Our lawyers are reviewing potential lawsuits for people who were injured by an Optease IVC filter, a medical device designed to prevent blood clots from reaching the lungs in patients who are unable to take anticoagulant medications.
Free Confidential IVC Filter Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Overview
The Optease Retrievable Vena Cava Filter is a small, cage-like device that is implanted in the inferior vena cava just below the kidneys. The filter is designed to capture an embolism, a blood clot that has broken loose from the lower body on its way to the heart and lungs. Optease is made by Cordis Corporation, and was cleared for sale on the U.S. market via the FDA’s 510(k) approval process, which requires little safety information and only some data concerning a product’s efficacy so long as it is ‘substantially equivalent’ to a device that is already on the market.
What’s the Problem?
Reports have surfaced indicating that IVC filters can break away from the implant site and migrate to the heart, lungs and other vital organs, leading to life-threatening complications and even death. Lawsuits are being filed nationwide because the medical literature has noted a significant rate of IVC filter failure, fracture, device migration, embolization, perforation of the filter, and other problems.
FDA Warning
On May 6, 2014, FDA updated [1] a 2010 Safety Communication [2] after receiving more than 1,000 adverse event reports associated with IVC filters. These included:
- 328 reports of device migration
- 146 embolizations (device component detachment)
- 70 perforations of the inferior vena cava
- 56 filter fractures
IVC Filter Complications
- Fracture of the IVC filter
- Perforation, Puncture, or Serious Damage to the Heart, Lungs, or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb Deep Vein Thrombosis (DVT)
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
- Respiratory Distress
- Infection
- Shortness of Breath
- Death
Optease IVC Filter Recall
In March 2013, FDA announced a Class 1 recall [3] for 33,000 Optease IVC filters for a labeling correction to minimize the risk of implanting the device backwards. Affected filters were distributed in the U.S. from May 5, 2010 to April 2, 2013. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the products will cause adverse health complications or even death.
Do I Have an Optease IVC Filter Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in IVC filter lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
