The U.S. Food and Drug Administration (FDA) in 2010 issued a safety warning and communication after receiving reports of adverse events linked to the filters in five years.The FDA’s warning included recommending that filters be removed as soon as the risk of pulmonary embolism subsides but in some cases, the filter it is claimed that the filter was left in the patient longer than was necessary.
In 2014, the FDA updated its safety communication specifically, the FDA updated information related to published research and post-market surveillance studies for the medical devices which include further information about the risk of serious complications linked to IVC filters.
The FDA warned, among other items that IVC Filters are linked migration, fracture, embolization (where the device or part of the device moves to the heart or lungs), perforation, and difficulty removing the device. The FDA noted that once the short-term risk of pulmonary embolism has passed, IVC filters should ideally be removed between 30 – 60 days after they were implanted.
IVC filter lawsuits?
IVC filter lawsuits have been filed across the United States alleging that manufacturers knew or should have known about the risks associated with this medical device and failed to warn patients or the medical community about the risks. They further allege negligence on the part of the manufacturer or marketer and design and manufacturing defects.