Recipients of the retrievable filters have already filed legal claims against two primary manufacturers – C.R. Bard and Cook Medical – who are at the center of the IVC filter litigation.
Filters Being Investigated:
– The Bard Recovery filter
– The Bard G2 filter
– The Bard G2 Express filter
– The Cook Gunther Tulip filter
– The Cook Celect filter
– Other retrievable IVS filters
Timeline
• 2010: The FDA received more than 900 reports of IVC filter injuries and adverse events:
– – 70 filter perforations
– 328 device migrations
– 56 filter fractures
– 146 embolisms
The FDA warns doctors there are long-term risks associated with IVC filters and should be removed as soon the patients risk for pulmonary embolism subsides.
• 2012: The Cardiovascular Interventional Radiology published a study stating that 100% of the Cook Medical filters perforated the study participant’s venal wall within 71 days of implantation.
• 2014: The FDA issues an updated safety communication warning after receiving reports of adverse events and product problems associated with the IVC filters. This update states most devices should be removed between the 29th and 54th day after implantation. However, this is not always occurring and the retrievable IVC filters are being left in long after a patient’s risk for blood clots has subsided.
• 2015: A study published in the Journal of the American Medical Association (JAMA) found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism.
• 2015: The FDA issued a warning letter to Bard in July 2015