Inferior vena cava filters are implanted in thousands of Americans to stop life-threatening blood clots from reaching the lungs. Investigations show that manufacturers may have hidden IVC filter complications and the device’s potentially fatal flaws.


The Truth

Studies + Science

Regulation Recap

The Next Steps
IVC filters may come with immediate and long-term complications, such as fracture and migration.Nearly 20 percent of IVC filter removal attempts were unsuccessful, while permanent filters pose a higher risk of deep vein thrombosis.Media organizations and the FDA are targeting manufacturers who hid device complications from the public.Individuals implanted with failed IVC filters can seek help from trained advocates.

 

 

The Truth: Complications from IVC Filters

IVC Filter ComplicationsAn inferior vena cava filter (IVC filter) is a metallic cone-shaped device designed to prevent blood clots from migrating to major organs. It’s used to protect against stroke and pulmonary embolism (PE), which occurs when a blood clot creates a life-threatening blockage in the lungs.

More than 250,000 people have IVC filters implanted in the inferior vena cava, an essential vessel that carries blood from the lower limbs to the heart and lungs. The devices are surgically embedded in the vein, usually after a traumatic accident or major medical procedure.

A number of IVC filters are marketed as retrievable, while others are sold as a permanent fix for PE. The devices are an alternative to pharmaceutical blood thinners, recommended for patients unable to tolerate anticoagulant medications like Xarelto and Eliquis.

Medical manufacturers began developing the IVC filter in the 1970s, but many health professionals believe it lacks an established safety profile. Approved through the Food and Drug Administration’s fast-tracked 510(k) clearance program, IVC filters skipped safety testing and are now linked to a long list of complications.

The FDA has received more than 900 reports of filter fracture, device migration, organ perforation and deep vein thrombosis (DVT). Thousands of people, unaware of the risks, will continue to have these potentially fatal filters implanted into their bodies.

Studies + Science

IVC Filter

About the Inferior Vena Cava

What is the inferior vena cava?

When the heart beats, its atriums and ventricles contract and send blood through the body. The blood follows a particular path through the vessels, supporting both pulmonary and systemic circulation.

The vena cavae are two large, extensive veins that deliver deoxygenated blood to the heart. The superior vena cava carries blood from the upper half, whereas the inferior vena cava carries blood from the lower half.

More specifically, the inferior vena cava brings deoxygenated blood to the bottom part of the right atrium of the heart. This allows the deoxygenated blood, which is made up of carbon dioxide, to become freshly oxygenated.
Who requires an inferior vena cava filter?

Most patients who receive inferior vena cava filters have experienced trouble with pharmaceutical methods to stop blood clots from developing. People who receive IVC filters are at a higher risk for pulmonary embolism. Inferior vena cava filters may also be suggested for patients who experienced a trauma, or for individuals who have difficulties with mobility.
How do doctors insert inferior vena cava filters?

An IVC filter is implanted in the body by a physician, using a catheter. A catheter is a very narrow tube, which is thinner than a pencil’s lead. The IVC filter is inserted through a catheter from an incision in neck or groin and then delivered to the abdomen through the tube. 

Physicians use contrast dye to monitor the location of the IVC filter as it’s being placed in the body. Once the IVC filter has reached its proper posture, the physician releases it. The IVC filter then opens and becomes nestled in the blood vessel, able to catch blood clots that develop in the legs. It’s placed within the abdomen, or sometimes, in the leg. 

Types of IVC Filter Complications

Studies show that IVC filters can come with a variety of complications, many of which occur when parts of the device break off and dislodge from the original location. People who experience IVC filter complications often notice chest pain and shortness of breath, in addition to other symptoms that may be hard to discern from normal day-to-day aches and pains.

The U.S. Library of Medicine published a study analyzing 10 common IVC filter complications. The study, conducted by University of Hospitals, divided the complications into three categories:

  • procedural IVC filter complications
  • delayed IVC filter complications
  • issues with IVC filter retrieval

According to the study, “certain complications are beyond the control of physicians.” For this reason, it’s important to be aware of the possible risks associated with IVC filters.

Procedural IVC Filter Complications

  • IVC filter bleeding
  • IVC filter hematoma
  • Inadvertent arterial puncture
  • Inadvertent infection
  • Filter malposition
  • Defective filter deployment

Delayed IVC Filter Complications

  • IVC filter migration
  • IVC filter fracture
  • IVC filter infection
  • IVC filter organ perforation
  • Vena cava vein perforation
  • IVC deep vein thrombosis
  • IVC filter difficult
  • IVC filter impossible retrieval

Procedural IVC filter complications, referred to as venous access and filter deployment, are usually minor and avoidable. But delayed complications, such as filter fracture, migration, IVC thrombosis and recurrent PE, can cause disease and death. Fracture and migration are the most common complications, which are also associated with arterial piercing, bacterial infection, and bleeding.

