Pharmaceutical

Fewer IVC filters implanted since FDA warning

IVC filter 294x210 Fewer IVC filters implanted since FDA warningThe rate of inferior vena cava (IVC) filter placement has declined nationally since reaching a peak in 2010, a trend experts say was triggered by a 2010 Food and Drug Administration (FDA) warning regarding serious risks associated with long-term use of the blood clot-catching devices.

An IVC filter is a tiny, cage-like device that is implanted into the inferior vena cava – the large vein that carries deoxygenated blood from the lower body to the heart – to prevent blood clots from reaching the lungs, a condition called pulmonary embolism.

The FDA warning stated that long-term risks associated with IVC filters included lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. The fragmented and/or migrated filters can damage tissue, puncture organs and lead to serious complications including death.

The warning appeared to have reversed a 31-year trend of rising IVC filter use, said researchers with the Washington University School of Medicine in St. Louis. It also triggered thousands of lawsuits.

The first bellwether trial against Cook Medical Inc.’s IVC filter is currently underway in the U.S. District Court for the Southern District of Indiana. Plaintiff Elizabeth Jane Hill alleges that she was implanted with Cook Medical’s Celect IVC filter before undergoing back surgery. Hill claims that the filter migrated from where it was placed and perforated both her vena cava and her duodenum, a portion of the small intestines.

Surgeons tried repeated to remove the allegedly defective device, during which Hill suffered severe gastrointestinal symptoms including diarrhea, vomiting, abnormal pain and fatigue. Once the filter was removed, doctors discovered that she had permanent damage, including narrowing of her inferior vena cava where the device was implanted as well as the part of her intestines where the device migrated, leaving scar tissue along the path her IVC filter traveled inside her body.

Sources:
MedPage Today
Righting Injustice