In September of 2011, Steven Akin was implanted with an Option IVC filter at Baylor University Medical Center in Dallas, Texas. But in May of 2016, when he began experiencing back pain, Akin sought medical help from Dr. Omar Colon, who ordered an X-ray. Upon examination, Dr. Colon discovered that the IVC filter was deeply embedded in the inferior vena cava. Because of its position, the filter could not be removed without tearing the vein.
The inferior vena cava is the largest vein in the body, and an IVC filter is a cage-like device implanted in that vein. Its purpose is to catch blood clots, preventing them from reaching the heart or lungs, particularly in patients that cannot take anticoagulation medication.
But retrievable IVC filters, such as the Option, are meant to be temporary, and the FDA recommends retrieval between 29 and 54 days after insertion. However, the retrievable filters have a tendency to fracture, tilt, perforate the vena cava wall and other organs, and migrate.
Akin now requires ongoing monitoring. “As long as the Option filter remains embedded in his vena cava, Plaintiff is at risk for future thrombosis, filter fractures, migrations, perforations, and tilting. He faces numerous health risks, including the risk of death,” his attorney says. Akin has filed a lawsuit against Rex Medical and Argon Medical Devices.
The device maker is now being sued for negligence, with claims that they have been selling a defective and “unreasonably dangerous” medical device. The lawsuit also includes claims that the manufacturer failed to warn about issues and side effects that the device allegedly causes.
Although the Option was FDA “approved,” it was only through a 510(k) application. This means that a new device is allowed to be sold on the market without having undergone clinical trials as long as it is equivalent to another device already on the market.
Unfortunately, the equivalent devices include C.R. Bard’s Recovery filter, which has been linked to 27 deaths and was recalled in 2005, and the G2 filter. Bard is currently facing more than 700 lawsuits regarding the two filters.