The Centers for Disease Control and Prevention (CDC) reports as many as 60,000 to 100,000 Americans die every year from deep vein thrombosis or a pulmonary embolism. Deep vein thrombosis (DVT) is a clot that originates in the leg. A pulmonary embolism (PE) develops in the artery to the lungs.
Both clots are called a thrombosis.
Often the first symptom of one of these blood clots is death, so treatment is warranted and soon after it’s discovered. Blood thinners or anticoagulants are the first line of defense. But some patients are unable to take these blood thinners. Others need additional treatment to avoid the blood clot from traveling.
IVC stands for inferior vena cava, the main and largest vein in the body. An IVC filter may be placed there to act as a basket to catch blood clots and prevent them from traveling to the heart or lungs where they can cause a fatal stroke or heart attack.
IVC filters can be both long-term or placed until the danger of a pulmonary embolism (PE) has passed.
Unfortunately, the Food and Drug Administration (FDA) issued a warning in 2010 that discouraged leaving an IVC filter in the body for an extended period of time. The FDA recommends IVC filters be removed within 54 days after being implanted if they are retrievable variety and if the risk is resolved.
Many patients change doctors, or their health care managers may be relying on the old standard which said to leave the filter in permanently. The patients may not return to a doctor for follow-up after they have an IVC filter implanted.
It’s estimated there may be as many as 400,000 patients walking around with an IVC filter implanted in the body.
Regardless of the reason, studies reveal with the passage of time there is an increased risk of complications with an IVC filter.
The FDA warning came after the agency received 921 reports of complications or adverse events. They include the IVC filter device migrating, filter perforation, device tilting, filter fracture and a detached device component also known as device embolization. Additional complications can arise when a surgeon attempts to remove a device that has been left in the body.
Consider the IVC filter is made of metal with long spider-like legs. Called struts, they are delicate and may break off inside the body. Once that happens, the small struts can migrate making retrieval impossible. Since they are made of metal, the fragments can also pierce arteries or organs causing death.
A study from Ohio State University Medical Center found 46 percent of filters had penetrated the vena cava vein and adjacent organs.
Fracturing is often accompanied by embolization or detachment of the device components. A fracture could cause the IVC filter to stop working, allowing a blood clot to bypass the filter, negating its purpose.
A New England Society for Vascular Surgery study found there was a 31 percent fracture rate in IVC filters with the fragments lodging in a patients’ right ventricle of the heart.
When Dr. William Nicholson of Pennsylvania’s York Hospital did a study on the Bard Recovery filter, he found a 25 fracture and embolization rate on the Recovery and a 12 percent on the Bard G2 filter, Bard’s first and second generation of IVC filter. The conclusion was the Bard Recovery and G2 filters have a high prevalence of fracture and embolization which could cause a life-threatening situation.
By 2010, the FDA issued its Safety Communication that warned most IVC filters should be removed from the body anywhere from 29 to 54 days after implantation. Unfortunately for those implanted earlier, that warning came too late.
Consider that the body is a dynamic environment, and though the IVC filter is made from metal intended to move, the two are of contrasting properties. The body may move in a way that permanently tilts the IVC filter from its original vertical positioning. If that happens the IVC filter could be essentially useless in preventing a pulmonary embolism. A blood clot can pass through a filter that is lying on its side.
The other problem with tilting – the top of the IVC filter can grow into the vena cava wall. If this happens retrieving the filter is a nightmare. A vascular surgeon must make an incision through the jugular vein and try to snare the hook on top of the filter. Imagine if it’s embedded into the main vein of the body.
Thousands of Americans could have these vena cava filter fractures and be unaware of the potential risk they face. Often the first symptom of a problem is life-altering pain, a migraine or death.
At least 27 deaths are associated with Bard’s Recovery filter and another 300 non-fatal problems are associated specifically with the Recovery.
That amounts to pain and suffering from an unknown future for thousands of Americans who are living with a faulty medical device that may not be able to be removed.