Retrievable Bard IVC Filters Associated with High Rate of Fracture, Other Life-Threatening Injuries

Bard IVC Filters (inferior vena cava filters) have been associated with reports of potentially life-threatening complications, including blood clots, fracturing, device migration and embolization.  In 2010, the U.S. Food & Drug Administration (FDA) issued a warning regarding serious injuries that occurred in recipients of IVC filters like those made by Bard.  That same year, the Archives of Internal Medicine published a study that concluded that Bard Recovery IVC and Bard G2 IVC filters have a”high prevalence of fracture and embolization, with potentially life-threatening” consequences.

Injuries associated with the use of Bard Recovery IVC filters and Bard G2 Filters include:

• Lower limb deep vein thrombosis (DVT)
• IVC filter fracture
• IVC filter migration
• IVC filter embolization
• Perforation of the inferior vena cava

IVC filters like the Bard Recovery IVC and  Bard G2 IVC filters are inserted into the inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs. Such devices are most often implanted in people who are at risk of pulmonary embolism, a life-threatening blood clot in the lungs.

The Bard Recovery IVC and Bard G2 IVC filters are both retrievable devices, which means they are only meant to be used for a short period of time and removed.  Both devices were approved for sale via the FDA’s 510(k) protocols, which allow for clearance of a device without human clinical trials if a device maker can prove it is substantially equivalent to another product already approved for sale and on the market.  The G2 was the replacement for the Recovery IVC, which was removed from the market in 2005.  However, it is believed that there are still Recovery IVC devices implanted in people.

In August 2010, the Archives of Internal Medicine published a study evaluating 80 patients who received either a Bard G2 or Recovery IVC filter.  Out of the 28 who received the older Recovery model, 25% experienced fracturing of the devices.  Of the 52 patients who received the Bard G2 model, six patients experienced a fracture, representing a 12% rate of fracture.  The average time between implantation and fracture was about 50 months for patients with Recovery IVC filters, compared to only about 24 months for patients with the Bard G2 filter.

That same month, the FDA issued an alert warning that it had received 921 reports of IVC filter complications since 2005, including:

• Filter Migration (328 reports)
• Embolization (146 reports)
• IVC Peforations (70 reports)
• Filter Fracture  (56 reports)

The FDA said that such IVC filter injuries cold be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism has subsided.  The agency said it was concerned that retrievable IVC filters are not always removed once a patient’s risk subsides.