Federal health regulators issued an initial communication today concerning complications seen with <"http://www.yourlawyer.com/topics/overview/Bard-IVC-Filters">Inferior Vena Cava (IVC) filters. Since 2005, the US Food & Drug Administration (FDA) says it has received more than 900 reports of injuries related to IVC filters. According to the agency, these injuries may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.
IVC filters are small, cage-like devices that are inserted into the inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs. IVC filters are frequently placed in patients at risk for pulmonary embolism, or PE, when anticoagulant therapy cannot be used or is ineffective. Some patients may require long-term protection from PE, and implantation of permanent IVC filters is often performed in these cases. Others only require short-term protection, in which case retrievable IVC filters are typically used, as these devices have the option to be removed once the patientâ€™s risk of PE subsides.
According to the FDA, IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012.
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, the agency said.
In its communication, the FDA said it is concerned that retrievable IVC filters, intended for short-term placement, are not always removed once a patientâ€™s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation. The agency is encouraging 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, the FDA said.
The agency plans to issue its final conclusions on IVC filter complications when its analysis of available data is complete. In the meantime, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of IVC filters to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
â€¢ Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
â€¢ Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.