FDA Updates Safety Communication on IVC Filter Retrieval
May 7, 2014—The US Food and Drug Administration (FDA) has issued a Safety Communication regarding removal of retrievable inferior vena cava (IVC) filters. The document, which contains no new safety concerns, updates a previously issued Initial Communication from August 2010 to include information on recently published research and postmarket surveillance studies for these devices.
The updated communication advises that the agency has received reports of adverse events and problems associated with IVC filter devices. The reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted.
The agency noted that other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion.
For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
The safety communication recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed. All physicians involved in the treatment and follow-up of patients receiving IVC filters are encouraged to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.
The FDA developed a quantitative decision analysis using publicly available data from the medical literature to assess whether there is a time period during which the risk of having an IVC filter is expected to outweigh the benefits. In October 2013, Jose Pablo Morales, MD, et al published the decision analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (2013;1:376–384).
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.
Although the results of the decision analysis provide important insight for retrievable IVC filters, the FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States. The studies will address safety questions that remain unanswered for both permanent and retrievable filters.
Manufacturers were given two options for obtaining the data. Some manufacturers are participating in the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study, an independent national clinical study that will examine the use of IVC filters to prevent pulmonary embolism. Other manufacturers are conducting investigations under the FDA’s 522 Postmarket Surveillance Studies program.
The data gathered from the PRESERVE study and the 522 studies will help the FDA, manufacturers, and health care professionals assess the use and safety profile of these devices, understand evolving patterns of clinical use of IVC filters, and ultimately improve patient care, stated the agency.
For questions regarding this communication, the FDA’s Division of Industry and Consumer Education can be contacted at DICE@cdrh.fda.gov or (800) 638-2041.