FDA IVC Filter Warnings
The FDA now warns doctors and patients that Bard IVC filter are only safe for short-term use. In as little as 4-6 weeks, the FDA says the risks of complications begins to outweigh the device's benefit.
IVC filters that are not removed promptly can move or break, causing the entire device or metal shards to damage vital organs including the heart, lungs, and brain.
What are Bard IVC Filters?
Bard inferior vena cava (IVC) filters are small, clawed metal devices implanted in the inferior vena cava to prevent blood clots from reaching the lungs, a health condition known as pulmonary embolism.
Blood-thinning drugs are considered the first line of defense against pulmonary embolism, but IVC filters are used in patients who cannot take anticoagulants.
Retrievable, or removable, Bard IVC filters feature metal struts or legs, which catch blood clots. These metal struts are prone to fracturing or breaking off. When this occurs, or the entire medical device moves, the patient can suffer life threatening health complications.
The longer Bard IVC filters are left in place, the greater the risk to the patient, according to the FDA.
Understanding the FDA Bard IVC Filter Warnings
In 2010, the first official FDA IVC filter warning was released. Directed at medical professionals and patients, the FDA warning warned that Bard IVC filters were prone to, "device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device."
According to the FDA report, these complications could lead to the following serious health problems:
- Insertion-site thrombosis
- Perforation of the vena cava
- Recurrent Deep Vein Thrombosis
- Recurrent Pulmonary Embolism
- Thrombotic complications
- Vena cava thrombosis
In 2014, the second FDA Bard filter warning was released, this time providing new information about the life span of Bard IVC filters. Research shows that Bard IVC filters should be removed starting 29-54 days after implantation. After that window of time, the high risk for complications outweighs any benefits of the device.
Doctors and patients did not know about the risk of IVC filter complications until the first FDA IVC filter warning in 2010. But Bard officials have been aware of the potential for complications since 2004.
By keeping the information quiet, Bard enjoyed growth and profit. Bard's market share for these devices rose from 12% in 2002 to 42% in 2012, bringing the company more than $3.3 billion in annual profits by 2014.
Bard also received FDA warning letters threatening regulatory action in 2014 and 2015 for failing to report injuries and deaths related to IVC filters in accordance with federal regulations.
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Bard IVC Filter Lawsuits
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Bard IVC Filter Inforamtion from RxWatch:
FDA IVC Filter Warnings
The FDA warns the longer an IVC filter remains implanted, the greater the risk. IVC filters have been found to cause serious injuries and death when the devices break, fracture, shift, or move in the body.
Bard IVC Filter Complications
Research shows that as many as 40% of Bard IVC filters will fail, causing life-threatening medical conditions. The device's metal struts, or legs, may break off and damage vital organs including the heart, lungs, or brain.
Bard IVC Filter Lawsuit FAQs
If you or someone you love has been harmed by an IVC filter, you are right to seek information on your legal options. Pharmaceutical companies that place profits ahead of patient safety must be held accountable.
