What Is An IVC Filter And What Is Its Primary Purpose?
An IVC filter is an implanted or implantable medical device. IVC is an acronym for “Inferior vena cava”, which is the primary route through which the lower half of the body supplies blood to the upper half of the body traveling through the heart. A person might have to go on Google to understand the design of these devices because they are somewhat space age looking. It looks like one of those head massaging things from Brookstone that has a small handle and then a number of wires that come out from it, almost like an upside down umbrella which is more or less what they look like. They are quite small because they are implanted into the inferior vena cava and they are then supposed to stay there in order to catch blood clots and break them up before they become pulmonary emboli that could harm the person or kill them. It can be somewhat hard to picture what these devices look like, but an upside down umbrella would probably be the best way to describe them.
How Accurate, Factual And Informative Are The FDA IVC Filter Warnings?
It is our contention against the companies we are litigating against, which are Bard and Cook, that they did not account for risks despite knowing and appreciating through post-market data findings that the devices were failing, and quite frankly at an alarming rate. More and more information has come out through independent vascular surgeons and radiologists about their experiences with these devices and some retrospective study of the adverse events rates versus what the manufacturers were putting in their package inserts or their directions for use. Quite frankly, these findings show an incredibly disparate number.
How Often Are These IVC Filters Used In The U.S.?
They have become more common in the past 10 years or so. The earlier ones were meant to be permanently implanted and just left there in the inferior vena cava. The indication for them or for the FDA clearance of these devices was that they were for people, who for whatever reason, were not able to take a blood thinning medication or an anticoagulant like a Coumadin, Warfarin, Xarelto and who were are at risk for a blood clot. We often see them being used in trauma patients who would need to be sedentary for a while because they would have to be in a hospital bed for a while. We sometimes also see them in patients with scheduled knee or back surgeries. Sometimes we might even see them being used prophylactically for people in bariatric surgery like getting a gastric bypass because they are typically obese when they come in, but after the surgery they would have to be laid up for a couple of days, so the doctors would want to make sure their patient did not develop a clot. These devices are quite common, although I do not have any statistics on how many have been implanted since their inception, although I do know that quite a lot of them have been implanted and it is a very big business. In late 2003, there was a movement towards optional, retrievable filters, or filters that could and should be removed once the risk of a blood clot subsided or if the patient could then get back on to a blood thinner subsiding the risk of a blood clot so there would be a device that could actually go in and pull them out. The problem we have seen with some of the optional retrieval models, particularly some of the Bard and Cook brand of IVC filters, is that they were not made to be able to withstand the body’s normal forces while they were in the body.
When Did IVC Devices Become Popular For Use?
They really exploded into the market in the early 2000s and then even more so around 2004 when the optional retrievable models came on the market. We think this happened because of aggressive promotional efforts and sales efforts by these manufacturers who essentially targeted interventional radiologists or general surgeons. They advertised to these doctors that they would be able to use this retrievable filter if for whatever reason they did not want their patient’s blood to become too thin because they were going to have a surgery so they might have a bleed, or at the same time they might be at risk for a clot, so once that risk subsided, they could just go in and pull it out. This sounded impressive to a lot of these doctors and they began to be placed more frequently, although ultimately the problem became that the retrievable ones were not made to last and then a lot of times, there was no proper follow-up. Through the data, we now know that the longer the filter is in, the more likely it would be to fail.
Is A Certain Age Group Or Are Certain People More Affected By These Cases?
We see these devices more often among the middle-aged population, but really anybody who was not able to take a blood thinner and who was nonetheless at risk for a blood clot, could get one of these devices. We do rarely see them in young adults, but we would usually see this device being used in middle age to advanced age people who, for whatever reason, were indicated for the device.
Is There Anything Else People Should Know About The IVC Filter?
I cannot stress enough how important it is for people to understand that if they have one of these devices installed at anytime from 2003 to the present, they may not know this device is problematic or would be problematic in the near future so it would be important that even before talking to a lawyer, they should talk to a physician and get some medical monitoring and have some imaging done to make sure they are not standing on the edge of the cliff of disaster. After that we would be able to guide them through the legal side of things but we are JDs, not MDs, so I am not going to tell anybody what medical treatment they need, but from the FDA’s May 2015 safety warning, it is the recommendation of the federal body who is governing these devices, that people should find out what is going on and if the devices are retrievable, then they should be removed within about 50 days at the maximum once the person did not need them anymore because then they would be useless and all they would be doing would be causing a risk of failure.
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