Inferior vena cava filters, also known as IVC filters, are small devices placed in a vein in the leg that are used to catch and trap blood clots. The purpose is to prevent any clots from traveling to the lungs, heart, or brain, where they may cause deadly stroke, heart attack, or pulmonary embolism. IVC filters are used for patients at risk for blood clot formation and are an alternative to blood thinner medication. There is evidence that these filters can cause more harm than good. Despite a 2010 warning from the U.S. Food and Drug Administration (FDA) about these risks, and a subsequent drop in their use, a recent study found that American patients are still receiving these implanted filters in spite of the dangers and at higher rates than European patients.
IVC Filters and Their Risks
While IVC filters have the potential to be life-saving, preventing strokes and heart attacks in patients vulnerable to the formation of blood clots and deep vein thrombosis, studies have found that they can also fail and cause life-threatening complications. IVC filters are often used when a patient is not a good candidate for blood thinners because of the risks of bleeding and other complications. These small medical devices, though, can cause their own problems.
Some IVC filters have been found to break loose from the vein in which they were implanted or to break into pieces. In either case the filter or its parts can travel through blood vessels causing damage. Some of the brands of filters that have had particular problems include Cook Medical and C.R. Bard. Retrievable filters that are left in longer than intended are most likely to cause damage and complications.
2010 FDA Warning
In 2010 the FDA issued a warning about IVC filters based on nearly 1,000 adverse event reports filed by patients or doctors. The issues caused by the filters in these reports included perforation of the inferior vena cava, broken filters, and filters that came loose and migrated from the insertion site. Some of the issues resulted from filters being left in the body too long. The FDA issued this warning with the recommendation that filters be removed as soon as the patient is at a lowered risk for blood clots.
Use of IVC Filters Still Higher in U.S.
Following the 2010 FDA statement about IVC filters and their risks, use of the devices declined a little bit in the U.S. The use of the filters dropped by about 29 percent. A recent study found that the rate of use of the filters in the U.S. is still high and much higher than the rate of use in Europe. In the U.S. the rate of use is 39 per 100,000 patients, while the rate in Europe is just 3 per 100,000. More than one million IVC filters have been implanted in the U.S. over ten years.
The authors of the recent study concluded that the rate of use of IVC filters in the U.S. is too high when compared to the known risks and the uncertain benefits. The researchers suggest that a much safer rate of use is three or fewer per 100,000 patients. Along with the fact that many retrievable filters are removed later than they should, or are never removed, the findings of the study show that many U.S. patients are being put at serious risk of complications from IVC filters. If you have suffered side effects from IVC filters, you can contact a lawyer and take legal action against the manufacturer of the device.