The Department of Cardiology at York Hospital in York, Penn., conducted a study to test the safety of C.R. Bard’s IVC filters – particularly the Recovery and G2 models – and concluded with shocking results.
A retrievable IVC filter is a spider-like device inserted into the inferior vena cava (the largest vein in the body) and is supposed to catch blood clots that could make their way to the lungs and/or heart, resulting in pulmonary embolism. The retrievable types are intended to be removed after a certain length of time, and are not to be permanent. However, when the device has been damaged or has moved, in some cases, it is impossible to retrieve.
When recipients of C.R. Bard’s inferior vena cava (IVC) filters began having issues with their device, York Hospital put them to the test. The patients were experiencing issues with perforation of organs and tissue, migration of the filter itself, and fractures of the legs of the device. The tests sought to determine the prevalence of fracture and embolization of the Bard filters.
Eighty patients participated in the trial, with 28 Recovery filters and 52 G2 filters. Thirteen of the 80 patients experienced serious issues.
All 13 experienced at least one strut fracture, which is where a leg of the device breaks off inside the body. Seven of the 28 Recovery filters failed, five of which had a fragment embolize to the heart. Six of the 52 G2 filters failed. These patients experienced anything from ventricular tachycardia, ventricular tamponade, end-organ fragment embolization, or even death.
With these shocking numbers, it’s no surprise that the lawsuits have piled up for makers of failed retrievable IVC filters resulting in injury or death.
Other IVC filters prone to failure are: Bard’s G2 Express, Cook Medical’s Gunther Tulip, and Cook Medical’s Celect Filter.