The inferior vena cava (IVC) is the main vessel returning blood from the lower body to the heart. IVC filters are small, cage-like metal devices that, when inserted into this vein, are intended to prevent blood clots from reaching vital organs such as the heart, lungs, or brain. The filters are often implanted in patients who are at high risk of pulmonary embolism (PE) or who have been diagnosed with deep vein thrombosis (DVT) and are not able to take anticoagulant medications (or blood thinners).
IVC filters have been linked to potentially deadly complications including a high risk that pieces of metal wire will break off and puncture the vein, migrate into the heart or lungs, and cause severe injuries including hemorrhage (severe bleeding), arrhythmia (irregular heartbeat), stroke, and even death. IVC filters have even been shown to cause the very problems they are designed to prevent: pulmonary embolism (PE) and deep vein thrombosis (DVT). They can also cause a condition known as cardiac tamponade, in which fluid builds up in the pericardium (the tissue lining surrounding the heart muscle), causing pressure and interfering with heart function).
The U.S. Food and Drug Administration (“FDA”) issued a warning on August 9, 2010 entitled “Removing Retrievable Inferior Vena Cava Filters: Initial Communication”, which states that the FDA has received nearly 1,000 reports of adverse events associated with IVC filters including reports of device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), and perforation of the IVC. In a May 6, 2014 update to its warning regarding IVC Filters, the FDA also reported other known long-term risks associated with IVC filters including lower limb deep vein thrombosis and IVC occlusion.
In addition to these potentially deadly complications, which call into question the safety of these devices, many studies have detailed the high rates of failure associated with these devices and the significant risks to patients when IVC filters are used or left in the patient for too long. For example, a study published in the Annals of Surgery examined data on over 800 patients who had received IVC filters and concluded, “High rates of prophylactic IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events.”
Several lawsuits have been filed by patients who suffered severe complications after being implanted with an IVC filter. These lawsuits allege that the IVC filters at issue were defectively designed, rendering them unreasonably dangerous devices. These lawsuits also allege that manufacturers of these devices knew of the dangers and failed to adequately warn patients and physicians of the risks associated with IVC filters.
If you or a loved one has received an IVC filter and experienced any adverse side effects, you may be entitled to compensation. The attorneys at Canepa, Riedy, Abele, & Fischer are currently investigating lawsuits on behalf of patients who may have been injured by an IVC filter. Some of the IVC filters being investigated are the Bard Recovery, Bard G2, Bard G2 Express, Bard Eclipse, Bard Meridian, Bard Denali, Cook Gunther Tulip, and Cook Celect. To learn more about your legal options, please contact us for a free consultation.