With more than 1,500 lawsuits currently pending against Inferior Vena Cava Filter (IVC filter) manufacturers, the defective devices are a widespread problem. With nearly a dozen IVC filter manufacturers and thousands of IVC filters implanted each year, how did the manufacturers get it so wrong?
A new study conducted by Baylor Scott & White Health’s Department of Radiology in Dallas may just have an answer. The study suggests the cause of device failure is the “foreshortening and flattening” of the inferior vena cava. The findings suggest the small devices are not flexible enough to withstand the body’s natural movement, and this could contribute to the side effects reported with the devices like perforation, fracture, and migration.
What Is An IVC Filter?
An IVC filter (inferior vena cava filter) is a type of surgical filter implanted into the largest vein in the body, the inferior vena cava, which carries blood from the body to the right atrium of the heart. The purpose of the IVC filter is to prevent a condition called a pulmonary embolism (PE), or when a blood clot forms in the body, passes into the lungs, and causes serious injury, coma, or death.
In 2010, the FDA issued a safety statement to patients and doctors warning of the serious and life-threatening adverse events reported from defective IVC filters. Between 2005 and 2010, the FDA received nearly 1,000 reports of device failure, including migration, perforation, embolization, and fracture.
In 2014, the FDA released an additional safety statement recommending the device be removed between 29 and 54 days after implantation to reduce the risk of device failure. However, this warning came too late for hundreds of patients who learned of the devices’ dangers from firsthand experience.
IVC filter manufacturers like C.R. Bard, Cook Medical, Boston Scientific, and Cordis Corporation are all facing product liability lawsuits alleging patients were not adequately warned of the dangers associated with the devices.