Artificial discs - not wise choice according to my doc

PNo

I hear you, but the optimist in me also says there were naysayers to hip and knee replacements, heart transplants, and other key medical advances that were once considered bad or not safe. Hearing both sides is important and the great medical advances in our society are made by people who are willing to take calculated risks, exploratory advances, under careful conditions.

Hopefully your advice is a good reminder to us all that it is important if pursuing new medical advances or trials to ensure we seek physicians in the top of the medical profession to be managed in those circumstances and make extremely informed decisions by researching and taking ownership of our own health!

ShepherdLady

Interesting, Your surgeon went to the same school of medicine as mine.

FWIW, I read these same things about these ADR on the Internet. IMO, I wouldn't even want one right now. Way to new....and the studies...a bit lop sided...although I think more about those studies will come to light. And not a good light, I might add.

Here in the USA they are only allowed to do one level, yet in Europe they do more levels. Kinda scary if you ask me.

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Severe Stenosis thanks to C4/5, C5/6 and C6/7 herniated disc's into my spinal cord.

SpineAZ

I'm an optimist and I hope that if the time comes I need C4-5 fused that ADR will be a good option for me. My Orthopedic Spine Surgeon thinks that as the technology advances these will work well for patients much as (as someone else said) knee replacements, etc.

__________________
Rt thumb fusion '13. R&L thumb arthroplasty '12 ; RT TKR & Bilat CTS' 11. Fusions: L5-S1('87), L4-S1('93), C5-C7('06), L3-S1('10), C4-C5('13). C5-C7 foraminotomy '08

Lilacs&Lillies

When I was researching which neurosurgeon to go to, I was told to stay clear of a certain doc - so of course I did. (His picture gave me the heebie-jeebies anyway)...

Last month I saw a local hospital newsletter that "Dr. Heebiejeebie" was doing a trial on ADR's for the company that makes them. I wasn't surprised.

Vegas74

i have done ADR on 2 levels with out any problems and met ALOT of Americans who have went to Europe and did it with out any problems, I think your DR. is just scared of what he dosent understand which seems typical of alot of Americans in general. I keep in touch with the other patients for over a year and havent heard of one problem, the implants they are using here in the clinical trials arnt good that is true, they stopped using first generation implants almost 20 years ago in Europe, why the FDA dosent consider the success of the new implants they use in Europe is a puzzle to me.

painful paul

From my research and understanding... most of Europe's adr ops are quite successful. What makes it attractive to me is that if adr fails.... you can still get the fusions. There are no long term results for adr available. All we know is that if the once the prosthesis is set, dislocation is almost impossible. The U.S. studies where on the Charite disc. It failed miserably. Charite came out with the SB3. This design is much better, but still not as good as the Maverick for lumbar. Either way, location and placement of the keel into the bone is the most critical variable in the operation (within millimeters.) It is my understanding that the prostheses failures in the US were due to misplacement and patient rehabilitation.

There is a new disc coming out in a few years- possible US, FDA approved. (I still would not trust an American doc to do it.) Its at spinalkinetics.com I called them and they were very careful about what little info they would give me. It looks like a great design though. Yall should check it out.

As far as ADR???? Do your own conclusions, but if you get adr, you can still get fusion later, but not the other way around.

Good luck to all.

bw67

FORESTPEAK-

check out my post- NON FUSION UPDATE. I chose to have a minimally invasive procedure for herniations at C5/6 and C6/7. It may be an alternative for you over fusion...

good luck

BW

Newbackguy

I don't want to call your dr. a liar, but after having three Prodisc ADRs in Austria, Vienna, I disagree with some of his information. The Prodisc has been used in Europe for over 15 years with great success. Dr Bertagnoli who performed my surgery has implanted 3500, yes thirty five hundred, Prodisc himself over the years. All have been successfull. My concern with alot of US doctors is the fusion has been around for ever. Like most people they are reluctant to except change. One of my Dr.s was against ADRs, but was it because he holds several pattends for fusion technology ? Also, if a dr. held stock in any drug companys, the ADRs would decrease the need for pain, neuro, and other meds. I haven't taken any meds since 4 wks post op. (almost 3 years) I would just like to see anyone who is considering ADRs to see and talk to the drs that did the FDA studies, and use the product.

