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 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 IVC filters can seek help from trained advocates.

 

 

The Truth

IVC Filter Complications An 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 ComplicationsStudies 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.

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 complications, delayed complications, and issues with 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

  • Venous access issues, including bleeding, hematoma, inadvertent arterial puncture and infection
  • Malposition
  • Defective filter deployment

Delayed IVC Filter Complications

  • Filter migration
  • Filter fracture
  • Vein/organ perforation
  • Infection
  • Deep vein thrombosis
  • Difficult or 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, 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.

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.

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.

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.

The Next Steps

Data shows that the widespread off-label use of IVC filters accounts for more than 50% 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. Thousands are taking action against C.R. Bard and other manufacturers of dangerous filters.

The story is still unfolding. We’re here to keep you informed.

When you’re ready, we’ll connect you with a team of advocates who will find the right path for you. It’s your right to know the truth about all the risks and side effects. And now it’s time to get the justice you deserve.