Drug, Device And Toxic Contamination News, Alerts And Recalls

Cook IVC Filter Cases Entering Discovery Pool The parties to the Cook IVC filter lawsuits are now in the process of selecting cases that will go into a discovery pool and from this pool, four cases will be chosen for bellwether trials. These early trials are conducted to help the parties determine how juries will react to the evidence and to facilitate settlement negotiations. What are IVC Filters? IVC filters are medical devices placed between the proximal vessels of the lower extremities and the right side of the heart to help prevent pulmonary embolism by catching blood clots and preventing them from traveling to the lungs. Over the past 30 years, the use of the IVC filter has steadily increased. While around 2,000 filters were implanted in patients in the U.S. in 1979, by 1990, over 120,000 IVC filters had been placed, and at the end of the decade, nearly 50,000 IVC filters were being implanted each year. IVC filters have been linked to life-threatening complications including migration, fraction and perforation, leading to embolism, organ damage and death. Manufacturers of these devices are facing a growing number of over injuries caused by the implants. Adverse Reports Since 2005, the U.S. Food and Drug Administration (FDA) has received more than 900 reports of adverse events connected to IVC filters. Common complications associated with IVC filters left in the body for long periods of time include: The progression of DVT Recurrent PE Filter migration Tilt, break, or embolism IVC perforation or occlusion According to the FDA, the majority of IVC filters are not retrieved, and their benefits continue to make them a frequent choice for doctors and patients, despite the risk of increased fracture, embolism, and IVC wall penetration. Yale Study Finds IVC Filters Widely Used, Benefits Uncertain A new study conducted by Yale School of Medicine researchers shows that the utilization rates of inferior vena cava (IVC) filters vary widely across different regions of the U.S., and is being used in nearly one in six patients, although the best use of the technology remains uncertain. The Yale team studied over 550,000 Medicare fee-for-service beneficiaries age 65 or older who had been hospitalized for pulmonary embolism between 1999 and 2010. Researchers found a frequent and increased use of IVC filters in patients with pulmonary embolism over time, even as death from pulmonary embolism decreased during the same period, regardless of whether IVC filters were used or not. They noted that the 30-day death rate in patients both with and without IVC filters decreased during that time period, raising questions about the best use of this controversial technology. Of the 556,658 persons studied, more than 15 percent had received an IVC filter. Head researcher Dr. Behnood Bikdeli commented that IVC filters might be indicated for a select group of patients, but not for such a widespread use, given that the procedure is often costly and not without complications. We really need good comparative effectiveness studies to determine which patients may benefit from IVC filters, he said.