What Complications may Result from Inferior Vena Cava (IVC) FiltersAug 8, 2016
Lawsuits Over Inferior Vena Cava(IVC) Filters Continues To Rise
The number of lawsuits over inferior vena cava (IVC) filters continues to rise, with over 1,500 cases filed, according to court records. IVC filters are umbrella-shaped devices placed in the inferior vena cava to prevent blood clots from reaching the lungs. Lawsuits filed over the devices allege that plaintiffs suffered injuries when the IVC filter fractured, migrated, tilted, and perforated.
Baylor University Medical Center Proceedings recently published a case report of a woman who suffered complications when her Bard G2 IVC filter was left in her body for six years following implantation. A CT scan revealed that two of the IVC filter’s struts fractured as the filter was tilted more than 15 degrees out of position; the fractured struts punctured the IVC in multiple locations. The researchers noted that a filter may move out of position due to foreshortening and flattening of the IVC, which is translated to the filter. The authors note that, although IVC removal has a high rate of success in the first year, allowing the device to remain for long periods of time may increase the risk of complications.
Study Indicates the Percentage of Complications of IVC Filters
Complications that may occur with IVC filters include perforation (0%-41%), filter migration (0%-18%), filter fracture (2%-10%), and IVC occlusion (2%-30%), the study indicates. The authors also note that “Caval perforation can result in injury to adjacent structures, although most are asymptomatic. Extreme examples include gastrointestinal hemorrhage and aortic dissection. Migration of fracture fragments can cause serious complications, such as life-threatening arrhythmias and myocardial perforation with cardiac tamponade.”
The U.S. Food and Drug Administration (FDA) issued warnings regarding IVC filter complications. In 2010, the agency advised health care professionals to remove the devices as soon as protection against pulmonary embolism was no longer warranted. The FDA issued another alert in 2014 advising doctors to remove the IVC filters approximately one to two months after the patient is no longer at risk for a pulmonary embolism. The agency issued this notification because the risk of complications appeared to be greater the longer the device is left in place.
IVC filter lawsuits have been filed against manufacturers such as C.R. Bard, Cook, and Cordis. These companies are accused of failing to disclose the risks of IVC filters and failing to warn doctors of potential complications associated with long dwell times.
One multidistrict litigation (MDL) in Arizona contains more than 700 Bard IVC filter lawsuits. In a separate MDL in Indiana, more than 650 lawsuits are pending against Cook medical. Additionally, more than 100 lawsuits have been filed against Cordis in California state court.