A recent study found that when it comes to IVC filters, certain brands may have an increased risk of vein perforation.

In a study published by the Journal of Vascular Interventional Radiology, researchers compared the Cook Celect IVC filter to the Option filter manufactured by Rex Medical and found that the Celect IVC filter posed a 43 percent greater risk of vein perforation.

For the study, researchers compared 185 patients implanted with an IVC filter, which is a small, metal cage-like device that is used to catch and dissolve blood clots, to determine if one brand of filter was harder to retrieve.

After two months, researchers discovered the Option IVC filter was slightly more difficult to retrieve, with a time rate of 6 minutes compared to the Celect with an average time of 4.5 minutes. However, during the study, researchers also found that 43 percent of the Celect IVC filters penetrated the vein compared to the Option filter which had a zero percent perforation rate.

Researchers concluded in the IVC filter study that while the retrieval rates were not significantly different, “The Celect filter had a significantly higher rate of strut perforation.”

IVC Filters and Health Risks

The U.S. Food and Drug Administration approved inferior vena cava filters which are placed in the main heart vein and holds them there until the body naturally dissolves them.

The FDA approved IVC filters for the following circumstances:

• Anticoagulant therapy fails to work in thromboembolic diseases
• Treating pulmonary thromboembolism when blood thinners shouldn’t be used
• Emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced
• Recurring pulmonary embolism when anticoagulant use has failed

However, since their introduction on the U.S. market the agency has reported more than 900 adverse event reports. Out of those claims, 328 involved device migration, 146 detached device components, 70 reported IVC perforation, and 56 claimed filter fractures.

The U.S. Food and Drug Administration believes that some of the events may have occurred because the IVC filters were not retrieved and left in the body for long periods of time. In 2010, the agency issued a warning to IVC filter patients claiming that the medical implants could move throughout the body by perforating blood vessels and organs.

In a 2014 safety communication, the FDA cautioned patients to remove the implant as soon as the risk of blood clots has subsided.

IVC Filter Lawsuits

IVC filters, including Celect and Gunter Tulip IVC filter, are named in more than 100 lawsuits consolidated into a multidistrict litigation in Indiana against manufacturer Cook. Plaintiffs in this mass tort claim that the IVC filters are defective and fracture into other parts of the body.

In general, IVC lawsuits allege that the medical device caused life-threatening side effects by perforating the vena cava and traveling to nearby organs including the bowels, liver and aorta.

If you suffered from IVC filter complications, contact an attorney to find out if you have legal claim.