In 2005, medical device company C.R. Bard withdrew the Bard Recovery IVC filter. Studies have linked it to a 40% risk of fracture after five years, and many other severe complications. Many people who do not have serious complications still must endure frequent monitoring when their implant cannot be safely removed.
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What is the Bard Recovery IVC Filter?
C.R. Bard’s Recovery IVC filter was approved by the FDA in 2003. After about 34,000 people were implanted with the Recovery, it was voluntarily withdrawn (but not recalled) in 2005 and replaced with a modified filter called the G2.
The Recovery is implanted in a patient’s inferior vena cava (IVC), the blood vessel between the heart and the lungs. It is designed with spider-like wire legs (called “struts”) arranged in a cone shape. It is supposed to catch blood clots before the heart can pump them into the lungs and cause a pulmonary embolism.
FDA Safety Warning
The Recovery is a retrievable IVC filter. Older IVC filters were permanent implants. Retrievable filters are temporary implants that should be taken out once the patient is no longer at risk of a pulmonary embolism. When retrievable IVC filters are not taken out in a timely manner, they have a higher risk of fracturing, migrating, and causing other severe injuries. The FDA issued a Safety Communication about this risk in 2010.
Recovery IVC Filter Withdrawn
The Recovery has been associated with a high risk of fracture and migration. Bard claims the G2 implants are less likely to migrate or fracture, and can be positioned more easily. However, researchers have warned that both the Recovery and G2 filters are associated with a high prevalence of fracture and embolization.
The Recovery gained FDA approval with a 510(k) application. The FDA allows manufacturers to gain approval for new devices without submitting safety data, so long as the new device is “substantially equivalent” to a device that has already been approved by the FDA.
Studies of the Bard Recovery IVC Filter
Researchers have conducted numerous studies of the Bard Recovery IVC filters. The following two studies found specific risks associated with the Recovery.
This study in February 2012 found that 40% of Recovery IVC filters fracture after 5.5 years. They also found that many people never had the device removed — of the 363 people in the study with the Recovery IVC filter, only 97 had the device removed. Fractured pieces of defective filters traveled to the pulmonary arteries, femoral veins, the heart, and renal veins.
Researchers published this study in 2010 with the following explicit warning: “The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.”
Side Effects of the Bard Recovery IVC Filter
There are many serious side effects of the Bard Recovery IVC filter, which may include the following:
- Filter fracture: This is one of the most serious side effects of a defective IVC filter. If pieces of the filter break off, they can be pumped in the bloodstream into an internal organ — usually the heart or lungs. These metal fragments can erode or perforate organs and cause life-threatening injuries.
- Migration: This occurs when the filter moves after it is placed by a surgeon. It is more likely when the device is placed incorrectly, but can occur spontaneously.
Once the device moves, it may not stop blood clots, or it may become clogged with blood clots and inhibit blood flow. There is also a risk that it could gradually erode into the inferior vena cava and perforate the vessel. A surgeon may not be able to remove the device if it migrates to an inaccessible location.
Even in cases where the filter does not cause life-threatening complications, people who have this implant may require lifelong monitoring and follow-up care, especially if a surgeon cannot entirely remove the device from the patient’s body.
IVC Filter Lawsuit Information
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