The FDA scandal/ disabling Americans for $$$$

Early in the 2000's a former russian man proposed a radical new medical procedure. Going thru patients sides and yanking out their spine discs and dropping in a spacer, then closing up the patient.

The FDA at the time released an Industry paper:

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072459.htm

"""FDA believes that these devices are significant risk devices "". Somebody saved you. Why? They knew Pseudoarthrosis would be the result, no bone fusion. Nothing holding the vertebrae together.

As time went on and doctors needed money to pay their college bills...enough pressure was mounted and the FDA allowed it ALL to happen...under the radar. Plus who did Obama put in charge of the FDA? Margaret Hamburg...interesting background. Complicit?

Here are the FDA 501(k) medical implant approval letters for the spacers:
www.accessdata.fda.gov/cdrh_docs/pdf4/K043405.pdf
www.accessdata.fda.gov/cdrh_docs/pdf5/K052210.pdf

Notice it says "Fixation" required?

Meanwhile a company had been formed of former employees that left another competing manufacturer that registered with the SEC and started pulling in millions from stock sales. They hired salesman and the two competing companies flooded doctors with money to get them to do this new procedure. Not telling them their FDA approval letter for the device said they needed to bolt the vertebrae together. They advertised it with videos saying it DIDN'T need fixation. They also said Doctors could bill insurance companies for a full fusion of the vertebrae....when in fact....no fusion was EVER done.

Surgeons across the country started going thru patients sides and yanking out their spine discs and hammering in the plastic spacer. Problem was....nothing was holding the vertebrae together. There still is no fusion. People have had this plastic spacer move around pinching nerves and causing tissue damage...some have even had the entire plastic piece come out and separation of their vertebrae.

How could the FDA have allowed this to be done to Americans?? $$$$
There are now 500,000 annual getting spine surgery..if the first one screwed people up they know they will be back. Could our FDA really be that evil?

You have to ask yourself why did the FDA just adopt "Bayesian Statistics" in 2010? What is Bayesian? "Learn from evidence as it accumulates". They knew all along what they were doing. It's just a legal move they did to cover the FDA over this fiasco when the Class Action Lawsuits start.

If you want to read some scary webchatter of the salesmen for these companies:
www.cafepharma.com/boards/showthread.php?t=221871

Maybe they want to file a Libel Lawsuit against me. I'm all for it. Here's me with no fixation:
i52.tinypic.com...

The metal pins in the plastic spacer don't even touch my vertebrae. There is no fusion.
I've found lots of pictures of other peoples Xray's where this thing came out, complete vertebrae separation.

I'll hold on to them for the lawsuit. Our Federal Government is 100% complicit in this.
The Department of Defense and CIA need to look at their lost manpower for WAR and who's been doing this to Americans for $$$$.....

Soviet Russia didn't dissolve. It's making money crippling Americans.

www.bloomberg.com/news/2010-12-30/highest-paid-u-s-doctors-get-rich-with-fusion-surgery-debunked-by-studies.html

NASS trying to justify Doctors charging for spine fusion when no fusions were ever done:
www.spine.org/Documents/XLIF_010510.pdf

reply to post by Pervius


Go get them Purvius....but in the end you still lose. Your health is affected, and emotionally you have been scarred by these thieves. This incident will impact you the rest of your life. I am so sorry. I hope you can find an ethical surgeon who can repair the damage.