Health Canada has issued a safety warning concerning health risks associated with inferior vena cava (IVC) filters, controversial medical devices that are designed to block potentially dangerous blood clots.
Issued on Monday, the IVC filter safety warning says serious complications have been reported among patients who received IVC filters, including filter fracture and fragment embolization, caval perforation, caval thrombosis, cardiac tamponade, cardiac perforation intracardiac migration, and, in some cases, death. Many of the aforementioned IVC filter complications were associated with long term filter implantation (individuals who have had the device implanted for more than 30 days).
In Canada and the United States, more and more people that have been harmed by IVC filter complications are making the decision to file an IVC filter lawsuit against certain manufacturers. As of June 6, Health Canada had received 121 incident reports involving serious IVC filter complications.
IVC filters are thin, umbrella-shaped metal devices that extend inside the inferior vena cava, the body’s largest vein. They are supposed to stop blood clots from migrating to the lungs or heart. But hundreds of people in Canada and the United States have reported serious problems after the device has been implanted, prompting questions about whether IVC filters are safe.
Below are the products affected by the Health Canada IVC filter safety warning:
|ALN IVC Filter||A.L.N.|
|Denali IVC Filter||Bard Peripheral Vascular|
|G2 IVC Filter System||Bard Peripheral Vascular|
|Simon Nitinol IVC Filter||Bard Peripheral Vascular|
|VenaTech LP IVC Filter||B. Braun Medical|
|Optease IVC Filter||Cordis Casual|
|Trapease Permanent IVC Filter||Cordis Casual|
|Option Retrievable IVC Filter||REX Medical, LP|
|Cook Celect Platinum IVC Filter||William Cook, Europe APS and Cook, Inc.|
|Cook Celect IVC Filter||William Cook, Europe APS and Cook, Inc.|
|Gianturco-Roehm Birds Nest IVC Filter||William Cook, Europe APS and Cook, Inc.|
|Gunther Tulip IVC Filter MREye Filter Set||William Cook, Europe APS and Cook, Inc.|
Gatineau, Quebec resident John Boehmer was implanted with a temporary IVC filter following a surgical procedure. When Boehmer went to the hospital eight months later to have the filter removed, doctors found that it had become stuck in the wall of his vein. It turned out that one of the filter’s thin legs nearly punctured his pancreas, and now the filter cannot be removed. He says he now lives in a state of anxiety, always wondering how the filter that is trapped in his vein will affect his health.
“The source of all this, as far as I’m concerned, is the manufacturer,” Boehmer told CTV News. “The device was supposed to be retrievable. It wasn’t. What’s your backup plan?”
IVC Filter Lawsuit
Victims who have filed IVC filter lawsuits in the U.S. claim that manufacturers C.R. Bard and Cook Medical, Inc. defectively designed certain models of filters and not properly test them before they were brought to market. According to the lawsuits, IVC filters can detach and migrate within the inferior vena cava, leading to serious complications.
NBC Nightly News ran a two-part report on the C.R. Bard Recovery IVC filter, discussing the safety and efficacy of certain IVC filters. In the investigation, NBC Nightly News found that 27 deaths and over 300 other adverse events had been linked to the Bard IVC filter over a span of a decade.
The company’s response to reported issues with the Bard Recovery IVC filter was not to fix the problems with the product but to hire a PR firm and conduct a confidential study, which found that the Bard IVC filter posed a significantly higher risk of filter movement, filter fracture and death than other IVC filters on the market. After the study was completed, C.R. Bard continued to sell 34,000 Bard Recovery IVC filters before the model was replaced.
The Bard IVC filter that replaced the Recovery model, the G2 filter, had problems of its own, per the NBC Nightly News report. C.R. Bard was aware of problems related to the G2 not long after the IVC filter was brought to market, but the company continued to sell it and a similar model called the G2 Express. Bard would go on to sell over 160,000 G2 IVC filters and G2 Express IVC filters in the span of only a few years, even though the company had knowledge of problems with both models.
IVC Filter Lawyer
Have you or someone close to you been injured by an IVC filter? If so, you should consider speaking with an IVC filter lawyer to discuss your options. Even if you haven’t been injured by an IVC filter, you still face the potential danger of being harmed in the event that the device fails.
The law firm of Baum Hedlund Aristei & Goldman is representing victims harmed by defective IVC filters. Our firm has successfully litigated against some of the largest drug and medical device companies in the world.