A group of already-vulnerable patients are facing yet another trauma as a wave of implantable heart device recalls hits the market. According Newsday, the FDA has targeted more than 300,000 such devices within the past 18 months alone, the majority of which came from Boston Scientific's Guidant. In some cases, it won't be necessary for doctors to remove the device, but others must go through additional surgery and risk to get the implant out of their body. Generally speaking, notes Dr. Paul Maccaro, such devices are much safer than the alternative. After all, such patients have a one in five chance of cardiac arrest, compared with a one in 1000 risk of getting an improperly functioning device. Meanwhile, the Heart Rhythm Society--a group of doctors who implant pacemakers and defibrillators--plans to announce within a few months its guidelines for how to communicate with doctors and patients about recalls.
- review this article from Newsday for background on the implantable device issue