IVC Filters May Increase Risk of Blood Clots and Deep Vein Thrombosis When Left in for an Extended Period
Many recipients of retrievable IVC filters, designed to protect against pulmonary embolisms, may have complications and yet not even be aware that there is a danger associated with the devices being left in place past a specified period of time. Devices left in place longer than 50 days may increase the risk of blood clots and deep vein thrombosis as well as other complications that include migration, fracture, embolization, perforation and the inability to remove the devices.
San Diego, CA, April 12, 2016 (Newswire.com) - In the midst of growing concerns about the alleged risk of complications from inferior vena cava (IVC) filters, which are designed to reduce the risk of blood clots, pulmonary embolism and deep vein thrombosis, a new study warns that retrievable IVC filters may actually increase the risk of blood clots and deep vein thrombosis when they are left in place for an extended period of time. Hundreds of IVC filter lawsuits have already been brought against C.R. Bard, Cook Medical, and other manufacturers of retrievable blood clot filters for injuries to patients, and as researchers continue to investigate the potential risks of IVC filters, it is ultimately expected that several thousand product liability lawsuits will be filed against IVC filter manufacturing companies.
What are Retrievable IVC Filters?
IVC filters are cage-like devices implanted in the inferior vena cava to capture and trap blood clots that may break free within the body, preventing them from traveling to the heart and lungs and causing a pulmonary embolism or other serious complications. In recent years, new designs have been developed that allow the filter to be removed from the inferior vena cava once the risk of pulmonary embolism has subsided. However, IVC filter side effects have been tied to thousands of serious and sometimes fatal injuries occurring when the filter migrated out of position, punctured the vein, or embolized to the heart or lungs, and many of these problems have been attributed to the issue of the filters being left in place for periods of time that exceed 29-54 days.
FDA Warnings for IVC Filter Recipients
In light of growing concerns about possible IVC filter complications, the U.S. Food and Drug Administration (FDA) has issued several warnings regarding the potential risks of IVC filters, including a 2010 safety announcement, which highlighted 921 adverse event reports submitted to the FDA in connection with the filters from 2005 to 2010. In 2014, the FDA updated its safety alert, indicating that “implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters [should] consider removing the filter as soon as protection from pulmonary embolism is no longer needed,” preferably within 29 to 54 days after implantation.
Possible Side Effects of Removable IVC Filters
According to a growing body of research, retrievable IVC filters may be associated with an increased risk of serious complications in patients, including a risk of filter migration, perforation of the inferior vena cava, filter fracture, and filter embolization. Studies have also found that retrievable IVC filters may actually increase the risk of blood clots and deep vein thrombosis, the very conditions they are designed to prevent. In this latest study, published this month in the medical journal JACC Cardiovascular Interventions, researchers from the University of Rochester Medical Center in New York indicate that unretrieved IVC filter thrombosis may account for 2.6% to 4% of all cases of deep vein thrombosis in patients implanted with blood clot filters.
Removable IVC filters have become increasingly more popular over the past decade, for use among patients at risk for pulmonary embolism who are unable to take anticoagulant medications, and the researchers involved in this study concluded that, “due to the substantial increase in the number of IVC filters placed in the United States and the very low filter retrieval rates, clinicians are faced with a very large population of patients at risk for developing IVC thrombosis.” Unfortunately, the makers of retrievable IVC filters have been accused of failing to issue adequate warnings about the importance of removing the devices to reduce the risk of complications, which may become more likely the longer the filter remains in place.
IVC Filter Complications are a Growing Concern
According to the researchers involved in the JACC study, patients who have untreated IVC filter blood clots face:
- A 90% chance of suffering post-thrombotic syndrome if the blood clot filter is not removed
- A 45% chance of experiencing disabling venous claudication
- A 30% chance of suffering a pulmonary embolism
- A 15% chance of a venous ulceration.
In an editorial accompanying the study, Dr. Michael R. Jaff of Massachusetts General Hospital in Boston writes, “Of tremendous importance is [the researchers’] recognition that the most common cause of this challenging disorder is thrombosis of previously deployed IVC filters.” He also warns that, “With the rapid expansion in placement of IVC filters, particularly in the United States, we can expect this problem to actually increase.”
If you or a loved one has suffered complications due to a faulty IVC filter, or a filter not being removed within the appropriate time period, you may be entitled to compensation. Consumer Safety Watch can assist victims of IVC filter negligence in locating legal services that meet their specification at no up front cost.
Source: Consumer Safety Watch