Inferior vena cava filters
Brand Names: Bard’s G2 Filter, Bard’s G2 Express Filter, Bard’s Recovery Filter,
Cook Medical’s Gunther Tulip Filter, Cook Medical’s Celect Filter
IVC filters are medical devices designed to prevent pulmonary embolisms that have high failure rates and can cause complications.
Inferior vena cava filters (IVC filters) are medical devices that are implanted into the inferior vena cava, the largest vein in the human body that carries deoxygenated blood from the lower body into the heart and then the lungs. IVC filters function by filtering out blood clots (pulmonary embolisms) to prevent them from traveling to the heart and lungs. They resemble small, spider-like shaped metal cages with thin metal legs.
IVC filters were first introduced in 1979, and the first retrievable IVC filter became available in the United States in 2001. Their use has rapidly increased from about 2,000 filters in 1979, to 167,000 in 2007, to over 259,000 by 2012. Many are designed for short-term (retrievable/temporary) use, while others are approved for permanent implantation.
In 2010, the FDA issued a safety alert regarding retrievable IVC filters, after receiving 921 adverse event reports over a five year period from 2005-2010 (328 device migrations, 146 detachments of device components, 70 perforations, and 56 filter fractures). The FDA expressed concern that retrievable IVC filters, intended for short-term placement, are being left in for extended periods of time, and are not always removed once the patient’s pulmonary embolism risk subsides, putting patients at risk for life-threatening problems. Read more here.
In 2014, the FDA issued an updated safety alert following the 2010 alert, citing that if a patient’s transient risk for a pulmonary embolism has passed, the risk-benefit analysis favors removal of the IVC filter between 29 and 54 days after implantation. Read more here.
A study done by Dr. William Nicholson and his colleagues that highlights the high failure rate of C.R. Bard’s Recovery and G2 IVC filters in the Archives of Internal Medicine examined 80 patients who had Bard Peripheral Devices implanted between April 2004 and January 2009. The patients underwent tests to assess the integrity of the filters. The results showed a high prevalence of fracture and fragment embolization with the Bard retrievable IVC filters. The research revealed that 13 of 80 patients implanted with the Bard Recovery and Bard G2 filters had at least one arm filter fracture. First-generation Bard Recovery filters had a 25% (7 of 28) fracture rate, with embolizations to the heart (the fractured particle traveled to the heart) occurring in 5 of these 7 cases. In second-generation devices, including the Bard G2 filter, that had been improved to incorporate engineering modifications to reduce these occurrences, 12% (6 of 52) IVC filters also fractured. In two of these six cases, the fragment blocked blood flow, one in the vein leading from the liver and one in the lungs. In the other four, the fragments remained close to the filter.
Research on retrievable IVC filters published in 2013 by the Journal of American Medical Association (JAMA) found that only 58 out of 679 retrievable IVC filters (or 8.5%) were successfully removed. Seventy-four thrombotic events occurred after IVC filter placement, including 25 pulmonary emboli. Another article published in 2015 by JAMA found that the prolonged presence of retrievable IVC filters is associated with retrieval failure rates as high as 43%, and device-related complications which include fracture, migration, organ penetration, and increased risk for venous thrombosis.
Studies reveal that several retrievable IVC filters are prone to failure:
• Bard’s G2 Filter
• Bard’s G2 Express Filter
• Bard’s Recovery Filter
• Cook Medical’s Gunther Tulip Filter
• Cook Medical’s Celect Filter
Research has uncovered problems with Bard’s IVC filters, specifically the G2 series filter and the Recovery filter, for migration, tilting, and perforation. In June 2015, the FDA sent a warning letter to Bard because they were manufacturing the Recovery Cone Removal System (Models RC-15, FBRC), used to retrieve IVC filters, without the FDA’s marketing clearance or approval in violation of the Food, Drug, and Cosmetic Act (FDCA). They were also in violation of federal laws for failing to investigate and log consumer complaints properly. The letter also raises concerns about Bard’s adherence to Quality System Regulations. For more in-depth information, see: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm
Bard IVC filter lawsuits are currently being filed in a federal multidistrict litigation (MDL) in the District of Arizona. Cook Medical IVC filter lawsuits are currently being filed in an MDL in the Southern District of Indiana.
Lenze Moss is actively investigating IVC filters and pursuing these litigations. If you or a loved one has been injured by the implantation of a Bard or Cook IVC filter device, please contact us.