When blood-thinning medication is advised against or isn’t helping, doctors often turn to inferior vena cava (IVC) filters to prevent pulmonary embolisms (PE) in patients. These cone-shaped devices are surgically inserted into the vena cava— the main vessel that returns blood from the lower half of the body to the heart—to capture blood clots and prevent them from entering the lungs. Although the filters are typically highly effective, the Food and Drug Administration (FDA) has reservations about their long-term use in patients.
The FDA Warns Healthcare Professionals About IVC Filters
In 2010, the Food and Drug Administration issued a health communication regarding the safety and use of IVC filters. This communication targets healthcare professionals who are responsible for implanting the devices and caring for patients after receiving them, such as vascular, bariatric, and orthopedic surgeons; emergency room physicians; interventional radiologists and cardiologists; and primary care physicians. The communication also addresses concerns associated with leaving the filters in for extended periods of time.
Since 2005, the FDA has received 921 adverse event reports regarding IVC filters, including incidences of migration, perforations, filter fractures, and detachment of device components.
The FDA continued to place pressure on healthcare professionals by issuing two additional safety communications regarding the risks of using IVC filters in patients, with the last statement containing stronger warnings about the device. The Administration also sent medical manufacturer C.R. Bard, who created the controversial Recovery filter, a warning letter in July of 2015 regarding safety violations.
The FDA is concerned that the filters will ultimately injure patients—and even result in death—if they remain implanted after the risk of developing pulmonary embolism passes. The Administration conducted a quantitative decision analysis, titled the “Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients Without Pulmonary Embolism,” and deducted that if the patient’s risk of pulmonary embolism has passed, removal of the IVC filter between 29 and 54 days after implantation is recommended.
Were You Injured by an IVC Filter?
As the number of IVC filter implantations grows, the amount of lawsuits grows, particularly against C.R. Bard. If you were injured because of a faulty filter, you may be eligible to receive compensation. Speak with a personal injury attorney from Kennedy Hodges, L.L.P, to learn more about your rights. Schedule your free consultation by calling 855-947-0707.