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85 Comments
- RealmDown, on 06/17/2009, -2/+36They'll be out of business tomarrow.
- VisualRhetoric, on 06/17/2009, -4/+21Does "bone cement" make anyone else's skin crawl?
- VisualRhetoric, on 06/17/2009, -0/+16Don't confuse Penis Putty with Bone Cement.
- Stirk, on 06/17/2009, -0/+14"The FDA had approved Norian XR to fill bony voids or defects in some parts of the body, but not in the spine."
- AmnesiacJack, on 06/17/2009, -1/+14What a bunch of stiffs.
- varun1s, on 06/17/2009, -1/+13Not more than "titanium screws through the bone."
- jjesusfreak01, on 06/17/2009, -1/+12They did 200 surgeries of the FDA approved substance (in other parts of the body) on people with spinal injuries, and 3 died. Now, im not a doctor, but I would imagine that the risks in any spinal surgery are substantial enough to propose that its possible that this substance was not to blame.
- beautifulbeast, on 06/17/2009, -2/+11The article is unreadable, but it sucks when companies do this and use untested products on their patients.
- slifty, on 06/17/2009, -2/+10That may be, but there are huge huge huge ethical obligations when it comes to using human subjects for testing. Even if nobody had died it would still be incredibly irresponsible and, to be honest, reprehensible to use human subjects without following ALL the procedures set up to guarantee as much safety and transparency as possible. The point of testing is that you don't know exactly what will happen.
- inactive, on 06/17/2009, -1/+9Don't know. I've never used it but I hear that's one of the side effects.
- GeekNurse, on 06/17/2009, -1/+9Informed Consent
http://en.wikipedia.org/wiki/Informed_consent - V3n0M, on 06/17/2009, -1/+8Hey! Bone cement cured my bōnitis!
- inactive, on 06/17/2009, -1/+7Ⓞ_Ⓞ
- Greg2b, on 06/17/2009, -1/+7Cheaper form of adamantium??
- asgardshill, on 06/17/2009, -0/+6Calcium? I hardly even knew 'em!
- OneOfNone, on 06/17/2009, -2/+8No informed consent? No stopping the trial after the first death?
Go to jail. Go directly to jail. Do not pass go, do not collect $200. - nirvanix, on 06/17/2009, -0/+5Listen to all you medical experts commenting. Man, you think quite highly of your opinions I guess. Perhaps the spine is substantially different that other bones (it's many small bones) and that's why the FDA wanted special research done?
- protodon, on 06/17/2009, -2/+7I ate my dog yesterday.
- dmcbride6, on 06/17/2009, -1/+5The title is a bit misleading (both of the digg and the article itself). The three patients died from a rapid loss of blood - of which nobody can even say whether it was due to this bone cement stuff or not.
I do think they should get FDA approval - but it sounds like they may have in this case. They didn't mention what 'areas' were specifically sanctioned for these tests - if they just said bony voids though, I can easily see how this could cover the spinal area.
Whatever happens, I highly doubt this will put the company out of business. - Frostek, on 06/17/2009, -0/+4My only regret... is that I had... ...boneitis...
- sjones, on 06/17/2009, -0/+4"Wyss is 74, a skier, and, according to Forbes, led Synthes for 30 years..."
Thanks. Knowing he was a skier contributed greatly to my understanding of this story. - Astark, on 06/17/2009, -1/+5You know, now that you mention it, I have found myself eating larger and larger amounts of Chinese food lately...
- VisualRhetoric, on 06/17/2009, -1/+4"cement does not neccesarly mean the substance that is used to construct skyscrapers.."
You're kidding me. I would have bet money the doctors were mixing up some Quickrete right there in the OR...
/s - inactive, on 06/17/2009, -2/+5http://instantrimshot.com/
- RealmDown, on 06/17/2009, -0/+3Have pity on them because those are probably to scale....
- thebigredcat, on 06/17/2009, -1/+4And I have been playing with my wang.
