Update: Health Canada Issues Warning on IVC Filter Complications
July 26, 2016 – Health Canada has issued a product safety warning regarding the potential health risks associated with vena cava filters. The agency received 121 injury reports linked to the devices since June 6, 2016. Most of the injuries occurred in patients whose IVC filters had been left implanted for over 30 days, according to Health Canada.
What is an IVC Filter?
Inferior Vena Cava (IVC) filters are implantable devices that catch blood clots before they get stuck in the lungs and cause a pulmonary embolism. Most IVC filters are designed with several thin wire legs called “struts” that are arranged in a cone-shape and anchored in the inferior vena cava, which is a major blood vessel that carries oxygen-depleted blood from the lower half of the body to the right side of the heart, where it is pumped into the lungs.
C.R. Bard IVC Filters
- Bard Recovery IVC Filter: Recalled in 2005. It was linked to a 40% fracture-rate after 5.5 years in a study published in 2012 by the Journal of Vascular and Interventional Radiology.
- Bard G2 IVC Filter: The second generation of C.R. Bard’s retrievable IVC filters. Although they claimed it was less likely to migrate and could remain in a patient longer, recent studies have linked it to a 12% failure-rate.
- Bard G2 Express IVC filter: Associated with a similar risk of fracture, embolization, and death as the G2 IVC filter.
Cook IVC Filters
- Cook Günther Tulip – Features 4 legs and 12 filter wires that capture blood clots while still allowing blood to flow through the vena cava. The Günther Tulip filter was introduced to the U.S. market in 1992.
- Cook Celect – Approved via the FDA’s controversial 510(k) loophole in 2008, this filter has been reported to become lodged in the vena cava, which can make it difficult to remove.
Other Retrievable IVC Filters
- ALN IVC filter
- Argon Medical OptionELTE IVC Filter
- B. Braun IVC filters (Tempofilter IVC filter, Tempofilter II IVC filter, VenaTech LGM IVC filter and VenaTech LP IVC filter)
- Cordis OptEase IVC Filter
- Crux Vena Cava Filter
FDA Warning For Bard Recovery and Retrievable IVC Filters
August 2010 — The U.S. Food and Drug Administration (FDA) has received nearly 1,000 adverse events associated with IVC filters, and they have published a Safety Communication to warn doctors about the risk of complications when retrievable IVC filters are not removed as soon as a patient’s risk of pulmonary embolism subsides. Since 2005, there were 921 adverse event reports involving IVC filters, including:
- 328 involves device migration
- 146 involved embolizations of filter fragments
- 70 involved perforation of the IVC
- 56 involved filter fracture
Study Links IVC Filter to High Rates of Fracture, Failure
In 2010, the Archives of Internal Medicine published a study by Dr. William Nicholson, a cardiologist who began his study after receiving a patient a heart perforation caused by a Bard IVC filter. After reviewing 80 patients who were implanted with a Bard Recovery or Bard G2 IVC filter from April 2004 until January 2009, Dr. Nicholson found that 25% of the Bard Recovery IVC filters were fractured, 71% of patients had filter fragments in their heart, three patients had life-threatening complications, and 1 patient died suddenly at home. In addition, 12% of the Bard G2 IVC filters fractured.
Bard IVC Filter May Have “Fatal Flaws”: NBC News Investigation
September 10, 2015 – A 2-part report aired last week on NBC Nightly News raised concerns about C.R. Bard’s Recovery IVC Filter — including whether the manufacturer told all it knew about the device’s potentially “fatal flaws.” To date, Bard Recovery Filters has been linked to at least 27 deaths and 300 non-fatal complications, according to NBC. Click here to learn more.
IVC Filter Risks & Complications
- Deep Vein Thrombosis (DVT)
- Chest pain
- Filter fracture
- Filter migration
- Embolization of filter fragments
- IVC perforation
- Perforation of the heart
- Organ damage
- Cardiac tamponade
- Hemorrhagic pericardial effusion
- Pulmonary embolism
- Emergency surgery
- Parts of IVC filter permanently embedded in body
Do I have an IVC Filter Class Action Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.