The Bard IVC Filter (also known as Bard G2 IVC Filter or Bard Recovery IVC Filter) is a small medical device that is implanted in the Inferior Vena Cava, which is the vein that carries blood to the heart. The IVC Filter is designed to catch blood clots before they can travel to the lungs and cause a pulmonary embolism. Unfortunately, the Bard IVC filter has been linked to high rates of failure and severe, life-threatening complications.
What You Can Do & How a Bard IVC Filter Lawsuit Can Help
The Schmidt Firm, LLP is currently accepting Bard IVC Filter induced injury cases in all 50 states. If you or somebody you know has been injured by the Bard IVC Filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Bard IVC Filter Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Researchers Question IVC Filter Safety and Effectiveness
March 21, 2013 – The Journal of the American Medical Association has published an editorial titled “How could a medical device be so well accepted without any evidence of efficacy?”, one study that shows wide variation in how IVC filters are used, and another study that recommends against using IVC filters due to the low retrieval rate and high risk of blood clots. Click here to read more.
January 31, 2013 – At least three IVC filter class action lawsuits are pending against C.R. Bard, the manufacturer of the Recovery and G2 IVC filters.
August 28, 2012 – A new study has found that the IVC filter does not reduce mortality for most people who have a pulmonary embolism. In fact, researchers found that only a small percentage of pulmonary embolism patients (those in shock or in need of ventilation) actually benefited from the IVC filter. The rest were exposed to a risk of severe, life-threatening IVC filter side effects.
August 8, 2010 – The U.S. Food and Drug Administration (FDA) has published a Safety Communication after receiving 921 adverse event reports related to the Bard IVC filters. Click here to read more.
Bard IVC Filter Overview
The Bard IVC Filter is a medical device manufactured by C.R. Bard. The company makes several types of retrievable IVC filters, which are intended for temporary use. These device include:
An IVC filter is a small wire cage that is implanted in the inferior vena cava to catch blood clots that could cause a pulmonary embolism. IVC filters are inserted in people who have a high risk of pulmonary embolism, but are unable to take an anti-coagulant blood-thinning medication. The IVC filter may be permanent or temporary. For people who only need temporary protection, companies such as Bard developed a retrievable IVC filter, which is intended to be removed as soon as the risk of pulmonary embolism subsides.
The Inferior Vena Cava (IVC) is the vein that carries oxygen-poor blood from the lower half of the body to the right side of the heart, which pumps this blood into the lungs to become oxygenated. Blood clots that form in the lower part of the body (usually in a condition called Deep Vein Thrombosis) are the leading cause of pulmonary embolisms. This occurs when blood clots become trapped in the small vessels in the lungs, causing severe, life-threatening lung tissue damage. Around 30% of people with an untreated pulmonary embolism will die.
FDA Warns of Safety Risks from Bard IVC Filter
On August 9, 2010, the FDA issued a Safety Communication regarding the Bard IVC Filter, which was originally designed as a temporary, retrievable IVC filter. The FDA was concerned that the temporary IVC filters were not being removed once the patient’s risk of pulmonary embolism subsided.
At the time of the communication, the FDA had received 921 adverse event reports. Of these reports, 328 involved device migration. 146 involved broken pieces of the IVC traveling in the bloodstream, become dangerous embolisms. 70 involved the device perforating the inferior vena cava. 56 involved filter fractures. The events may have been caused by devices remaining in a patient for long periods of time, after the risk of pulmonary embolism had subsided.
Scientific Study of Bard IVC Filter
A study published in the Archives of Internal Medicine showed a high rate of fractures and fragment embolization in patients who received the Bard IVC filter.
The study was prompted when Dr. William Nicholson received one patient who had suffered chest pain, fluid build-up around the heart, and perforation of the right ventricle caused by the Bard IVC filter. After reviewing this case, Dr. Nicholson asked all 80 of his patients who had been implanted with a Bard IVC filter come into the clinic for an exam.
Some patients had received the older, recoverable Bard IVC filter. Dr. Nicholson found that 25% of the devices implanted in these patients had fractured and become embolisms. One patient suffered sudden death. Of the patients who received the newer Bard G2 IVC filter, 12% of the devices had fractured. Two patients suffered embolization of the fragments.
Though the study appeared to show that the newer Bard IVC filter had a lower fracture rate, this may be due to the fact that the rate of complications increases over time.
Complications of Bard IVC Filter
What potential problems could occur with the Bard IVC Filter?
- The IVC filter could move, migrate, or change position, and become stuck in a place where it is not designed to be. This could cause it to become ineffective, or cause damage to internal organs.
- The IVC filter could perforate or erode into the inferior vena cava, causing damage to this vein. It could also protrude and damage internal organs.
- Parts of the IVC can break off, travel in the bloodstream, and severely damage the heart or lungs
- The filter may become clogged with clots, which could block the flow of blood from the lower body into the heart
- Damage to the heart, lungs, inferior vena cava, or other internal organs.
- A doctor may be unable to take out the IVC filter
Bard IVC Filter Side Effects
Serious side effects may include:
- Hemorrhagic pericardial effusion (excess fluid around the heart)
- Cardiac tamponade (compression of the heart caused by excess fluid around the heart)
- Lower-limb Deep Vein Thrombosis (DVT)
- Filter fracture
- Filter migration
- Filter embolization
- Perforation of the inferior vena cava, heart, or lungs
Do I have a Bard IVC Filter Lawsuit?
The Schmidt Firm, LLP is currently accepting Bard IVC filter induced injury cases in all 50 states. If you or somebody you know has been injured by the Bard IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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