• By:admin

Despite New Technology, IVC Filters Continue to Fail

There is currently only one IVC filter still available on the market, but it possibly poses the same problems and risks as its predecessors.

Inferior Vena Cava (IVC) filters are tiny medical devices implanted into the large vein that returns blood from the body to the heart (the “Vena Cana”).  The filter’s function is to stop any traveling blood clots before they move to the lungs, resulting in a pulmonary embolism (PE). The devices are intended to be “retrievable,” implanted only as long as necessary to prevent a PE.

In 2010, the FDA issued a warning that retrievable IVC filters were remaining in the body past the time when they should have been removed, leaving patients at risk for the filter to fracture or migrate, causing puncturing or perforation.

At the time the agency recommended that physicians and clinicians responsible for the long-term care of their patients remove the IVC filters as soon as possible—that is, as soon as the patients were no longer at risk for a PE.

The manufacturer primarily responsible for the G2 IVC filter is Bard, a New Jersey-based medical device maker. Bard recently released an updated version of their IVC filter, the Denali, which is the only version of the product which the company still sells. It was approved in 2013 and uses different materials than the earlier versions. However, reports began coming in as early as 2015 of the filter fracturing, shooting fragments into patients’ ventricular walls.

In March 2017, a Washington state patient sued Bard, alleging that the company has once again downplayed the risks of its IVC filters.

IVC filters have been in use since 1993, and complaints about the devices began to surface in 2004. But the company continued to sell the devices and did not notify the FDA of complaints or device failures.

The first lawsuits regarding medical injury caused by Bard IVC devices were filed in state courts in California and Pennsylvania in 2012, but several lawsuits in federal courts followed. The company currently faces hundreds of lawsuits from patients across the country.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

Related Post

VIEW all
insulin pump
Automated Insulin Pumps and Smart Devices Use on Rise Due to Pandemic
  • By:B. Shaffer

Even the movie industry has noticed the increasing use of smart medical devices. The movie trailer for the animated Pixar film “Turning Red” features a diabetic kid who appears to be wearing an Automated Insulin Pump. The COVID-19 pandemic changed the lives of most people and has led to a restructuring of lifestyle and priorities. Businesses have had to rethink the way they work, some industries have seen dramatic downshifts in usage, while others have seen growing interest. One of …

CPAP problems
Philips CPAP Recall Severity Upgraded by FDA
  • By:B. Shaffer

A recent recall of Philips CPAP and ventilator devices has been upgraded to Class I by the U.S. Food and Drug Administration. Class I is the most severe type of recall which indicates that a malfunctioning medical device may cause serious health problems or result in death. The Philips recall was issued June 30, 2021, for multiple models of CPAP, BiPAP and Ventilators made by Philips Respironics. It was initially issued as an unclassified recall, only as a safety notification …

Woman Undergoes Ninth Surgery to Reverse Hernia Mesh Damage; Legal Action Continues to Mount
  • By:admin

As lawsuits continue to be filed against hernia mesh manufacturers, one patient is about to undergo her ninth surgery to undo the damage caused by the mesh. Carmen Pacheco of Georgetown, Texas, suffered for years after her hernia repair process. The problems triggered by the mesh implanted into her during the procedure caused financial and emotional stress for her and her family. Pacheco and her medical team opted for the mesh implant because the product was marketed to last longer …

Have you been affected by a drug or device listed?