Warnings issued by FDA over IVC Filters

Recently, the Food and Drug Administration (FDA) issued a warning to C.R. Bard, Inc for violations of federal law relating to the safety of its Inferior Vena Cava (IVC) filter product. These violations concern safety of certain filters that were implanted in people as retrievable filters who had a temporary need to prevent a blood clot from going to the heart or lung. One of the violations claims that C.R. Bard sold and misbranded IVC Filters and failed to report adverse events from these filters.

IVC Filters are made to be inserted temporarily in patients to catch blood clots before the clot enters into the heart or lung, causing pulmonary embolism. Unfortunately, these IVC filters have been shown to have a high risk of fracture. The arms of the filter fracture and travel into the heart and other organs causing injury or death. The filters can also dislodge completely and travel through the bloodstream, tearing tissue and arteries. In some instances, the filters can also migrate through the body in a way that they are irretrievable.

The FDA now warns that these devices are dangerous and should be removed as soon as the patient’s risk of blood clots has subsided. Common models of IVC filters at issue are the Bard Recovery and the Bard G2.

If you have been implanted with an IVC filter, and have had problems as a result, call the Manchin Injury Law Group today for a free consultation at 1-800-557-4LAW.