Government Issues New IVC Filter Warnings
Health Canada recently told doctors to remove IVC filters from their patients to avoid serious, long-term complications.
After receiving over 100 verified reports, the government medical watchdog officially linked the Inferior Vena Cava filter to organ perforation, fragmentation, and other possibly fatal conditions. Additionally, of the two Randomized Controlled Trials connected with IVC filters, neither of them indicated that these devices were particularly effective, according to the agency. Therefore, Health Canada strongly urged physicians to limit the use of IVC filters to extreme cases only and remove them after a few days. The agency stopped short of issuing a recall, but has demanded additional information about safety and efficiency from at least six manufacturers.
To facilitate legal action, Health Canada may also require device manufacturers to set up online registries.
The U.S. Food and Drug Administration approved these devices in 1979, and manufacturers touted them as a good treatment for patients with deep vein thrombosis (DBT, or blood clots in their legs) who could not tolerate anticoagulant medicine, because these blood clots could migrate to the heart and cause a fatal pulmonary embolism.
As with many other medical devices, such as MoM hip implants, gadget makers aggressively marketed IVC filters to increase sales, and what was designed as a temporary stopgap measure became a standard part of many treatment regimens, leading to serious complications like:
- Migration: To allow blood to flow somewhat freely, the IVC filter is incredibly small, and blood current often pushes it where it does not belong, causing intense pain.
- Perforation: As bad as it is, pain is one of the less caustic side effects. If pushed just a few inches, dislodged IVC filters often perforate internal organs and blood vessels.
- Embolization: The fragile device often breaks, and when it does, the fragments quickly travel to the heart, lungs, and other vital organs.
In 2014, the FDA warned physicians in the United States to only use IVC filters in specific situations and remove them as soon as they were no longer medically necessary, because otherwise the proven risk of serious side effects greatly outweighs the device’s purported effectiveness.
At a minimum, victims in defective medical device cases are entitled to compensation for their economic damages, such as the cost of revision surgery, and their noneconomic damages, such as pain and suffering. Juries often award substantial punitive damages in these cases as well.
Many victims have already filed lawsuits against Bard and other IVC filter makers. To start your claim for damages, contact the Morgantown office of Attorney Gary S. Logsdon. We guarantee client satisfaction.