How Must It Feel To Have A Recalled Product Inside You?

St.Jude Medical’s Riata and Riata ST Implantable Cardiac Defibrillators (ICD) have popped up even more than PIP breast implants on our pages, as the world of interventional cardiology deals with the problem of the leads associated with these devices. I hardly need to start at the beginning do I, but where we are now is in a sort of limbo land where all parties have acknowledged that the full extent of the problem has yet to be established. That means we really don’t know how many of these leads will suffer the fate of “externalisation”, where the conducting wire erodes itself through its coating, how many externalised leads will fail to function and over what period of time all of this will happen.

So we’re in data collection mode with everyone from the manufacturer to the FDA gathering the facts and poring over the information to hand. The latest news is that FDA has this week issued a press release and additional guidance for clinicians on how to handle the situation, which includes a recommendation to closely monitor all implantees, consider X-rays as part of individual treatment plans, consider home monitoring of all patients and avoid prophylactic lead removal unless the risk of taking it out is clearly lower than the risk of leaving it in.

Recalls of medical devices are not uncommon and are straightforward logistical exercises when they pertain to disposable widgets sat on hospital shelves or even capital equipment. However when the recalled device is residing inside a human, and when there is a very real risk that the device will fail in that human it introduces a new dimension to the recall process, as clearly evidenced by the European PIP breast implant scandal and the metal-on-metal hip prosthesis debacle. Riata represents the third of that triumvirate of recent recall giants, affecting a reported 79,000 Americans and goodness knows how many citizens across the world (227,000 of the devices have been distributed worldwide).

So, you’re an implantee… let’s call you a “person”, sufficiently at risk of some major cardiac event that a medical professional has performed a procedure to implant one of these clever, life-saving devices in you. And now you’re told that there’s a chance (we really don’t know the odds or the timeframe, but lets guess at double figure percentage in say 2 years) that your device will either not work the way it was designed to work (although we don’t really know whether externalised leads won’t work either).

If you’re lucky enough to be an American citizen it would appear that your FDA is making sure you’re looked after and that you have an individualised care and monitoring programme. Outside the U.S. it’s a rather different matter. If it wasn’t for FDA and St.Jude itself, which has put in place the excellent riatacommunication.com website, as a patient you’d have little to go on other than a 3 monthly check up (in UK at least). X-ray assessment now being recommended by FDA has only been indicated by UK’s MHRA in the event of a suspected lead failure. ¬†And while U.S physicians are now being told to consider remote monitoring of patients, no such guidance has been issued in Europe to the best of our knowledge.

Back to the point then, what is most important here is the “victim”… yes let’s use that word. Having a heart condition must be one of the most terrifying of all fates, feeling as it will like a ticking time bomb right up until the time it’s been corrected by whatever miracles of modern science are most appropriate. People with coronary stents, CABGs, valves, corrected arrythmias usually feel “cured”, yet here’s a situation in which one ticking time bomb has been replaced by another. And fixing the second one is a helluva lot more risky than it was first time around. As a patient that worry must take (even more) years off your life, surely.

Calling what I’m about to say “The solution” misses the point that there isn’t a solution, but however far away from ideal it may be, “the solution” has to involve giving patients as much reassurance as possible that they’re being monitored and looked after. If it was me I’d be scared witless at the possibility that a rusty old bit of wire is about to discharge its “therapy” at any time and may not do so when it’s actually needed. Only the full raft of reassuring tests would calm my nerves. It looks like between them the U.S. regulator, the company and the physician community may have got that about right, but I do wonder about the rest of the world.

Source: FDA, St.Jude Medical