Saturday 27 August 2016

An Overview Of IVC Filters: What Does Research Say?

By Michael Monheit

A 2013 editorial in the journal of the American Association questioned the existence of IVC filters that have been on the market for a very long time without proof of efficacy. The medical journal pointed out that IVC filters should work given that they work on the logic that you can prevent a traveling blood clot from reaching the lungs by catching it through placing a small wire net in the largest body vein.

America's largest manufacturers of IVC filters are Cook Medical and C.R. Bard who are credited for making seven different models, which include several that have been withdrawn from the market due to safety concerns. There has been a widespread use of these devices since their inception and have made their way to thousands of bodies.

Were The Devices Tested?

No member of the vast medical community could determine how effective the device was until 30 years after their invention when a French study was conducted between 1997 and 2005 besides a 1973 study. During this time, the manufacturers would come up with new features and ease the process of implantation for healthcare professionals.

The new designs were spurred by many studies that showed little benefits and serious long-term consequences associated with IVC filters that were designed for permanent implantation. Since the very first device to the present, the benefits of IVC filters remain completely untested which means they may be useless. states that the only clinical trial to assess the effectiveness of IVC filters done in 1973, revealed that they had no effect on ultimate mortality rates, but they would reduce the rate of pulmonary embolism

According to the US Food and Drug Administration (FDA) in 1979, approximately 2,000 IVC filters were implanted mainly to patients likely to suffer from a pulmonary embolism. 28 years later after numerous product redesigns, an estimated 167,000 patients had received IVC filters with an increased demand for the product.

Why Is There Legal Action Being Taken Now?

Despite IVC filters being widely accepted for many years, there has never been empirical evidence that shows that they perform the function they are being sold for. The previously mentioned French study was conducted on 400 patients with deep vein thrombosis, a lower limbs blood clot that can pass up to block veins in the lungs. This risk is usually referred to as pulmonary embolism and is what IVC filters are designed to prevent. Out of the 400, 200 were treated with only "standard anticoagulant treatments" such as warfarin while the other half were outfitted with IVC filters. Subsequently, for eight years the researchers recorded health outcomes and tracked the progress of patients.

The results revealed that IVC filters indeed lower the risk of pulmonary embolism (thus preventing blood clots from reaching the lungs). Twenty-four patients from the group without filters suffered from "symptomatic" PE, while only nine from the group with the filters did. Unfortunately, the devastating result was that patients with IVC filters were at an increased risk to develop deep vein thrombosis. It was apparent that filters would cause one of the conditions they were designed to treat.

FDA On IVC filters

Apart from facing several civil lawsuits, Cook Medical and C.R. Bard have been hit with several formal warnings from FDA. Bard has received a warning letter citing eight violations of FDA requirements, the worst violation being manufacturing and marketing IVC models not cleared for sale by FDA and failure to report serious complications to the FDA.

The FDA released an update of its 2010 safety communication in 2014 that retrievable IVC filters shouldn't be left for too long in patients and should be removed by doctors between 29 and 54 days after being implanted. Now there have been over 200 personal injury lawsuits that have been filed against Cook Medical, by patients who have suffered from the lack of medical research of the devices. Lawsuits have alleged that Cook marketed a defective medical device and falsely represented its efficacy and did not adequately warn the public of the potential dangers associated with it.

Author Bio:

Michael Monheit, the managing attorney at Monheit Law, has been working to assist individuals and families who have been harmed by defective drugs and products. In fact, Mr. Monheit served on the Plaintiff’s Steering and Executive Committee for MDL 1148. He understands how stressful it can be to stand up to a major corporation and is committed to making sure that plaintiffs know they have someone on their side.

No comments:

Post a Comment

Pharmaceutical Microbiology Resources

Special offers