IVC Filter Lawsuit Lawyer

FDA Warning:  Filters Short-Term Only

On May 6, 2014, the FDA updated its safety communication: “Removing Retrievable Inferior Vena Cava Filters”. The intended audience was implanting physicians and clinicians in charge of caring for patients with inferior vena cava (IVC) filters, as well as interventional radiologists and cardiologists, vascular surgeons, emergency room (trauma) and primary care physicians, and bariatric and orthopedic surgeons.

In August 2010, the FDA issued an initial warning against leaving inferior vena cava filters implanted in patients for extended periods due to their potential to cause adverse health complications. (See PDF) The FDA warned that IVC filters are meant for short-term use only and only for patients at risk for pulmonary embolism. FDA advised implanting doctors to remove the devices once PE risk subsides. The agency was concerned about doctors not retrieving IVC filters intended only for short-term placement, hence exposing patients to fractures and all the problems which can follow.

The FDA Reports Adverse Events

Since 2005, the FDA has received “921 device adverse event reports involving IVC filters, 328 for device migration; 146 for embolizations (detachment of device components); 70 for perforation of the IVC; 56 for filter fracture.”  Some of these events led to problems for patients, according to the FDA,  which also said the events could be related to a retrievable filter remaining in patients’ bodies beyond the time when pulmonary embolism (PE) risk subsided:

“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”

Doctor Questions 510k Clearance

The FDA warning followed a study by Dr. Nicholson and others which found a high prevalence of fracture and fragment embolizations with retrievable inferior vena cava filters. Nicholson’s study was used to challenge the FDA’s medical device approval process. The agency considers IVC filters as Class II devices, or low risk, clearing them without clinical safety or effectiveness data via the questionable 510k approval loophole.

IVC Filters Erode in Veins

In a study published in 2013 in Cardiovascular and Interventional Radiology, researchers followed 50 patients who had been implanted with a Günther Tulip or a Celect filter between July 2007 and May 2009. After 71 days, all of the filters had some degree of erosion into the vena caval wall. In addition, 86% perforated the vena cava, 40% tilted into the vena cava.

Attorney David Matthews is a member of the plaintiff’s steering committee (PSC) for the Cook Medical MDL in Indiana. He and other IVC Filter Lawyers expert in vena cava lawsuits at Matthews & Associates represent several plaintiffs in various IVC filter lawsuits. The firm is accepting new IVC filter injury cases in all 50 states and Puerto Rico.

Contact our IVC filter lawyers by calling (888) 923-7001 today!