Phillips was implanted with Bard’s RFS on August 4, 2005. “It subsequently failed and migrated to his heart, perforating his heart and causing severe and life-threatening complications requiring emergency open-heart surgery on April 30, 2010, and resulting in various economic and non-economic damages,” court documents state.
In August, 2011, the Food and Drug Administration (FDA) received a personal injury report of a patient requiring hospitalization due to the breakage of an implanted Bard inferior vena cava (IVC) Filter, specifically a G2 IVC Filter. According to the report, the fracture of IVC arm was found on CT scan. This incident, which is not isolated, came after an FDA- issued warning in August 2010, citing problems with retrievable IVC filters including hematomas. In a study published in 2010 in the Annals of Vascular Surgery, migration/tilt was higher in Bard filters compared to other filters.
READ MORE LEGAL NEWS
The reported problems with the BARD IVC filters include a high rate of perforation of the vena cava resulting in perforation of the surrounding tissue, intestines, spine, vertebrae and arteries.
IVC filters are small, spider-like devices which are surgically inserted into the inferior vena cava to prevent blood clots from reaching the lungs. But these devices can suffer from fatigue, causing them to fail and fracture, ultimately migrating through the body causing damage which could be life-threatening.
Complications due to a failure of an IVC filter can include pulmonary embolus, severe and constant pain in the chest, heart or other parts of the body, respiratory distress, tissue perforation, organ perforation, vessel perforation, and hemorrhage.