FDA Warns Against IVC Filter Usage
Patients who suffer from the threat of pulmonary embolism and are contraindicated for anticoagulation therapy may find themselves receiving an Inferior Vena Cava filter or IVC to prevent pulmonary embolism.
Since the introduction of the IVC filter in 2005, the FDA has received roughly one thousand adverse reports involving these filters. Specifically, it was reported that the IVC filters fragment and embolize in the body.
Research of these devices and the reports made by physicians and consumers has caused the FDA to urge physicians who advise their patients to use an IVC filter to consider the risk and benefits for individual patients instead of simply choosing the IVC for all patients who are ineligible for anticoagulation therapy, and to remove the device once the symptoms have diminished.
IVC filter complications are very serious and can be life threatening. Out of the 921 reported events to the FDA, there were:
- 328 device migrations
- 146 involved embolizations or detachment of the device components
- 70 IVC perforations
- 56 IVC filter fractures
After reports that the radial arms and struts of the Bard Recovery IVC filter had broken off inside the body of patients in 2005, Bard attempted to modify this filter to correct this deadly defect. The redesigned filter is the G2 IVC filter and has since been implanted in more than 65,000 patients.
According to reports posted on line, the November 8 print issue of the Archives of Internal Medicine, an archive journal of JAMA, is expected to publish a study conducted by William Nicholson M.D. and researchers from York Hospital in Pennsylvania concerning the safety of the implantation of Bard’s Peripheral Vascular Recovery and the G2 vena cava filters. Specifically, the researchers examined the rate of complications after implantation of these IVC filters.
Nicholson and his colleagues evaluated 189 patients with an implanted Bard Recovery or the Bard G2 vena cava filter between April 2004 and January 2009. Among this group, 35 patients died, 10 already had their filter removed and one person was pregnant. Eighty of these patients study underwent fluoroscopy to assess the integrity of the filter. Patients who experienced any kind of fragmentation of the filter underwent echocardiography and cardiac CT. Out of the 80 patients, 52 had the Bard redesigned G2 filter.
The Nicholson study found that 16 percent of the implanted filters fractured. Associated with the original recovery filter, 25% fractured such that one or more arms of the filter device would break off. Approximately 71% of the fragmented pieces would migrate through the veins of the patient to the heart, presenting life threatening symptoms such as rapid heartbeat and fluid buildup, including sudden death.
Despite the actions taken by Bard to redesign the original Recovery filter, the study has shown that 12 percent of the patients that had the G2 filter still experienced filter fractures. The average time the patients in the study had the implants was 50 months with the Recovery filter and 24 months with the G2 filter.