An inferior vena cava (IVC) filter is a device closely resembling a spider that is inserted into the inferior vena cava, the largest vein in the body. Its purpose is to catch blood clots and prevent them from reaching the heart or lungs. Patients who can’t tolerate anticoagulation medication are often implanted with IVC filters as a means to prevent pulmonary embolism.
The retrievable IVC filter models are intended to be temporary, and according to the FDA should be retrieved between 29 and 54 days after insertion.
C.R. Bard, a medical device manufacturing giant, has been under fire recently for problems reported in conjunction with its IVC filters, which patients claim have caused extensive injuries. Lawsuits claim that the device tilted or migrated within their bodies, or fractured. Reports say fractured arms have impaled organs, ripped through the vena cava, and passed through hearts of many patients, creating pain and health problems that have been difficult to resolve. Many surgeries have been required to retrieve broken IVC filter arms, and in some cases, the filter or parts of the filter were simply unretrievable at all.
Bard’s Recovery filter alone has been linked to at least 27 deaths and hundreds of non-fatal injuries. The G2 and G2 Express were meant to be updated and safer versions of the filter, but they have proven to have just as many reported issues.
Now, Bard’s new-and-improved filter, the Denali, is beginning to show signs of similar issues. The Denali is a filter that Bard proudly states is a “completely redesigned Bard Filter with advanced filter technology to help prevent movement, tilt and penetration.” Bard further claims that the filter has been “clinically tested in the largest and longest IDE filter study.” The Denali is supposedly both a permanent and temporary filter with 12 needle-thin arms.
Jessica Williams of Texas has gone through two of them, and is now filing a lawsuit against Bard alleging injuries resulting from the filters.
Williams received her first Denali in May of 2014, then received a second one that following September. In her legal complaint, Williams alleges she received painful injuries as a result of the Denali, and is now seeking compensation from the device maker, C.R. Bard.