In a MedWatch posting, the FDA has recommended that physicians consider removal of retrievable Inferior Vena Cava (IVC) filters “as soon as protection from Pulmonary Embolism is no longer needed.” Previously, in most places the standard of care regarding IVC filters was to consider placement to be irrevocable unless otherwise indicated.
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
While it’s nice to know the risks and attach numbers to the different kinds of (sometimes spectacular) device failures, our sense of the matter is IVC filters aren’t placed on just anybody. These are patients that have failed medical management of DVT, have clotting disorders, or both. For many of these patients, the risk for PE will never “subside” so IVC removal isn’t an appealing prospect. If the FDA (or some specialty society) could give guidelines as to how frequently these filters should be replaced, well, we’d be happy to report that good news.
FDA: Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
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