The U.S. Food and Drug Administration (FDA) now recommends that doctors responsible for the care of patients with retrievable Inferior Vena Cava (IVC) filters consider removing the filter as soon as protection from pulmonary embolism (PE) is no longer needed. The FDA recommendation was made after it received 921 medical device adverse event reports involving IVC filters since 2005.
IVC Filter Injuries
According to the FDA, the types of adverse events reported may be related to a retrievable filter remaining in the body for long period of time, beyond the time when the risk of PE has subsided.
The 921 IVC filter adverse events, some of which have injured patients, were broken down as follows:
- Device Migration – 328 reports
- Embolizations (detachment of device components) – 146 reports
- Perforation of the IVC – 70 reports
- Filter Fracture – 56 reports
The FDA expressed concern that “these retrievable IVC filters, 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 (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
About IVC Filters
IVC filters are inserted into the inferior vena cava (the main blood vessel that returns blood from the lower half of the body to the heart) to filter and prevent blood clots from reaching the lungs, where the clots (also referred to as a PE) can cause a blockage in a lung artery. Because a PE can block blood flow to the lungs, it can be disabling or fatal. IVC filters are placed in patients at risk for PE when anticoagulant therapy cannot be used or is ineffective.
Some patients may be implanted with permanent IVC filters due to long term PE risks. However, some patients may only require short-term protection from PE in which case retrievable IVC filters are implanted. The retrievable IVC filters can be removed from the patients’ body one the risk of PE subsides.
FDA Recommendations and Actions
As part of its IVC Filter Safety Communication the FDA recommends:
- FDA 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 PE is no longer needed.
- FDA 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.
The FDA will communicate its final conclusions to the public and after an analysis of available data is complete.
To learn more about IVC Filter medical devices and your legal rights, visit IVC Filter Lawsuit.
Report IVC Filter Problems To The FDA
The FDA encourages healthcare professionals and consumers to report device problems and device adverse events to MedWatch.
Obtain a Free IVC Filter Lawsuit Evaluation
If you are a loved one has been injured by a retrievable IVC filter, and you have a question concerning your legal rights, please call The Weinberg Law Firm toll free at 1-877-934-6274 for a free legal case evaluation. You can also contact our firm online by submitting the easy-to-use “Free Legal Case Evaluation Form” found on this page. To learn more about our legal services related to pulmonary embolism, please see www.pulmonaryembolismlawsuit.com.
