FDA OKs Artificial Spinal Disc

Discs Have Long Been Used In Europe

Oct 27, 2004 7:17 am US/Pacific
WASHINGTON (AP) The Food and Drug Administration granted approval Tuesday for the first artificial spinal disc for use in patients suffering from persistent lower back pain.

The Charite artificial disc is made by DePuy Spine, Inc., of Raynham, Mass. Artificial discs have long been used in Europe.

The disc, a plastic core sandwiched by two metal plates, is intended as an alternative to spinal fusion surgery. The operation eases pain, but can put more pressure on other discs.

More than 200,000 Americans undergo spinal fusion surgery each year. The damaged disc is removed and bones on either side are grafted together.

Government approval followed a study by DePuy Spine that found that two years after surgery, patients with the artificial disc did no worse than patients who had spinal fusion surgery, the FDA said.

The company was more glowing in its own assessment of its product, issuing a statement saying patients who received the artificial disc left the hospital sooner and were more satisfied than patients who had fusion surgery.

The FDA said the disc can be implanted only in patients who have degenerative disc disease and who have had no relief from back pain after at least six months of non-surgical treatment.

Surgeons place the artificial disc in the spine through a small incision just below the belly button. Patients are given general anesthesia.

The bones of the spine have spongy discs between them, tough collagen rings surrounding a fluid-filled cushion, that act as shock absorbers. They keep vertebrae properly separated, cushioned and flexible.

A disc damaged from injury or aging can cause intense pain, especially if nearby nerves are crunched or the disc degenerates enough that bone grinds on bone.

Millions of Americans suffer back pain, often caused by a degenerating disc. Time, painkillers and special exercises help most recover.

The FDA directed DePuy Spine to conduct another study to measure the product's long-term safety and effectiveness, including its impact on other discs

this is good news

This couldn't have come at a better time for me; I'm due for another spinal fusion - possibly two - so these artificial disks might make these surgeries the last ones I'll need.

I wonder how many people out there actually have artificial organs, limbs etc...

Technically, having such makes you a cyborg.  Should make an interesting study.

Quoted: I wonder how many people out there actually have artificial organs, limbs etc... Technically, having such makes you a cyborg.  Should make an interesting study.

No, to be a cyborg the artifical implant has to be power driven.

I have one or two but have no idea what kind. Five vertebrae fused in two different places, metal plates, screws, hip bone fusion, and two titanium BAK cages. Wish they had that a few years ago, they went all the way through me from both sides. The surgery hurt worse than what was messed up.

Awesome - the fiancee had one fusion, and might need another one down the road.

Quoted: I have one or two but have no idea what kind. Five vertebrae fused in two different places, metal plates, screws, hip bone fusion, and two titanium BAK cages. Wish they had that a few years ago, they went all the way through me from both sides. The surgery hurt worse than what was messed up.

I have 4 BAK cages, too. Two discs removed and BAK cages with bridging installed.

My back feels great!

I am waiting for the full spinal replacement.

Carbon ceramic vertibre with poly urethane disc's (in flourescent colors, of course)

Quoted: Quoted: I have one or two but have no idea what kind. Five vertebrae fused in two different places, metal plates, screws, hip bone fusion, and two titanium BAK cages. Wish they had that a few years ago, they went all the way through me from both sides. The surgery hurt worse than what was messed up. I have 4 BAK cages, too. Two discs removed and BAK cages with bridging installed. My back feels great!

Damn!  I wish mine did.  My surgery was a complete and utter failure!


These sound like a good idea but are a few years to late for me.  And I still think it will take another 5 years before they get ALL the bugs worked out.  I don't trust most new things that come from the medical field.


Sgtar15

Goddammit I NEED this

that would have been nice last December when I had a fusion in my neck........

Quoted: Quoted: Quoted: I have one or two but have no idea what kind. Five vertebrae fused in two different places, metal plates, screws, hip bone fusion, and two titanium BAK cages. Wish they had that a few years ago, they went all the way through me from both sides. The surgery hurt worse than what was messed up. I have 4 BAK cages, too. Two discs removed and BAK cages with bridging installed. My back feels great! Damn!  I wish mine did.  My surgery was a complete and utter failure! These sound like a good idea but are a few years to late for me.  And I still think it will take another 5 years before they get ALL the bugs worked out.  I don't trust most new things that come from the medical field. Sgtar15

why did your back fail? shoddy doctoring or not following directions on the new cyber parts?

