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Old 01-10-2011, 01:14 AM   #1
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Class Action Against Nuvasive??

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:

< edited >

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

< edited >

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

There is nothing holding us together!!!

Last edited by hb-mod; 01-10-2011 at 01:40 AM. Reason: Please do not post unapproved links or websites, per Posting Policy. Thanks!

 
Old 01-20-2011, 11:53 AM   #2
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Re: Class Action Against Nuvasive??

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 December 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 meds to take home. By that Thursday, I was off all pain meds 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.

 
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Old 01-20-2011, 03:12 PM   #3
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Re: Class Action Against Nuvasive??

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 needs 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.

 
Old 02-15-2011, 10:00 PM   #4
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Re: Class Action Against Nuvasive??

[QUOTE=tetonteri66;4665706]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 needs 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.[/QUOTE]
Di you have anymore information about this. I had surgery back in 2008 and eneded up with damage to my quads and my femornal nerve was cut during surgery. I had no recourse. No one wanted my case. My statue of limitations is up for med mal practice but not for product liability> If u have the time read back on my post Vlaud777.

 
Old 02-15-2011, 10:09 PM   #5
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Re: Class Action Against Nuvasive??

Is there a class action against Nuvasive. After this surgey my life was taken away. i lost my job. On Oxycontins and mor meds to control the pain. Walk with a walker short distances otherwise in a wheelchair. Walked into surgery fine, no leg issues just localized back pain. Cant lift my left leg. NS had no med malpractice insurance wheich is common in Miami. You can see my post Vlaud.Any iffo on this matter would be helpful. Thanks

Last edited by Mod-S4; 03-05-2013 at 11:32 PM. Reason: Quote removed.

 
Old 03-03-2011, 12:17 PM   #6
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Re: Class Action Against Nuvasive??

"""I had surgery back in 2008 and eneded up with damage to my quads and my femornal nerve was cut during surgery."""

Vlaud, guess what I found on the FDA Maude website?

If you had muscle relaxants or epidural blocks....the Nuvasive nerve monitoring system would not feed correct data to the surgeon during your XLIF...resulting in Surgeons cutting nerves:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1918239

Did you also have epidural blocks/muscle relaxants prior to surgery? Apparently epidurals effect nerves for several months post-injection.

When the doctors hit my knees now with a hammer my legs don't move. I didn't know what that meant and nobody would tell me. Wikipedia says Femoral nerve is bad. Maybe they cut mine too during surgery?????

 
Old 03-10-2011, 03:01 PM   #7
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Re: Class Action Against Nuvasive??

[QUOTE=guy484;4698129]"""I had surgery back in 2008 and eneded up with damage to my quads and my femornal nerve was cut during surgery."""

Vlaud, guess what I found on the FDA Maude website?

If you had muscle relaxants or epidural blocks....the Nuvasive nerve monitoring system would not feed correct data to the surgeon during your XLIF...resulting in Surgeons cutting nerves:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1918239

Did you also have epidural blocks/muscle relaxants prior to surgery? Apparently epidurals effect nerves for several months post-injection.

When the doctors hit my knees now with a hammer my legs don't move. I didn't know what that meant and nobody would tell me. Wikipedia says Femoral nerve is bad. Maybe they cut mine too during surgery?????[/QUOTE]
HI Guy 484
Thanks for the information it was helpful. How are you recovering? Do you have a plan of action against the doctor or the company NuVasive. I was wondering confused what I'm going to do. My statue ran out on medical malpractice. So i'm considering a product liability suit or class action. My life has changed and i'm in pain every day. Hate the changes in my life.

 
Old 03-14-2011, 07:55 AM   #8
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Re: Class Action Against Nuvasive??

I'm not doing good.

Did you get fixation for your procedure? Like I said when they hit my knee caps with a hammer now my legs don't move. People ask me if I have diabetes now because when I stand for long my feet turn red. It's very painful to stand for long, it's nerve caused. As I struggle to stand for awhile to try and do something they just start turning red as I struggle to suck up the pain and stand.

Both legs feel like I'm losing nerves to them or something and they bother me trying to sleep/lay down in any position. I wish I understood more of what the Femoral Nerve damage means. I just got my latest MRI radiologist report and have to spend some time translation what all the stuff on it means. Lots of bad things in it from glancing at it. Things have collapsed/impingement.

I noticed FDA letters between them and the company show the FDA cautioning against false advertising. I think they were warned.

