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In May 2014, the FDA issued a safety alert after receiving hundreds of complaints about IVC filters. The warning indicated that removable IVC filters should be taken out within approximately 1 to 2 months after the initial concern about blood clots is resolved. The FDA also expressed concern about long-term use of the IVC filter, which increases the risk of life-threatening complications.
Numerous studies have supported this concern and others related to the device. Here are some of the details:In a 2003 to 2011 study, researchers followed 952 IVC filter patients at Boston Medical Center. Only 8.5% of 679 removable devices were taken out successfully. Unsuccessful efforts occurred in 18.3% of cases. The patients experienced 74 venous thrombotic incidents including 25 blood clots, which that resulted despite implantation of the filter.
In 2004, C.R. Bard started to receive reports about the IVC filter becoming loose, breaking and moving. The company did not inform the FDA but asked Dr. John Lehmann, an independent consultant, to compare newer and older models. The document, intended for internal distribution, was unintentionally made accessible to plaintiffs. After the manufacturer later removed sensitive information, some suggested that Bard attempted to hide the results.
A 2005 study by the New England Society for Vascular Surgery identified a 31.7% Bard Recovery fragmentation rate after examining FDA complaint reports..
A 2008 study in the Journal of Vascular and Interventional Radiology found a 21% Bard Recovery failure rate in participants.
A 2010 study, published in the Archives of Internal Medicine, indicated that only half of all IVC filter implantation surgeries were needed. Researchers learned that a quarter of the study participants did not require the device and could not agree on the remaining 23 percent of patients. The death rate of IVC filter patients in the hospital was nearly double, and additional research was recommended.
In August 2010, the FDA reported receiving 921 complaints about the device including 328 cases of filter migration, 146 IVC filter separations, 70 IVC punctures and 56 incidents of fragmentation. The FDA recommended short-term use and removal of the device when the risk of blood clots was resolved.
In April 2012, study findings published in CardioVascular and Interventional Radiology indicated that the Cook Celect and Gunther Tulip filters resulted in some degree of IVC punctures 100% of the time after 71 days. Complete piercing occurred in 86% of the patients, and 40% had devices that moved from the original insertion point. Cook Medical received FDA 510(k) fast-track approval for the devices, which involved only minimal testing before selling the devices for nationwide use.
In 2013, "Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism" was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. The mathematical model indicated that if the patient’s risk for blood clots has been addressed, device removal should occur between 29 and 54 days after implantation.
To date, the FDA has not issued an IVC filter recall despite warnings and adverse findings.