Best wishes to all.

javanoginn

Dear ALL: If any of you believe this, then dont be surprised when you end up with the same horror that I have seen others go through who have had to have removed the Dr. B. implanted-Prodisc.

Do you really believe Dr. B. implanted 3500 devices - ALL perfectly? Do you realize that Dr. B. shares the Patent on the Prodisc-C and helped co-design the latest version of Prodisc-L ... and is a consultant of Synthes ... and (according to NASS 2007), is on the Synthes board of directors? Do you realized that Dr. B. says 90% of his fusion patients are now Prodisc patients ...while exhaustive reports [Wong et al] show that only 0.05% of fusion patients meet all criteria for ADR? Do you really believe the E.U. Class IV data that claims 94, 96, 100% successes, while the U.S. FDA Class I (refereed, controlled) data ends up with 53% success?

I wont cast aspersions upon Dr. B's talent, nor can I or anyone technically contest his data, but I dont recall anywhere that Dr. B. claims he has done 3500 devices without failure.

You can believe the hear-say, "I know 3 people who did well - so you will too", or you can read the evidence, and opinions of professionals.

Enjoy.

Lumbar Disc Arthroplasty: A Critical Review
Daniel K. Resnick, M.D., M.S., and William C. Watters, M.D.
[url]http://www.neurosurgeon.org/publications/clinical/54/pdf/cnb00107000083.pdf[/url]

Incidence of Contraindications to Total Disc Arthroplasty:
A Retrospective Review of 100 Consecutive Fusion Patients with a Focused Analysis of Facet Arthrosis
David A. Wong, MD, MSc, FRCS et. al.

“Also, this disc (Prodisc) replacement will predictably cause excessive loads to the facet joints.” Dr. John Peloza
[url]http://www.centerforspinecare.com/approach/minimalinvasive/lowerback/realities.html[/url]

Effect of artificial disc placement on facet loading: unconstrained vs. semi-constrained.
Moumene M, Geisler F.
Finite element analysis shows CHARITÉ Artificial Disc replacement reduced facet loading by 50% compared to the intact segment while ProDisc increased facet loading by 10%.

CHARITE Versus ProDisc: A Comparative Study of a Minimum 3-Year Follow-up
[url]http://b.lib.bioinfo.pl/pmid:17450077[/url]
Shim CS, Lee SH, Shin HD, Kang HS, Choi WC, Jung B, Choi G, Ahn Y, Lee S, Lee HY.
Spine. 2007 Apr 20;32(9):1012-8
Degradation of the facets was seen in 36.4% of the CHARITE and 32% of the ProDisc.

Degenerative changes of discs and facet joints in MR and CT images after lumbar total disc replacement using prodisc - 3 year follow-up study
C.K. Park, K.S. Rhyu, S.J. Lee, K.Y. Lee
SAS7

purpletrail

It looks like the research studies on the Prodisc in the U.S. were tainted by allowing the physicians to invest in the product. They did not disclose their financial ties to the FDA. The FDA is looking into the matter.

They are suspicious of the number of cases thrown out of the results being higher than what is considered normal. Texas Back Institute seems to be one of the biggest investors.

I work with securities in my business and I sure know all about conflicts of interest. If I did anything close to this I would lose my securities registration.

Who is monitoring this anyway? The FDA is totally underfunded. I learned after the fact that the spine surgeon who implanted a titanium plate in my neck was making $400,000 from the manufacturer for doing what amounted to 10-20 hours of training per year. His name was all over the newspaper headlines for a couple weeks last year.

Holly

Newbackguy

The evidence and information is mostly personal opinions from Dr.s, but probably are not hosts themselves to any of the ADRs on the market. I am well aware of the problems the Charite has had, and unfortunately it never should have been approved. I researched ADRs for a long time before making my choice.

I was also in the FDA lottery for an Prodisc-C. I lost and got a fusion at C5-6. Now due to the fusion, C3-4, C4-5, and C6-7 are herniated. I am waiting for FDA approval of the Prodisc-C, then my insurance company will pay for me to go back to Vienna for three cervical ADRs.

When it comes down to it. Most information available is personal opinion. My opinion is mine, and only mine. I am a firm believer in the Prodisc over a fusion if possible. I lift very heavy at the gym, but I am also smart enough to not do anything that would put my health at risk. I just hope others can use all the information available to them to make their lifes better, and pain free.