Study Suggests FDA Warnings on IVC Filter Complications Impacted Placement Rates

Published on November 9, 2017 by Sandy Liebhard

Results of a recent study suggests that the U.S. Food & Drug Administration’s warnings about the risks and complications associated with inferior vena cava (IVC) filters led to declining rates of placement among doctors and hospitals throughout the country.

According to a Research Letter published this month in JAMA Internal Medicine, a team from the Washington University School of Medicine in St. Louis identified IVC filter placement among U.S. adults between 2005 and 2014 via the Nationwide Inpatient Sample, the National Inpatient Sample and the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

While IVC filter placement increased from 322.1 per 100,000 hospitalizations in 2005 to 412 per 100,000 hospitalizations in 2010, the rate declined to 374.1 per 100,000 hospitalizations in 2011. It continued to decline to 321.8 per 100,000 hospitalizations in 2014.

The Percentage of prophylactic filter placement was reduced from 28.9% in 2005 to 22.6% in 2014.

FDA IVC Filter Warnings

IVC filters are placed in the inferior vena cava, the body’s largest blood vessel. They are indicated for use in patients at risk for pulmonary embolism who can’t use standard blood-thinning drugs. Once in place, the small, wire devices catch blood clots before they can make their way to heart or lungs.

In 2010, the U.S. Food & Drug Administration (FDA) warned that its adverse event database had logged more than 900 IVC filter complication reports, including:

• 328 instances of filter migration
• 146 incidents where filter components broke free
• 70 cases where the filter perforated the inferior vena cava
• 56 reports of filter fracture

The FDA suggested that many of the adverse events could have been the result of retrievable IVC filters that were left in place longer than necessary. The agency reminded healthcare providers to remove the filters as soon as the blood clot risk subsided in order to reduce the potential for patient harm.

In May 2014, the FDA issued a second alert to remind doctors of the importance of IVC filter retrieval.

IVC Filter Lawsuits

More than 4,000 IVC filter lawsuits have been filed against C.R. Bard, Inc. and Cook Medical, on behalf of patients who  suffered serious and life-threatening complications due to the allegedly defective devices. Plaintiffs claim that C.R. Bard and Cook Medical failed to provide doctors with appropriate safety warnings, including information regarding the importance of filter retrieval.