IVC filter complications fact sheet
Inferior Vena Cava Filters are dangerous medical devices meant to reduce the risk of pulmonary embolism. They have been associated with high risk of breakage and malfunction.
These filters were meant to be used on a temporary basis only, but manufacturers kept marketing them for years as a permanent solution. Filters were not removed even when the need for filtration was over.
Thousands of patients were not aware that the risk of developing a serious complication increases the longer the device is kept in place. As a consequence, many suffered grievous injuries after a metal fragment perforated one of their organs.
What is an IVC Filter and when should they be used?
Pulmonary embolism (PE) is a life-threatening condition that occurs when a blood clot (thrombus) travels to the lungs from the arms or legs.
Roughly 60 to 70 Americans every 100,000 suffer from PE, although silent (and even more lethal) forms of this condition can develop in 40% – 50% of patients with deep vein thrombosis (DVT). If untreated, PE can lead to a mortality rate of roughly 30%, with up to 10% of acute PE patients dying suddenly.
According to the Centers for Disease Control and Prevention (CDC) about 60,000-100,000 Americans die every year of PE, and 10 to 30% of them die within one month of diagnosis.
Usually, the preferred therapy to prevent this risk consist of blood thinner medications such as heparins, warfarin or antiplatelet drugs that stop clots from forming. However, when a high risk of bleeding is present, or the use of some of these medications is contraindicated, the IVC filter represents a valid alternative to these drugs.
Inferior vena cava filters (IVC filters) are spider-like metal cage used to trap blood clots inside the inferior vena cava before they can reach the lungs. The inferior vena cava is a large blood vessel that carries the non-oxygenated blood that comes from the legs to the heart and lungs.
These medical devices are temporarily inserted inside the vena cava to be later retrieved within a short time. Note that the circumstances where they are actually indicated are quite limited, so their widespread use is often unmotivated.
In particular, the U.S. Food and Drug Administration (FDA) approved the use of these filters only in the following conditions:
• Pulmonary thromboembolism when anticoagulant therapy is contraindicated
• Failure of anticoagulant therapy in PE and DVT
• Emergency treatment following massive pulmonary embolism when conventional is not effective
Article references
1. Bĕlohlávek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism. Experimental & Clinical Cardiology. 2013;18(2):129-138.
2. KJ McElrath. Bard Medical Forges Signature to Get FDA Approval on Dangerous Blood Clot Filter. The Ring of Fire. September 19, 2015.
3. Sarosiek S, Crowther M, Sloan JM. “Indications, complications, and management of inferior vena cava filters: the experience in 952 patients at an academic hospital with a level I trauma center.” JAMA Intern Med. 2013 Apr 8;173(7):513-7. doi: 10.1001/jamainternmed.2013.343.
4. U.S. Food and Drug Administration (FDA). “Inferior Vena Cava (IVC) Filters: initial Communication: Risk of Adverse Events with Long Term Usage”. August 09, 2010. www.fda.gov.
5. U.S. Food and Drug Administration (FDA). “Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication”. May 6, 2014. www.fda.gov.
6. Tam MD, et al. “Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications.” J Vasc Interv Radiol. 2012 Feb;23(2):199-205.e1. doi: 10.1016/j.jvir.2011.10.017.
7. Nicholson W, et al. “Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade.”Arch Intern Med. 2010 Nov 8;170(20):1827-31. doi: 10.1001/archinternmed.2010.316.
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