A Florida family has filed a wrongful death lawsuit over the failure of an Option Inferior Vena Cava Filter (IVC filter) manufactured by Rex Medical to prevent a fatal pulmonary embolism.
The Florida man had the Option IVC filter implanted in September 2014 to prevent a blood clot from the lower extremities from traveling into the arteries in the lungs and blocking blood flow. Despite having the Option IVC filter, the man suffered a bilateral pulmonary embolism a week after the filter was implanted, and he died in early October, according to Consumer Advocacy News.
Inferior vena cava (IVC) filters are used as a defense against blood clots for patients who cannot take blood-thinning drugs or for whom such drugs do not work well enough or quickly enough. A surgeon implants the small, spider-like device in the vein, where it should trap blood clots and prevent them from traveling from the lower body to the heart or lungs, where they can be fatal.
By 2012, more than a quarter million IVC filters had been implanted. But patients and doctors were reporting serious problems with the filters. Patients experienced severe pain, bleeding, further clots, and organ perforation. In some cases, the filter moved from the original insertion site and became lodged in another part of the body. Filters tilted, making them ineffective in trapping clots. There have been numerous reports of the “legs” of an IVC filter breaking off and becoming embedded in the vein or in an organ. Blood clots can form around the broken-off filter fragments.
Medical experts are concerned about the FDA’s approval process for the IVC filters and other devices. The 510(k) device clearance process is a streamlined process that allows a device to be cleared for use without extensive clinical trials if the device is considered “equivalent” to other devices already on the market. But in many instances, devices cleared through the 510(k) pathway has proved to be ineffective or unsafe. A seemingly small difference in materials or design can have a large impact on the device’s safety and effectiveness. With the rapid increase in implantable medical devices such as pacemakers, defibrillators, and insulin pumps, and external devices that provide breathing and cardiac support and deliver nutrition and medication, many in the medical community are calling for device approval procedures that require all devices to be tested.
The equivalent-device provision paved the way for the Option IVC filter approval, based on C.R. Bard’s Recovery and G2 IVC filters. Unfortunately, the Bard filters are prone to failure. In 2005 Bard replaced the Recovery filter with the G2, which also proved to have problems.
The FDA has determined that it is best to remove the IVC filter when the danger of blood clots has passed and not longer than three months after insertion. But many of these supposedly temporary IVC filters are never successfully retrieved, which adds to the long-term health risks. When an IVC filter moves or breaks or becomes lodged in a vein or organ, the filter may be difficult or impossible to safely remove. When the filter has to be left in place, the patient is at risk for injury.