Sometimes blood clots, or an embolism, can break from one of the leg’s deep veins. The IVC then carries the embolism to the heart and lungs, creating a severe blockage in the pulmonary artery. These blockages, known as a pulmonary embolism, can cause strained breathing and chest pain, and could even lead to death.
Purpose of IVC Filters
IVC filters capture blood clots, preventing them from reaching the lungs. The filter is a small, cage-like metal device shaped like a cone. The filter is implanted in the IVC just beneath the kidneys. The IVC filter allows the blood to flow regularly through the filter while trapping the blood clot. In time, naturally-occurring blood thinners, or anticoagulants, help break down the clot.
IVC filters are generally implanted in people that experience pulmonary embolisms or deep vein thrombosis (DVT) despite the regular and monitored use of prescribed anticoagulants. In less common cases, patients that are unable to take prescription blood thinners are also candidates for IVC filters. The filters are generally designed to be permanent implants.
IVC Filter Complications and Safety Concerns
Initially intended to be permanent implants, the Food and Drug Administration (FDA) began recommending in 2010 that IVC filters be removed as soon as the risk for pulmonary embolism has based and the patient can withstand the removal surgery. From 2005 to 2010, the FDA received nearly a thousand complaints regarding several serious and less severe issues related to IVC filters.
Long-term Use of IVC Filters Risks Damaging Patients
IVC filters have led to several serious issues in patients. Filters left in the vein have broken into pieces or migrated wholly from their original position. This has led to perforating the inferior vena cava or other organs, creating serious damage and risk for patients.
The heart is at significant risk from moving filters, leading to heart damage and fluid buildup, known as cardiac tamponade.
Long-term use of IVC filters can also lead to recurrent pulmonary embolism, recurrent deep vein thrombosis (DVT), and thrombosis in the vena cava.
FDA Warning on Risks Associated with Long-term IVC Filters
Originally approved by the FDA in 1979, the use of IVC filters has grown exponentially in the proceeding 30 years. However, based on the significant number of consumer complaints received by 2010, the FDA they recommended IVC filters be removed from patients when and as soon as possible.
In October 2014, the FDA updated this recommendation to remove IVC filters in light of new research. The research suggested that once a patient’s transient risk for pulmonary embolism had passed, the risk/benefit profile starts to favor IVC filter removal between 29 and 54 days after its implantation.
Further research published by the Journal of the American Medical Association (AMA) in August 2015 warned that the long-term risks of IVC filters may negate any alleged health benefits.
Other Medical Problems
The FDA has also found less serious side effects of IVC filters, including irregular heartbeat, chest pains, and loss of breath which has led to loss of consciousness.
IVC Filter Lawsuits
Many individual and class-action lawsuits have been brought against manufacturers of IVC filters. At least one major manufacturer, Cook Medical Inc., has a pending multi-district litigation. The U.S. District Court for the Southern District of Indiana is overseeing the multidistrict litigation No. 2570.
Manufacturers of IVC Filters
Several American and international companies manufacture IVC filters.