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IVC Filter

Since the introduction of IVC filter in 2005, the FDA has received thousands of adverse reports involving these filters. Specifically, it was reported that the IVC filters fragment and embolize in the body.

 

What is an IVC Filter?

IVC filters are small, cage-like devices that are inserted into the inferior vena cava to capture blood clots and prevent them from reaching the lungs. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective. IVC filters are designed to be permanent implants although some of these devices may have the option to be removed.

The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes such as:

  • Death
  • Cardiac tamponade (fluid build up)
  • Deep vein thrombosis (DVT)
  • Emergency removal of device
  • Hemorrhage
  • IVC filter migration
  • Perforation of tissue, vessels, and organs
  • Pulmonary embolism
  • Respiratory distress
  • Severe Pain
  • Shortness of breath

 

Removal of an IVC Filter

Unless there is a very good reason to keep the IVC filter in place, the FDA now recommends the removal of retrievable IVC filters.

According to a safety communication posted by the FDA in August of 2010, IVC filters are intended for short-term placement and have caused risks when left in long-term including lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation. The FDA’s original safety alert was then followed up by a decision analysis published in the Journal of Vascular Surgery: Vein and Lymphatic Disorders in October 2013.

Research studies confirm the problems with the retrievable IVC filters. A 2013 research study published in the Journal of American Medical Association (JAMA) looked at the filter’s failure. It reviewed medical records of a level 1 trauma center for the indications, complications, and management of the IVC filters.

 

Despite FDA Warnings, Physicians Were Not Removing the Filters

Researchers discovered only 58 out of 679 (less than 10%) retrievable IVC filters inserted were actually removed. Other results discovered a majority of the filters remained in patients longer than medically necessary with the following results:

  • 18.3 percent failed attempts at removing the filters
  • 7.8 percent had venous thrombotic events.
  • Approximately 25 of those events were pulmonary embolism

 

Lawsuits Filed on Behalf of Injured IVC Filter Patients

It is up to the manufacturer to satisfy safety concerns using a combination of testing and trials. However, many lawsuits have been filed claiming that the manufacturers of these filters have not satisfied safety concerns and, instead, continue to move forward with sales of these filters.

As of 2012, it is estimated that 259,000 filters were deployed and the market value of vena cava filters continues to increase despite FDA warnings. Today, the IVC filter market is worth $190 million and is growing.

As of today, several hundred lawsuits have been filed and continue to move forward against Bard and Cook Group, the largest manufacturers of IVC filters.

The most recent trial to make it through the court system ended with a settlement in January of 2015. After 11 days of trial, Bard made a confidential offer accepted by the plaintiff.

IVC Filter lawyers presented evidence that showed that Bard was aware that failures of the Recovery filter were causing patient deaths and severe injuries by early 2004. Furthermore, IVC filter lawyers claim that the IVC filter used posed an unacceptable risk to human health and the public is not being warned of these risks.

 

References:

“Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism.” Journal of Vascular Surgery Venous and Lymphatic Disorders, www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM396384.pdf.

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