Class Action Against Nuvasive??

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guy484

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From what I've found Nuvasive was pushing the XLIF surgery as a way Doctors could make fast money with a simple spine surgery.

They were saying you could go in thru a patients side and rip out their disc, drop in a cage implant with some bone growth on it....yank everything out and yer done.

Problem is their FDA Approval letter for that cage implant says "fixation required"

www.accessdata.fda.gov/cdrh_docs/pdf4/K043405.pdf
www.accessdata.fda.gov/cdrh_docs/pdf5/K052210.pdf

Sooooo.....why were Surgeons doing this procedure WITHOUT adding the fixation? The Cage implant itself doesn't hold anything together. As you can see from my Xrays the metal pins in the cage don't even touch bone:

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Also WHY have some insurance companies been refusing XLIF saying it's "expiramental"????

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Because the way they are using the cage implant is NOT FDA Approved!!!!

There is nothing holding us together!!!
 
After several years of serious back pain, I talked to several nerosurgeons to discuss what was wrong with my back. At first I thought I needed hip replacements and my pain was through my buttocks and done my left and right legs.

There was not a position that I could get into where I would feel comfortable. I was in severe pain.

All the surgeons I talked agreed that my problem was mechanical and that I needed to have a fusion done between L4 - L5. I had already had 2 decompressions and tried shots, chiropracters, and everything I could prior to having a third back surgery.

I was finally referred to a young Nerosurgeon who talked to me about the the Nuvasive Xlif procedure. Since I could hardly walk from the bedroom to the kitchen, I decided to have this procedure done on Deceraber 6, 2010. At 6:30 AM I went in for the operation. That evening, although sore from the procedure, I felt I could walk again. Although I was on serious pain medication, I was able to walk and I was released from the hospital on Wednesday. I was sent home for recovery and was given pain meRAB to take home. By that Thursday, I was off all pain meRAB and felt like I was 18 years old again. To me this procedure was a miracle. I hadn't felt this relieved in a couple of years.

I would highly reccommend this procedure depending upon what the problems are. For me this is a life saver.
 
And there you have it in a nutshell. For people who are able to avoid the horrible issues with the psoas muscle, etc. XLIF is a wonderful procedure. But many more people seem to be developing the psoas issues than they thought possible during clinical trials.

I think the jury is still out on this procedure....so, as always, anyone contemplating surgery really neeRAB to do some research, and to the best of his/her ability, be sure they know what they are getting into before signing on that line.
 
NuVasive is required to provide a surgical technique guide that gives the procedure and should recommend the use of additional fixation (i.e. pedicle screws, facet screws, etc.). The problem is that surgeons will often use the product "off-label" (meaning other than the indications for use as stated in the Instructions for Use or technique guide), and the company has no control over surgeon discretion in that respect. They can only emphasize the use of fixation, but they're not in the OR enforcing it. Neither is the FDA. If there is a problem that results from off-label use, it should be against the doctor, not the manufacturer.

As a side note, the pins in the XLIF cage are not intended for fixation. The PEEK material the cage is made of does not show up on x-rays, so the manufacturer inserts pins of some sort of metal that allow visibility on x-rays to verify correct placement. So they're not supposed to hold the cage to the vertebrae; the additional fixation for fusion should take care of movement.
 
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