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Federal health regulators are warning that Inferior Vena Cava (IVC) filters, which are small, spider like devices inserted into the vein to “catch” blood clots travelling to the lungs, should be removed within about one to two months after the risk of a pulmonary embolism has passed.
On May 6, the FDA issued a safety communication that updates recommendations on removing retrievable IVC filters.
The update comes nearly four years after the agency warned that it had received hundreds of reports of IVC filters breaking inside patients, causing damage to the heart, lungs and other organs.
Inferior vena cava filters are an alternative treatment for patients at risk for a pulmonary embolism, which are often used when an anticoagulant is contraindicated or if such medications have not been effective. They contain a number of legs or struts that extend out within the inferior vena cava to prevent blood clots that may broken free elsewhere in the body from entering the lungs.
In August 2010, the FDA reported that it had received more than 900 adverse event reports involving the filters. Researchers also found a high rate of failure with the Bard Recovery IVC Filter, which had a 25% failure rate, and Bard G2 IVC Filters, which had a 12% failure rate. At the time, the agency indicated that doctors should consider removing the filters, which were often being left in place even though they are designed to be retrievable.
The new, more detailed recommendations released this week advise doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.
Studies Find Rampant Off-Label Use, Question Effectiveness
That determination came from the findings of a decision analysis published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013.
The filters are only supposed to be used in patients who have suffered a previous pulmonary embolism and for whom blood thinners have been contraindicated. However, the study also revealed that many doctors in the U.S. are using IVC filters off-label; implanting them in patients with blood clot problems without a history of pulmonary embolism (PE) and for whom blood thinners have not been tried.
“The widespread off-label use of IVC filters outside of FDA-cleared indications is believed to account for more than 50% of IVC filters implanted in the United States, and this percentage is likely to increase,” the study’s authors noted. “According to the most recent IVC filter consensus panel, 50% or fewer of retrievable IVC filters are ever removed, although it is unknown whether they were implanted for transient high risk of PE or for the management of chronic venous thromboembolism.”
Another study published in JAMA Internal Medicine in March 2013 raised questions about whether IVC filters made a difference even when used correctly. Researchers found that less than 10% of the filters were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.
Of the 921 adverse event reports described in the 2010 FDA warning, the agency indicated that 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.
C.R. Bard faces a number of IVC filter lawsuits over its Bard Recovery and Bard G2 filters. Allegations raised in each of the complaints indicate that C.R. Bard knew for years that their IVC filters were prone to fracture, which can cause severe complications, including death, but failed to warn doctors and patients.