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Old 08-16-2011, 11:41 PM   #1
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Anybody had failed fusion with either Aspen device & spineology bags?

Hi, I had a 3 level lumbar fusion, the surgeon used Aspen devices (clamps) & optimesh spineology bags instead of cages, the surgery fell apart before i got home but i was ignored for over a month telling me it was normal even though i could not get to the bathroom used bedpan for weeks, after a CT scan there was no doubt there was a huge problem.

I got a second opinion & had the surgery redone, i had two reherniated extruding disk & one non union everything was loose, I was told everything was to be taken out & rods screws were to go in, he mentioned those devices are not stable enough niether were the bags, just short of 12 mth later still have lots of pain i went today to see if i fused or not, two fused fine with peek cages but the 2nd surgeon left one of the spinology bags in there it has not healed at all, you can imagine my frustration especially when hes talking two more surgerys one to redo the one disk & then after fusion remove hardware, looks like ive been burnt twice i cannot keep having spine surgeries for the fun of it because they keep messing up.

All i can find on these products are they are in trials, FDA approved the aspen on one level, the only info is that sheep and cadeaver spines did ok as far as they know, the spineology bags are not approved at all they dont have a medical code even they were on my bill as peek cages now i know why, they have a black box warning that safety is not established in fusion patients also, these products are supposed to be minimal surgery too i had a six inch midline scar & two stab wounds over my hip which was more trauma than traditional surgery.

Anyways was wondering if anyone else had any problems with any of these products as in not told its new technology or them being used inappropiatley ive had a nightmare which today turned into the twilight zone, really dont think i can go through another lumbar surgery im so gutted

Last edited by Administrator; 08-18-2011 at 05:23 PM.

 
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Old 08-17-2011, 08:15 AM   #2
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Re: Anybody had failed fusion with either Aspen device & spineology bags?

I would be furious with both surgeons. Revision surgeries have a lower rate of success and present a variety of problems, so it is never good to plan on having several surgeries when all can be accomplished with one surgery.

I don't mean to question the credentials of your surgeons, but they seem very willing to use you as a guinea pig.

I have no idea where you live, but I hope you will be extremely careful in the selection of a new surgeon. You are quickly reaching the point where no one will take you on as a patient.

 
Old 08-17-2011, 08:37 AM   #3
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Re: Anybody had failed fusion with either Aspen device & spineology bags?

OK, I did a little bit of research and it looks like there are class-action lawsuits forming on the use of the OptiMesh (spineology bags). It was approved in 2003 for very specific, limited use with spinal tumors.

According to a letter sent to Spineology by the FDA in 2007, "OptiMesh was required to bear a contraindication not to use the device in patients with instability and to state that the device does not provide structural support. The device was also required to have a black box warning that the safety and effectiveness of the device for use in fusion of the inter body space has not been established."

If you are interested in reading more, just look for articles on OptiMesh, back surgery and law suits.

I also ran across a clinical trial investigating the use of OptiMesh in minimally invasive spinal fusion. It didn't have any dates on it so I have emailed the facility to see if the trial is ongoing. This will be interesting to know as it would indicate your surgeon really jumped the gun on using this stuff on you.

I'll let you know what I find out.

 
Old 08-17-2011, 03:51 PM   #4
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Re: Anybody had failed fusion with either Aspen device & spineology bags?

You might file a report with your state's medical licensing board, and report the incident.

Have you been able to talk with the surgeon after you realized it was failing and ask him about using this product for a multi-level fusion? Are you going to let this guy operate on you again?

Last edited by Administrator; 08-18-2011 at 05:32 PM.

 
Old 08-17-2011, 04:01 PM   #5
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Re: Anybody had failed fusion with either Aspen device & spineology bags?

just reread your post about the optimesh trials, a surgeon is advertising for people to try it on his website at one level, at least those people choosing this procedure know what they are getting into i did not.

i will carry on with this story to state health board its so unfair to be a studied specimen when you are unaware & the damage done was huge, I could have been getting on with my life at this point if done traditionally in the first place those two fused disk i have tell me that. I was shocked to find out how new technology is brought to us it seems there is little by the way of anyone watching that guidelines are followed, I will post any additional info on these two products too, they may be great if used as intended im not sure theres no trials published, so anyone thinking of having a large multiple surgery with either this is a big red flag.

Last edited by Administrator; 08-18-2011 at 05:57 PM.

 
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