A report posted online today that will appear in the November 8 print issue of
Archives of Internal Medicine, one of the JAMA/Archives journals, says that two specific types of vena cava filters, devices used to prevent blood clots from reaching the lungs, appear to have evidence of fracturing inside the body, with some fractured fragments traveling to the heart and causing potentially life-threatening complications.
Venous thromboembolism, or the formation of blood clots in the veins, occurs in more than 200,000 Americans per year, according to background information in the article. Anti-clotting medications are the standard therapy for patients with this condition. However, some patients cannot take these drugs and others may continue to develop clots despite taking medications. Vena cava filters, devices placed in the vena cava, the large vein returning blood to the heart from the lower body, are designed to trap clots before they travel to the lungs and have been used as an alternate therapy in these patients. Complications associated with these devices include erosion through the wall of the vena cava, along with migration, obstruction and additional clotting of the filter.
One such filter, the Bard Recovery filter, was developed as a device that could either be left in permanently or retrieved as needed and was commercially available from April 2003 through October 2005. The device consisted of two levels of six radially distributed "arms" and "legs" that anchor the filter to the vein and trap any clots, the authors note. However, these arms and legs reportedly have broken off in some patients. In September 2005, Bard modified the design of the filter to improve its resistance to fracture. The modified Bard G2 cava filter has been implanted in more than 65,000 patients since September 2005, according to information in the article.