I woke early this morning with a pit in my stomach - a very familiar pit.
There's an old saying, "Fool me once, shame on you. Fool me twice, shame on me."
I'm not as dumb as I appear.
That's why, until I hear from the editor of Europace, A. John Camm, MD (whom I e-mailed last evening) about why a case report published in their journal and reported by me was retracted, I have decided to bring down my blog post. The case was about a recent Biotronik 340 VR-T implantable cardiac defibrillator (ICD) battery failure that ruptured the device, injuring a patient. In that post, I published a portion of the figure from the case report with a link citing the reference. The pictures were dramatic.
But like an X-rated movie, for some, they might be too dramatic.
That's why today I've decided to practice something I rarely do - defensive blogging - and brought down the post. The ramifications of those photos to the multi-billion dollar medical device industry were simply too compromising - for them and me.
Perhaps more importantly, we should ask ourselves how far we've gotten with the whole issue of device failure reporting to the public. Ever since the 2005 published report in the New York Times about Guidant's failure to disclose flaws in its line of Prism defibrillators, the industry has worked hard to improve its image on how adverse device events are reported. Large websites and complicated trade-marked systems have been put in place to better quantify when a device "advisory" should be issued to the public in conjunction with the FDA.
And now this - a horrible, unusual and exceedingly rare single case of an ICD battery failure from a device that was supposed to just sit there and prevent sudden cardiac death splashed all over the Internet.
Hard to put those pictures in perspective to the over 250,000 patients have had these devices implanted with numerous lives saved as a result.
You never hear about the saves.
But the real reason this case was so important is that we now see that one set of photos is probably worth thousands of safety databases and there's not too much any group of engineers or doctors can do to change that reality.