In August 2010, The Food and Drug Administration (FDA) issued an important safety communication regarding retrievable inferior vena cava (IVC) filters. These filters were originally believed to be a safe long-term treatment for those at risk for suffering pulmonary embolism (PE). Now, the FDA is advising they are no longer safe for permanent placement.
The warning was given after the FDA received almost 1,000 adverse events reports regarding IVC filters.
Reported IVC filter complications include:
- Device migration—328
- Detachment of device components—146
- IVC perforation—70
- IVC filter fractures—56
The longer the IVC filter is left in, the more at risk the patient becomes for suffering one of the these adverse events. The FDA has recommended that the IVC filter be removed as soon as the risk of PE has gone away. Patients using an IVC filter are encouraged follow up with their doctor regarding the appropriate length of IVC filter treatment and potential IVC filter risks.
Since the FDA’s warning, several lawsuits involving Bard IVC filters have been filed.