The Food and Drug Administration (FDA) issued two safety memos on August 9, 2010, regarding the installation and use of Inferior Vena Cava (IVC) filters. FDA’s Medwatch memo was targeted toward surgeons and emergency medical personnel. The Safety Communications memo was targeted toward all medical personnel involved in the installation and continuing treatment for patients receiving the device. If you are at risk for Pulmonary Embolism (PE), or blood clots in the lungs, and an anticoagulant therapy is not an option, you may be a candidate for an IVC filter.
The IVC device is installed in the vena cava, the main vein returning blood from the lower body to the lungs, and is a cage-like object with a filter, which prevents clots from moving past. Complications may range from, detaching of device components, filter fragmentation, movement of the entire assembly, and perforation of the vena cava. Complications may be serious and may lead to death.
Since 2005, the FDA has had nearly a thousand adverse events reported regarding this device, with complications ranging from devices moving or detaching, to filter fragments breaking off and moving through the blood stream to the lungs.
- 35% of reported problems for device migration
- 15% of reported problems involved detachment of device components
- 7% of reported problems involved device perforation of blood vein
- 6% of reported problems for filter fractures
In 2007, over 167,000 IVC filters were installed, with expectations that 2012 would have nearly 260,000 filters installed nationwide. Filters are built to either be permanently installed, or removed after the risk of PE subsides. The FDA encourages all physicians to consider removal of filters when no longer needed to mitigate the risks of device failure.