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Drugs & Medical Devices

IVC Filters: FDA Was Wary Four Years Back

— December 23, 2014
CR Bard Logo - IVC Filters
CR Bard is one of the world’s largest manufacturers of IVC filters.

Have you ever seen one of those metal head massagers, the ones with thin, spider-like metal legs that bend and flex to tickle your scalp?  That’s pretty much exactly how inferior vena cava filters look, except IVC filters are much smaller – they fit inside a vein, and are used to catch blood clots before they get to your lungs.

[Click to watch an animation showing how IVC filters work]

Inferior vena cava (IVC) filters have been used at an increasing clip since the late 1970s.  These small, removable, “cage-like devices … are inserted into the inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs.  IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective.” (FDA)

Sometimes, IVC filters are implanted permanently, but this is not usually necessary, and most patients use removable models.  Unfortunately, the FDA writes it has “received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes.”  The Administration noted that these adverse events could be related to how long the filter had been implanted in the IVC – and this makes sense: the longer a tiny metal head massager sits in one’s vein, the more likely it could be to poke through the vein, or become difficult to remove.

The FDA continues, stating, “Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion.”

Because it’s recently come to light that many IVC filter manufacturers knew of these risks and downplayed them, a number of IVC filter lawsuits have been filed – at least 39 so far, all across the county.  And further, IVC filter multidistrict litigation has been filed, consolidating the cases against Cook Medical in Indiana’s Southern District. (In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices, and Products Liability Location, MDL No. 2570.)

Again, as the results of these IVC lawsuits and IVC MDL become clear, we’ll update you here at LegalReader with everything you need to know.

FDA logo - IVC Filters

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