FDA Warnings Against IVC Filter Usage
The IVC filter is a device that is supposed to help prevent blood clots in patients. Inserted into the inferior vena cava (the largest vein in the human body), these devices are small and cage-like, capturing blood clots so they cannot reach the individual’s lungs.
If a patient is at risk for pulmonary embolism and no other treatments — such as anticoagulants — are working, IVC filters may be used. While these are designed to be permanent implants, the U.S. Food and Drug Administration has issued recommendations to implanting physicians suggesting removal as soon as the protection is no longer necessary.
The FDA has also encouraged that any physician who is involved in the treatment of patients with the IVC filter to consider benefits of removal, as well as the risks. If the benefits outweigh the risks, the filter should be removed.
Warning against the use of IVC filters comes after the FDA had received numerous reports of adverse side effects associated with the product. These side effects include:
- Device migration
- Perforation of the inferior vena cava
- Filter fracture
One maker of the IVC filters, C.R. Bard, revealed that the FDA sent them a warning letter as well, stating that they misfiled customer complaints, manufactured the Recovery Cone Removal System without clearance or approval, and failed to inform the FDA of any serious device malfunctions. One of the customer complaints included a report of patient death. In 2014, the FDA reported that they believed most IVC filters should be removed anywhere between the 29th and 54th day after insertion. Prior to this statement, though, many individuals had already started filing claims.
At Fleming | Nolen | Jez, L.L.P., we believe that anyone who has suffered as a result of IVC filter failure has the right to pursue compensation. Our national trial lawyers work diligently to compile the necessary strategy in order to hold IVC filter manufacturers accountable for any pain caused as a result of their device. Call today for a free case evaluation and learn how we can help.