M6-L or Prodisc-L

[Vicki_in_Florida]

Since several people have asked me to share what Dr. Boeree had to say,
I am willing to share but again remind everyone that every doctor has his/her own
opinions on the ADR subject. I have included some things Dr. Z had to say as well.

It was a pretty lengthy conversation but I will share what turned me away from Prodisc..

1. It's all metal. Dr. Boeree said that your real discs are like shock absorbers. They should cushion you from impact.
The metal disc isn't going to budge. That puts more pressure on your surrounding discs..

2. The Prodisc is made with a plastic ball per say in the center of the disc. It puts the weight of you on the center of the disc, which is not natural like your real disc. Also, they have studies now showing that in time, that ball starts to wear down.

3. The Prodisc is a ball inside of two domes. It can turn 360 degrees. Dr. Boeree said that it would be like slamming a door.
When you slam a door, the wall stops it from going further.
What stops the Prodisc? Your facets!

Dr. Boeree basically feels that the Prodisc was good at the time it came out, but its not the best disc today. It's just the best that the US has to offer.

He said TBI sends patients to him all the time when they know the M6 is best for them or they have a complicated case. I guess they can't loose all of their surgery money sending people overseas. It just makes you wonder how they decide to be honest and tell certain people the truth.

Dr. Boeree said he hadn't done any revisions on the M6 due to the M6.
He had one lady who had an accident at work and a wall fell on her.
She's the only person he had to revise because of her accident.
Said to search online for anybody having an M6 failure or revisions.
You'll see lots of Charite and Prodisc.
There are now over 10,000 M6's placed.

The M6 is was named this way because you're real disc should have 6 degrees of motion which is what the M6 has. He said that when you twist, the M6 is designed like a bungy cord per say, in that it will allow you to twist, but only so far just as the natural disc would.

I feel kinda bad saying a few things he said on a public forum that he was discussing with me in a private phone call. I have left out a few comments but I think there is one comment that should be shared for newbies reading this and considering Germany.
He does more revisions from ADR's gone bad from Dr. Bertagnoli.
He said when considering a doctor, you want one who stays in touch with their patients.
You don't want a guy who is a back surgery factory. Dr. Zigler told me this as well.
Difference here is Dr. Zigler tried to convince me that the Prodisc was the way to go because even Dr. Bertagnoli prefers the Prodisc or the M6.

I mentioned this to Dr. Boeree and he said that Dr. B is one of the owners of the Prodisc.
He said it's not hard to figure out why he wants the Prodisc to be the disc of choice.
Dr. B does the surgery and basically moves on from there. You deal with his staff etc, but Dr. B is more interested in just doing the procedure and leaving follow up to his staff.

Dr. Boeree gets no kickbacks for using any disc. Owns no stock in any disc company.
He can use any disc he likes. He said in his opinion, the M6 is to date, the best choice of ADR's. It was designed to be most like a real disc and it had way more testing done on it before being approved than the Prodisc did.

Dr. Boeree is always one of the first doctor's called to try new products as they come out for trials. He said there have been a few that he just declined because he didn't care for something about it.

Dr. Boeree was very honest, upfront and not afraid to share his opinion. I had the call on speaker phone and when we hung up, my hubby said "we are going to that doctor".

The European rep for the M6...his wife has 3 M6 cervical discs and she does competitive horse jumping with those discs!
That's impressive and I believe she can do this because they are not metal like Prodisc's are.

Dr. Zigler told me that with the Prodisc-L if there is a problem, he can just go in and do a
spinal rhizotomy. He said this very nonchalant and that bothered me.
I don't want them to have to go back in! Especially when I told him several times that I was concerned because I was paying out of pocket and couldn't afford to have plan B and etc done if needed.

I can't remember everything from the conversation, but I tried to write down the things that seemed most important to me.
I am speaking to Dr. Boeree again and have more questions to ask him.
Like: I forgot to ask him if he uses a vein barrier.
__________________________________________________ __________________________________________________ _________________________________

THE FOLLOWING IS COPIED AND PASTED FROM DR. Z'S EMAIL TO ME:

Overstuffing the disc space and hyperextension can be problems with any ADR, and are not at all unique to ProDisc. They are related to surgical technique and to each patient's particular anatomy. It is pretty rare to cause a probem, in my experience.

Facet proboems developing after ADR were a ig problem with the Charite, but have not been an issue with ProDisc. The Charite (no longer on the US market) was an unconstrained implant and put huge stresses on the facets. ProDisc is semi-constrained and internally checks enough of the force on the facets that we do not generally see much facet disease developing after ADR/ Some patients do have postop facet pain, but that can usually be treated successfully with injections or a rhizotomy, both outpatient procedures, if needed.

Some of my most successful outcomes have been in patients who were bone-on-bone preoperatively. We have done a study reporting that there is no correlation between preoperative disc height and postoperative outcomes. In other words, small height preop does not influence outcome. A narrow preop disc height does make the mobilization (my job) more difficult, and I always make sure that all my arthroplasty patients (especially those with narrow discs) understand that they may wind up with a fusion if, during the case, I do not feel that it is safe or appropriate to place a ProDisc. I will always make my intraoperative decisions with your safety as my primary goal. That judgment is what you are primarily trusting me to exercise, with the manual skill a close second.

