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A Reason to Be Afraid: IVC Filters May Migrate to Other Body Parts
Starting as early as 2005, the FDA received numerous reports of adverse events occurring with IVC filters — a medical device that is supposed to help prevent PE’s (pulmonary emboli’s) from reaching the lungs.
The adverse events vary with IVC filters. From IVC filter perforation to IVC filter fracture and detachment of device components, it can seem like anything is possible with these potentially very dangerous medical devices. But it’s not as chaotic — or far-fetched as it may seem at first glance. Instead, the dangerous side effects that may come with IVC filters can easily be grouped into different categories of potentially dangerous outcomes. And of these potentially dangerous outcomes, it is device migration that may be the most common.
In terms of the adverse event reports received by the FDA, a large portion of the reports have to do with device migration. In the year 2005 alone, device migration comprised a third of the reports.
Device migration is a fancy name for the terrible thing that happens when the IVC filter itself — typically as a whole — moves away from where it was first placed. It’s called “device migration” because the device literally migrates away from where it was first placed. Only, with this type of migration, it is in no way intentional, and the movement can be extremely dangerous. When the device migrates, it finds a whole new territory of potential body parts that in no way need the IVC filter or expect its arrival. This can cause another host of injuries: From internal bleeding to scarring, damage of organs, severe pain and, also, PE’s, as the device may move or break and no longer work as intended.
It’s the kind of pain and physical trauma we would not wish on anyone. And, unfortunately, it may happen much more often than we think.
While IVC filters were first introduced to the market decades ago, the full scope of their serious potential complications is only just now surfacing, largely due to the fact that the IVC filters have to be implanted and “live” in a patient in order for the serious complications to emerge. Another factor has to do with the fact that some of the biggest manufacturers of IVC filters, such as Bard and Cook, re-branded their packaging in 2003 and 2004, saying that formerly permanent IVC filters were now impermanent (also known as “retrievable” IVC filters), even though little if anything was done to adjust the actual device.
If you or someone you know was implanted with an IVC filter, the device may migrate very soon after the implantation or it may take a few months or even years. The problem at hand is not necessarily the time. Instead, the problem has to do with the design itself. IVC filters were unfortunately designed in such a way that they can more easily migrate through the body. It may not have been intentional,but had the manufacturers and marketers of IVC devices listened to all of the adverse event reports coming into the FDA sooner, then maybe the device would have been improved and made safer for patients.