The defective medical device attorneys of Techmeier Law Firm currently are reviewing cases involving patients who have suffered complications after being implanted with retrievable inferior vena cava (IVC) filters.
Bard and Cook Medical are among the major manufacturers of these devices, which have been increasingly used in recent years to prevent pulmonary embolism, or blood clots in the lungs.
However, the U.S. Food and Drug Administration (FDA) reports that the agency has received numerous reports of “adverse events and product problems associated with IVC filters,” including potentially life-threatening issues caused by the fracturing and migration of the devices.
If you believe that you or a loved one has suffered harm connected to the implantation of a retrievable IVC filter, contact Techmeier Law Firm without delay.
Our attorneys have extensive experience with defective medical device litigation. We can provide a free case review and explain the legal options available to you. We serve clients in Milwaukee and throughout Wisconsin. Call or reach us online today to discuss your case.
What Are Retrievable IVC Filters?
The FDA describes IVC filters as “small, cage-like devices.” They are implanted in the inferior vena cava, or IVC, which is the main vessel that returns blood from the lower part of the body to the heart.
IVC filters are often used in patients who are at risk of developing blood clots in the legs, or deep vein thrombosis (DVT). The filter is designed to catch blood clots from reaching the lungs – a potentially life-threatening condition called pulmonary embolism (PE).
Although IVC filters have been around for many decades, their use has spiked in recent years. An estimated 259,000 IVC filters were used as recently as 2012, according to the FDA.
However, concerns have grown over the use of “retrievable” IVC filters, which are marketed as permanent filters that can be removed.
In May 2014, the FDA issued a safety communication in which it warned that problems could arise from retrievable IVC filters being left in patients after the threat of pulmonary embolism had subsided.
According to the FDA, the longer a retrievable IVC filter remains in a patient’s body, the greater the risk of complications. For this reason, the FDA has advised that retrievable IVC filters be removed within 29 to 54 days after they are implanted in patients who have only a temporary risk of PE.
What Risks Are Associated with Retrievable IVC Filters?
In an August 2010 safety communication, the FDA reported that it had received 921 adverse event reports related to IVC filters during a five-year period. Among the adverse events reported to the FDA were:
Several studies have also identified problems with IVC filters, including one study published in November 2010 in the medical journal, JAMA Internal Medicine.
For that study, researchers analyzed 80 patients who had been implanted with either a Bard Recovery or Bard G2 IVC filter. Out of those patients, 16 percent experienced fracture of the device.
Additionally, in seven of the 28 patients with a Bard Recovery IVC filter, the device fractured and embolized. In five of those cases, the embolization was to the heart.
The researchers concluded that “Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening” consequences.
A study published three years later in the Journal of Vascular and Interventional Radiology found that the perforation rates of Cook Celect and Gunther Tulip retrievable IVC filters were higher than the perforation rate of permanent IVC filters. The researchers also found that the perforation rate “increases with time from placement.”
More recently, a study published by JAMA in April 2015 called into question whether there is any need to use retrievable IVC filters in patients who can be treated with anticoagulant medication alone.
In July 2015, the FDA issued a warning letter to Bard that raised a number of concerns about its IVC filter products, including an allegation that the company was marketing its Recovery Cone Removal System without the agency’s approval or clearance.
What Legal Options Are Available to Defective IVC Filter Victims?
The lawyers of Techmeier Law Firm currently are investigating whether defects in the design of retrievable IVC filters manufactured by Bard, Cook Medical and other medical device companies make the filters more likely to fracture, migrate, tilt or perforate the IVC, causing injuries to patients.
If you or a loved one has suffered harm after being implanted with one of these devices, we will work hard to pursue full and fair compensation for your medical expenses, lost income, pain and suffering and other damages.
You should know that numerous lawsuits have already been filed in state and federal courts across the country against retrievable IVC filter manufacturers.
Many lawsuits that have been filed in federal courts have now been consolidated into multidistrict litigation proceedings, or MDLs. The purpose of this consolidation is to save time and money for all parties during pretrial proceedings. Unlike a class action, each plaintiff in a MDL maintains a separate lawsuit.
It is important to work with a law firm that will make sure your rights and interests are fully protected during the course of complex “mass tort” litigation such as the current litigation involving retrievable IVC filters.
Get Help Today from a Milwaukee IVC Filter Attorney
The product liability lawyers of Techmeier Law Firm are committed to protecting the rights of patients. We have extensive experience with taking on manufacturers of defective medical devices and other dangerous products on behalf of our clients in Milwaukee and throughout Wisconsin.
Contact us today if you believe that you or a loved one has suffered harm that is connected to the use of a retrievable IVC filter. We can provide a timely and free consultation.
Sources / More Information
- Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, FDA
- Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, JAMA Internal Medicine
- Inferior Vena Caval Wall Perforation on CT by Celect and Tulip Filters: A Single Institution Experience, Journal of Vascular and Interventional Radiology
- Effect of a Retrievable Inferior Vena Cava Filter Plus Anticoagulation vs Anticoagulation Alone on Risk of Recurrent Pulmonary Embolism, JAMA
- Warning Letter, FDA