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As a growing number of IVC filter lawsuits continue to be filed by individuals who experienced severe and debilitating problems after the blood clot prevention device punctured the vein, fractured or otherwise failed, new research suggests that the risk of complications during retrieval increases the longer the filter is left in place.
Inferior vena cava (IVC) filters are small, spider like devices that are implanted among individuals at risk of suffering a pulmonary embolism. While they are designed to catch blood clots that break free elsewhere in the body and prevent them from reaching the lungs, thousands of individuals have experienced IVC filter complications, commonly involving devices that were designed to be retrievable after the blood clot risk had passed.
In a study published in the medical journal Circulation: Cardiovascular Interventions on June 12, researchers from the Northwestern University Feinberg School of Medicine found that it becomes harder to retrieve IVC filters the longer they are left inside of patients, resulting in a higher risk of health problems and the need for more advanced retrieval techniques.
Researchers looked at data from 762 IVC filter retrieval procedures from 2009 to 2015, which were conducted at Northwestern. A number of different IVC filters were retrieved, with the Cook Celect IVC filters being the most common.
According to the findings, IVC filters were successfully retrieved in 82% of patients, with 18% of retrieval procedures failing. However, the researchers found that the longer the IVC filter had been in place, the harder they were to recover, with the failure rate reaching nearly 41% if the filter was left in the patient for seven months or more.
IVC filter retrieval failures increased the risk of a number of injuries, including groin hematoma, injury to the inferior vena cava, and risks that the filters could fracture, making them irretrievable. Overall, adverse events occurred in 2% of all retrieval cases.
Researchers suggested that the devices should be removed as soon as possible, and that patients who experience difficulty having IVC filters removed may have better outcomes if they are sent to a facility with advanced retrieval procedures.
Other data suggests that the actual IVC filter retrieval rate nationwide could be as low as 8.5%, once facilities without advanced retrieval procedures were factored in, with many patients told not to worry about it after retrieval failed, and some being completely unaware that they have the filters still in their bodies.
“The necessity of advanced techniques to maintain technical success of retrieval increases with dwell time,” the researchers concluded. “Patients with retrievable inferior vena cava filters in place beyond 7 months may benefit from referral to centers with expertise in advanced filter retrieval.”
IVC Filter Concerns
Thousands of product liability lawsuits have been filed against C.R. Bard, Cook Medical, Cordis and other manufacturers over IVC filter retrieval failures, each raising similar allegations that consumers and the medical community were provided inadequate warnings about the risk of complications and the importance of removing the device. In many cases, the IVC filter moves out of position, punctures the vena cava, or fractures, sending small pieces into the blood stream that could cause fatal complications if they enter the heart or lungs.
In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after an individual was no longer at risk of suffering a pulmonary embolism, since the risk of problems appeared to be greater the longer the filter was left in place. However, many manufacturers sold the devices for years without adequately informing physicians about the risks associated with leaving them in place.
There are currently more than 1,800 Bard IVC filter lawsuits pending throughout the federal court system, which are currently centralized before one judge for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation. Another 1,900 Cook IVC filter lawsuits are centralized as part of a separate MDL, raising similar allegations of problems associated with filters manufactured by Cook Medical.
As IVC filter injury lawyers continue to review and file additional claims over the coming months and years, it is ultimately expected that the size of the litigation will continue to grow.
In each MDL, a small group of “bellwether” cases are being prepared for early trial dates, which are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes of these early trials will not be binding on other plaintiffs, they may influence eventual IVC filter settlements the manufacturers may reach to avoid facing hundreds of individual trials nationwide.