IVC FILTERS

Product

IVC Filters

Drug Class

Medical device implant

Indication for Use

Prevention of pulmonary embolism

Injuries

Filter fragmentation or fracture
Fragmentation embolism
Pulmonary embolism
Perforation of vessel walls
Filter migration
Filter tilt or shift
Infection
Death

About

IVC filters are devices surgically implanted into the inferior vena cava below the renal branches and attached to the wall of the vessel to filter out blood clots and prevent pulmonary embolism. While anticoagulant medication is the first choice for clot prevention, IVC filters were initially developed for permanent placement and use where anticoagulant medication is unsuccessful or contraindicated.

Retrievable IVC filters were developed around 2002 to 2003 for use in a patient population where removal was possible once a medical condition improves, such as with trauma patients or those undergoing orthopedic procedures. However, removal becomes increasingly complex the longer the IVC is left in place. Both permanent and retrievable IVC filters pose substantial risks.

In August 2010, the FDA issued a safety communication regarding retrievable IVC filters. The agency was concerned about doctors not retrieving IVC filters intended for short-term placement, exposing patients to substantial health risks.

Litigation is pending in state and federal court against the two manufacturers with the largest share of IVC filters on the market, C.R. Bard and Cook. Multidistrict Litigation (“MDL”) number 2570 is pending against Cook in the Southern District of Indiana before the Honorable Judge Laura A. Briggs, and it is anticipated that an MDL will be formed for the Bard litigation as well.