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Dangers of Retrievable Inferior Vena Cava Filters: FDA Investigates Delayed Removal Risk of IVC Filters

Christine Loughran

Last updated: November 9, 2016 8:39 pm

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Retrievable inferior vena cava (IVC) filters are sometimes implanted in people at risk for developing serious and life-threatening blood clots, especially those who cannot take blood-thinning medication or have had recurrent blood clotting problems in spite of being on blood-thinning medication. 1 The U.S. Food and Drug Administration (FDA) reported in August 2010, that use of IVC filters has increased dramatically. Nearly 167,000 IVC filters were implanted in 2007, according to the agency. In 1979, that number was just 2,000. 2

The purpose of the inferior vena cava is to transport blood from the lower half of the body back to the heart. For patients at risk of  blood clots, which can then travel to the lungs, a condition known as pulmonary embolism (PE), retrievable IVC filters may be chosen as an alternative to anticoagulant medicines (commonly referred to as blood thinners), especially if a person cannot take blood thinners or clots keep forming after they are put on a blood thinner. 3

FDA Says Delayed Retrievable IVC Filter Removal May Cause Medical Complications

In May 2014, the FDA issued an official safety communication to physicians who implant IVC filters or care for patients that have had them implanted. The FDA advised that once a patient is determined to no longer be at risk for PE, physicians should “consider removing the filter as soon as protection from pulmonary embolism is no longer needed.” According to a quantitative decision analysis conducted by the FDA, “the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.”

Why? According to a notice published on the FDA’s website, the agency has received numerous adverse event reports that mention the following retrievable IVC filter complications:

  • Blood clot filter migration
  • Filter fracture
  • Embolization (movement of the entire filter or filter fracture fragments to the heart or lungs)
  • Perforation of the IVC
  • Difficulty removing the filter 4

The FDA determined that the adverse events described in these reports might not have occurred if the retrievable IVC filters had been removed sooner. The FDA ordered device manufacturers to collect additional data regarding use of retrievable IVC filters in patients, to get a clearer picture on the safety of these devices. 5

The FDA’s analysis on blood clot filter removal, which looked at retrievable IVC filter removal data, was published in an October of 2013 issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders. 6

FDA Warns Against Blood Clot Filter Misbranding

In the past year, the FDA has taken a closer look at companies producing retrievable IVC filters. Most recently, C.R. Bard, Inc. was sent a warning letter for adulterating and misbranding its Recovery Cone Removal System, Model RC-15, intended for use by the company with its Recovery Filter, Recovery G2 Filter and the G2X Filter.

Learn more about the risks and possible side effects of retrievable IVC filters.

  1. https://my.clevelandclinic.org/services/heart/services/venous-blood-clots-treatment/ivc-filter-retrieval 

  2. U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: Initial Communication. August 9, 2010. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm.  

  3. WebMD, Lung Disease & Respiratory Health Center. http://www.webmd.com/lung/tc/pulmonary-embolism-other-treatment

  4. U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. May 6, 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm

  5. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm; Endovascular Today, PRESERVE Study to Be a Comprehensive Evaluation of Inferior Vena Cava Filter Use. October 11, 2012. http://evtoday.com/2012/10/preserve-trial-to-be-a-comprehensive-study-of-inferior-vena-cava-filters 

  6. U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. May 6, 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm; Morales JP, et al., Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. http://dx.doi.org/10.1016/j.jvsv.2013.04.005