Statistics for Retrievable IVC Filter Complications
- 35.6% involving filter migration
- 15.9% involving embolization of fractured device components
- 7.6% involving perforation of the inferior vena cava
- 6.1% involving filter fracture
Inferior vena cava filters (IVC filters) are designed to minimize risk of pulmonary embolism by capturing and disintegrating blood clots before they can cause any damage. Today, IVC filters are available in temporary or “retrievable” form, but with this advancement comes some serious complications and side effects.
Approved by the United States Food and Drug Administration (FDA) in 1979, IVC filters are now available as permanent or retrievable implants, with the retrievable option intended for short-term use. From 2005 to 2010, the FDA received nearly 1,000 complaints regarding adverse events connected to the failure of the newer retrievable filters and IVC filter removal complications.
The FDA did not report on the remaining 34.8% of adverse event reports, but did issue a warning regarding an increased risk of IVC DVT. In light of these reports, the agency began advising doctors to remove retrievable IVC filters once the threat of pulmonary embolism was no longer present.
Unfortunately, many of the worst complications were experienced upon the removal of the retrievable filters. Few were due to the implantation procedure, or the presence of the device in the body.
IVC filter complications typically fall into three categories: procedural, delayed, and retrieval. The following risks are well documented, but complications can vary significantly between patients.
|Procedural Complications||Delayed Complications||Retrieval Complications|
In addition to the complications related to insertion, removal, or prolonged use of an IVC filter, some serious complications and side effects can occur due to the filter’s presence within the body.
While older IVC filters were made of titanium or stainless steel, the newer retrievable devices are created using a variety of high-tech alloys. Since these filters become flexible with temperature changes, fluctuations in body temperature can alter the device’s configuration, allowing it to detach.
If the filter detaches from the IVC’s walls, it can migrate to other parts of the IVC, the heart, or other organs. During this migration (also known as embolization) the device is carried “upstream” with the blood flow, moving through the body and often perforating everything in its path.
Migration & embolization symptoms can include:
People with migrated IVC filters are considered at high risk for serious complications like ventricular arrhythmia (rapid heart rhythms) and cardiac tamponade, a potentially fatal medical emergency where blood escapes into the gap between the heart muscle and outer layer. For example, in 2009, cardiologists at Michigan’s William Beaumont Hospital documented the case of a 54-year-old man whose retrievable IVC filter migrated to his heart. As a result, he was diagnosed with non-Q-wave myocardial infarction, a less severe type of heart attack.
Many sources, including the FDA, have reported that there’s a trend toward doctors leaving retrievable IVC filters in for too long, increasing the risk of device failure over time. In fact, a 2014 study published in the Journal of Vascular Surgery reported that retrievable IVC filters left in place for extended periods are associated with significantly higher complication rates than permanent filters. The FDA’s adverse event reports from 2005 to 2010 included 202 filter fractures. 146 of these instances involved broken pieces migrating toward the heart. The disseminated pieces are extremely difficult to extract during the removal procedure.
In 2010, York Hospital in Pennsylvania examined 80 patients with filters manufactured by C.R. Bard, a New Jersey company that now faces a number of IVC filter lawsuits. Their results, published in the Journal of the American Medical Association, revealed some troubling statistics:
Throughout the implantation, general presence, and removal process of the IVC filter, the device has been shown to cause perforations that can lead to potentially life-threatening situations. The FDA reported 70 adverse event reports between 2005 and 2010 in which some degree of perforation had occurred. Once a strut has punctured the vessel wall, the sharp wire is likely to pierce surrounding tissues and organs. Since IVC filters are typically placed near the kidneys, the intestines and ureter are often damaged, along with other blood vessels in the area.
The primary IVC filter complications associated with perforation include:
IVC filters have also been shown to cause blood clots, the serious condition that they were designed to treat. When a blood clot forms in the IVC, the flow of deoxygenated blood may be blocked from reaching the heart, causing IVC thrombosis, a subtype of DVT. IVC thrombosis is associated with a number of serious symptoms and can lead to other conditions, including:
The FDA has also found less serious IVC side effects, including irregular heartbeat, chest pains, and breathlessness, often resulting in the loss of consciousness.
In light of the widespread acknowledgment of IVC filter removal complications and significant filter risks, patients have started filing lawsuits against C.R. Bard and Cook Medical, the primary manufacturers of these devices.To learn more about IVC filter complication lawsuits, visit the dedicated tab.