In the year 2012, surgeons inserted around 250,000 IVCs in patients across the country. That’s a far cry from the mere 2,000 IVC filters that were first inserted in patients in the year 1979 — and even a far cry, too, from the number of IVC filters that were implanted in 2007 (around 167,000).
Typically, when we see such an astounding rise in sales, the high sales serve as a form of validation for the quality or value of the product at hand. Unfortunately, that may not be the case for IVC filters. Instead, the high sales of IVC filters rose at a similar pace to the negative reports. By 2005, the FDA had received 921 “device adverse event reports” for IVC filters. These negative reports are like a bad Yelp review, but much more consequential — they help alert the FDA to potentially serious complications patients have had with pharmaceutical drugs and devices that are already on the market. Today, the growing number of patients who have come forward, voicing their concerns to the FDA through their adverse event reports or through IVC filter lawsuits, paints a terrifying picture for a medical device that is still on the market — and extremely popular.
Thanks in part to the 921 adverse event reports that the FDA had received by 2005, the FDA issued a report of their own, warning the various types of doctors who may be implanting IVC filters in patients across the country. From interventional radiologists and cardiologists to surgeons and more, the FDA’s report was a first step in getting the necessary communication going between all of these varying fields of medicine that relied on IVC filters to help their patients. It’s a communication that, in an ideal world, would have been performed without prodding or encouragement by the pharmaceutical companies themselves.
To quote the FDA, they were concerned that ” these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include, but are not limited to, lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
Since that early report, the FDA’s concern has only grown, as demonstrated by several proceeding communications. And so has ours — we’ve heard from too many patients or loved ones of patients who were drastically hurt by IVC filters not to see that this very popular device with astronomical sales and growth may have a horrifying, and under-communicated, dark side.
How does it happen?It happens when sales and marketing are pushed and pushed and pushed by major companies, while the evidence that points to medical complications (and lower sales) is ignored for far too long. After all, these very powerful and should-be experienced pharmaceutical companies had over thirty years to either pull their IVC filter devices from the market, or greatly improve their function. Instead, IVC filters, and especially retrievable IVC filters, may be just as dangerous now as they day they were born.