Go online and read the Companies latest SEC annual report just filed. Very informative, go to the "Risk" section. Maybe why their stock went down?

Last edited by guy484; 03-14-2011 at 07:55 AM.

 
Old 03-25-2011, 10:48 AM   #9
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Re: Class Action Against Nuvasive??

Hi guy,

Sorry it took me so long to get back to u. I have the same problem my right foot turns bright red and burns and itches when i'm standing even if for a short period of time. The pain continues to be horrible Lately my back pain has gotten worse and have been having spasms. Yes i did have fixation did u?. And prior to my surgery went through a series of epidurals with the pain specialist who referred me to the surgeon who did the surgery. I can't believe that the doctors were pushing a surgery that they knew had these complications. I really feel there was fault in the nerve monitoring equipment and we are the ones paying for it.are u trying to take legal action maybe we can put our minds together

Last edited by moderator2; 03-25-2011 at 11:59 AM.

 
Old 03-25-2011, 12:34 PM   #10
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Re: Class Action Against Nuvasive??

Hi guy could not figure how to get to that web site. Could u give me instructions. I looked at Nuvasive SEC and could not find anything under risk

 
Old 03-27-2011, 05:42 AM   #11
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Re: Class Action Against Nuvasive??

http://www.ncbi.nlm.nih.gov/pubmed/20965732

That may explain your leg issue. Femoral nerve getting cut/damaged from the XLIF appears to be common.

 
Old 03-29-2011, 01:13 AM   #12
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Re: Class Action Against Nuvasive??

[QUOTE=Pickles4u;4716446]http://www.ncbi.nlm.nih.gov/pubmed/20965732

That may explain your leg issue. Femoral nerve getting cut/damaged from the XLIF appears to be common.[/QUOTE]
Thank you. It's been a hell of a journey and its not over with. After an injury lke that I was diagnosed with CRP type 2. Due to the nerve damage. And unfortunately it spreads. I just had i spread into my left foot which before wasn't affected.

 
Old 03-29-2011, 05:00 AM   #13
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Re: Class Action Against Nuvasive??

vlaud,

Did you read your MRI radiologist reports post-surgery?

Mine says infection. Vertebrae keeps moving around as plastic spacer isn't holding them together since they weren't fixated.

FDA allowed this surgery to be done without fixation because fast money was changing hands....even tho their FDA Approval Letter said fixation was required.

In any other country people would be going to jail.

 
Old 03-30-2011, 10:08 AM   #14
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Re: Class Action Against Nuvasive??

"""I looked at Nuvasive SEC and could not find anything under risk """"

Their SEC filings state there is risk anyday they could be in trouble. It's their financial disclosure to the SEC/investors.

2004 FDA ruled they were "high risk"....2005 Patent issued to nuvasive. Then they started advertising it's as "minimally invasive"...safer than normal surgery. Plus they advertised their Coroent PEEK spacer could be used without fixation. They were saying it takes 1 hour for a 1 level procedure.

National average is 4 hours to do a 1 level procedure....not 1 hour.
Their FDA 510(k) said fixation was supposed to be used with their device.

Patients and surgeons are getting exposed to more fluoroscopy than was advertised....surgery was advertised as 1 hour...but takes 4 hours...means more radiation exposure to surgeon and patient than was advertised.

An article just came out in the big medical journal "Contralateral femoral nerve compression, unrecognized complication from XLIF".....it wasn't unrecognized...it was reported by the patients long ago....surgeons/docs just ignored their complaints post-surgery.

It's called a "fusion" surgery and NASS finally got 2 insurance companies to call it a "fusion" surgery and bill for a full fusion. When in fact there is NO fusion, there is nothing holding the vertebrae together.

Maybe yer body will naturally heal and eventually fuse.....or maybe you'll be like me and get an infection in your spine and get disabled instead.

We were'nt FUSED....that's the biggest scam.

 
Old 03-31-2011, 01:39 PM   #15
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Re: Class Action Against Nuvasive??

Use google and look for this medical journal story that just came out:

DOI: 10.3171/2011.2.SPINE10369

Since the XLIF takes 4 hours+ patients are getting too much fluoroscopy....radiation. Because the x-ray machine being left on so long as they try and weave into the surgical area.

Procedure was advertised as taking only 1 hour...national average is 4 hours.
Surgeons and patients are getting exposed to more radiation than they were advertised as going to get.

"Minimally Invasive" turns out was actually quite invasive.

 
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