Cordis Corporation, makers of OptEase and TrapEase IVC filters, currently faces over 140 lawsuits alleging life-threatening injuries after being implanted with their filters.
IVC, inferior vena cava filters are spider-like device that are inserted into the vena cava and designed to capture and trap blood clots passing through the artery and prevent them from reaching the lung. The filters were designed to be temporary and according to the FDA, should be removed within 29 and 54 days of implantation. The problem has been that most are not removed in that time frame and the risk of fracture, tilting, and migration increases the longer they remain implanted. According to the FDA, the resulting adverse effects can involve complications such as:
- Filter fracture
- Embolization of broken components
- Migration and tilt
- Organ damage (heart, lungs, kidneys, etc.)
- Perforation of the vena cava
- Internal bleeding
- Deep Vein Thrombosis (DVT)
- Filter is clogged with blood clots
- Filter or Broken pieces can’t be removed
Nationwide there are currently over 1500 lawsuits involving IVC filters and the number continues to climb. The bulk of those lawsuits have been filed against manufacturers C.R. Bard and Cook Medical, but this has brought smaller manufacturers like Cordis under increased scrutiny. A limited 2011 study by Japanese researchers found that 10 out of 20 patients implanted with the Cordis TrapEase IVC filters had a fractured strut within 50 months of implantation.
Cordis was also forced to issue a Class 1 recall for almost 33,000 OptEase IVC filters due to a labeling error that could cause the filter to be implanted backwards and result in it migrating towards the heart.
An estimated 30,000 IVC filters have been implanted in the last 30 years. Patients need to be acutely aware of the high failure rates associated with these devices. Along with the Cordis TrapEase and OptEase, other IVC filters being named in lawsuits areCook Celect Filter, Cook Gunther Tulip Filter, Bard Recovery Filter,Bard G2 Filter and Bard G2 Express Filter.
At Saunders & Walker we continue to represent victims harmed by drugs and medical devices. If you or someone you know have been injured after the having an IVC filter implanted please contact us for a free consultation.
