A recent study shows an increase in the frequency of deep venous thrombosis among trauma patients who were administered an IVC filter.

The study was published in the October 2015 issue of the journal Annals of Surgery. Researchers analyzed data from trauma patients from 2010 to 2014.

In the cases of 803 trauma patients who received an IVC filter as part of their treatment, the researchers found no change in their rate of mortality. They did, however, find an 83 percent increase in the rate of deep venous thrombosis among IVC filter recipients.

An IVC filter, or inferior vena cava filter, is a device used to prevent blood clots from traveling from the lower body to the lungs in patients for whom anticoagulant medication is not a suitable option.

It’s a small, cage-like device that is placed inside the inferior vena cava, the large blood vessel that returns blood to the heart. It’s designed to trap loose blood clots and hold them in place, preventing them from migrating to the lungs and causing a pulmonary embolism, which can lead to serious complications or death.

The use of IVC filters has gotten extra scrutiny lately due to reports of IVC filter complications. In August 2010 the FDA issued a safety communication summarizing reports it had received of adverse events associated with these devices.

The communication says that since 2005 the agency had received 921 device adverse event reports involving IVC filter complications. In some cases, the device migrated away from where it had been implanted; other filters broke apart or perforated the walls of the inferior vena cava. Based on the risks of these complications, the agency recommended that retrievable IVC filters be removed as soon as the risk of pulmonary embolism subside.

In May 2014, the FDA issued a follow-up to the 2010 communication, essentially reiterating the prior statement of the risks and recommendations, and adding new information based on research and postmarket studies. Subsequent reports of adverse events had noted that some filter fragments or the entire filter itself had migrated from the implantation site to the heart or lungs. The communication also noted that risks of deep vein thrombosis and occlusion of the inferior vena cava had been associated with long-term IVC filter use.

IVC Filter Lawsuits

Hundreds of patients who say they suffered IVC filter complications have begun to file their own IVC filter lawsuits. Generally, these plaintiffs argue that the manufacturers of IVC filters were aware of the risks of IVC complications yet failed to adequately disclose those risks to patients or physicians.

They argue that the manufacturers’ efforts to promote IVC filters as safe and effective are inconsistent with the results of studies and clinical trials that show evidence of IVC filter complications.

In the federal court system, these IVC filter lawsuits have been consolidated into two separate multidistrict litigations, or MDLs. Claims related to the Cook Celect IVC filter and Gunther Tulip IVC filter have been consolidated in a federal court in Indiana since October 2014. Claims implicating the Bard G2 filter are now being consolidated in a federal court in Arizona.