Product News and Recalls

Overused and Easily Forgotten – The Threats of IVC Filters

threats loom large for IVC filter patientsWhen a patient is implanted with an IVC filter, they may not know it but a clock starts. Small, brittle, and with a long history of faults, the risks of injury posed by some filters start to accumulate within days of the implantation. And, perhaps unbeknownst to the patient, the longer the device stays in place, the greater the chance becomes that those risks turn into actual medical issues and emergencies.

With well over 100,000 IVC filter implantations taking place since the 1960s, they are one of the most widely-used medical devices in the world. How they reached that plateau, however, has become an issue of contention for medical professionals, lawyers, and federal regulators.

The statistics on IVC filters are staggering. Studies show device fracture and splinter rates reaching upward of 30% in some cases. Some of those splinters can be carried away from the implantation site and into the patient’s heart or lungs. Assuming that the device manages to stay in one piece, its design is such that perforation of the inferior vena cava then becomes a possibility. One study showed that after just 71 days of being in place, 100% of patients implanted with a particular brand of IVC filter showed at least some degree of perforation.

Many IVC filters were never intended to be long-term solutions. In fact, they were specifically designed to be retrieved after the risk of pulmonary embolism in the patient had subsided. It wasn’t until one IVC filter manufacturer, Bard, petitioned to have the device reclassified as a permanently implantable solution that the idea of leaving the devices in place permanently began gaining traction. Sadly, records show that Bard petitioned for this change even after its own research indicated that the filters posed dangers to patients because of splintering.

Present day, less than a third of all IVC filters are ever retrieved after being implanted.

That this is allowed to happen, especially given the capabilities of today’s scheduling tools – and in the face of such inherent risks – is unconscionable. As the pulmonary newsletter referenced above suggests, there is little reason why an immediate follow-up to remove the device could not be scheduled for 60-90 days after it is implanted. Such retrievals should be routine.

After all, anyone with a smartphone knows that we have all kinds of appointments scheduled out for weeks and months ahead at this point. Using this same system, then, to ensure the safe removal of a potentially harmful device should not be exceedingly difficult, especially when lives are on the line.