According to a 2000 report published by the U.S. General Accounting Office, “Experts believe that FDA’s system includes an estimated 1 to 10% of adverse reactions.” That means that for every ten events that get reported, 90 adverse events go unreported.
IVC Filter Problems Unreported
Most MAUDE reports are filed by device manufacturers, which typically presents a problem because in many (if not most) cases the device makers never hear of the adverse event. Meanwhile, it takes a doctor at least 20 minutes to file a MAUDE report, according to most doctors we have asked; therefore, very few ever take the time to file such a report. Doctors simply do not have or cannot take the time, and even if they did have the time, filing adverse event reports could find them dragged into a lawsuit regarding a faulty or troublesome device, another time-consuming proposition that most doctors would rather avoid. So there is very little incentive and perhaps worse than no reward to prompt a doctor to file an adverse event report.
Meanwhile, we the public are unfortunately stuck with MAUDE as our only publicly accessible medical device source. We say “publicly accessible” in very broad sloppy fashion, because even though you can navigate to the FDA’s MAUDE pages and even the IVC Filter section of it, you will be hard pressed to determine even the 10% of actual adverse events that have been reported concerning, Bard, Cook, Boston Scientific, Greenfield, or any other IVC filter.
The MAUDE – a messy acronym for Manufacturer And User Facility Device Experience – is the U.S. FDA’s web page (FDA: MAUDE Data) set up to record adverse events of medical devices. It is at least supposed to contain that 10% of the total adverse events which it was estimated by the 2000 study to record; but trying to locate even that lowly 10% portion of adverse events reported can prove a daunting task on the site.
For IVC Filters, the MAUDE database includes a May 6, 2014 update on an earlier IVC Filter Warning:
Summary of Problem and Scope
“The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”
Temporary IVC Filters not Removed
We will take up the topic of the late removal or the failure to remove what were supposed to be temporary IVC filters in our next IVC Filter post. Many so-called “temporary IVC filters” are left in indefinitely to the great detriment of their unwitting implantees, as many are trauma patients who never had a say in the matter.
To be continued. . .