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The findings of a new study warn that doctors may find it difficult to remove inferior vena cava (IVC) filters from children, particularly when they tilt out of position or become embedded.
Researchers from Children’s Hospital of Philadelphia, a part of the Perelman School of Medicine at the University of Pennsylvania, conducted a 10 year study and found that while all IVC filter retrieval procedures performed on children were successful, a significant percentage required adjunctive techniques, often because the filter had moved out of position.
The study involved a retrospective 10-year review of 20 children, including 13 males and 7 females, between the ages of 12 and 19, who underwent IVC filter removal. The findings were published in the medical journal Pediatric Radiology on January 21.
Researchers indicate that the success rate was 100% for removing the IVC filters, but standard retrieval procedures only worked in 85% of the cases, or on 17 of the children. Approximately 15% of the children had to undergo adjunctive techniques to get the filters out, including the double-snare technique, balloon assistance, and endobroncial forceps retrieval.
The study notes that a quarter of the children’s IVC filters had tilted out of position, anywhere from eight degrees to 40 degrees, with a mean angle of 17 degrees. One child’s IVC filter had a strut penetrating the vena cava and another had a filter where the tip had embedded itself. There were also two complications, including an IVC mural dissection and in one case a snare catheter fractured during retrieval, which then required that the fractured device be retrieved as well.
“In children, IVC filter retrieval can be performed safely, but may be challenging, especially in cases of filter tilt or embedding,” the researchers concluded. “Adjunctive techniques may increase filter retrieval rates.”
IVC filters are designed to “catch” blood clots that may break free within the body, preventing them from traveling to the lungs. However, the devices have been linked to thousands of reports involving problems where the filter punctured the vein, migrated out of position or fractured, often sending small metal pieces into the heart or lungs.
In recent years, concerns over the safety and effectiveness of retrievable IVC filters, such as the Bard G2 and Bard Recovery, have result in questions about whether the benefits outweigh the risks, and hundreds of IVC filter lawsuits have been filed after the devices migrated, perforated or fractured.
The litigation over IVC filter problems first emerged in 2010, after the FDA indicated that more than 900 adverse event reports had been received involving the devices. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.
IVC Filter Lawsuits
Each of the complaints raise similar allegations that the small devices are unreasonably dangerous, and contain inadequate warnings about the potential risk of problems with IVC filters.
As IVC filter injury lawyers continue to review and file complaints on behalf of individuals who have suffered migration or perforation problems, it is ultimately expected that several thousand cases will be filed against Bard, Cook and other manufacturers of the devices.