Device name: IVC filter
Uses: Inserted into the inferior vena cava to catch blood clots and prevent them from migrating to the lungs, heart or brain.
Malfunctions: A tendency to break apart, creating the risk of shards traveling through the bloodstream and embedding in major organs.
Bard IVC Complications:
A blood clot in a major vein, called deep-vein thrombosis, can be deadly if it breaks off and travels to the heart, brain or lungs – where it can trigger a heart attack, stroke or pulmonary embolism. The Bard IVC filter is a small, cage-like device inserted into a major vein that runs from the legs to the heart, which is supposed to catch blood clots before they can reach any major organs.
But the device’s tendency to break apart can be just as dangerous as the conditions it’s supposed to prevent.
— A study by the New England Society for Vascular Surgery found a 31 percent fracture rate in IVC filters, with most of the broken-off splinters migrating to the hearts’ right ventricle.
— Another study conducted at York Hospital in York, Pa., found that 25 percent of IVC filter recipients had splinters break off, migrating to organs including the heart and lungs.
IVC filters, designed to be temporary and retrievable, were never intended for long-term use. The U.S. Food and Drug Administration recommends that they be removed as early as possible.
But Bard allegedly petitioned for the devices to be approved as a permanent implant, despite the fact that the company’s own research showed as early as 2003 that the filters posed an unreasonable danger to patients.
The company allegedly withheld those findings from the FDA and continued to sell and market the a dangerous filter, only withdrawing it from the market once the company had a replacement ready in 2005
The company failed to warn patients of the danger, change its recommendations or recall the product in a timely manner, putting the lives of patients at risk for two years or more.
Dangerous Complications Reported for Blood Clot Filters
According to a story in the Boston Globe, the U.S. Food and Drug Administration reported more than 900 reports of problems with IVC filters, such as those manufactured by Bard, since 2005.
The story describes the filters as small devices with spidery metal legs, inserted inside a large abdominal vein to keep clots from traveling to the lungs.
The problem is that the filters can shift. Or pieces can break off to drift through the bloodstream, where they’re at risk of perforating vital organs including the heart.
About 30,000 filters are implanted each year, according to the story. Although they’re sometimes left in for the long term, the FDA says doctors should consider removing them as soon as a patient’s risk of clots subsides.