Need opinions of Dr. Bertagnoli and ProDisc

[LauraB]

Thank you both Zenmunk and TPatti.

I can definitely see mechanical issues with either device. I'm hoping for the lesser of two evils (which I really believe is fusion in my case). I have spoke with Dr. Bierstedt (personally) and Dr. Bertagnoli about their chosen device. Both make a great argument toward the functionality in the spine. I am noting the load on the facet joints (prodisc) and will look into that as well. From what I understand "stenosis" and bone density play a significant factor in the success of implementation and longevity. I plan on addressing these issues by having a specific bone density test for the cervical spine and having a surgeon review the stenosis issue.

I came into this endeavor when I discovered ADR and the M6. Like you, Zenmunk, my husband is very concerned about the stability of the core. He fears that over the course of time, it will wear and break down. He liked the simplistic design of the ProDisc. As for me, I want my life back and it is true, anxiety if playing a big factor and I fear it could cloud my judgment.

TPatti - I am envious that you are there right now being fixed up. I wish you the best. I am a teacher as well and had to resort to substituting this year due to my physical condition and potential for absence. Since I'm not tenured in my district, I couldn't risk taking time off and losing my position so I'm doing the next best thing....financially it stinks (other choice of words but I'm suppose to be a role model for my kids). Thank you for responding during your recuperation time. I truly appreciate it.

[LauraB]

Jeff, I agree that one bad "rap" has more weight than a positive one. I've only been on this site for about a month and the information i gleaned about TBI had to do with the number of surgeries - I was more concerned about Stenum (since that was my first introduction to possible sites). Dr. Zigler seems to have a fantastic reputation - I had inquired a few times as to the number of multi-levels he performed, and had not received an answer. It was one of my first questions when interviewing surgeons as I had learned that the complexity of multi-level cannot be compared to a single level. Either way, that being said....I do feel good about either surgeon...Dr. Bertagnoli or Dr. Bierstedt. My real concern is the device. I also want to live with it for a minimum of 20+ years. To spend my entire savings (and then some) only to be back in the place where I started (looking at fusion) is futile. I really appreciate the information. I need to re-examine my options.

[TPatti]

Have you looked into the Kineflex disc? It is a hard disc as well but unlike the prodisc it has a restraining ring to stop movement before the facet joints are forced to do so. Dr. Cappuccino, the doctor that is doing my follow-up stateside, had given me this disc as a hybrid option. He would have fused L4/L5 and implanted a disc below and above. It is also not fda approved but Dr. Cappuccino is a member of AIMIS and could have performed the surgery in Cypress. He discussed both options, his hybrid or 3 M6's, said they both had pros and cons and the final choice would be up to me and that he would follow up with me if I choose to find a doctor to implant the M6's.

[zenmunk]

TPatti,

Thanks for the timeline. So, hopefully I'll talk with Dr. Bierstedt approximately 3 weeks from Wednesday (when they're expected to receive my stuff). Organizing and waiting for all of these diagnoses/consultations with numerous surgeons at home and abroad is really draining when you feel like s&#@. I keep hoping I don't do something stupid to make myself worse before I have the surgery.

__________

Jeff,

I've heard that Dr. Bierstedt was told at a conference that the M6 failed at L5-S1, but that Bierstedt attributed it to one or both of the following:

- the M6 should not have been put at L5-S1 in that particular patient
- poor surgical technique

Why exactly are you concerned about the M6 housing infection? Can you elaborate on that a little more?

__________

LauraB,

Advanced facet hypertrophy and poor bone density are contraindications for TDR. Some would argue that even mild facet hypertrophy is a contraindication. As TPatti points out, perhaps some discs will allow for more hypertrophy than others. I suggest you get checked for both and then trust your surgeon's recommendation. You might also consider a metal allergy blood test to make sure your body is good with whatever is implanted: metal allergy testing

If you believe that fusion is the lesser of two evils, then you should strongly consider it. I know it's sort of apples to oranges since it's lumbar, but I was fused at L5-S1 in 1992. It afforded me almost 20 years of relatively little pain and no restrictions. Unfortunately, in 2011, adjacent segment disease finally started catching up with me at L4-5. I believe fusion will inevitably lead to adjacent segment disease. How much and when will vary greatly. That said, sometimes it's undeniably the better (or only) choice. Even if ADR was available to me in 1992, I wouldn't have been able to get it, because my condition was spondylolisthesis. Point is - don't make the mistake of drinking the ADR cool-aid. It can do wonders for the right candidates and cause horrors for the wrong ones.

[jss]

Zen,

Inside the M6 ADR sheath, there is a lot of empty space and a lot of surface area of the internal components. The sheath contains two pin holes that will allow our interstitial fluid to fill up the inside of the M6 and will also allow that fluid to flow in and out of the disc. It seems plausible that a pathogenic microbe could pass into the disc through the aforementioned pin holes and begin reproducing inside the M6, feeding off our interstitial fluid, creating a colony that, due to poor access to the microbes, our immune system could never eradicate.

