Product News and Recalls

Study: Perforation the Rule, Not the Exception for Longer-Indwelling Cook IVC Filters

long term ivc filter use shown to lead to perforationA study published in CardioVascular and Interventional Radiology has turned up startlingly high rates of vena caval perforation by Cook Celect and Gunther Tulip inferior vena cava (IVC) filters.

IVC filters are a type of medical implant designed to prevent blood clots from forming in and traveling throughout the body, thus reducing the incidence of strokes and other life-threatening events. IVC filters have grown in popularity since they were introduced in the 1960’s, with an estimated 100,000 implanted annually in the United States. However, recent research has revealed that IVC filters from companies like C. R. Bard, Inc., and Cook Group, Inc., can be potentially fatal to those treated with them.

Patients injured by defectively designed IVC filters have filed Cook and Bard IVC filter lawsuits, in which they allege that the devices pose an unreasonably high risk of puncturing the vena cava or fracturing and migrating to vital organs, such as the heart and lungs. Plaintiffs further claim that IVC filter manufacturers like Cook and Bard failed to adequately warn doctors and patients of the dangers posed by their devices.

The study looked at records of 272 Cook Celect and Gunther Tulip IVC filters that had been implanted between July 2007 and May 2009. From these, researchers identified 50 IVC filters (27 Celect, 23 Gunther Tulip) that had further been assessed with computer tomography scans. These scans were examined for evidence of filter malfunction, including vena caval perforation, filter tilt, and pericaval tissue injury.

According to the study, “perforation of at least one filter component through the IVC was observed in 43 of 50 (86%) filters on CT scans obtained between 1 and 880 days after filter placement. All filters imaged after 71 days showed some degree of vena caval perforation, often as a progressive process. Filter tilt was seen in 20 of 50 (40%) filters, and all tilted filters also demonstrated vena caval perforation.”

fda issues safety alert over failed IVC filtersThe U.S. Food and Drug Administration (FDA) long ago issued a safety alert warning about the dangers of long-term IVC filter use. The agency stated that it received 921 adverse event reports about IVC filters between 2005 and 2010, ranging from device migration to perforation of the inferior vena cava.

Earlier this year, a study in the Journal of the American Medical Association revealed that retrievable IVC filters may in fact confer “no benefit in terms of pulmonary embolism recurrence or mortality”. If this is indeed the case, then plaintiffs in Cook and Bard IVC filter lawsuits will likely feel even more wronged by the manufacturers of these faulty IVC filters. Speak with your doctor or physician about any health concerns you may have.