Bone cement company accused of experimenting on humans

[NCTraveler]

SEATTLE - Reba Golden hurt her back after falling two floors while building an addition to her house in Honduras. But when she returned to Seattle for a routine spinal surgery, she suffered blood clots, severe bleeding and died in 2007 on the operating table.

Joan Bryant's back had bothered her since a 1990 car accident, so in 2009 she sought help from a Seattle spinal surgeon, but she bled out on the operating table and could not be revived.

Like at least three spinal-surgery patients before them, Golden and Bryant died after their doctor injected bone cement into their spine and some of the material leaked into their blood stream, causing clotting.

The patients were never told Norian bone cement wasn't approved by the Food and Drug Administration. Instead, Norian and parent company Synthes used surgeons in what one doctor called "human experimentation." Federal prosecutors say the aim was to skirt a long, costly regulatory process.

http://www.cbsnews.com/news/bone-cement-company-norian-accused-of-experimenting-on-humans/

[WhiteTara]

1. OMG! That is horrifying!

This has been going on for a long time and it's just now coming out? I wonder if they even told the patients what they were doing.

[LisaL]

2. Per the article, patients were not told that this cement wasn't approved for injections into spine.

So patients didn't know. Thankfully it was used in a limited number of cases-or there would likely be a lot more dead patients.

[WhiteTara]

5. They didn't tell them it wasn't approved, but did they

even tell they were going to cement their spine? Yikes.

[LisaL]

6. I am not sure what you are trying to say here.

This company didn't invent the procedure itself. It's called vertebroplasty. The problem here is not the procedure itself, but the un-approved cement used.
http://www.spine-health.com/treatment/back-surgery/vertebroplasty-procedure

[WhiteTara]

8. You mean cementing the spine is a practice?

Thanks. I think the idea seems too weird.

[NCTraveler]

9. The manner in which they went about this is as bad as it gets.

It seems they were less than honest about the brand of cement being used, that it hadn't been approved, they weren't suppose to be using it, ignoring the government and medical community, etc... Every bit of it is criminal.

[Baobab]

12. They "had to inject her with the goop to see what was in it"

nt

[LisaL]

10. Yes, the procedure itself wasn't experimental.

The cement they were injecting into spine wasn't approved for injections into spine. It is not the same cement they use in construction, it's special cement used in medical procedures. It was supposed to turn into bone once injected. However it wasn't approved for injection into spine. And even if small amount of this cement got into blood stream, it caused clots to form and patients to die.

[REP]

11. Yes; this is a common and usually low-risk procedure for minor fractures in the vertebrae

The cement used is more like an epoxy and the procedure provides almost immediate improvement in pain - when done with an approved, safe cement. As another poster mentioned, it's not construction cement; cement is used here in its more generic sense. H

[NCTraveler]

3. As this story reads it is truly horrific. Nt

[LisaL]

4. Sure is.

Sounds like most victims were elderly. So when they died during surgery, relatives weren't asking too many questions.

[dembotoz]

7. cue the lawyers