The New York Times is reporting that the US Food and Drug Administration approved the sale of the first fully implantable artificial heart. Apparently, this device allows the patient to move about freely for up to two hours at a time.
The approval was given even though the grapefruit-size device was implanted in just 14 patients at four hospitals from 2001 to 2004. All of the patients, who agreed to receive the heart as an experimental device, were men, and all have died.Did I read that right? Fourteen patients in a four year period? All who received the device eventually died? If this was a medication, then it would be laughed out of the room instead of being approved.
Two died from the implant operation. A third never regained consciousness, and the rest survived an average of five months. The longest survivor lived 512 days, when the mechanical heart failed.
The company is approved to sell 4,000 a year. But, in all likelihood will only be about 25-50. The cost? A cool $250,000. The company is not even sure if it will receive insurance coverage for the device yet.
For me, this is under the category of "just because we can do something, doesn't mean we have to do something." Granted, I realize that there are thousands of people who die each year waiting for a donor heart. The article also states that in the last six months of live, the slowing dying heart patient incurs an average of $1 million in ICU expense alone.
But, 14 patients in a four year period? Fourteen months ago, according to the article, the FDA voted to deny this same device because of concerns of complications like bleeding, strokes, and infection. Like the FDA is not embroiled in enough controversy with Plan B, Vioxx, Bextra, and other medications in the news.
In my opinion, these are just lawsuits waiting to happen. And, there are attorneys salivating out there just waiting for something to go wrong so that they can swoop in to defend these "victims" against the evil entrepreneur doctor who is seeking fame and fortune at the expense of a patient with a failing heart.
Update: I didn't realize the New York Times site only has limited access. Here's the article from The Washington Post. Hopefully, there are no access problems with this.