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Researchers Question IVC Filter Safety and Effectiveness

Researchers Question IVC Filter Safety and Effectiveness

March 21, 2013 — An editorial and two studies published in the Journal of the American Medical Association are questioning whether IVC filters are safe or effective. These filters are cone-shaped wire cages that are implanted in a patient’s inferior vena cava (the blood vessel between the heart and the lungs) to prevent blood clots in the lungs (pulmonary embolisms). They are usually used in patients at high risk of a pulmonary embolism who cannot take a blood-thinning medication.

Unfortunately, there is little evidence that IVC filters are actually safe or effective. In an editorial titled “How could a medical device be so well accepted without any evidence of efficacy?” researchers warned that scientific studies do not back up assumptions about the safety of IVC filters.

The editorial also warned about “shortcomings of medical device approval in the United States.” Modern IVC filters (such as the Bard G2 and Recovery IVC filters) were approved by the FDA would requiring clinical studies because they are “substantially equivalent” to products that were originally designed in the 1960s and 1980s. The editorial noted that the original IVC filters were “plagued by high rates of IVC occlusion (in over half of patients), pulmonary embolism (PE), and migration.” In 1981, the Greenfield filter became standard. Although the Greenfield was an improvement, safety studies are “uninterpretable” due to a lack of a control group and the fact that many subjects died. Even so, by 2000, about 50,000 IVC filters were implanted every year and four major medical groups endorsed IVC filters.

Today, this study indicates that there is no standard practice for when to implant IVC filters. Researchers found wide variation in the rate of IVC filter placement in California hospitals between January 2006 and December 2010, even after controlling for socioeconomic and clinical factors. It is unknown why some hospitals are more likely to implant an IVC filter than others.

JAMA also published another study that raises serious concerns about the safety of retrievable IVC filters:

  • In a study of 679 retrievable filters, only 58 (8.5%) could be successfully removed. This is concerning because the FDA has warned that retrievable IVC filters should be removed as soon as they are no longer necessary due to an increasing risk of life-threatening complications over time.
  • In 13 cases, surgeons tried to remove the filter, but were unsuccessful.
  • Blood clots occurred in 7.8% of 952 patients implanted with an IVC filter.
  • Pulmonary embolism occurred in 2.6% of patients implanted with an IVC filter.
  • 48% of patients who developed a blood clot suffered the complication after getting an IVC filter.
  • Researchers found that a blood-thinning medication may have been a more appropriate way to prevent a pulmonary embolism for many patients. Nearly 25% of patients were prescribed a blood-thinner when they were discharged.

The researchers warned against using IVC filters due to the high risk of blood clots:

“Our research suggests that the use of IVC filters for prophylaxis and treatment of venous thrombotic events, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes due to high rates of venous thromboembolism.”

Do I have an IVC Filter Lawsuit?

The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.

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