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Study: IVC Filters Don't Save Trauma Lives

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Boston, MAA new study suggests that not only do IVC filters not save the lives of trauma patients, but leaving the IVC filters in for too long could put patients at increased risk. The study, which examined the use of inferior vena cava (IVC) filters in trauma patients, was published online in the journal JAMA Surgery (9/28/16). Lawsuits have been filed against Bard and Cook, two companies responsible for making IVC filters.

IVC filters are implanted in patients who are at an increased risk of pulmonary embolism but cannot take anticoagulant medications. They are designed to prevent blood clots from reaching the patient's lung. Researchers in the JAMA Surgery study, however, note that although the use of IVC filters in trauma patients is increasing there is not enough high-quality evidence that proves the filters work.

To conduct the study, researchers from Boston University examined trauma patients who had an IVC filter inserted in them at Boston Medical Center from August 1, 2003 to December 31, 2012. Researchers found that there was no significant overall difference in mortality or cause of mortality when patients who did not have an IVC filter implanted were compared with those who had an IVC filter implanted, if those patients survived the initial 72 hours following the injury. Patients who had an IVC filter implanted, however, had a higher survival rate in the first 24 hours of implantation.

"The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place," researchers wrote.

Researchers also noted, however, that only eight percent of the IVC filters that were implanted were actually removed during the 3.8 years following implantation. The FDA has warned that retrievable IVC filters should be removed between 29 and 54 days of implantation if the risk of a pulmonary embolism has passed because there are risks to leaving the filters implanted too long.

Among the risks associated with IVC filters are a reported risk of the filters breaking and or migrating from their implantation site and perforating vital organs or other tissues.

The Bard multidistrict litigation—which currently has 886 pending actions—is MDL 2641, while the Cook multidistrict litigation—which currently holds 933 pending actions—is MDL 2570. Bellwether trials are expected to reach the courts in 2017. Lawsuits filed against the companies allege they failed to adequately warn patients about the risks associated with the filters.


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