FDA Issues Update to Initial Medwatch Safety Communication
On May of 2014, the FDA issued an update to its first Medwatch safety communication regarding IVC filter complications.
The first safety communication dealing with these devices, which are small umbrella or cone-shaped metallic devices implanted in the inferior vena cava to capture blood clots and prevent a pulmonary embolism (PE), detailed many complications associated with the devices.
The pertinent additions to the original update included the following:
Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided.
Both the original safety communication and the updated communication mention that medical staff caring for patients with these devices should, “consider removing the filter as soon as protection from pulmonary embolism is no longer needed.”
However, the update discussed the FDA’s pursuit of additional data on these filters, and stated that, “the FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States, and that manufacturers could participate in and “independent national clinical study that will examine the use of IVC filters in the prevention of pulmonary embolism.”
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If you or a loved one has been implanted with an IVC Filter, call Martin Baughman at (214) 761-6614, or contact us for a free initial consultation. We are a small firm that offers immediate answers and big results, all with no obligation. Call today.