ADRSupport Community - M6 surgeons

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Someone may have more current info., but last I heard, about a year ago, Spinal Kenetics had decided not to seek FDA approval for use of the M-6 in the U.S. due to the cost and length of the approval process. Since they already have a strong oversees market they were just going to stay with marketing its use outside the U.S.?

JPJH

Hi Jen,

It's strangely comforting knowing that I'm not the only one going through all of this. To answer your questions, I had a general allergy test done several years ago and the results indicated that I am highly allergic to nickle (amongst a long list of other things, silver, gadolinium dye used for MRIs w/ contrast) which is in surgical steel. Some of my pain is caused by facet joints, damaged tissue, and nerves... this I know from physical examinations, MRIs, Xrays, and the fact that I've been living with two herniated discs since 2006 and had a failed C5-6 Discetomy and Foraminotomy in October 2011 :( I wish you the best of luck.

Sorry, for reasons I explained through the years, I believe the M6 is too complicated a design. I like the kinematics, moreso than most, but the number and complexity of materials give me some angst.

That said, many people have had this implanted in the last few years and most are doing well (but not all).

My bias is toward a design that requires minimal parts and simple design; with an attention to minimal surface areas which do not break over the long term or attract biofilm.

Since 2004, when I launched this site, has anyone here (or people reading), actually calculated the total surface area of an artificial disc implant? All the surfaces, including endplates and any exposed surfaces? Or when the protective sheath of the "next" generation disc fails, all the surface areas exposed to the immune system or infection? Similar disc designs have failed (including the M6) and had to explanted.

It is possible that the "next generation" of discs are over-engineered. That is only my opinion and concern. And it is one that bothers me and sometimes causes to me to lose sleep!

Speaking of that... :sleeping:

Quote:

Originally Posted by sully1 (Post 94456)

Hi Jen,

I'm baffled by why the M6 disc is not available in the United States as well, especially since it is manufactured in the state of California! The M6 is used practically everywhere except for the United States. I blame the FDA. I'm currently consulting with Dr. Ritter-Lang in Germany and Dr. Clavel in Barcelona. The M6 is most appealing to me for several reasons: 1) some of my pain is caused by facet joints, damaged soft tissue, and motion irritating nerves, 2) the M6 restricts some motion relieving pressure from these damaged areas, 3) I am not allergic to any of the materials used to make the M6, the few discs approved for use in the United States contain a lot of metals, specifically surgical steel, which contains nickle which I am allergic to. 4) I'm seeking multi-layer M6 ADR for C5/6 & C6/7 for it seems more promising than a double layer fusion for someone my age with DDD. 5) You can have a fusion after having ADR if the ADR is not successful, however, you cannot have ADR once fusion has been done. 6) Fusions are helpful for some and done all the time by the surgeons I mentioned above, however, it does not seem like the best option for me given my age, and the rate at which my discs are degenerating.

Sully, who did you finally go with; Ritter-Lang or Clavel....or neither? Thanks, Mike

That is an interesting argument against the M6 Harrison. I had never thought about the over design of the artificial disk. Sometimes simple is better. Thanks for the insight.

Quote:

Originally Posted by Harrison (Post 94473)

I thought somewhere I read that there have been no device failures to date for the M6, any failures were surgical error?