Quoted: Goddammit I NEED this img.photobucket.com/albums/v95/rayra/nonsense/disc.jpg

looks like the disc is pressing on the spinal cord!!!

i wonder if one of those could make me taller....

Quoted: why did your back fail? shoddy doctoring or not following directions on the new cyber parts?

Two reason that I can conclude:  1)  Bad doctor.  I found out later this guy had many complaints with the Cali medical board.  2) at 4 months post -surgery I fell down the stairs, that couldn't have helped.



SGatr15

Interesting ... my doctor recommended my L5 S1 disc come out and a fushion take place. I'm 35 and this scares the shit out of me. My sciatic and low back pain is killing me!!! I was told they would have to cut me open from the back AND the front! Scarry stuff.

Anyone ever get the shots in the spine to kill the pain for a few months? Did it work?

Hey Damageinc............I have had 3 epidurals to the lower back and 3 to my neck.............they lasted about a week before they gave out, but they may work longer for you. I have spinal stinosis, and those damn things dont work well at all on me............

Quoted: Quoted: Goddammit I NEED this img.photobucket.com/albums/v95/rayra/nonsense/disc.jpg looks like the disc is pressing on the spinal cord!!!

L4 / L5, pressing on the right sciatic, sit for more than 15mins and my right leg tingles / goes numb. Not so bad anymore, been like that for ~10yrs.
Don't know wtf I'll do while working the polls for 14hrs on Tuesday.

Quoted: Interesting ... my doctor recommended my L5 S1 disc come out and a fushion take place. I'm 35 and this scares the shit out of me. My sciatic and low back pain is killing me!!! I was told they would have to cut me open from the back AND the front! Scarry stuff. Anyone ever get the shots in the spine to kill the pain for a few months? Did it work?

I got a couple.

The Dr did mine under flouroscopy, though.

Damnit my right foot is tingling! I need the artificial disc now!

Has anyone had there L5 S1 disc removed with a fushion? What's the recovery period like?

Damage............I had a microdiscectomy...............they trimmed the disc off where it protrudes into the sciatic nerve.............I was out for about 2 weeks............my neck fusion took 1 1/2 months to heal........if that gives you any idea

Quoted: Damnit my right foot is tingling! I need the artificial disc now! Has anyone had there L5 S1 disc removed with a fushion? What's the recovery period like?

I had that and L4 removed due to an accident.

I had surgery at 7am on a friday and I was walking the halls of the ortho ward 6am the next morning.

I went home with 5 days and started walking around the block. After two weeks home I got on a stationary bike. The stationary bike saved my life from pain pills. Yeah, it's painful, but with such a massive surgery you get large amounts of scar tissue. You need to keep it "loose".

Your surgery(fusion) can be a total success but a tiny bit of scar tissue pressing on a nerve can be hell.

And, if they go in to remove the scar tissue it just returns 2x as bad.

Excercise is the key to overcoming this. Don't sit in front of the tv or pc.

Quoted: Damnit my right foot is tingling! I need the artificial disc now! Has anyone had there L5 S1 disc removed with a fushion? What's the recovery period like?

It varies.  I have heard of people walking very soon.  I had a double level L4-S1 done with two collasped disk above that.  It took we 3 months to learn how to walk again...and I still have pain and numbness.  But like I said, mine failed.


SGatr15

The concept of low back surgery is frightening. They want to remove my bottom disc (L5 S1), fuse it with bone and install large screws and rods (a bridge?). I just can't picture getting up to go to the bathroom within a week of having this done. Well, in the mean time, it's Motrin, Vicodin, Flexeril and Wild Turkey for me!

This doesn't really sound like much of an improvement over the fusion.

Guys, I had a percutaneous disk decompression done, and after a few months of healing, my back pain has been greatly reduced. I still have to do the exercises, and be very careful, but I don't need narcotics anymore except on rare occasions. On those rare occasions I still don't take actual narcotics, I use the synthetic opiods like Ultram and Ultracet.
After many years and damn near every other treatment known to man, this is what gave me some relief. I recommend it whenever I can. I would HIGHLY suggest trying it before going the fusion route. It is minimally invasive, and it's just a fiber optic cable that burns away the leaking tissue and seals up the disk. I had it done on two disks, and will wait on the third. Please consider this before going under the knife. If anyone has questions IM me.

