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The findings of a new study suggest that early placement of inferior vena cava (IVC) filters does not help prevent pulmonary embolism after a major trauma, raising potential questions about the usefulness of the blood clot filters, some of which have previously been linked to reports of painful and life-threatening health complications.
Australian researchers published a study this month in The New England Journal of Medicine which looked at prophylactic use of IVC filters, which are often used without a clear medical need among individuals who have been severely injured, to reduce an anticipated risk of pulmonary embolism or death.
IVC 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 blood clot filters are designed for use among patients who are at a known risk for a pulmonary embolism, when they are unable to take anticoagulants or after those medications have failed.
In recent years, the usefulness of the devices have come under scrutiny, due to high rates of IVC filter failures, where the struts have punctured the vena cava, migrate out of position, or even fracture, sending pieces into the heart and lungs, which can be fatal.
In this latest study, researchers conducted a multicenter, randomized and controlled trial involving 240 severely injured patients who could not be given blood thinners. Some had IVC filters placed within 72 hours of hospital admission, and others did not.
According to the findings, early placement of an IVC filter failed to result in significantly lower rates of pulmonary embolism or death, when compared to patients who did not receive a filter.
“Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter,” the researchers concluded.
IVC Filter Lawsuits
Concerns about the potential overuse of IVC filters first emerged in 2010, when the FDA warned that it had received hundreds of adverse event reports involving problems with filters that had moved out of position, fractured or failed. At the time, the agency indicated that doctors should consider removing the filters when the risk of a blood clot passed, as the devices were often being left in place long-term.
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after an individual was no longer at risk of suffering a pulmonary embolism, since the risk of problems appeared to be greater the longer the filter was left in place. However, many manufacturers sold the devices for years without adequately informing physicians about the risks associated with leaving them in place.
These latest findings come as medical device manufacturers face thousands of IVC filter lawsuits, each raising similar allegations that the devices are defective and unreasonably dangerous as designed. Plaintiffs also claim the manufacturers have failed to adequately warn consumers and the medical community about the risk that the devices may fracture, move out of position or puncture the vena cava, resulting in serious and potentially life-threatening injuries.
There are currently more than 4,000 Bard IVC filter lawsuits pending throughout the federal court system, which are currently centralized before one judge for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation. Another 2,000 Cook IVC filter lawsuits are centralized as part of a separate MDL, raising similar allegations of problems associated with filters manufactured by Cook Medical.