Retrievable IVC Filter Litigation

Inferior Vena Cava filters (IVC filters) are spider-like medical devices inserted into the inferior vena cava to catch blood clots before they move to 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.

 

Many IVC filters are designed to be permanent implants although some of these devices are designed to be retrieved and removed.  Retrievable IVC Filters are at the center of this litigation.  Each year, approximately 200,000 blood clot filters (IVC filters) are implanted by surgeons to prevent pulmonary embolisms.

 

Reports of adverse events and product problems with IVC Filters have grown and have caused the Federal Drug Administration (“FDA”) to perform post market surveillance studies on these devices. The following adverse events have been found to potentially occur with these devices:

 

• Filter fracture

• Migration of the filter

• Perforation of the heart, lungs, kidneys, or blood vessels

• Erosion into the inferior vena cava (IVC)

• Bleeding or fluid build-up around the heart (hemorrhagic pericardial effusion)

• Embolization of broken filter fragments into the heart or lungs

• Deep Vein Thrombosis (DVT)

• Pulmonary Embolism

• Irregular heartbeat

• Additional surgery

• Disability

• Death

• Difficulty removing the devices

 

For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides. 

 

The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.

 

When feasible and clinically indicated, the FDA suggests retrievable IVC filters be removed.

 

"Removing Retrievable Inferior Vena Cava Filters: Initial Communication" - by the FDA, August 9,2010

 

"Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication" - by the FDA, May 6,2014

 

If you, or someone you know, has been injured by an IVC Filter... contact us today for FREE case evaluation.