New Study Questions the Use and Safety of IVC Filters in Trauma Patients
A new study published in the scientific journal JAMA Surgery has questioned the effectiveness and safety of inferior vena cava (IVC) filters. These are small, cage-like medical devices that are implanted in the main vein that takes blood from the lower legs back to the heart. The device is designed to capture and dissipate any blood clots that may otherwise make their way from the lower extremities to the heart and lungs. They are used in patients who are at risk for pulmonary embolism (PE), which is a potentially deadly blood clot in the lungs.
There have been questions about the safety of these devices, however, because they can sometimes break and migrate to other areas of the body, where they can puncture organs and lead to other health issues. A number of lawsuits have been filed by plaintiffs who were implanted with an IVC filter and then went on to suffer serious injuries.
Now, this new study reports that the use of IVC filters in trauma patients “should be reexamined,” because of an increased risk of morbidity in patients with filters that are not removed.
Researchers Find No Benefit in Implanting IVC Filters
In this study, researchers examined medical data from patients who received an IVC filter at Boston Medical Center between August 1, 2003 and December 31, 2012. They found 451 trauma patients who had received an IVC filter during the relevant period, and 1,343 matched controls without a filter.
Though the filters are supposed to improve trauma outcomes and help prevent blood clots, the researchers found no difference in overall mortality in patients with or without a filter who survived more than 24 hours from the time of injury. They examined the data again at six months and one year after discharge, and still found no significant difference.
Based on these results, the researchers concluded that doctors should reconsider whether to use IVC filters in trauma patients, since they don’t seem to improve patient outcomes, and could actually lead to an increased risk of injuries and even death in patients with filters that are not removed.
FDA Warns that IVC Filters Should Be Removed Quickly
In 2014, the FDA reported that it had received reports of IVC filters migrating, fracturing, and perforating the inferior vena cava or moving to the heart and/or lungs. They recommended that doctors remove IVC filters as soon as possible after the risk for pulmonary embolism had passed, optimally within 29 to 54 days after implantation.
By that time, however, many patients have suffered the consequences of having an IVC filter in place for too long. Because of the large number of lawsuits filed against IVC filter manufacturers like C. R. Bard and Cook Medical, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally-filed Bard IVC lawsuits into one court in the District of Arizona in August 2015. Consolidation also took place in Cook IVC lawsuits in October 2014, and pre-trial proceedings are ongoing in the Southern District of Indiana.
Meanwhile, a number of other studies have shown that these devices can be dangerous. In 2010 for example, researchers found that, out of a total of 80 patients who received a Bard IVC filter, 16 percent had filters that fractured. In five cases, patients had at least one fragment from the filter embolize to the heart, which resulted in life-threatening complications.