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Canadians Initiated Class Action lawsuits against IVC Filter Manufacturers

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Given the reportedly high rate of failure of the IVC Filters, there is a need for every individual with an IVC to have medical monitoring to monitor the IVC Filter to see if has the potential to break and cause injury, As per a recent class action suit filed in Canada concerning the use of IVC filters, according to the reports, one plaintiff in Canada has filed a lawsuit alleging that she was not warned of the risks associated with IVC filters. The plaintiff stated that after implanting the Cook Medical IVC filter in August 2013, doctors later attempted to remove the filter only to find that it had broken. A piece that had broken off was then piercing her internal jugular and the rest of the device had moved to her lower intestine. Doctors stated that the surgery was too risky and they were unable to proceed. It was then determined that the device could not be removed, and the plaintiff now has to remain on blood thinners for the rest of her life. She now lives in fear that it’s only a matter of time until the device kills her.

On February 22, a plaintiff filed another class action lawsuit against the manufacturer, claiming his doctors have made two unsuccessful attempts to remove his IVC filter and a third is scheduled at the end of the month. In his claim, Plaintiff declared that he has suffered from dizzy spells and doctors have informed him of the possibility that his device is gradually clogging, which is obstructing blood flow. Major complications related to IVC filters are usually rare; safe removal of the device is possible for approximately 80% of patients. However, the longer the IVC filter remains in the body, the more challenging it becomes to remove the device.

The inferior vena cava is the body’s largest vein. It is responsible for moving de-oxygenated blood from the lower extremities of the body to the heart’s right atrium, subsequently proceeding into the lungs. IVC filters are medical devices which are implanted into patients who are unable to take blood-thinning drugs. The devices work as filters to prevent potential blood clots from traveling from the lower body to the heart and lungs, where they could become fatal. The devices are often used temporarily until a patient can be placed on blood thinners.  If patients require long-term protection from PE, surgeons may implant permanent IVC filters. If people require short-term protection, doctors may implant retrievable IVC filters. In August 2010, FDA issued an initial warning against leaving inferior vena cava filters implanted in patients for extended periods due to their potential to cause adverse health complications.

The FDA updated a 2010 safety communication in May 2014 regarding device removal complications. FDA has received more than 1,000 reports of serious adverse events related to Bard IVC Filters. Reports include 328 for device migration, 146 for embolizations (device component detachment), 70 for perforation of the IVC, 56 for filter fracture. Similar problems have been found with other IVC filters made by Cook Medical, Boston Scientific, B. Braun and others. The FDA claims the manufacturer has sold these devices without approval and that the facilities that manufactured these devices failed to meet quality guidelines. The FDA also states that until C.R. Bard fixes the problems listed in the warning letters, they will not approve the recovery system filter for use.

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According to a report, the number of lawsuits filed against IVC filter manufacturers in the United States increased to 750 cases last month. Lawsuits declared that manufacturers negligence in the design of the devices. Lawsuits claims that the devices are prone to fracture, migrate, tilt or perforate the inferior vena cava, resulting in serious injury to the patients.

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