When Billy H. Jr. had his Cook Celect IVC filter implanted in September 2012, he had no idea what he was in for. Studies of the Celect IVC filter have shown high rates of perforation. In one study of 99 patients with Celect filters, 43% of patients suffered device perforation of the inferior vena cava wall within two months of implantation. In another study of 27 patients, all patients experienced some degree of perforation within 71 days.
Billy Jr. now suffers from severe complications caused by his defective Celect IVC filter. He filed a lawsuit against Cook Medical alleging the device is defective in design and manufacture. More than 980 other patients share his claim of experiencing complications from their Cook IVC filters.
The FDA approved the Cook Celect IVC filter through the controversial 510(k) approvals process. Devices approved through this pathway do not have to provide extensive clinical trial data because they have been deemed similar to other devices already approved by the FDA.
In the case of IVC filters, one of the devices already approved by the FDA was the Recovery filter by C.R. Bard. However, Bard voluntarily recalled this filter after the company discovered the devices had a high rate of fracture.
Despite the shortcomings of other IVC filters, the 510(k) approvals process continued to be used on subsequent models of the device. In 2010 and again in 2014, the FDA issued safety warnings to patients and doctors after the agency received nearly 1,000 reports of adverse events related to IVC filters.
The FDA recommends removing IVC filters within 29 to 54 days after implantation, but studies have shown as little as 20% of patients with IVC filters ever get them removed. This puts patients at a much higher risk of experiencing severe complications.
The first Cook IVC filter lawsuits will go to trial in early 2017.