Inferior vena cava filters are tiny cone-shaped metal cages implanted into the largest vein in the body—the inferior vena cava. They can be either permanent or retrievable, meaning temporary and removable. The medical devices are intended to intercept blood clots that have developed in a deep vein in the leg, known as deep vein thrombosis, but have broken free and are on the way to the pulmonary artery. Without an IVC filter, these clots could potentially block the pulmonary artery, which is central to the function of both the heart and lungs. The resulting pulmonary embolism can be deadly.
Unfortunately, there are serious questions about whether the benefits of retrievable IVC filters outweigh the risks. In 2010, the Food and Drug Administration (FDA) detailed more than 900 adverse event reports involving IVC filters, including filter perforations and fractures, several hundred device migrations, and nearly 150 embolisms. At that time, the FDA released warnings about these risks and recommended removal of devices as soon as the risk of embolism was reduced.
In 2014, the FDA got more specific and recommended most IVC filters be removed between days 29 and 54 after being implanted. Unfortunately, many lives had already been significantly altered by the faulty medical devices. Hundreds of patients had suffered life-threatening injuries. Others had tragically lost their lives as a result of a medical device intended to save them.
The Indianapolis product liability attorneys at Wagner Reese, LLP are currently working on behalf of individuals who experienced serious injury as a result of problems with an IVC filter. If you or a loved one were a victim of an IVC filter that fractured, migrated to another body part, perforated an artery or organ, or otherwise caused damage due to a defect or improper use, you may have an IVC filter lawsuit case against the company that produced or designed your device.
Who Receives an IVC Filter & Why?
Blood clots can form as a result of various kinds of injury. They can happen after surgeries, such as cesarean section births, cancer removal, or those enacted to save someone from violent gunshot or knife injuries. Serious blood clots can also form after car accidents or any other injury that causes internal trauma to the body. The person with the clot may not know it exists until it poses a life-threatening risk.
Blood thinners are usually the first line of attack for treating blood clots; however, if a patient continues to develop clots regardless of blood thinner use or if the person has another medical condition that prohibits the use of blood thinners (such as Hemophilia), an IVC filter may be recommended. Individuals who develop bleeding complications from due to anticoagulants (blood thinners) and those with large clots in the iliac veins or inferior vena cava itself are also candidates for IVC filters. In 2015, the Journal of the American Medical Association (JAMA) published a study showing the failure of IVC filters to be as effective as blood thinners in preventing pulmonary embolism.
Are All IVC Filters Equally Risky?
Though there are risks inherent in the use of any medical device implanted into the body, the lawsuits are intended to address faulty design and use of the retrievable IVC filters. Thus far, the defective products include the following IVC filters manufactured by C.R. Bard and Cook Medical:
- Bard’s Recovery
- Bard’s G2
- Bard’s G2 Express
- Cook’s Gunther Tulip
- Cook’s Celect
The Cook Celect has been shown to have the highest risk of perforating arteries, veins, or organs by far, with complications occurring in over 40% of patients. It is critical to speak with your doctor about the kind of filter you already have in place or are about to have implanted. It is also important to understand the timeline and plan for removal of the device, as the evidence overwhelming points to length of implantation as a major impetus for malfunction or breakdown of the device. Do everything you can to understand the risks and explore other options when available.
Hundreds of thousands of IVC filters are implanted each year. Mounting evidence indicates patients are often not informed of the time frame within which the devices should be removed. Many patients discover this information only when there is a problem with the device or after the device has already perforated the IVC or another organ and is impossible to remove. Essentially, they have a ticking time bomb inside their bodies—one that could kill or injure them at any time.
Medical device companies like Bard and Cook Medical owe a duty to create safe products for consumers. For this reason, they are required to conduct thorough studies on their products. In the case of IVC filters, it is alleged the companies failed to complete the necessary studies, particularly on the risks to humans over time after the device had been implanted. The product liability lawsuits also allege the companies knew or should have known the defects existed and still did nothing to warn patients of the potential adverse effects. These allegations are based on numerous medical studies showing the wide range of complications caused by the prolonged presence of IVC filters.
File Your Claim Now
Wagner Reese, LLP offers a free consultation about your case and we do not take payment unless there is a verdict or settlement in your favor. Going to court against a large medical device company can be daunting, and it is a grueling process. With the help of our experienced Indianapolis-based defective medical device attorneys, you can fight against the company that knowingly put you or your loved one at risk, and you can win. Though nothing can undo the damage that has been done, you can still win compensation to cover the costs of a lengthy medical recovery.
If you have lost a loved one as a result of an IVC filter malfunction, we can help you recover necessary compensation to ensure your family does not need to worry about finances during a time of such great loss. Call us now for your free consultation at (888) 204-8440.