IVC Filter Maker Sued For Negligence A Woman Lives A Constant Fear of “Sudden Catastrophic Medical Emergency”.
A South Dakota woman who received an Eclipse IVC inferior vena cava filter (IVC) to lower the risk of blood clots that could lead to a pulmonary embolism has filed suit against with C.R. Bard, the manufacturer of the IVC filter, reports digitaljournal.com.
The suit alleges, in part, that she lives under the constant fear of “a sudden catastrophic medical emergency“ occurring at any time.
An IVC filter is implanted to prevent the development of an embolism and meant to be used as a temporary method of treatment. Surgeons implant IVC filters in patients who are unable to tolerate anticoagulants (blood thinners). IVCs stop the clots that may be forming in the blood stream and over a period of time, clots normally dissipate, according to drugwatch.com.
Plaintiff Reported the Device Travelled and Became Stuck In Her Internal Organs
The plaintiff reports that the device allegedly travelled and became stuck within her internal organs. In spite of a surgical attempt to remove the device, the IVC filter remains in her organs essentially putting her at risk for further potentially life-threatening complications.
IVC filter migration, fracturing, embolization, and perforation have been complaints received by the U.S. Food and Drug Administration (FDA) by at least 900 women since 2010. As a result, four years later, the FDA recommended to physicians and the medical community that IVC filters should be removed with a time frame of 20 to 54 days after implantation.
In the April 2013 issue of JAMA: Internal Medicine, it was revealed that less than 10 percent of patients implanted with IVC filters were able to have them successfully removed.