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An FDA warning that came out in the last decade, apparently had a significant impact on IVC filter use. A number of different patients came forward and filed adverse event reports with the FDA, in addition to reporting concerns to their physicians. IVC filter use became widespread when the product was initially introduced. However, claims of serious injuries and fatalities prompted the FDA to conduct an investigation.
IVC filter use began to decrease in 2010, the same year that the FDA first issued a warning about the dangers of long-term use of these inferior vena cava filters. Researchers show that placement rates engaged in a downward turn for IVC filter use after that point. This research was recently presented at the Society of Interventional Radiology meeting.
They conducted a retrospective analysis of IVC filter use between 1993 and 2014 from the National Inpatient Sample. Prior to the FDA’s safety alert in 2010, IVA filter use was increasing by 9.36 percent annually.
However, rates dropped to an average of 7.36 percent per year after that safety warning. The rates of pulmonary embolism and deep vein thrombosis, two of the primary reasons why patients would obtain an IVC filter to begin with, remain constant over that same period.
A second study also supported decreased IVC filter use after the FDA advisory in 2010. In that study, IVC filter retrieval was also explored and they identified a 3.9 percent complication rate associated with IVC filter retrieval. The primary problem behind those complications were access site issues.
Basics of IVC Filters
Those most likely to have an IVC filter implanted are patients at risk for developing life-threatening blood clots. This is particularly true for patients who cannot take medication for the purpose of blood-thinning. A blood clot that might otherwise travel to the lung should be captured by the IVC filter, but research shows that many patients with this device are at risk for serious injury.
In as short as one month after implantation, patients may suffer critical problems. FDA guidance was eventually given to doctors suggesting that physicians remove an IVC filter as soon as the risk of pulmonary embolism had subsided for a patient.
IVC filter use may present unique challenges for patients who discover severe pain and other side effects after having the IVC filter implanted. If you or someone you know has been seriously injured because of IVC filter use, or have developed complications and had to go through revision surgeries and other treatment options because of the filter, you may have grounds to pursue a defective medical device lawsuit with the help of an attorney.
Have you already had to deal with severe side effects because of an IVC filter? The lawyers at McDonald Worley are here to help patients who have been injured after using an IVC filter. Fill out the form on this page for a free case evaluation.