On August 9, 2010, the FDA issued a warning letter stating that since 2005, the FDA has received over 900 device adverse event reports involving IVC filters. The FDA expressed concern that these IVC filters, which are intended only for short-term placement, are not always removed once a patient’s risk for pulmonary subsides.
Unfortunately, removing the devices has proven to be problematic. A March 2013 study published in JAMA Internal Medicine found that less than 9 percent of filters were successfully removed, with 8 percent of IVC patients suffering a deep vein thrombosis, and 2.4 percent suffering pulmonary embolism, in spite of having an IVC in place.
On May 6, 2014, the FDA published an update to its August 9, 2010 warning letter, providing information on then-recently published research and postmarket studies for IVC filters. Specifically, the FDA developed a “quantitative decision analysis using publicly available data available in the medical literature to assess whether there is a time period during which the risk of having an IVC filter in place is expected to outweigh the benefits. The decision analysis (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 in October 2013. The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.”
Information about the May 6, 2014 FDA warning letter can be found here:
If you have experienced complications as a result of an IVC filter, please call Cowper Law at 877.LAW.3707 to speak with an attorney about your rights. We are attorneys with experience in medical device and pharmaceutical litigation. Let us help fight for you.