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IVC Filter Controversy

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Inferior vena cava filters have been around since the late 1960s, and the first FDA approved removable IVC filters were approved in 2003 and 2004. Permanent filters had already been FDA approved at that time. On average 250,000 people each year have an IVC filter implanted. According to an article in the Journal of American College of Cardiology from 2013, Accepted indications for IVCF placement include the presence of acute venous thromboembolism with inability to administer anticoagulation medication or failure of anticoagulation. Despite these clear indications, IVCF have been commonly placed in patients for primary prevention of pulmonary emboli in patients deemed to be at high risk, along with several other “soft” indications. As a result, …show more content…

Bard has been at the center of controversy due to its link to increase risk of serious medical complications after implanted. Furthermore, it has been alleged that Bard forged its FDA application for that product, and was aware of defects in the device. In 2005 Bard stopped producing the Recovery filter, but never officially recalled it. Since then Bard has manufactured other IVC filters that have been approved but are associated with medical complications as well. Additionally, 11 companies sell IVC filters. Although Bard knew about the problem with the ICV filters, the company did not disclosed this fact to the FDA. In early 2004, Bard began receiving complaints of IVC filter malfunctions with allegations that pieces of the device were prone to break off, and thus travel to other parts of the body potentially causing serious injury. Bard, worried about the complaints, contracted with litigation consultant Dr. John Lehmann, who prepared a report regarding the fracture and migration rate of the filters to previous models. The “Lehmann Report” provided legal advice to Bard about its vena cava filters and copies were distributed to a small number of employees with instructions that the report was …show more content…

In a 2014 Safety Communication Update, the FDA recommended that physicians who used retrievable IVC filters consider removing the filter as soon as the risk of pulmonary embolism had abated. They cited to a 2013 decision in the Journal of Vascular Surgery: Venous and Lymphatic Disorder, which suggested that if a patients risk for pulmonary embolism had passed, “the risk/benefit profile begin to favor removal of the IVC filter between 29 and 54 days after implantation.” Previously in 2010, the FDA published a Safety Communication about the risk of leaving a retrievable IVC filter in a patient too long., and recommended removing the filter as soon as “protection from the PE is no longer needed.” Furthermore, a study from the Journal of Vascular and Interventional Radiology, published in February 2012, found that 40% of Bard Recovery IVC filters fractured after 5.5 years. Additionally, of the 363 people who were implanted with the device, only 97 had it removed. The study evaluated cases involving filter migration into the pulmonary arteries, iliac/femoral veins, on in the right ventricle of heart, and the renal

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