What Are IVC Filters?

An IVC filter is a small medical device inserted into the inferior vena cava (IVC), the largest vein in the body, to prevent potentially fatal blood clots that sometimes occur after surgery or injuries. They are most commonly used in people at risk of pulmonary embolism or deep vein thrombosis (DVT) when prescription blood thinners are not a viable option.

Purpose of IVC Filters

In some cases, blood clots can form in the leg’s “deep” veins (that is, veins located deep within the body as opposed to near the skin’s surface). These clots, also known as embolisms, can break off and travel through the blood stream to the lungs, where they can create a life-threatening condition known as pulmonary embolism. Such clots tend to form after surgeries on the lower extremities, such as to insert knee replacement devices.

IVC filters are designed to capture blood clots that form in the inferior vena cava, the largest vein in the body, thereby preventing them from reaching the lungs. The IVC filter is a small, cage-like metal device shaped like a cone, and it is typically implanted in the IVC just beneath the kidneys. The filter allows blood to flow regularly through the filter while trapping the blood clot. In time, naturally-occurring blood thinners help break down the clot, thereby eliminating the danger of pulmonary embolism.

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 who are unable to take prescription blood thinners like Xarelto or Plavix are also candidates for IVC filters. The filters are generally designed to be permanent implants.

IVC Filter 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 passed 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.

1000
IVC filter injury reports were received by the FDA over a 5 year period

Most complaints seem to be related to long-term use of IVC filters. For example, some patients experienced pieces of their filter breaking off and traveling through the bloodstream, while others have had their filters migrate entirely from their original position. Depending on the severity of the movement, IVC filter can cause perforations in a blood vessel or organ, causing serious pain and damage to the body.

The FDA has also found less serious IVC filter complications, including irregular heartbeat, chest pains, and loss of breath which has led to loss of consciousness.

IVC Filter Lawsuits

Many individual and class-action IVC filter lawsuits have been brought against manufacturers of the devices. 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.