Posted on 05/21/2016 3:24:33 PM PDT by Olog-hai
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. …
(Excerpt) Read more at bigstory.ap.org ...
Is there really any such thing as "routine" spinal surgery?
This is a bad violation of medical ethics.
There are people who would be willing to take a risk for the sake of an experimental treatment, and maybe even the ones who took this risk unknowingly would have consented to the risk of dying for the sake of trying to have a pain-free life. But no one knows since they were denied that consideration.
Also with the risks, such as they were, understood, maybe those patients could have been more closely monitored for problems and the side effects headed off by being quickly detected and treated.
The answer cannot be to ban experimental treatments, but to ensure that they are always offered as such and to eliminate perverse incentives to skirt that system.
Today there is, it is called back surgery. But calling the experimental procedure routine, is wrong.
The company that manufactured this cement was owned by the notorious Swiss billionaire and leftist Hansjorg Wyss at the time all this was happening.
Look him up on wikipedia.
People complain about the high costs of new drugs and the “obscene profits” of “big pharma.” The high costs are a direct consequence of the time, effort, and expense of testing drugs (and medical devices) for safety and efficacy prior to marketing. If that testing were bypassed as some anti-”big pharma” advocates seem to want, we would see stories like this every day.
The problem is not that this company conducted human experimentation, but that it did NOT conduct human—or any other—experimentation prior to using it on patients. In fact, the stuff should have been tested extensively, first, in vitro, then in animals, then in a small group of humans, then progressively larger groups of humans.
Most prototype drugs fail the testing process long before they reach human testing stage. No doubt, had this company gone through the proper regulatory requirements for testing, this stuff would have never been used in humans to begin with, because it would have failed long before that point.
Ping.
Vertebroplasty isn't not a new or experimental procedure. As in, “bone cements” have been used to stabilize vertebral compression for at least twenty years.
“Bone cement” has been used for around 60 years.
Likewise, the complication of blood clots has been known...for around 60 years.
Blood clots. But the reporter kept using the phrase “bled out.” Clots, as one would assume, cause blockages not massive hemorrhage.
The mentioned patients were elderly. Where they the usual elderly patients with limited mobility and on Coumadin, plavix, and daily aspirin? If so, what was the PT/INR time? These patients are a high risk surgical group for even a mole removal or biopsy.
Oh, yes. All drugs, implants, pins, replacements, suture materials have been developed with human experimentation. Pigs can only get you so far. Human trials are required.
Lastly. Synthes was a huge Obama/ Hillary donor. A couple huge donations got the DOJ to give a basic slap on the wrist for the CEO and a term at Club Med prison for a couple others. So why the press six years later?
Medical ethics like science is circling the drain thanks to progressives and their twisted view of life.
Don’t know the particulars of this substance, but it sounds like DIC, disseminated intravascular coagulation, which can be caused by several different insults, trauma, infection.
It is a domino effect of abnormal clotting throughout the bloodstream. The clots themselves are small, but there are so many that they basically use up all of the blood’s ability to clot. Then you start bleeding from everywhere.
O2
That sounds like a similar problem which can occur when amniotic fluid enters the blood stream.
Several years ago I broke my back in an auto accident...compression fx of L1. I was supposed to have the bone cement installed the following day, then a 5 day healing phase and I’d be able to go back to work. However, I didn’t have enough insurance coverage at the time to have the surgery.
I still have problems as a result of that break, but after reading the article, I think I’m glad I didn’t. I didn’t know that such a huge risk was involved with the cement. I’ve often thought of having the repair done since now I have insurance to cover it, but I think I’ll leave it alone for now.
Thanks for the article.
Bone cement is acrylic based, MMA, or calcium or magnesium phosphate based. I have seen reports of severe vasoconstriction from calcium phosphate entering systemic circulation. Acrylics will cause clotting but I did not see any conclusive cases where it caused acute DIC.
Usual culprits are multiple emboli, hypersensitivity, transfusion reaction, etc. or just that elderly females are high risk for surgical procedures.
In any case, they violated regulations in this off label use.
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