IVC Filters Studies Found High Complication Rates
For several years, studies have documented a high risk of fracture of the arms or legs of retrievable inferior vena cava (IVC) filters—medical devices placed in the large vein that brings blood to the heart designed to prevent blood clots from traveling to the lungs.
The defective IVC Filter attorneys at Shrader & Associates, L.L.P.,
found numerous studies showing a startling high percentage of filter fracture
after different lengths of time.
The manufacturers of several types of retrievable IVC filters, C.R. Bard and Cook Medical, Inc., are currently facing dozens of lawsuits regarding the devices, including claims of filter fracture, migration, and perforation of the filter through the IVC and into surrounding organs, and resulting complications like pulmonary embolism. The litigation is expected to grow as more complications come to light.
What did the studies show?
According to researchers in 2011, 40 percent of Bard’s Recovery IVC filters—a product approved in 2003 and taken off the market in 2005—will fracture after 5.5 years. To read more about this study, click here.
Bard’s next generation retrievable IVC filter that replaced Recovery, the G2 and G2 Express, was found to have a fracture rate of approximately 37.5 percent after 5 years of implantation. For more information, click here.
Even more troubling, researchers in 2014 found that Cook Medical’s Günther Tulip and Celect models of IVC Filters had a 100 percent rate of perforation after 71 days of insertion. The same study concluded that Cook Medical’s retrievable filters had a 40 percent tilt rate—a problem well known to increase the likelihood of fracture, perforation and other complications. To read the abstract, click here.
What do researchers conclude?
Other studies have found lower rates of fracture and complications, but may have looked only to a short period of time from filter placement. Overall, the majority of studies retrospectively assessing the safety of retrievable IVC filters have found that the rate of serious complications increases over time after placement. Therefore, many have suggested that retrievable filters be removed once the risk for a pulmonary embolism is resolved.
This conclusion comports with FDA recommendations to physicians and patients with respect to retrievable IVC filters. To read more about the FDA’s warnings and advisories regarding IVC filters, click here.
What types of injuries do IVC Filters cause?
Retrievable IVC filters, including Bard’s Recovery, G2, G2X, and
Eclipse, and Cook Medical’s Günther Tulip, and Celect can lead
to the following severe complications:
Specifically, these filters can cause the following:
- IVC Filter migration
- IVC Filter fracture
- IVC Filter perforation
- Tilting of the IVC Filter
- The inability to retrieve the IVC Filter
- Pulmonary embolism
Dangerous IVC Filter litigation
In October 2014, the Judicial Panel on Multidistrict Litigation agreed to consolidate claims against Cook Medical related to its defective IVC filters in the Southern District of Indiana. Similarly, in August of this year, the panel coordinated claims against C.R. Bard in the District of Arizona.
Numerous claims remain pending in Indiana, Arizona, and in other jurisdictions across the country. For more information, contact defective IVC Filter lawyer A. Layne Stackhouse at:
A. Layne Stackhouse | BIO
Shrader & Associates, L.L.P.
3900 Essex Lane Suite 390 | Houston, TX 77027