If you or a loved one has experienced complications from a Bard or Cook IVC filter, please contact The Law Offices of Edward W. Sampson, PC. today.
Dangers of an IVC Filter
When a temporary IVC filter migrates from its intended position, it can potentially erode into the inferior vena cava or get stuck in an ineffective position, where it may fail to catch blood clots or prevent a pulmonary embolism. IVC filters can also fracture, allowing embolization of filter fragments in the bloodstream. They may eventually travel to the heart valves or right ventricle and ever perforate the heart. This can cause a complication called cardiac tamponade, in which fluid accumulates around the heart and causes pain and heart rhythm disturbances. IVC filters difficult or impossible to remove — especially when the dangers of removing the filter outweigh the potential benefits, such as when filter fragments get stuck in the heart or lungs. This increases the risk of long-term complications, such as deep vein thrombosis (blood clots in the legs).
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 high rate of fracture 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.
The Law Offices of Edward W. Sampson, PC is currently accepting IVC filter injury cases in all 50 states. If you or somebody you know was injured by IVC filter, you should contact our office at (214) 617-3223 for a free case evaluation.
Complications of 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
Cook IVC Filter Lawsuit Information:
- The Gunther Tulip and Cook Celect filters are also under scrutiny because they are proving difficult to retrieve and numerous complications have been noted.
- More than 25 lawsuits involving IVC filters had been lodged against Cook Medical in 11 different districts.
- There is an atttempt by the plaintiffs to transfer all the litigation to the U.S. District Court for the Southern District of Indiana.