Cordis Corporation makes the OptEase and TrapEase IVC filters, which are designed to prevent pulmonary embolisms Unfortunately, recent studies have found alarming rates of filter fracture, migration, and tilting when the filters are not removed after a few months.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: Lawyers Seek “Mass-Tort” for Cordis IVC Filter Lawsuits
June 16, 2016 — Lawyers are asking judges in California to create a “mass-tort” to centralize Cordis IVC filter lawsuits involving 115 personal injury plaintiffs at the federal level. Click here to read more.
Cordis IVC Filters
Cordis Corporation makes two temporary IVC filters, the OptEase and TrapEase. These devices are implanted in a major blood vessel called the inferior vena cava (IVC) to catch blood clots before they cause a pulmonary embolism.
Cordis IVC Filter Approval
Cordis IVC filters are not designed to be permanent. They were never studied for long-term use. Instead, they were approved with a 510(k) application that said they were “equivalent” to the Recovery IVC filter, which as withdrawn in 2005, and the Günther Tulip. Unlike these “equivalent” devices, which are both cone-shaped, the OptEase and TrapEase are balloon-shaped.
What is the problem?
Temporary vena cava filters can have severe complications when they are not removed. The risk of fracture, tilting, and migration increases the longer they remain implanted.
The problem is that studies have found that most of them are not removed when they are no longer necessary.
In 2011, the FDA recommended removing IVC filters within 29 and 54 days after implantation. In 2008, the agency also issued a Safety Warnings after receiving over 900 adverse events involving 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
Cordis IVC Filter Linked to 50% Fracture Risk
A small study published by Japanese researchers in November 2011 found that 10 out of 20 patients who were implanted with the Cordis TrapEase IVC filters had a fractured strut within 50 months of implantation. No life-threatening events occurred.
Cordis IVC Filter Recall
In March 2013, Cordis issued a Class 1 recall for about 33,000 OptEase IVC filters due to a labeling error that could cause the filter to be implanted backwards. If the fixation barbs are pointing in the wrong direction, there would be nothing to stop the filter from migrating to the patient’s heart.
IVC Filter Lawsuits
Over 1,000 IVC filter lawsuits have been filed as of May 2016. These lawsuits are not part of a class action. Instead, the vast majority have been centralized in federal court — about 550 have been filed against C.R. Bard in Arizona (MDL No. 2641) and over 600 more have been filed against Cook Medical in Illinois (MDL No. 2570).
Do I have a Cordis IVC Filter Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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