IVC filters like the OptionELITE made by Argon Medical have been reported to cause serious personal injuries to recipients, including heart attack, pulmonary embolism, organ perforation, punctured veins and more.
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.
Option ELITE IVC Filter Lawsuit Filed in Philadelphia
March 3, 2017 – A California woman whose doctor was allegedly unable to retrieve an Argon IVC filter from her body has filed a lawsuit against Argon Medical Devices and Rex Medical in the Philadelphia County Court of Common Pleas. Plaintiff Debra Victor claims the filter couldn’t be removed because it had become embedded in her vena cava, and is suing the companies for manufacturing a defective medical device.
Overview
Argon’s OptionELITE nitinol IVC filter is designed to protect against recurrent pulmonary embolism, a condition in which one or more arteries in the lungs become blocked by a blood clot. The device is different than many other IVC filters in that it can be retrieved or remain implanted, depending on whether the patient needs short-term or long-term protection from pulmonary embolism. The OptionELITE was originally designed by Pennsylvania-based Rex Medical, but is now manufactured and marketed by Argon Medical Devices.
What’s the Problem?
Studies have found that when left in place for an extended period of time, IVC filters have been linked to serious, potentially fatal complications including:
- Fracture of the IVC filter
- Device Migration / Embolization
- Insertion-site Thrombosis
- 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 (PE)
- Respiratory Distress
- Infection
- Shortness of Breath
- Death
FDA Recommendation
FDA now advises doctors responsible for patients with retrievable IVC filters to consider removing the devices as soon as protection from pulmonary embolism is no longer needed. The agency’s recommendation was made after it received 921 adverse event reports involving IVC filters since 2005. Of these:
- 328 involved device migration
- 146 involved embolization
- 70 involved perforation of the IVC
- 56 involved filter fracture
IVC Filters Don’t Save Trauma Patients, Study Finds
Patients who suffered trauma and received IVC filters to prevent blood clots in the lungs (pulmonary embolism) had no survival advantage, according to a study published in JAMA Internal Medicine in September 2016. A research team led by Dr. Shayna Sarosiek at the Boston University School of Medicine looked at data from 451 IVC filter recipients and 1,343 controls, and found that the devices did not save a significant number of these patients and doctors removed just 8% of the filters after 3.8 years. This is a problem because the FDA recommends doctors remove these filters in about 60 days after initial placement.
“The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the researchers concluded. “Given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”
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.