Understanding the FDA’s Position on IVC Filters

What is an IVC Filter?

An inferior vena cava (IVC) filter is a small metal device that is implanted in the inferior vena cava in order to prevent life-threatening blood clots from moving to the patient’s lungs. These devices have been used by medical specialists for decades, and they were only recommended in high-risk scenarios where less invasive treatments (such as anti-coagulants) were not feasible.

FDA Communications

In 2010, the FDA released its first official communication regarding IVC filters. Below is an excerpt from that communication, specifically referring to the 2005-2010 time period:
“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforations of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients.”

At the time, it was believed that the majority of these complications were due to the device remaining in place for longer than necessary.

Known Long-Term Risks Associated with IVC Filters

The FDA has recommended that IVC filters be removed as soon as the patient’s risk for pulmonary embolism has subsided.

This reduces the risk of long-term complications, which may include any of the following:

  • Vena Cava Thrombosis • Deep Vein Thrombosis (DVT)
  • Filter fracture • Filter embolization • Device migration • Perforation of the Vena Cava • Device-associated death

In October 2013, the Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. Among other information provided in the publication, it was found that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor the removal of the IVC filter between 29 and 54 days after implantation.

If you or a loved one have suffered from complications as a result of a poorly-managed inferior vena cava filter, contact Coxwell & Associates, PLLC at (601) 265-7766 for a consultation.

Disclaimer: This blog is intended for general information purposes only, and is not a substitute for legal advice. Anyone with a legal problem should consult a lawyer immediately.

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