A New Jersey woman filed a lawsuit against Rex Medical for a fragment of a broken inferior vena cava (IVC) filter that became lodged in her lung.
Cindy H. was implanted with a retrievable IVC filter called the Option ELITE on Aug. 5, 2010 at Virtua Voorhees Hospital in New Jersey, the Daily Hornet reports. The purpose of the filter was to prevent blood clots from traveling to her lungs, which would result in life-threatening pulmonary embolism.
On Oct. 20, 2015, Cindy underwent a procedure to have the filter removed after the threat of blood clots had passed. Her doctors discovered that the filter was drastically tilted. When the doctors attempted removal, one of the filter legs fractured and made its way to her lungs.
“During the removal surgery a leg of the filter near the apex broke off and has now become lodged in her left central lung field,” the lawsuit states.
Fractures are common with retrievable IVC filters, which are made with a more fragile structure than permanent designs. Because IVC filters are implanted into the inferior vena cava, the largest vein in the body, fractures are extremely dangerous. Broken fragments may easily travel through the bloodstream to the heart, lungs, or another vital organ. Thousands of patients allege injuries connected to retrievable IVC filters, and at least 12 deaths have been linked to them.
The lawsuit includes accusations that Rex Medical sold an “unreasonably dangerous medical device.” The lawsuit also accuses the company of failure to warn about hazards or potential side effects.
Currently, about 3,000 lawsuits are pending against IVC filter manufacturers for faulty devices, including Argon Medical Devices Inc., Rex Medical L.P., Cook Medical, and C.R. Bard.