Fractures of IVC Filters as a Complication of Implant Surgery

IVC filters can fracture after being implanted, causing serious medical complications. Some of those complications can be life-threatening, especially if the fractured IVC filter migrates from where it was implanted. Injured victims of these fractures have filed IVC filter lawsuits against the companies that make the implants, claiming that their design was defective and that they failed to warn doctors and patients of the risks.

ivc fracture

1. How IVC filters can fracture after being implanted

IVC filters are tiny medical devices with thin parts that are implanted in a vein. While inside, they are under considerable pressure that can break or fracture pieces of the implant. Worse, many IVC filters are meant to be temporary implants. They slowly deteriorate over time, increasing the likelihood of fracture as the days pass.

The problem is far from rare. The U.S. Food and Drug Administration (FDA) found 56 reported instances of IVC filters fracturing between 2005 and 2010, plus another 146 reports of IVC filters fracturing and then migrating to the patient's heart or lungs.1

1.1 IVC filters can fracture under pressure and trauma

The design of IVC filters makes them susceptible to fracturing under the pressure they withstand after being implanted.

IVC filters look like the frame of an umbrella: The handle of the umbrella is the “head” of an IVC filter, while the metal prongs attached to the top of the umbrella are called the “struts” on an IVC filter. Just like an umbrella, those struts open and close on an IVC filter.

The struts of an IVC filter are closed while the device is inserted through an incision in the patient's groin or neck and navigated to the inferior vena cava – the vein that runs from the patient's legs up to their heart and lungs. Once in place in the vein, the struts are sprung open to gain a foothold in the walls of the vein. Some IVC filters even have struts that end in hooks to gain a better foothold.

In the inferior vena cava, IVC filters keep blood clots from traveling from the patient's legs, up the vein, and to the heart or lungs, where they can cause serious medical complications like a pulmonary embolism.

The small size and fragility of these struts, though, make IVC filters poorly equipped to withstand the pressure and trauma that they undergo while inside the inferior vena cava. IVC filters can get jostled whenever the patient breathes or moves, or whenever their heart beats.

This pressure and trauma can prove to be too much for an IVC filter, causing its struts to break or fracture.

1.2 IVC filters can deteriorate and fracture

Most IVC filters that are implanted now have not been designed to stay in the human body forever. Instead, the FDA has recommended that IVC filters be removed as soon as the dangers of a pulmonary embolism have subsided.2 Medical studies have found that the risks of having an IVC filter implanted begin to outweigh the benefits between 29 and 54 days after the procedure.3

Nevertheless, removal procedures are often delayed or disregarded.4 The metal in the IVC filters that are left implanted beyond the recommended time period can degrade from the oxygen-rich blood that is constantly flowing past it, weakening the struts and frame of the device, creating structural fatigue, and increasing the odds of a fracture.5 IVC filter fractures tended to happen more than a year after being implanted.6

2. Medical complications caused by a fractured IVC filter

IVC filters that fracture can cause severe and even life-threatening medical complications.

When an IVC filter fractures, the piece that has broken can migrate elsewhere in the body. Because the blood flow in the inferior vena cava is towards the heart and lungs, though, most migrating pieces of fractured IVC filters go there. This can create life-threatening medical complications, including:

  • Heart attacks,
  • Deep vein thrombosis,
  • A hole in the heart,
  • Internal bleeding, and
  • Torn veins and arteries leading to the heart and from it.

Even if the fractured portion of the IVC filter does not break away from the rest of the device and migrate in the inferior vena cava vein, the medical complications of a fractured IVC filter can still be dire. An IVC filter with a fracture in it will likely be unable to block a blood clot that travels up the inferior vena cava. Without the IVC filter's intervention, the clot can reach the lungs, where it can block an artery and cause a pulmonary embolism.

3. Symptoms of a fractured IVC filter

Complicating the medical conditions that can be caused by a fractured IVC filter is the fact that most people who have an implanted IVC filter that has fractured have no symptoms.7 Without a sign that their IVC filter has fractured, patients are unable to notify their doctor and take action to prevent serious medical problems, including:

  • Pulmonary embolisms, or
  • Heart or lung conditions caused by a migrating piece of a fractured IVC filter.

Instead, symptoms that something is wrong typically only happen after the fractured piece of IVC filter has migrated. These symptoms often include:

  • Generalized back or abdominal pain,
  • Neck pain,
  • Chest pain,
  • Nausea,
  • Lightheadedness,
  • Confusion and disorientation,
  • Low blood pressure, and
  • Heart arrhythmia.

References:

  1. U.S. Food and Drug Administration, “Removing Retrievable Inferior Vena Cava Filters: Initial Communication” (Aug. 9, 2010).

  2. U.S. Food and Drug Administration, “Removing Retrievable Inferior Vena Cava Filters: Initial Communication” (Aug. 9, 2010).

  3. Morales JP, et al., “Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism,” Journal of Vascular Surgery 1(4):376-84 (October 2013).

  4. Andreoli JM, Lewandowski RJ, Vogelzang RL, Ryu RK, “Comparison of complication rates associated with permanent and retrievable inferior vena cava filters: a review of the MAUDE database,” Journal of Vascular and Interventional Radiology 25(8):1181-5 (August 2014).

  5. See Grewal S, Chamarthy M, Kalva S, “Complications of inferior vena cava filters,” Cardiovascular Diagnosis and Therapy 6(6):632-41 (December 2016).

  6. Kalva SP, Wicky S, Waltman AC, Athanasoulis CA, “TrapEase Vena Cava Filter: Experience in 751 Patients,” Journal of Endovascular Therapy 13(3):365-72 (June 1, 2006).

  7. See note 5.

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