In some cases, IVC filters will have migrated so far and so deep that they become embedded in organs and tissue. The devices can pierce organs, back muscles, and even stab into the heart and lungs.
Retrievable Filters

The majority of complications stem from IVC filters meant to be removed when a patient’s risk of PE has subsided. Retrievable IVC filters are marketed as a temporary treatment for pulmonary embolism, as an attempt to avoid long-term problems caused by permanent filters. Researchers have discovered that in many cases, part or all of the IVC filter cannot be removed.

In April 2013, the Journal of the American Medical Association published a study that tested the safety of retrievable vena cava filters. Researchers analyzed 952 medical records, and of the 679 retrievable IVC filters that were placed, only 58 were successfully removed. Additionally, 25 patients experienced pulmonary embolisms.

The study showed that 18.3 percent of removal attempts were unsuccessful and 7.8 percent of patients experienced thrombosis. Researchers concluded that “unretrieved removable IVC filters may carry significant long-term risks.”

One consensus panel, published by the Journal of Vascular Surgery in 2013, estimated that 50 percent or fewer of retrievable IVC filters are ever removed.

Permanent Filters

While retrievable filters may get stuck, permanent filters can also cause damage. According to a systematic review of 37 studies, IVC filters aren’t a forever fix. The complication rate actually increases with time. When IVC filters are left in place for longer than 30 days, it can lead to recurrent deep vein thrombosis, vena cava thrombosis, organ penetration, migration, and strut fracture.


5 Most Common IVC Filter Complications

  1. Filter Migration

Since many filters are designed as temporary solutions, filter migrations become increasingly likely the longer the device remains in the body. Complications arise when the filter migrates to areas such as the lungs or heart, which is referred to as a cephalad migration. When the IVC filter migrates in a downward motion, its known as a caudal migration. Migration often makes retrieval difficult or impossible without surgery.

  1. Deep Vein Thrombosis

Although IVC filters are clinically proven to reduce the likelihood of PE, they have also been shown to increase the occurrence of blood clots in the deep vein. This condition is known as deep vein thrombosis  (DVT). A 2006 study found that 40 to 44 percent of patients who received an IVC filter developed DVT by the follow-up appointment.

  1. IVC Perforation

One of the least predictable vena cava filter complications is IVC perforation. Perforation occurs when one or more of the struts of the filter puncture the wall of the IVC. Over time, an IVC filter can erode the walls of the IVC and become embedded in the tissue. Perforated filters are very difficult to remove, and they can cause fatal bleeding if left untreated.

  1. Filter Fracture

Usually occurring before migration, fractures are one of the most common filter complications. Over time, the struts, which are essentially the legs of the device, can break off. When they’re no longer placed in the inferior vena cava, fractured struts migrate to the heart or lungs. They can also migrate to the kidney, liver or spine. Some people experience ongoing chest pain, whereas others lose their lives. 

  1. IVC Infection

Resulting from improper sterilization protocols, an IVC filter may contain bacteria that infects surrounding tissue. In the event of bacterial colonization, the filter should be immediately removed as it poses a severe health concern.

IVC filters may also tilt or shift, which can make them ineffective in preventing pulmonary embolism.

Regulation Recap

Despite clear concerns about the device complications, IVC filters were approved through the FDA’s 510(k) approval process. The process is a loophole that allows manufacturers to skip clinical testing and put the product straight to market. It wasn’t until hundreds of people experienced issues with their IVC filters that the FDA had begun to address the problem.

2010 FDA Safety Communication

In 2010, the FDA released an initial communication informing the public about the potential dangers of IVC filters. The regulatory body cited the growing popularity of these devices, which increased from 2,000 IVC filters used in 1979 to almost 167,000 filters in 2007. The FDA refers to a number of difficulties that may arise from IVC filter implantation.

“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforations of the IVC, and 56 involved filter fracture,” according to the FDA’s report.

The NBC Exposé

NBC News launched an investigation into IVC filters to assess the scope of the damage done by IVC filters. In addition to 300 reports of IVC filter injuries, NBC News discovered that 27 people died from complications linked to IVC filters in the last decade. The media organization posted two in-depth pieces about IVC filter problems:

One of the thousands of people implanted with IVC filters, a 45-year-old woman named Dodi Froehlich, nearly died when a part of the IVC filter broke off and moved to her heart. She had the device implanted after a car accident that made her more susceptible to clotting, NBC reports.

