Since 2005, the FDA has received 921 injury reports regarding IVC filters including device migration, filter fracture, and device breakage.
With the rising concern about these incidents, the FDA is currently investigating how safe these devices are and why these reported problems may be occurring.
What are IVC Filters?
Introduced back in 1979, inferior vena cava (IVC) filters have been used for decades as a viable prevention treatment against serious blood clot injuries. By 2012, nearly 259,000 IVC filters had been in placed in patients to prevent pulmonary embolism.
Doctors often perform IVC filter placement when patients cannot use anticoagulants due to a high risk of uncontrollable internal bleeding. Even though these devices were meant to be safe and effective, patients and doctors have recently alleged serious IVC filter complications pertaining to the temporary models such as the device breaking apart or perforating a vein.
The inferior vena cava is the largest vein in the body, in which its primary function is to move deoxygenated blood from the lower legs to the heart and lungs. When blood clots form in the lower legs, they could potentially travel up to the lungs and heart as well resulting in a potential heart attack.
IVC filters are designed to catch the embolism and allow the blood clot to resolve itself without major damage to the patient. To prevent this, doctors perform IVC filter placement procedures by implanting the cage like device inside the inferior vena cava.
Originally IVC filters were only meant for permanent placement, but various medical device manufacturers have produced temporary models in the last few years. Even though this was meant to be a convenient measure for patients who did not want a permanent IVC filter placement, these temporary models have been causing concern amongst doctors and patients alike.
Overview of IVC Filter Complications
In 2010, the FDA announced a major safety alert regarding IVC filter complications. The agency announced that it had received over 900 injury reports from 2005 to 2010 indicating a variety of injuries, including device migration, filter perforation, filter fracture, and detached device components.
Approximately 35 percent of these injury reports involved device migration, which occurs when the device migrates away from the implantation site. The FDA reported that device fracturing was the second most reported complication, with a majority of these patients needing to undergo emergency IVC filter removal procedure.
The majority of the injuries were linked to temporary IVC filters, causing the FDA to release an updated safety warning in 2014. At this time, the FDA recommended that patients undergo IVC filter removal within 29 to 54 days after the risk of pulmonary embolism subsides.
IVC Filter Lawsuit Information
Despite the severity of these complications, the manufacturing companies allegedly failed to warn patients and doctors of these potential side effects and risks.
Patients who had to undergo IVC filter removal after suffering complications, may be eligible to file legal action against the manufacturing companies. Potential claimants should contact a specialized attorney, to determine whether or not they are eligible to file a lawsuit.
In general, IVC filter lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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