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Inferior Vena Cava (IVC) Filters

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The Device
 

IVC filters are small metal devices inserted into the inferior vena cava via access to the jugular or femoral vein.  The umbrella-like filter shape allows the device to catch clots traveling through the bloodstream before they can reach vulnerable organs, preventing complications such as pulmonary embolism.  The filters are typically used when blood-thinners are contraindicated, and come in two types: permanent and retrievable.  To date, the focus of IVC filter litigation has primarily revolved around the poor design and inadequate safety and efficacy profile of the retrievable filter models.

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The Controversy

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In August 2010, the FDA issued a warning to doctors, alerting them about the risk of adverse events with retrievable IVC filters, such as those manufactured by Cook, Cordis and C.R. Bard.[i] The agency indicated that the filters should be removed in many cases once the danger of a pulmonary embolism has passed.

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At least 900 adverse event reports have been received by the FDA involving complications from IVC filters. One of the most common complaints is of the filter, or a piece of the filter, breaking off and migrating through the patient’s body.  Perforation and tilting of the device has also been reported, and in many cases result in the inability to retrieve the device safely.

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In May 2014, the FDA issued an updated safety statement indicating that patients may face an increased risk of problems with IVC filters the longer they remain in place, advising doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.[ii]

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In April 2015, a study published in the Journal of the American Medical Association (JAMA) found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism. The researchers found that filter recipients were twice as likely to have a blood clot travel to their lungs than those on blood thinners. [iii]

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A study published in August 2015 in a letter in JAMA warned that the long-term risks of IVC filters may negate any health benefits they provide in catching blood clots.[iv]

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The FDA issued a warning letter to Bard in July 2015 for illegally marketing a device used to remove IVC filters, failing to report adverse events, failing to cooperate with the FDA, as well as highlighting problems with its Denali IVC filter.[v]

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Finally, in August 2015, NBC Nightly News aired a two-part special on the Bard Recovery IVC filter, one of the first retrievable devices on the market.  In their report, NBC detailed failures in reporting known adverse events (including deaths), suppression of internal-data exhibiting how dangerous the devices are compared to competitors, and that FDA clearance was based on a forged document.[vi]

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Injuries

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  • IVC filter migration

  • IVC filter fracture

  • IVC filter perforation

  • Tilting of the IVC filter

  • The inability to retrieve the IVC filter

  • Pulmonary embolism

  • Compromised respiration

  • Stroke

  • Death

 

We want to help

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If you or a loved one have suffered from any of the above complications associated with IVC filters, please contact Freese & Goss today. 

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[i] http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm

[ii] http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm

[iii] http://jama.jamanetwork.com/article.aspx?articleid=2279714

[iv] http://archinte.jamanetwork.com/article.aspx?articleid=1669099

[v] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm

[vi] http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

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