- DrJG, on 06/17/2009, -0/+3That is where animal trials come in, before the permission for human trials with informed consent.
- tgc1, on 06/17/2009, -0/+3Makes you wonder how many more experimental procedures are being conducted without permission, authorization or certification.
- Gumphlumph, on 06/17/2009, -0/+3It was that bastard Burke wasn't it? Damn it Ripley!
- DrJG, on 06/17/2009, -0/+2"When company executives began these surgical tests in 2002, they knew that Norian XR caused blood clots in test tubes and that clots became lodged in the lungs in tests with pigs, the indictment said."
That would be the damning part. Added to the hugely unethical part about lack of informed consent that is, after the question of impropriety of not following guidelines for testing. - buckrogers1965, on 06/17/2009, -0/+2No. Not everyone. I'd say that vast majority of people are great and want what is best. The problem is that it only takes a few scum bags to ruin it for everyone.
And that is why we can't have nice things. - JoshCBFL, on 06/17/2009, -2/+4I thought that Penis Putty wasn't being made anymore and that it was replaced by Boner Cement.
- Biohazard6601, on 06/17/2009, -0/+2"Richard E. Bohner"
please tell me that name is a joke, i wonder what the "E" stands for... - varun1s, on 06/17/2009, -2/+4Yes. Surgeries, with or without, carry some risk of mortality. It's not zero.
I'm not defending them or criticizing them. Only watching. I don't believe in making judgemens outside the courtroom. Everyone should be treated as innocent until proven guilty. Someday it may be your turn. - nicktheawesome, on 06/17/2009, -2/+4@RealmDown
One of the reasons I love and frequent Digg is because of awesome/horrible puns...
Your comment cemented my reasoning. - EminNew, on 06/17/2009, -0/+2Cause of death was hypotension, or abnormally low blood pressure. It is most commonly produced by reduced blood volume, but there are other possible causes.
http://en.wikipedia.org/wiki/Hypotension#Mechanism ...
Hypotension doesn't necessarily mean rapid blood loss was the cause of death. - RealmDown, on 06/17/2009, -0/+2If they had given informed consent, I would agree with you.
- insertAliasHere, on 06/17/2009, -0/+2"The FDA had approved Norian XR to fill bony voids or defects in some parts of the body, __but not in the spine__. The agency insisted that Synthes conduct clinical trials, which are lengthy and expensive and require FDA oversight, if it wanted to expand the uses of Norian XR to treat spinal fractures."
The distinction was made. They didn't have approval. - wing05, on 06/18/2009, -0/+2I swear, my glass is half empty compared to the other guy's.... 8)
- dystra, on 06/17/2009, -0/+2well i just found a new band name.
- Mareshalu, on 06/17/2009, -0/+2Where else could this be done without getting caught?
- DrJG, on 06/17/2009, -0/+1Bohn in German is bean.
- GeekNurse, on 06/17/2009, -0/+1Animal trials are useless unless trying to determine LD50 or organ destruction / failure. Only human trials show therapeutic benefits, if any.
- insertAliasHere, on 06/17/2009, -0/+1This is just an article, I have serious doubts that the FDA would be that vague.
- DrJG, on 06/17/2009, -2/+3"Does "bone cement" make anyone else's skin crawl?"
Only at first glance if you think it is cement for building construction made from bones, like bone china (finer, expensive variety of porcelain) - but you stop to think and read the article, it becomes clear it is the other way around.
Here cement is from the verb cement and is the substance used to repair bones, something rather useful when you have a problem.
Details of most medical procedures are horrifying or disgusting until you are in a position where you need one. - Kythas, on 06/17/2009, -0/+1Doesn't he play bass for Lounge Against the Machine?
- Bangaarang, on 06/17/2009, -0/+1Awesome to the max!
- MrMischief20, on 06/17/2009, -0/+1Damn, I never would have expected this from my hometown.
- Nishnabotna, on 06/17/2009, -0/+1Man, dugg down by bone cement haters.
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