A recent study found that the use of IVC filers in trauma patients in hospitals did not save lives. There was no mortality difference between those that received a filter and those that did not. These results led the researchers to conclude that the use of IVC filters needs to be reevaluated. They are not helping patients survive, and there are risks associated with using them, according to warnings issued previously by the U.S. Food and Drug Administration (FDA).
IVC stands for the inferior vena cava, a large vein in the leg into which these filters are inserted. They are used to collect blood clots that form in the legs and to prevent them from migrating to the lungs, heart, or brain, where they can cause serious damage and even death. People in trauma situations and those who have had surgery are at risk for forming dangerous blood clots. When taking a blood thinner is too risky for a patient, an IVC filter may be used as an alternative.
The FDA has issued more than one warning about IVC filters. The first came in 2010 when the agency announced that it had received 921 adverse event reports regarding the filters since 2005. These adverse events included migrating devices, fractures in the filters, and perforation of the IVC. The FDA concluded that many of these were incidences of filters that were supposed to have been removed.
Following further study, the FDA issued another warning that essentially said the same thing as the earlier warning. It recommended that IVC filters be removed as soon as the risk of blood clots is lowered for a patient. When the filters remain in place too long they can move or break apart, causing blockages in other parts of the body or damaging the vein. Because of the damage these filters have caused, some patients have filed lawsuits against the manufacturers.
IVC Filters Failing to Save Lives
The purpose of inserting an IVC filter is to reduce the risk that a patient will be harmed or will die because of a blood clot. In the most recent study, researcher concluded that the filters did not save the lives of trauma patients. The researchers looked at 451 trauma patients who had received IVC filters as well as over 1,000 control patients who did not receive the filters.
The results showed that there was no decrease in the death rate in the patients who received filters as compared to those who did not. Some of the patients already had blood clots, while others did not, but all were considered to be at risk for the formation of clots.
Another finding from the study was that only eight percent of the surviving recipients of the filters in the study had them removed four years later. This seems to contradict the warnings and recommendations from the FDA regarding the risks of keeping the devices in place for a long period of time.
What the results of the study demonstrate is that there is a device that poses risks to patients and that may not provide any real benefits. At least in the case of trauma patients, it seems that IVC filters do not reduce mortality rates and do not save lives. Those patients with the filters still in place years later may face serious risks as a result, including perforation of a major vein. The use of IVC filters should be reevaluated, as suggested by the researchers, and more study may be needed to determine if they provide benefits to any type of patient or if any benefits outweigh the risks.