Another woman, 55-year-old Gloria Adams, died after a powerful blood clot propelled the entire spider-like IVC device to her heart. The filter was meant to protect her after a brain aneurysm.

NBC News also investigated if manufacturer C.R. Bard knew about the design flaws and health risks. In a growing number of lawsuits, the pharmaceutical behemoth is accused of marketing a defective device and failing to warn the public about the risks.

Manufacturer Misinformation

When patients began to speak out about complications, C.R. Bard didn’t issue a recall. Instead, the company hired a public relations firm for damage control while simultaneously launching private testing. The study showed that the IVC filter Recovery model was associated with a greater risk of fracture, migration and early death. C.R. Bard kept the results hidden and continued to sell thousands of rebranded filters, NBC reports.

After the study, the FDA began a correspondence with C.R. Bard and mandated that the company resubmit for agency approval. The IVC filter manufacturer has also been accused of falsifying signatures on these FDA applications.

Despite insufficient clinical trials, the company claims that the product meets federal safety standards. Representatives from C.R. Bard issued a statement that IVC filters offer “significant benefits to patients.”

2014 FDA Safety Communication

In 2014, the FDA released an updated communication on the subject of IVC filters. The agency mandated that some manufacturers either participate in the independent national PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, or conduct postmarket surveillance studies. PRESERVE is composed of approximately 2,500 patients who will undergo IVCF placement in up to 50 centers across the United States.

The organization will continue to collect additional data on both retrievable and permanent IVC filters. The FDA recommends that physicians weigh the benefits and the risks of IVC filters. If a patient’s risk of pulmonary embolism has diminished, doctors should consider removing the device in order to prevent future complications.

2015 FDA Warning Letter

The FDA began a long correspondence with C.R. Bard, going up against the manufacturer for inadequate product inspections, misbranding and unlawfully introducing the Recovery Cone Removal System to the market. C.R. Bard’s violations also include selling products in adulterated packaging and failing to adequately organize and review complaints.

While an IVC filter can be very beneficial for some, it can also be dangerous. Doctors should analyze patient history to determine if IVC filter implantation is necessary and closely monitor all patients using the device by following up to check the status of each individual.

For patients who can’t have the filter removed, there might be few options. However, with media attention and FDA up to bat, that’s no longer the case.

IVC Filter Lawsuits

There have been a number of IVC filter lawsuits and settlements, though not all are public information. These lawsuits are part of a multi-district litigation, which groups complex cases with similar elements together to streamline the legal process.

As of spring 2018, there are currently more than 4,000 lawsuits against Cook Medical, along with more than 3,000 against C.R. Bard. Specific device that has been associated with failure are represented in the lawsuits, such as the C.R. Bard Recovery, G2 and G2 Express models. For Cook Medical, the Cook Celect and Cook Günther Tulip are also under scrutiny.

MDL Lawsuits: IVC Filter Brands

  • Cook Filter
  • Cook Günther Tulip Filter
  • Bard Recovery Filter
  • Bard G2 Filter
  • Bard G2 Express Filter

IVC filter manufacturers have been facing legal action for at least five years, with some cases ending in private settlements. From 2013 to 2015, C.R. Bard reached settlements with three people injured by IVC filters.

One Michigan case, in 2013, involved a Bard G2 Filter fracture and migration to the heart. Another settled case related to the same device took place in Illinois, and it also involved a broken filter causing heart and lung problems.

Some cases have resulted in public verdicts, such as: 

  • In March 2018, a jury awarded $3.6 million to a Georgia woman named Sherr-Una Booker who suffered IVC filter injuries related to a device manufactured by C.R. Bard. 
  • In May 2018, a jury awarded $1.2 million to a Texas firefighter who experienced injuries associated with at Cook Celect IVC filter.

People who have experienced complications like fracture and migration have a right to file IVC filter lawsuits, both for compensation and assistance with ongoing health costs. Additionally, families of people who died from related IVC filter complications can also seek help. 

The spring 2018 count includes an estimated 8,000 lawsuits against manufacturers of IVC filters, with the potential for more injured patients to come forward.  

The Next Steps

Despite the fact that IVC filter use has declined nationwide, data shows that the widespread off-label use of IVC filters accounts for more than 50 percent of IVC filters implanted in the United States.

IVC filter complications require close monitoring, prolonged hospital stays, and expensive correction treatments. Individuals implanted with IVC filters may have to deal with high medical bills and a diminished quality of life.

If you’re struggling to deal with IVC filter complications, you’re not alone. The story is still unfolding. We’re here to keep you informed.

MedTruth can provide support by connecting you with a team of advocates. If you’re ready, you can explore options to get the justice you deserve.