Despite FDA Warnings IVC Filter Use Remains ‘Unacceptably High’

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U.S. doctors have decreased their use of inferior vena cava (IVC) filters since a 2010 safety communication from the U.S. Food and Drug Administration, but the devices — an alternative for blood-thinners to prevent a pulmonary embolism — continue to be implanted at “unacceptably high rates,” according to an article published on TCTMD.com, an interventional cardiology site for clinicians and industry professionals.

The filters are tiny devices placed in patients at risk of pulmonary embolism who cannot take an anticoagulant (blood-thinner) or for whom anticoagulant therapy is ineffective.

IVC FilterThe inferior vena cava is the body’s largest vein, and along with the superior vena cava, carries deoxygenated blood from the body to the heart.

The superior vena cava transports blood from the upper half of the body, while the inferior vena cava is responsible for the body’s lower half.

The FDA in 2010 warned that IVC filters intended for short-term placement could pose health risks if not removed once a patient’s risk of pulmonary embolism had subsided.

In 2014, the agency issued an updated safety communication noting that it had received reports of adverse events that could be associated with long-term IVC filter use.

While IVC filter use declined following the FDA’s warning, a new analysis shows that American doctors continue to implant the devices far more often than seen in Europe, according to a research letter published in the peer-reviewed medical journal JAMA Internal Medicine.

“Because the rate of (IVC filter use) in five large European countries is less than 3 per 100,000 population, we believe that the appropriate implantation rate in the United States should be similar to or lower than the rate observed in Europe,” the study’s lead author, Dr. Satyajit Reddy of Temple University Hospital wrote.

Comparatively, IVC filter implantation rates in the U.S. in 2014, the final year of the study period, were 39.1 per 100,000.

The study found that given the complications associated with IVC filter use, the devices “should be mostly reserved for those patients with an absolute indication like active bleeding.”

Johns Hopkins Medicine’s Dr. Elliott Haut told TCTMD that it’s possible that IVC filter use is “overused in some patient populations and underused in others.”

“We know they help some patients,” he said. “We just don’t know how exactly to pick the one-in-a-thousand person that’s going to need it and benefit from it the best. So the broad approach of putting tons and tons and tons in to prevent one fatal pulmonary embolism . . . is probably not cost-effective, probably not efficient, probably not safe for patients, but I think we have to figure out a better way to know which are the patients who are going to benefit from it.”

If you suffered injuries due to IVC filter use, contact the attorneys at McDonald Worley for a free case evaluation. Fill out the form on this page and an experienced IVC filter attorney will contact you about litigation options.