Some patients who received an IVC filter say they came down with IVC filter removal complications, forcing them to leave failed filters in place.

These filters are implantable devices used as an alternative to anticoagulant medication in patients for whom such medication is not a good idea.

The “IVC” stands for “inferior vena cava,” the large vein that returns blood from the lower body to the heart.

A doctor positions the filter inside the inferior vena cava, where if all goes well it remains in place and blocks blood clots from traveling from the legs towards the heart and lungs, where they could otherwise cause a potentially fatal pulmonary embolism.

Some IVC filters are designed to remain in place indefinitely. Others are designed to be removed after the risk of embolism has passed.

But some IVC filter removal complications may prevent retrievable filters from being removed.

In a study published in the Journal of the American Medical Assocation in 2013, researchers noted that over 18 percent of attempts at removing IVC filters were unsuccessful. Patients whose filters can’t be removed may then have to live with the ongoing risk of future IVC filter complications.

The risk of IVC filter removal complications prompted the FDA to issue communications in Aug. 2010 and updated in May 2014, recommending that retrievable IVC filters should be removed from the patient as soon as they are no longer at risk for embolism.

The agency says the risk of IVC filter removal complications warrants that these devices remain implanted no longer than is absolutely necessary.

FDA Relays Reports of IVC Filter Removal Complications

The FDA keeps track of these reported incidents though its adverse event reporting system.

According to the agency’s 2010 communication, the FDA at that time had received over 900 reports of adverse events involving IVC filters. Among those reports:

• Over 300 involved device migrating out of their proper position;
• 70 reports involved perforation of the surrounding tissue; and
• Over 50 reports said the filter had fractured into pieces.

In the 2014 update, the FDA also noted cases of IVC filter occlusion and lower limb deep vein thrombosis have been observed in conjunction with the long-term use of these filters.

The FDA believes complications like these happen in part because the filter is left in place longer than is medically necessary.

For that reason, the agency recommends they be removed as soon as they’re no longer needed.

The risks associated with these devices – and more specifically, the ways in which their manufacturers dealt with those risks – have prompted a wave of products liability litigation.

Manufacturers like C.R. Bard, Cook Medical and Boston Scientific have been on the receiving end of claims of negligence by patients who say their IVC filter removal complications could have been avoided.

One plaintiff claims pieces of her fractured IVC filter migrated to her heart. When informed that removal of the pieces would require open-heart surgery, she opted instead to take anticoagulant medications for the rest of her life.

Other plaintiffs allege fractured filter parts migrated throughout their bodies, sometimes lodging in place and defying attempts at removal.