Bionic eye thrown out by the FDA
In the 1970s TV show "The Six Million Dollar Man," the strapping young astronaut got a bionic eye. A U.S. company had hoped that next year that might be your grandmother. Not so fast, a federal advisory panel said Friday.A tiny telescope designed to be implanted in the eyes of some elderly patients should not receive
Food and Drug Administration approval, the panel recommended on a 10-3 vote.The FDA's ophthalmic devices panel recommended against the pea-sized bionic device for safety reasons, spokeswoman Heidi Valetkevitch said.
The first-of-its-kind device is called the Implantable Miniature Telescope. The telephoto lens could enable some patients to do away with the special glasses and handheld telescopes they now use to compensate for the loss in central vision caused by age-related macular degeneration, according to VisionCare Ophthalmic Technologies Inc., its manufacturer.
...
In clinical trials, 141 of 193 patients implanted with the device showed after a year improved distance and near visual acuity, defined as the sharpness of vision in reading an eye chart, according to FDA documents. Ten patients reported a loss in acuity in either distance or near vision. Doctors removed eight of the devices, four of them from patients dissatisfied with how they worked, FDA documents show.
It seems like the FDA is entirely too strict with their decisions. Shouldn't it be my own choice what I put in my body? Isn't it my own decision what I consider an acceptable risk? I guess I shouldn't be surprised - considering the draconian drug laws of this country.
6 Comments:
Not to start a flame war, but I've heard that the lab invovled was very 'if-fy'. They wouldn't produce any data, went on lots of talk shows, wouldn't talk any numbers. I'm in an associated field, and whenever their work came up, it was always, "well, we have no real evidence that what they're doing works, so we'll see howt aht turns out."
As for freedom to do whatever with your body, I agree, but, we have to protect people that will do anything a doctor tells them. I know I have been able, on many occassions, to fool people into thinking I know exactly what I'm doing, and those folks had PhDs (of course, later I told them I was kidding). Imagine if you were an iliterate blind person and a big university doctor asks you if you want to make history, and see again.
Sat Jul 15, 05:17:28 PM CDT
well if the company is crappy thats fine with me if the FDA rejects it but...
I still want the option of being conned.
Sat Jul 15, 07:09:35 PM CDT
I can't debate the merits of this particular device. In general, however, the US is the most medically litigious country, and it's one of the reasons medical procedures cost 2-3 times more in the US than in other countries. FDA decisions take this into account. The lack of FDA approval is why I had my bionic parts implanted outside the US. And I didn't sign a single HIPAA statement, consent form, or liability release.
Mon Jul 17, 12:02:40 PM CDT
what parts did you have implanted?
Mon Jul 17, 04:23:47 PM CDT
That is top-secret, classified information!
Mon Jul 17, 07:07:47 PM CDT
lame!!! I wanna know hahaha
Tue Jul 18, 11:55:26 AM CDT
Post a Comment
Links to this post:
Create a Link
<< Home