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FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Sunday, November 10th, 2013 | Uncategorized | No Comments

FDA STILL DOESN’T GET IT! “TYPES OF METALS” is the correct answer!

(This is part of the long FDA announcement and meeting notes.)

Agenda: On December 12, 2013, during Session I, the committee will discuss and make reco…mmendations regarding the classification of spinal sphere devices. These devices are spheres manufactured from metallic (e.g., cobalt chromium molybdenum) or polymeric (e.g., polyetheretherketone) materials. They are intended to be inserted between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft. These devices are not intended for use in motion-sparing, non-fusion procedures.

PLEASE NOTE the types of metals they are going to “suggest (dictate?)”¬†for orthopaedic surgeons to place in the spine!

“Cobalt, Chromium and Molybdenum”

Chromium and Molybdenum are only 1 element away from being twins! That means double the trouble for metal inserts, especially in the spine area! Those types of metals almost destroyed my mom’s kidneys. Beware of what types of metals are placed in your body.

Chromium causes renal and digestive failure. Google it! Learn and share, please! The photo below is my mom’s left hip after her third revision with repeated metals of Cobalt-Chromium-Nickel.

Also, note: Approximately 30 percent (varies with dermatologists) of the general population are allergic to Nickel.

WHY USE Cobalt, Chromium and Molybdenum metals? Because ortho mfgs can make a boat load of money on inexpensive hardware that is an alloy and not pure! Guess that’s how they make their billions.

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