I have no patent interest in ProDisc, and receive no royalties from its sale or use. I was an investor in the parent company when it first raised money to start the FDA study (year 2000), but that investment is long finished (around 2005). I am currently paid as a teacher and consultant to Synthes, so I make indirect income from teaching other surgeons about the device, helping them with clinical questions, and helping Synthes' engineers to improve the implant an instruments. Besides ProDisc, there is no other lumbar ADR available in the US right now, so it is almost a moot point unless you leave the country for surgery. I believe I also told you that, in my opinion, there is not a better disc in the pipeline (and we at TBI have been a clinical site for the next 3 that will be potentially released in the next 3-4 years). ProDisc is the one I would want my wife to have if she needed one, because I am comfortable with the clinical data we have on our FDA patients regarding long-term use. Other devices availabke outside the US do not have that large database of reliability.

We do use a vein barrier, although it is really only an issue above L5-S1 because of the vascular anatomy.

Revision is possible, but pretty rarely indicated. The revision approach is the issue, not the actual device revision. Revison rates in the first 1,000 patients done after ProDisc was released were 0.5%, or about 1 chance in 200. That is far lower than the revision rates for most spine operations, including fusion.

Limitations once the spine has healed (by 3 months) are determined by your level of rehabilitation. The military has sent many guys back to active combat with lumbar ProDiscs.

I don't know enough about Mesoblast specifically to advise you. Biologics are the next great frontier in treating disc disease, but are still a long way from being recommendable. The early trials will be for very early degeneration, and not for collapsed discs. Feel free to check on this.
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So, which Doctor do you listen to?
One doctor has limited choice of discs to use and one doesn't.
One lives in your country and one doesn't.
Both are wonderful to talk to and very caring.
Sometimes it feels like you are trying to listen to whoever is the better
salesperson.

The M6 seems like it would handle the spine the way it should be...more like your natural disk. Ugh!!!

After you read this, which one would you pick for a lumbar disc?

[Jstuckey]

Thank you for sharing. I said the same thing when I hung up the phone with him - that's my surgeon! Bonus that he uses the disc I was most impressed with as well. I feel like I'm getting the best of everything (minus the insurance component).

Yes, he uses a barrier device for protecting the major blood vessels near the spine. If you haven't seen Tim's blog, here's a link to his pictures. (They are graphic). One of the pictures shows the barrier being placed.

Spinal Kinetics M6-L L5-S1 disc replacement surgery with Mr. Boeree - a set on Flickr (Hope that's OK to post!)

[Vicki_in_Florida]

I looked at the link...I loved that he even shows what dinner will look like.
I find myself thinking of them saying "looks lovely or looks brilliant"..LOL
Now, if they serve Yorkshire Pudding...I might just stay and never come home

[Jstuckey]

Let me know when you go. We will likely be there at the same time! I'll be staying from Sep 25th, surgery the 28th, and returning home Oct 19th. I'll come visit you if you like!

[Vicki_in_Florida]

I'm waiting for Jo to get me that quotes, etc...
They are about 4 weeks out so I will let you know
when I go. That would be awesome to see each other.
There is another member on here who also might be
choosing this path, waiting to see. Would be fun
to have 3 members of this forum there at the same time.
Lots of encouragement would be nice

Anyone who's been there have any suggestions as to where you stayed?
You can PM this info if you'd like.

[jss]

Vicki,

Thank you for sharing that information from both Dr's Boree and Zigler.

I assumed that Dr Zigler was still financially tied to Synthes; well, he is, but not in the way he was some years ago.

Thanks again and good luck, Jeff

[Jstuckey]

We are renting a house. (Homeaway.com or the towns of Winchester and Southampton also have tons of housing info on their tourism sites - both houses and bed/breakfasts.) If the short notice hampers those plans, lots of Boeree patients stay at the Holiday Inn in Eastleigh. (Staying in a hotel right after back surgery sounded like a nightmare to me.)
Looking forward to hearing more from you.

[Vicki_in_Florida]

I'm for renting as well.
I am one of those people who cannot sleep when there is noise.
I hate when people let their hotel doors slam shut at whatever hour.
Then you get the cleaning people who talk in the hallway in the morning.
I always bring clips with me to keep the blinds tightly closed too.
I have to sleep in a dark room. I just don't sleep good when there is a light on.
I think you are right and renting a house would be much better for resting and recouperating.

I will check out that website.

[Marti in Benicia]

Hello. I'm either the first or one of the first US patients for Nick Boeree and I can't say enough good stuff about him, his staff, and the hospital staff.

However, first I chose my disc type. In my opionion -- based on my extensive research -- a ProDisc is very much mechanically like putting a mini-hip proesthesis in the neck. Why would I do that when I could have the closest thing to a human spinal disc ever invented so far? I've heard the same opinion from two engineers about why they are opting for M6 over all other options.

I'm working on affecting policy change at the FDA to require them to accept devices with documented, successful track records in other trusted nations/unions without having to drudge thru the FDA's inappropriately inefficient approval processes. We have supportive ears in Congress, too, based on the feedback I received from many of the committee members I testified before in July. You want to help by adding your oice, let me know.

Marti in Benicia
Marti@CongerResources.com

[Jstuckey]

Originally Posted by Marti in Benicia

I'm working on affecting policy change at the FDA to require them to accept devices with documented, successful track records in other trusted nations/unions without having to drudge thru the FDA's inappropriately inefficient approval processes. We have supportive ears in Congress, too, based on the feedback I received from many of the committee members I testified before in July. You want to help by adding your oice, let me know.

Marti in Benicia
Marti@CongerResources.com

Always nice to hear positive comments right before surgery! Once I recouperate and find the energy to redirect elsewhere, I would love to add to your voice! Awesome!