Bard Recovery IVC Blood Clot Filter Lawsuit | Lawyer
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Matthews & Associates is accepting Bard Recovery IVC filter induced injury cases in all 50 states and Puerto Rico. If you or someone you know has been injured by a Bard Recovery filter, contact us now for a free legal case consultation.
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What is a Bard Recovery IVC Filter?
The Bard Recovery IVC filter, a medical device made by C.R. Bard, was approved by the FDA in 2003. Bard Recovery blood clot filters and other IVC filters are implanted in the inferior vena cava (IVC), the blood vessel between the heart and lungs. They are supposed to catch blood clots before they can reach the lungs and cause a pulmonary embolism. These filters are often implanted in people at risk of pulmonary embolism who cannot take blood-thinning medication.
Retrievable vs. Permanent IVC Filters
The Bard Recovery is meant to be a retrievable IVC filter. It is a short-term implant that can be removed once the patient’s risk of a pulmonary embolism subsides. Retrievable IVC filters have a higher risk of complications than permanent filters. The longer the implant remains in one’s body, the higher the risk of fracture, migration, and other serious complications. The FDA published a Safety Communication in 2010 assessing the risk of leaving a retrievable IVC filter in a patient too long.
Recovery IVC Filter Withdrawn
Bard voluntarily stopped selling the Recovery IVC filter in 2005, and replaced it with the G2 IVC filter. Bard sold the G2 with claims that it was more resistant to fracturing and migrating, and claimed it could be positioned more easily than the Recovery.
510(k) Approval avoided Safety Studies
The Bard Recovery was approved by the FDA under the aegis of the 510(k) approval process. This process allows medical device makers to avoid conducting safety studies, so long as the device is similar to an existing device. The FDA allowed Bard to forego safety studies on the Recovery blood clot filter because the agency considers IVC filters to be Class II devices, which are considered “low risk.”
Bard Recovery IVC Filter Studies
Scientists have conducted many studies of the Bard Recovery IVC filter, and many have warned about the high risk of life-threatening complications.
One study, published in February 2012, found 40% of Bard Recovery IVC filters fractured after 5.5 years. Of the 363 people who were implanted with the Recovery, only 97 had the device removed. The study described cases where fractured pieces of the Recovery IVC filter migrated into the pulmonary arteries, femoral veins, heart (right ventricle), and renal vein.
In 2010, researchers who published this safety study warned “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
Two of the most serious side effects of the Bard Recovery IVC filter are filter fracture or migration. The filter is designed with thin wire legs – called “struts” – in a cone shape. When these struts break, they can travel in the patient’s bloodstream and become trapped in an internal organ, usually the heart or lungs. Fractured filters do not always cause problems. In some cases, pieces of the filter may erode and/or perforate the heart tissue, causing life-threatening conditions such as cardiac tamponade. This occurs when fluid builds up around the heart and inhibits heart rhythm.
The filter can cause the very problems it is designed to prevent. Migration of the filter can be as life threatening as any clot. A shifting filter may not prevent a pulmonary embolism. It may also be more likely to become clogged with clots, which could inhibit normal blood-flow through the inferior vena cava. The device could also erode and/or perforate the inferior vena cava. It could also shift into a position that makes it impossible to remove.
Do I have a Bard Recovery IVC Blood Clot Filter Lawsuit?
Matthews & Associates is accepting Bard Recovery IVC filter induced injury cases in all 50 states and Puerto Rico. If you or somebody you know has been injured by an IVC filter, contact us now for a free legal consultation.
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