Pharmaceutical

Study: IVC Perforation is ‘rule rather than exception’ for the Günther Tulip, Celect IVC Filters when not retrieved timely

IVC filter 294x210 Study: IVC Perforation is rule rather than exception for the Günther Tulip, Celect IVC Filters when not retrieved timelyAt the University of California, San Francisco a study was conducted to test the “incidence, magnitude, and impact” of the ability for a retrievable inferior vena cava (IVC) filter to be retrieved, and the impact of timely retrieval. The Gunther Tulip and Celect model IVC filters, made by Cook Medical, were the chosen to be tested.

Medical records were used to identify 272 filters placed between July 2007 and May 2009. When 50 of those patients received a follow-up CT scan unrelated to the IVC filter, all patients showed “some degree” of vena caval perforation, after the filter had been left in for 71 days. In 20 of the 50 patients (40 percent), the filter was tilted, all of which had perforated the vein.

The study noted that incidents of the vena cava being perforated by parts of the filter was “infrequently reported in the literature,” but “can be significant.” The study pressed that retrieval of the filter as early as possible would be advised.

Cook Medical is dealing with an onslaught of lawsuits related to injuries allegedly caused by its retrievable IVC filters. Patients began filing lawsuits against Cook Medical related to IVC filters just four years ago, but the number of complaints has now risen to 560.

Other medical device companies that manufacture IVC filters are facing similar lawsuits, including Johnson & Johnson subsidiary Cordis, and C.R. Bard, the maker of the Recovery filter. Lawsuits allege the device is linked to 27 deaths and hundreds of non-fatal injuries.

Sources:
National Center for Biotechnology Information
Righting Injustice