Lawyers for Cordis OptEase and TrapEase IVC Filters
The IVC filter lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for individuals throughout the United States who have experienced problems with the Cordis TrapEase Permanent filter or Cordis OptEase IVC Filter, which have been linked to reports of devastating internal injury and life-threatening complications.
Cordis Corporation sold the inferior vena cava (IVC) filters for use in patients at risk of a blood clot traveling to the lungs and causing a pulmonary embolism. However, design problems may cause individuals to face a risk of potentially serious Cordis IVC filter side effects, including:
- Filter Migration or Tilting Out of Place
- Perforation of Vena Cava
- Filter Fracture
- Pulmonary Embolism or Thombosis
- Inability to Remove or Retrieve IVC Filter
- Wrongful Death
Financial compensation may be available through a Cordis IVC filter lawsuit due to the manufacturers failure to adequately warn about the risks associated with their product, and failure to disclose problems experienced by users.
All cases are reviewed by our law firm under a contingecy fee agreement, which means that there are no fees or expenses unless a recovery is obtained for an injury. Request a free consultation and claim evaluation.
Cordis TrapEase, OptEase IVC Filter Problems
IVC filters are small, spider-like devices implanted into the inferior vena cava (IVC) to prevent blood clots from traveling to the lungs and causing a pulmonary embolism. They are often implanted when anticoagulant therapy is contraindicated or has failed.
The Cordis TrapEase is a permanent vena cava filter, which was approved by the FDA in 2001. The Cordis OptEase is a retrievable vena cava filter, which was introduced in 2003.
Cordis obtained approval for the IVC filters under the controversial FDA 510(k) fast track approval process, which allowed them to perform only minimal testing before selling the devices for use in patients nationwide.
As a result of problems with Cordis IVC filters, individuals have reported suffering severe complications including perforations of the vena cava, internal injuries when the filters tilt out of position, migrate to other areas or fracture, potentially sending small pieces to the heart or lungs.
A number of studies have raised questions about the safety of IVC filters, suggesting that the products may be unreliable and ineffective in many cases. Specifically, researchers have raised concerns about the risks with Cordis OptEase and TrapEase filters, suggesting that the devices may have a high failure rate and risk of filter fractures.
In 2012, a study published in the medical journal JAMA Internal Medicine found that half of patients implanted with the permanent TrapEase IVC filter suffered filter fractures after an average of 50 months. For those with filters implanted for longer than four years, 64% suffered filter fractures.
Researchers concluded that the Cordis TrapEase IVC filter failure rate posted an “extremely high risk of strut fractures,” which may occur within a few years of placement. The researchers suggested that permanent IVC filters should be used with caution, and indicated that removal should be encouraged for retrievable filters, such as the Cordis OptEase IVC filter, which has a similar structure to the TrapEase.
A 2005 study published in the Journal of Trauma-Injury Infection & Critical Care found that the Cordis OptEase IVC filters pose a risk of puncturing the vena cava wall after just a month, indicating that strut protrusion through the vena cava wall prohibited successful and safe removal after extended periods of time.
Cordis OptEase IVC Filter Recall
In 2013, Cordis sent a letter to medical professionals in the U.S. and Canada, warning that labeling problems could result in doctors implanting the OptEase IVC filter backwards, which could pose a risk of serious injury or death.
The FDA classified the letter as a Class I medical device recall, the most serious classification, suggesting that the defect poses a risk of serious adverse events or death.
In May 2014, the FDA issued a safety communication in response to hundreds of reports involving IVC filters breaking inside patients and causing damage to the heart, lungs and other organs. As a result, the federal regulators warned that retrievable IVC filters, such as the Cordis OptEase, should be removed within about one to two months after the risk of a pulmonary embolism has passed. This has raised questions about the warnings and instructions provided by Cordis and other manufacturers.
IVC Filter Class Action Lawyers
Saiontz & Kirk, P.A. provides free consultations and claim evaluations for individuals to help determine if they or a loved one may be entitled to financial compensation through a Cordis TrapEase IVC filter lawsuit or Cordis OptEase IVC filter lawsuit.
Similar claims are being reviewed against the manufacturers of other devices that have exhibited similar problems, including Cook Celect and Gunther Tulip IVC filter lawsuits, Bard Recovery filter lawsuits and Bard G2 IVC filter lawsuits.
Individual claims, as well as potential Cordis IVC filter class action lawsuits, are being reviewed as a result of the manufacturer’s apparent decision to place the desire for profits before consumer safety by introducing a defective and unreasonably dangerous IVC filter design and failing to provide adequate warnings for doctors and consumers.
Our IVC filter attorneys can help determine what legal rights may be available if you have experienced problems where a Cordis IVC filter or similar product caused a puncture injury, pulmonary embolism, moved out of place or fractured.
There are never any out-of-pocket costs to hire our law firm and we only receive an attorney fee or any expense reimbursement if you are successful in securing a recovery for a Cordis IVC filter injury.