2IDdoc

Quoted: The concept of low back surgery is frightening. They want to remove my bottom disc (L5 S1), fuse it with bone and install large screws and rods (a bridge?). I just can't picture getting up to go to the bathroom within a week of having this done. Well, in the mean time, it's Motrin, Vicodin, Flexeril and Wild Turkey for me!

LOL...yup....the stories I could tell ya......



Sgatr15

My wife is a nurse in Chicago.  Their hospital is one of the few in the nation to do the artificial disc replacement.  Those cases sometimes takes 5-6 hours depending on the doctor doing the work.  She sees a lot of fusions too.

Quoted: The concept of low back surgery is frightening. They want to remove my bottom disc (L5 S1), fuse it with bone and install large screws and rods (a bridge?). I just can't picture getting up to go to the bathroom within a week of having this done. Well, in the mean time, it's Motrin, Vicodin, Flexeril and Wild Turkey for me!

The recovery and success of the total operation is going to depend mostly on the patient.

If it's not damaged too bad, go with the one that heats to cut it out. About two week down time from what I heard. I have had surgery in one place four times, know what you mean about the scar tissue. The last two I had was a cervical fusion and the lumbar fusion after waiting for two years until it was unbearable. Just take it until it's too bad. I was having muscle shrinkage from nerve damage. All I did was trade one pain for another.

Quoted: The concept of low back surgery is frightening. They want to remove my bottom disc (L5 S1), fuse it with bone and install large screws and rods (a bridge?). I just can't picture getting up to go to the bathroom within a week of having this done. Well, in the mean time, it's Motrin, Vicodin, Flexeril and Wild Turkey for me!

That's why I never got it done. Initially my pain was debilitating without massive doses of drugs. My Dr's initial diagnosis was 'pinched nerve / overwork' - had been doing some heavy work trying to salvage my Northridge Quake -destroyed home. 3 weeks of antiinflammatories and painkillers and muscle-relaxants and some Chiro that wore off before I even drove home from the appointments, and after HAVING to continue working at a high-dollar tech contract, I pitched enough of a fit to get an MRI - that pic above is from that series of images.
Was recommended for a microdiscectomy but I had already had one general-anesthetic surgery that year -

-to repair a severed ACL in my left knee (a skiing accident a few months earlier).
That, combined with my leeriness at the surgery - they described it as a 50/50 proposition, 'it could work, some recovery period, but if it shifts you'll need to do it again - and if it shifts AGAIN you'll need fusion surgery' led me to be VERY concerned about even starting down that path.
I declined the surgery and kept popping that drug mix like M&Ms. A couple months later, we took a week's vacation in hawaii. Sometime during that trip, things adjusted / shifted enough that the excruciating pain lessened considerably. Enough that I've just 'put up with it' for the last decade.

addednum - after the vacation 'miracle', I stopped the megadoses of narcotics without a problem. I've maintained prescriptions of all three drugs, and only take them 4-5 times a year (usually after periods of extensive home remodeling projects, which I continue to do, or after periods of lengthy road trips).

It's just part of my 'background noise', now.

It should be very popular in France and Germany.  These people need whole sets.

So, John Kerry can now buy a spine?

Quoted: Goddammit I NEED this img.photobucket.com/albums/v95/rayra/nonsense/disc.jpg

Mine looked like that about tow weeks ago.  I walked out of the hospital three hours after the surgery 100% pain free.  Still about 98% pain free.  Good luck!

Quoted: ....CENSORED due to Bad evil pic....

 DON'T BE POSTING THAT SHIT!!  

DAMN!


Some of us have nightmares still DAMMIT!!


Sgtar15

Quoted: Quoted: ....CENSORED due to Bad evil pic....  DON'T BE POSTING THAT SHIT!!   DAMN! Some of us have nightmares still DAMMIT!! Sgtar15

what was nightmarish about it?

the saws and drills you get to see before the op or the nurse yanking the foley out of your willy?

Quoted: Quoted: Quoted: ....CENSORED due to Bad evil pic....  DON'T BE POSTING THAT SHIT!!   DAMN! Some of us have nightmares still DAMMIT!! Sgtar15 what was nightmarish about it? the saws and drills you get to see before the op or the ->FEMALE? nurse yanking the foley out of your willy?

....a guy might know better. I got pissed at mine after a day or so and tried to yank it out undeflated, because I could control my bladder I'm no control freak!