IVC FILTER COMPLICATIONS

IVC FILTER COMPLICATIONS

Retrievable IVC filter devices have been linked to a number of adverse health risks that the manufacturers failed to test for and warn consumers about.  IVC filters are used in patients who are at risk of developing blood clots, but who are not candidates for blood thinner medication.  Despite these being temporary filters, IVC filters were rarely removed and patients are reporting serious IVC filter complications and injuries including perforation or other damage to organs when the device migrates or fractures.  If you or a loved one were injured by an IVC Filter, please fill out our free case review form or contact us at 1.888.213.0761.

WHAT IS AN IVC FILTER?

IVC filters are small, cage-like devices that are surgically implanted into the inferior vena cava (IVC) to capture blood clots and prevent them from reaching the heart and 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.  Reports estimate that more than 250,000 devices are implanted each year, but only a small percentage of the filters are removed.

 

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.

IVC FILTER COMPLICATIONS

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

  • Deep vein thrombosis (DVT)

  • Emergency removal of a device

  • Hemorrhage

  • IVC filter migration

  • Perforation of tissue, vessels, and organs

  • Pulmonary embolism

  • Respiratory distress

  • Severe pain

  • Shortness of breath

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FDA WARNINGS - IVC FILTERS

The FDA first released a public safety communication in 2010, warning of possible adverse health events associated with long-term IVC filter use.

  • August 2010: The FDA reported that it had received more than 900 reports of people suffering adverse events following the implantation of a filter. These events included device embolization, fractures, perforation of organs, and device migration. The agency recommended that doctors remove filters as soon as they were no longer needed.

  • May 2014: The FDA updated its 2010 warning to recommend that doctors take out IVC filters within 29-54 days of implantation. It is requiring IVC Filter manufacturers to conduct studies of the device’s safety.

  • July 2015: The FDA issued a warning letter to C.R. Bard after an FDA investigation found that the manufacturer was producing a certain IVC filter device removal system without marketing clearance or approval.  The letter also informed Bard that it was (1) not following good manufacturing practices in the manufacture, storage, and packaging of IVC filters; (2) did not properly establish and maintain procedures in regard to reviewing and evaluating complaints relating to certain models; and (3) did not report information that reasonably suggested its devices had malfunctioned, and those malfunctions could lead to either a severe injury or death.

IVC FILTER COMPLICATION NEWS

HOW WE CAN HELP

FrancoLaw is currently pursuing IVC filter lawsuit cases for patients who used retrievable IVC filters manufactured by the following companies (C.R. Bard, Cook, Cordis and Argon) and sustained the following injuries:

  • Filter fracture

  • Filter migration

  • Perforation of the vein

  • Embedment into organs/tissue

  • Death

If you believe that you have suffered one or more of the injuries mentioned above because of an IVC Filter manufactured by one of these companies, you may want to consider filing a lawsuit.  For more information, or to speak with someone about your potential case, please call us toll-free at 1.888.213.0761 or fill out our free case review form. FrancoLaw is experienced in handling medical device cases and we welcome any questions you may have.

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