of serious and sometimes fatal injuries occurring when the filter migrated out of position, punctured the vein, or embolized to the heart or lungs, and many of these problems have been attributed to the issue of the filters being left in place for long periods of time.
In light of growing concerns about possible IVC filter complications, the U.S. Food and Drug Administration (FDA) has issued several warnings regarding the potential risks of IVC filters, including a 2010 safety announcement, which highlighted 921 adverse event reports submitted to the FDA in connection with the filters from 2005 to 2010. In 2014, the FDA updated its safety alert, indicating that “implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters [should] consider removing the filter as soon as protection from pulmonary embolism is no longer needed,” preferably within 29 to 54 days after implantation.
According to a growing body of research, retrievable IVC filters may be associated with an increased risk of serious complications in patients, including a risk of filter migration, perforation of the inferior vena cava, filter fracture, and filter embolization. Studies have also found that retrievable IVC filters may actually increase the risk of blood clots and deep vein thrombosis, the very conditions they are designed to prevent. In this latest study, published this month in the medical journal JACC Cardiovascular Interventions, researchers from the University of Rochester Medical Center in New York indicate that unretrieved IVC filter thrombosis may account for 2.6% to 4% of all cases of deep vein thrombosis in patients implanted with blood clot filters.
Removable IVC filters have become increasingly more popular over the past decade, for use among patients at risk for pulmonary embolism who are unable to take anticoagulant medications, and the researchers involved in this study concluded that, “due to the substantial increase in the number of IVC filters placed in the United States and the very low filter retrieval rates, clinicians are faced with a very large population of patients at risk for developing IVC thrombosis.” Unfortunately, the makers of retrievable IVC filters have been accused of failing to issue adequate warnings about the importance of removing the devices to reduce the risk of complications, which may become more likely the longer the filter remains in place.
According to the researchers involved in the JACC study, patients who have untreated IVC filter blood clots face a 90% chance of suffering post-thrombotic syndrome if the blood clot filter is not removed, a 45% chance of experiencing disabling venous claudication, a 30% chance of suffering a pulmonary embolism, and a 15% chance of a venous ulceration. In an editorial accompanying the study, Dr. Michael R. Jaff of Massachusetts General Hospital in Boston writes, “Of tremendous importance is [the researchers’] recognition that the most common cause of this challenging disorder is thrombosis of previously deployed IVC filters.” He also warns that, “With the rapid expansion in placement of IVC filters, particularly in the United States, we can expect this problem to actually increase.”