While the ProDisc suffers from this same potential, its only hard to reach surface area, between the polyethelene sheath and lower plate, is far smaller than exists within the M6. Which should greatly reduce the ProDisc's potential for such a scenario.

Is that scenario possible? I don't know, but it does seem plausible.

Make sense?

[NJ Gene]

Originally Posted by TPatti

Have you looked into the Kineflex disc? It is a hard disc as well but unlike the prodisc it has a restraining ring to stop movement before the facet joints are forced to do so. Dr. Cappuccino, the doctor that is doing my follow-up stateside, had given me this disc as a hybrid option. He would have fused L4/L5 and implanted a disc below and above. It is also not fda approved but Dr. Cappuccino is a member of AIMIS and could have performed the surgery in Cypress. He discussed both options, his hybrid or 3 M6's, said they both had pros and cons and the final choice would be up to me and that he would follow up with me if I choose to find a doctor to implant the M6's.

Todd, are you sure that U.S surgeons can't implant the M6 off-label? Just because it's not FDA approved doesn't mean it's illegal. Vitamin supplements and many over-the-counter meds are not FDA approved, yet they're still sold in stores. Furthermore, if you recall, there was a problem with many people who received epidural injections, where the medicine came from a compounding facility in New England. Apparently compounding facilities are not subject to FDA approval, and this facility was more interested in profit than the well-being of the patients. They were ultimately shut-down. However, their mere existence was legal. I was also told by surgeons in the U.S. that they could do 2 level fusions "off-label" before it became FDA approved. Don't get me wrong, I would rather stick with a device that is FDA approved or well documented by experienced surgeons in Europe. BTW, my spine surgeon advised against AIMIS. He was one of the founders of it. Once he heard that it consisted of mostly U.S. surgeons doing risky operations outside the umbrella of the FDA and without risk of U.S. malpractice, he divested his funds from it and no longer has anything to do with it. That being said, I'm sure many of those surgeons are excellent, and I would consider using them here in the U.S.

Gene

[LauraB]

Zenmunk, Like you, just entering into this journey really does take a toll on your energy. I keep myself sane by investigating everything and making positive movement in the right direction. Although I'm still young for osteoporosis, I don't want anything to conflict with my success. I will have any possible test that might cause a possible "failure;" which includes the bone density and metal testing as well - although I do have a titanium plate fused in there. As far as fusion being the lesser of two evils - no way. I waited 5 years for something better - otherwise I would live with my pain. My fusion, I believe, is the root cause of my new troubles - typical DDD below and herniated, bulging discs above. I spoke with Dr. Bertagnoli's office today, and feel very good about the steps he takes during surgery. He is open for discussion on any type of device I'm concerned with and his personal attention to my unique quality of my cervical spine. I feel better.

TPatti - I did look into the Kineflex briefly as it is designed for DDD. It does have some good qualities and will be part of my presurgical discussion. Thank you.

Jeff - You brought up some pretty scary biofilm complications (possible). I'm sure the potential is there for almost any type. I did read (few years back) about a staph infection setting in during surgery - causing failure.

I believe ADR is the best option for me at this point in my life. Come what may I do have to take that leap of faith and go with my gut. I'm sure I will be back on this forum worrying about something else - as I have 8 more weeks to wait and I'm climbing the walls right now (running out of meds).
I pray to have a positive outcome and will still enjoy skiing when I'm 84. That's the plan! Thanks all.

[TPatti]

I could be wrong, but I am going off of what Dr. Laurysen told me. He is going thru a lot of trouble trying to find a hospital overseas to use for M6, I think he would using here if he could. Spinal Kinetics website states that it is not available for distribute in the US:

Spinal Kinetics, M6, Motion for Life, 6 Degrees of Natural Freedom, and the Spinal Kinetics Spine Logo are trademarks or registered trademarks of Spinal Kinetics, Inc.
M6-C Artificial Cervical Disc - CAUTION: Investigational Device. Limited by Federal law to investigational use.
M6-L Artificial Lumbar Disc - WARNING: This device is not cleared by the FDA for distribution in the United States.
Copyright © 2012 Spinal Kinetics, Inc. 7/12

[zenmunk]

Jeff,

Yes, it does make sense. Very scary sense. Here's hoping none of us ever suffer that fate. I plan to mention that kind of infection risk when I consult Clavel, Bierstedt, Lauryssen and Zeegers.

LauraB,

I misunderstood you. When you wrote, "I'm hoping for the lesser of two evils (which I really believe is fusion in my case)," I took that to mean you thought fusion was the lesser of two evils in your case.

Now I know you feel the opposite. I think most people on this forum do. I want to avoid another fusion if i can as well. However, for some conditions that isn't possible or advisable.

Best of luck navigating these rough waters.

[NJ Gene]

Zenmunk, why do you say three weeks until Dr. Bierstedt receives your stuff? Do you mean three weeks before you hear back from him with an evaluation? i sent my records to Malte Peterson via U.S. Global Priority Mail. It cost about $20.00 and took about 4 days to get to Germany.

Gene