Have you suffered complications as a result of an IVC filter procedure?
Inferior vena cava (IVC) filters are small, umbrella-like devices used in patients at risk of experiencing a pulmonary embolism. A pulmonary embolism is a situation that can lead to grave medical complications and in some cases, death. Although this method has proven advantageous in many instances, some patients have suffered dire consequences as a result of IVC filters.
Many different types of IVC Filter Systems are connected to high rates of fractures and migrations, and, therefore, have the potential to cause severe and catastrophic internal injury that can lead to life-threatening complications for those who received the inferior vena cava (IVC) filter to stop a blood clot from causing a pulmonary embolism.
The most popular brands of IVC devices include:
- The Cook Gunther Tulip filter
- The Cook Celect filter
- The Boston Scientific Greenfield filter
- The Bard G2 Express filter
- The Bard G2 filter
- The Bard Recovery filter
The most common IVC filter problems include:
- Punctured Vena Cava
- Shortness of Breath
- Lung or Heart Perforation
- Hemorrhagic Pericardial Effusion
- Cardiac Tamponade
- Ventricular Tachycardia
- Pericardial Pamponade
- Chest Pain
What are IVC Filters Used For?
The purpose of IVC filters is to prevent or intercept blood clots that travel through the inferior vena cava, and in doing so, prevent pulmonary embolisms from occurring. The IVC filter was designed for patients at risk for pulmonary embolisms and are incapable of taking medications to reduce their risks of blood clots.
How Often Do Injuries Occur From IVC Filters?
A study published by the Archives of Internal Medicine in 2010 made a note of the fact that IVC filter fracture rates were 12% and that the Bard Recovery Filter system failure rate was 25%. The study took note that in some cases, fractured pieces of the Bard G2 filter traveled to the hepatic vein or the lung. Based on the researchers’ findings they concluded that the rate of Bard IVC filter fractures was equivalent to the length of time that the retrievable device was left in place in the patient. Accordingly, the rate of Bard G2 filter problems and complications increases with time.
An April 2012 study conducted by the CardioVascular and Interventional Radiology established that Cook Celect and Gunther Tulip filters presented a noticeable degree of vena cava perforation after only 71 days of implantation. Researchers uncovered that perforation of through the IVC wall occurred in 86% of all cases with regards to a component of the filter.
Over 900 adverse event reports have been sent to the FDA involving complications as a result of IVC filters. Of the adverse events reported the most frequent complaint involves the filter or a piece of the filter breaking off and migrating to different parts of the patient’s body. As a result of the numerous adverse event reports that the FDA has received the FDA issued in 2014 an updated safety statement. The updated safety statement meant that patients face an increased risk of problems with IVC filters if the filters remain in place for extended periods of time. The safety statement advised doctors that the ideal time for removal seems to be between 29 days and 54 days after implantation. Some studies have uncovered that 40% of IVC filters were left in for five years and, as a result, many of those patients suffered extensive injuries.
What is Wrong With IVC Filters?
Because there were improper warnings and instructions in place, numerous doctors were not informed of the significance of removing the IVC filters. Even with that said, there still existed design defects that increased the risks of IVC filter failures that included but is not limited to device fracturing and subsequent perforation of the vena cava or other serious and complicated injuries.
Pieces of the IVC filter can travel through the bloodstream and become lodged in other parts of the body, such as the heart or lungs, if, the IVC filter is left in place when the risk of a pulmonary embolism has passed. The reasons pieces of-of the filter can travel through the bloodstream if because the legs or struts of the filter that extend out in a spider-like shape can fracture or collapse.
Is Anything Being Done to Correct the Problems?
Because of the injuries linked to numerous makers of IVC filters, lawsuits are currently being reviewed since the manufacturers failed to take sufficient steps to shield consumers from harm or caution consumer regarding the filters risk of migration or fracture.
Both researchers and the FDA are commanding for the removal of IVC filters because of clinical test results. In fact, numerous cases related to the filters required emergency treatment and removal, which in some cases can produce the need for open heart surgery.
Patients who have experienced critical complications from IVC filters, as well as the families of those who have died because of complications with an IVC device, are encouraged to seek the advice learn more about their legal rights and remedies.
Call the Testa Law Group at 877-780-9052 to begin your path to recovery with a free consultation today.