Some recipients of the Celect IVC filter say they should have been given better warning about the device’s potential complications.

An IVC filter is a medical device used to prevent blood clot-related complications in patients for whom anticoagulant medication would be either unsafe or ineffective. It consists of a basket-shaped assemblage of metal wires.

The filter is positioned inside the inferior vena cava, the largest vein in the body. There an IVC filter can trap blood clots that form in the lower part of the body and migrate toward the heart and lungs, preventing them from causing pulmonary embolism.

These filters don’t necessarily have to be permanent. Some, like the Celect IVC filter, are designed to be removed once the danger of pulmonary embolism has lessened.

The FDA recommends removing these removable filters as soon as possible once they are no longer needed to avoid possible complications. In a safety communication issued in August 2010, the agency said it had received over 900 reports of adverse events involving IVC filters. These reports included instances of perforation of the vein, migration away from the device’s proper position, and fracture of the filter.

Study Shows a Higher Rate of Perforation

A recent study of two such retrievable filters found the Celect IVC filter had a higher rate of perforations than a competitor filter.

The study was published in the June 2015 issue of the Journal of Vascular and Interventional Radiology. Researchers wanted to evaluate how retrievable the Celect IVC filter is in comparison to the Option IVC filter made by Rex Medical. While the two different filters’ retrieval rates were “not significantly different,” the researchers did note that the incidence of strut perforation with Celect IVC filters was 43 percent, compared to zero for the Option filters.

In an earlier study from 2009, researchers noted that in some cases the Celect IVC filter could not be removed because its hooks had become imbedded in the walls of the vein where it had been implanted.

The Celect IVC filter is made by Cook Medical. The FDA approved the Celect for sale using an expedited approval process that does not require the manufacturer to conduct new clinical studies for safety when the device to be approved is similar to another device that has already been approved.

Lawsuits Over the Celect IVC Filter

Filters made by Cook Medical are the subject of a collection of lawsuits now pending in a federal court in Indiana. This multidistrict litigation contains over 100 such IVC filter lawsuits, transferred into a single court to promote more efficient pretrial processing.

Plaintiffs making these claims say they suffered complications that were in some cases life-threatening. In a few cases, they say that fragments of their broken IVC filter lodged inside their heart, requiring open-heart surgery for removal.

Plaintiffs typically allege that Cook Medical failed to properly warn doctors and patients about the dangers that can be associated with IVC filters. Some patients’ spouses have also brought claims for loss of consortium related to the effect of the alleged complications on their marital relationship.