The OptEase vena cava filter is a retrievable implant. When it is left implanted too long, serious risks like fracture, migration, and organ damage significantly increase.
Need a Texas IVC Filter Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a serious complication, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the OptEase IVC Filter?
Cordis Corporation manufactures the OptEase retrievable vena cava filter. It is implanted in a patient’s inferior vena cava (IVC) to prevent blood clots in the lower half of the body from traveling to the lungs and causing a pulmonary embolism.
What is the problem?
In March 2013, Cordis recalled about 33,000 OptEase Retrievable Vena Cava Filters due a labeling error involving an arrow pointing the wrong way on a storage tube.
The problem which might result in the filter being implanted backwards. With fixation barbs pointing in the wrong direction, there would be nothing to prevent the filter from migrating to the patient’s heart and causing a deadly cardiovascular event.
On April 3, Cordis sent an “URGENT Medical Device Correction” letter to inform customers in the U.S. and Canada about the error. In August, the FDA announced a Class I recall for filters that were distributed in the United States from 2010-2013. Click here to read more.
Cordis Studying Long-Term Risks in PRESERVE Trial
Cordis is participating in the PRESERVE clinical trial, a 5-year safety study involving seven types of retrievable vena cava filters. The study began in early 2015 and will enroll about 2,100 patients, including at least 300 who are implanted with the TrapEase or OptEase vena cava filter.
FDA Safety Warnings
The FDA has issued several warnings about the dangers of leaving retrievable vena cava filters implanted for long periods of time, after the patient is no longer at risk of a pulmonary embolism.
In 2010, the FDA issued a Safety Communication to report nearly 1,000 adverse events since 2005. In 2014, the agency recommended removing filters 29-54 days after implantation, so long as the patient’s risk of pulmonary embolism had passed.
The longer a retrievable filter remains implanted, the higher the risk of complications such as:
- Filter fracture
- Broken pieces of the filter may travel in the body (embolization)
- Migration or tilt
- Perforation of the vena cava
- Internal bleeding, hemorrhaging, or hematoma
- Organ damage
- Heart problems
- Deep vein thrombosis (blood clots in the legs)
- Surgery may be unable to remove pieces
- And more
IVC Filter Lawsuits
Hundreds of people who were injured by vena cava filters have already filed lawsuits against manufacturers like C.R. Bard and Cook Medical. These lawsuits are not part of a class action — instead, they are individual lawsuits that have centralized at the federal level in Arizona and Indiana (MDL No. 2570).
Need an IVC Filter Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas IVC Filter lawyers for a free lawsuit review.