There are approximately 50,000 people with IVC filters in America. The majority of these patients have already suffered a pulmonary embolism. Along with anticoagulation therapy, these filters have become the treatment of choice for some doctors. It wasn’t until they became widely used that their effectiveness was questioned.
IVC Filter Dangers
When an IVC filter is placed in the body and works as it was designed to, they are quite helpful. It’s when the filter migrates that the issues begin. A hook on the filter holds it in place within the vein. Some patients have experienced a migrating filter after the hook has failed. In some instances, the filter tips instead of migrating. The filter causes damage as it moves, puncturing organs and veins as it travels.
IVC filters have been known to fracture in some more serious cases. The small pieces of filter that break off travel through the body posing the same dangers as blood clots. The pieces can be so small that they can travel through the veins and into the brain, lungs or heart. They can then cause damage or conditions that can prove fatal.
Surgeons are aware that the IVC filters are potentially dangerous, prompting the creation of removable filters. The removable filters may be safer, but they can be difficult to remove. Some patients have been put under only to wake up and find out that their filters are still in place due to difficulty in their removal. To avoid complications during the removal process, some doctors choose to leave these removable filters right where they are. In fact, it has been reported that only about 1/3 of those filters that are implanted end up being removed. The longer the filter is left in the body, the harder it is to get it out.
Three Categories of Complications
There are procedural, retrieval and delayed complications associated with the use of IVC filters.
- A procedural complication is one that includes damage to the access site, puncture of blood vessels, placement concerns and defective deployment.
- A retrieval complication occurs when there is damage to the body during the removal of an IVC filter.
- Delayed complications include device infection, migration, swelling in the lower limbs and deep vein thrombosis.
Warnings from the FDA
An official communication was released by the FDA in 2016 to medical professionals who utilize IVC filters. There was also a communication given to patients who had the filters implanted. The governmental body had determined that the filter should be considered for removal once a patient was not considered at risk for pulmonary embolism. The agency stated that removal should be considered between days 29 and 54 after implantation.
The FDA decided that removal of the filter during this time frame would help to eliminate complications such as difficulty in removal, filter fracture and filter migration. Manufacturers of the devices were ordered to research the use of the filters and to collect data regarding their efficacy and complications.
IVC Filter Recalls
IVC filters have been recalled in 2005, 2013 and 2018. The recalls have been issued for different reasons. The latest was considered to be urgent in nature, advising Boston Scientific to cease use of their Greenfield Vena Cava Filter immediately. The recalls listed possible adverse health conditions as its reason.
Lawsuits
A woman in Georgia was recently awarded more than $3 million in a lawsuit stating she suffered complications after having an IVC filter manufactured by C.R. Bard, Inc. implanted. It was the first of over 3,500 lawsuits filed in Arizona to be heard in court. It is expected that other lawsuits will follow this path and compensate patients who have been injured by the filters, their implantation or their removal.
Alternatives to IVC Filters
Like many medical procedures, there are alternatives to having an IVC filter implanted. Any patient who is told they need one of these filters should explore all their options before consenting to the procedure. Some patients have been able to avoid implantation by making lifestyle changes and taking certain prescription medications.
If an IVC filter is the only viable option, a patient should know the complications to watch for and when to contact their doctor. There should be a plan in place for the removal of the filter. Patients are urged to remember that they are their own advocate and need to speak up if they have questions about IVC filters and alternatives.
Call Our Office Today
If you have had an IVC filter implanted and sustained injury or suffered with complications , please reach out defective medical device lawyers. Our experienced team of attorneys will review the details of your case and advise you of your legal options. Your first consultation will be held at no cost to you and we will help you make decisions appropriate to your situation.