ATTENTION: HEALTH WARNING
Studies have shown that removable IVC filters can cause catastrophic injury, in some cases even death.
We want to educate consumers on the IVC filter, the complications, and the injuries that can result. If you are a patient with an IVC filter implanted, we encourage you to speak with you primary care physician about your IVC filter.
Some of the complications include:
- device migration
- filter penetration
- filter fracture
- IVC perforation
- IVC thrombosis
- Pulmonary Embolism
even with the presence of the device.
These complications can result in:
- cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart)
- cardiac arrhythmia
- severe and persistent pain
- perforation of tissues
- perforation of blood vessels
- perforation of organs.
The Inferior Vena Cava (IVC) is a vein that returns blood to the heart from the lower portions of the body. IVC filters are spider like devices that were designed to filter or catch blood clots traveling from the lower portion of the body the heart or lungs.
Originally, the IVC filter was used for patients who had a history of Deep Vein Thrombosis (DVT) or Pulmonary Emboli (PE) where anticoagulant therapies did not work. They initially were designed to be permanently implanted in the IVC. Now, in order to gain market share and increase sales of these devices, manufacturers designed filters for temporary use. These manufacturers engaged in aggressive marketing campaign for the filter despite negative clinical data. This allowed manufacturers to access new patient groups such as bariatric, trauma, orthopedic, and cancer patient population.
These “temporary” filters received clearance by the FDA, under FDA Section 510(k) by claiming that the new retrievable filter was substantially similar to the permanent filter in safety, efficiency, design, and materials. Clearance was obtained despite a lack of adequate testimony on safety, and efficiency. There are multiple manufacturers of IVC filters, most notably are the Cook, Bard, Braun, and Cordis corporations. Each brand has it’s own unique filter design and shape.
IVC filters have been plagued with problems, most notably the absence of any evidence that the products were effective in preventing pulmonary embolisms (the very condition the product was indicated to prevent). The manufacturers knew that there were fracture rates as high as 37.5% after five years from the date of implant. Although the manufacturers new of these complications they continued to market to physicians as a safe alternative to anticoagulation therapy.
If you or a loved one has had an IVC filter implanted in the past 10 to 15 years, we urge you to speak with your doctor. If you or a loved one suspect you may have been injured by an implanted IVC filter and you would like to know what your legal rights are, please complete the consultation form here or call an experienced defective product attorney at The Ruth Law Team for a for a free, no obligation consultation.