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IVC Filter Complications

Inferior vena cava (IVC) filters are designed to stop dangerous blood clots from migrating toward the lungs. These devices essentially look like small wire cages, which are surgically implanted into certain veins within the body. Typically, patients at risk of traveling clots are given of one several blood thinning agents. However, because some individuals are unable to tolerate such medications, IVC filters have emerged as a useful option. First appearing in the United States back in 1979, the IVC filter has been used on a regular basis for decades, becoming a common method of preventing blood clots in a wide array of patients.

Conditions treated with IVC filters

One of the primary conditions regularly addressed via the use of IVC filters is that of deep vein thrombosis (DVT), in which blood clots can form in a patient’s extremities or pelvis and pose a very real danger of traveling to the lungs to become a potentially fatal pulmonary embolism (PE). Approximately 300,000 deaths occur each year as a result of PE, and IVC filters are one preferred method of reducing that number.

The process of treating patients with IVC filters is relatively straightforward, with the devices being implanted by a radiologist, vascular surgeon or cardiologist by means of a catheter inserted in the neck or groin region. Though these filters are manufactured in both permanent and retrievable form, the latter type is quite commonly used.

IVC filters that have been designed to be removed once the risk of blood clot travel has passed are often allowed to remain inside patients for extended periods, concerning many in the medical community, including the Food and Drug Administration.

IVC filter complications

Despite the popularity of IVC filters as a means to treat blood clot risks in certain categories of patients, in August of 2010, the U.S. Food and Drug Administration issued a safety alert describing a marked increase in adverse event reports related to their use.

Some of the IVC filter complications outlined by the FDA include:

  • Filter fractures
  • Aortic perforations
  • Vena cava punctures
  • Filter migration
  • Device embolization

Out of these concerns, roughly 35 percent of reports stemmed from migration of an IVC filter to a part of the body distinct from the original site of implantation. The FDA cautioned physicians about the routine practice of leaving these devices inside patients long after the true risk of blood clot travel has passed, noting that it escalates the risk of eventual, potentially life-threatening complications.

Even though IVC filters are meant to treat only those patients with histories of pulmonary embolism and who cannot make use of conventional blood thinners, many doctors are implanting them in patients with neither factor. As a result, countless individuals are being placed at unnecessary risk of harm, and increasing ranks of injured patients and their families are opting to file IVC filter lawsuits in order to secure compensation for complications that have included:

  • Respiratory compromise
  • Pulmonary embolus
  • Hemorrhage
  • Ongoing discomfort and pain
  • Vein, organ and tissue perforation
  • Anxiety about risk of harm
  • Death

IVC filter fracture and migration

In addition to the FDA’s adverse event reports, recent studies have suggested that particular types of IVC filters were especially prone to fractures and migration. It is not uncommon for fractured pieces of the devices to eventually migrate to the patient’s heart and lungs, though they can also reach other key organs. Once a metal fragment of this sort becomes lodged in an area of the body, bleeding, extreme pain, further embolus and grave injury can occur.

An important study in the journal Archives of Internal Medicine provides additional cause for concern with regard to two specific types of retrievable filters, the Bard Recovery and Bard G2 models. The fracture and disintegration rates for these devices was alarmingly high.

Furthermore, a study published in the Journal of the American Medical Association revealed that among the data sample investigated, only 58 of 679 IVC filter patients ever actually had the devices removed, despite the fact that their risk of blood clots had long since subsided.

Once an IVC filter device has been determined to have failed in this manner, patients are often forced to undergo a surgical procedure to remove the device as well as any broken pieces. However, it is frequently too dangerous to eliminate all of the fractured parts, leaving patients exposed to ongoing risk of harm. For these reasons, many are calling upon physicians to be more proactive about removing these filters as soon as the patient’s condition permits, in order to ameliorate undue dangers.

Tissue and vein perforation due to IVC filters

Perforation of veins and tissues throughout the body are additional concerns when it comes to the use of IVC filters. Permanent functional damage can occur, as can severe, sometimes uncontrollable internal bleeding.

Individuals with IVC filters currently implanted must remain vigilant about the warning signs of IVC filter failure, which can include shortness of breath and serious pain and discomfort.

  1. Jama Internal Medicine, Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, http://archinte.jamanetwork.com/article.aspx?articleid=226212
  2. U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: Initial Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm
  3. Cleveland Clinic, Inferior Vena Cava (IVC) Filter Removal, http://my.clevelandclinic.org/services/heart/services/vascular_surgery/ivc-filter-retrieval
  4. United States District Court Southern District of Indiana, MDL Case Information – MDL No. 2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation, http://www.insd.uscourts.gov/mdl-case-information
  5. U.S. Food and Drug Administration, Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm
  6. United States Judicial Panel on Mutidistrict Litigation, IN RE: Bard IVC Filters Products Liability Litigation – Transfer Order, http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2641-Initial_Transfer-07-15.pdf
  7. Journal of Vascular and Interventional Radiology, A Comparison of Retrievability, Celect versus Option Filter, http://www.jvir.org/article/S1051-0443(15)00148-7/abstract