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LindaRacine
01-18-2018, 04:24 PM
For those who think it's smart to roll out a medical technology before it's gone through the FDA's process....

https://www.scoliosisclaim.com/

Please note that I'm not saying there's anything actually wrong with MAGEC implants. I'm just saying we don't really know about these things until the patients mature a bit.

Pooka1
01-18-2018, 09:42 PM
This completely blows my mind. The only difference between traditional growing rods and MAGEC was how they are expanded. I am not grasping why there aren't class actions for traditional growing rods also.

titaniumed
01-18-2018, 09:54 PM
For those who think it's smart to roll out a medical technology before it's gone through the FDA's process....


That would be Ellipse... Anthony had a "compassionate" release from the FDA....May 2013, He was the first Magec patient. This was 4-1/2 years ago.
https://www.rchsd.org/about-us/newsroom/press-releases/surgeons-implant-magnetic-growing-rods-in-groundbreaking-treatment-for-scoliosis/

2 years ago, NuVasive bought Ellipse
https://www.fiercebiotech.com/medical-devices/updated-nuvasive-to-enter-scoliosis-arena-via-380m-buy-ellipse-says-more-deals-way

It looks like NuVasive did a re-design......and got the FDA approval back in September.....2017

https://www.prnewswire.com/news-releases/nuvasive-receives-fda-510k-clearance-for-leading-eos-innovation-300514377.html

We can only hope they ironed out the problems....Sigh....

Ed

LindaRacine
01-18-2018, 11:32 PM
This completely blows my mind. The only difference between traditional growing rods and MAGEC was how they are expanded. I am not grasping why there aren't class actions for traditional growing rods also.

There were differences in material and connection.

It's possible that the lawsuits are baseless, though it would be pretty stupid for the law firm to advertise and enroll litigants without some proof that a class action suit will prevail. I've got a friend who works for NuVasive Spine, so I'll see what I can find out.

--Linda

titaniumed
01-19-2018, 12:28 PM
This is such a delicate matter for me, in defense of spinal hardware manufacturing, where would we be without innovation? Basically nothing happened for thousands of years, now its this progressive improvement, ideas that help us prevent, limit or improve on this insidious, subtle, painful disease we have to struggle with....

My hardware saved my life. My surgeons saved my life. I will never forget.

These poor kids, sometimes they cant wait....it is such a tough call knowing that there are odds, and things can and will happen. We are warned about this by our surgeons. The hope is that there will be improvement, that it will help.

The overall "combined" intent is positive....when things are not black and white, which scoliosis or serious surgery never is, we need to remember this before going to court. Its hard to over-engineer spine hardware, and prove out tensile and yield strengths in specific areas using accepted bio materials. Ionization and particulates from wear is also another difficult problem.

Spine is everyone's problem. It just is. Spine problems need to be solved in a positive manner with current and new technologies, and nothing good ever comes easy, and giving up is never an option.

I say, Kudos to NuVasive!

Ed

burdle
01-29-2018, 06:05 AM
Maybe if treatments paths for Scoliosis were not so awful. Maybe if groups like Setting Scoliosis Straight and SRS and SOSORT actually came though with their promises and actually got to grips with providing correct accurate information about scoliosis and did not 'lump' everyone together so that the uninformed can propagate inaccuracies and poor treatment paths and the unscrupulous can muddy the waters with quack chiropractic techniques - MAYBE if they actually did what they were supposed to do and help safeguard scoliosis patients then MAYBE desperate parents would not have to take a leap of faith and trusting their instincts have to go for growing rods and VBT hardware that has no FDA approval because they are so desperate that their children do not have a life of pain and deformity!

I do not for one minute consider MAGEC rods or VBT instrumentation to be 'quack' but how easy is it for medical professions to point the finger while the situation is as it is now?