August 8, 2010
FDA Issues Statement on Treatment and Follow-Up Regarding IVC Filter Complications
August 9, 2010—The US Food and Drug Administration (FDA) has issued an initial communication recommending that “implanting physicians and clinicians responsible for the ongoing care of patients with retrievable inferior vena cava (IVC) filters consider removing the filters as soon as protection from pulmonary embolism is no longer needed.”
The FDA further stated that the agency “encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.”
Bram Zuckerman, MD, director of the FDA's Center for Devices and Radiological Health's Division of Cardiovascular Devices, commented to the Associated Press that approximately 30,000 filters are implanted each year. Several brands are sold, and Dr. Zuckerman said that problems have been seen with all retrievable filters. He noted that although some reports to the FDA involve patients who died, patients with blood clots often are very sick to begin with, so it is unknown if filters played a role in any deaths. Dr. Zuckerman added, “It is thought that too many retrievable filters stay in permanently because patients are lost to follow-up,” or that doctors do not know that problems can occur when the devices are left in long-term.
However, speaking with Endovascular Today, FDA experts also noted, "IVC filters represent an important option for patients who have pulmonary embolism and have contraindications to standard anticoagulation treatment with the drug warfarin."
According to the FDA, this initial communication is in keeping with the agency's commitment to inform the public about emerging device safety issues, and the agency will communicate its final conclusions when the analysis of available data is complete. As part of developing its final position, the FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about the FDA's decision analysis model including risk/benefit implantation timeframe suggestions will be made available in a later update.
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which, 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided.
The FDA is concerned that these retrievable IVC filters, which are intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long-term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization, and IVC perforation.
The FDA noted that IVC filter usage has increased rapidly during the past 30 years. In 1979, 2,000 IVC filters were used compared with 2007, when almost 167,000 filters were implanted. The market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012.
The FDA communication coincides with the online publication in Archives of Internal Medicine of a single-center study of vena cava filter fractures. Click here to read Endovascular Today's News coverage of this study.