Product News and Recalls

Warnings issued about IVC filter

An article on TheHeart.org discusses more than 900 reports of adverse events that the U.S. Food and Drug Administration has received about inferior vena cava (IVC) filters.

According to the report, the FDA has warned clinicians that the devices should be removed as soon as safely possible.

It quotes the following FDA statement: “The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for pulmonary embolism [PE] subsides. Known long-term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis [DVT], filter fracture, filter migration, filter embolization, and IVC perforation.”

IVC filters are small cage-like devices inserted into the inferior vena cava, which is one of the main veins connecting the heart to the lungs. It’s meant to catch blood clots before they travel to the lungs — a potentially deadly event called a pulmonary embolism.

But the report cites a study published in the Archives of Internal Medicine, in which researchers found up to 25 percent of the devices manufactured by Bard Peripheral Vascular had fractured. Another study conducted by the New England Society for Vascular Surgery noted a 31 percent fracture rate in IVC filters, with potentially deadly consequences.

Bard allegedly knew of these risks, but concealed them from patients and the FDA.

The report quotes the authors of the Archives of Internal Medicine report as writing: “It is essential that patients and their treating physicians be educated about this previously underrecognized and potentially life-threatening complication of these devices.”

If you’ve received an IVC filter, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a IVC filter lawyer to discuss your legal rights.

See the report here:

http://www.theheart.org/article/1109059.do