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The findings of a new study suggest that implanting inferior vena cava (IVC) filters in trauma patients does not increase their chances of survival, and may actually lead to additional blood clot problems.
Prophylactic use of IVC filters among trauma patients has increased in recent years, since individuals may face an increased risk of suffering a venous thromboembolic (VTE) event.
The small filters are designed to catch blood clots that may break free, and prevent them from traveling to the lungs where they may cause a pulmonary embolism. However, researchers from the University of Michigan indicate that they were unable to find any evidence that the devices provide any additional benefit.
The findings were published last month in the medical journal Annals of Surgery, indicating that use of IVC filters had no effect on the mortality of the patients. They did not survive, on average, any longer than patients not given IVC filters after trauma. Researchers also found that those who were given a prophylactic IVC filter had an 83% increased risk of DVT.
In recent years, a growing number of questions have emerged about the effectiveness and potential safety side effects of IVC filters, with federal health regulators expressing concern about the large number of adverse event reports submitted on behalf of individuals who suffered an injury when the filter moved out of position, punctured the vena cava or fractured, potentially causing tiny pieces to travel to the heart or lungs.
As a result of the long-term IVC filter risks, federal regulators have warned doctors about the importance of removing the devices once the blood clot risk has passed.
In this latest study, the researchers looked at trauma data from 2010 to 2014 and found 803 cases where trauma patients were implanted with IVC filters to address an increased risk of VTE events, such as pulmonary embolism and deep vein thrombosis (DVT).
“High rates of prophylactic IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events,” the researchers concluded.
The findings add to a growing body of research that questions whether IVC filters are safe and effective for many individuals who received them in recentyears.
IVC Filter Risks
The FDA issued an alert about the risk of problems with removable IVC filters in August 2010, indicating that the agency had received more than 900 adverse event reports at that time. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.
A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and eight percent of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.
Following reports of IVC filters failing, with the struts or legs fracturing or puncturing the vena cava, the FDA issued a warning in May 2014, urging doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed.
Hundreds of individuals who have experienced complications are now pursuing an IVC filter lawsuit against the manufacturers of several different designs, alleging that the products are defective and unreasonably dangerous.
In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings in the federal court system for all Cook Celect and Gunther Tulip filter lawsuits, centralizing the cases before U.S. District Judge Richard L. Young in the Southern District of Indiana, where a small group of representative cases are being prepared for early trial dates that will begin late next year.
Similar consolidated proceedings were established for all Bard G2 filter lawsuit and Bard Recovery filter lawsuit in August 2015, centralizing the litigation against C.R. Bard before U.S. District Judge David G. Campbell in the District of Arizona to reduce the risk of duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.