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#11
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M-6 in the U.S.
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
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11/13/10 M-6 ADR C 4/5 & 5/6. Dr. Pablo Clavel 01/15/2008 Evaluated via MRI UCSF Spine Center. Recommended sinlge level C 4/5 ADR with Pro Disc or fusion. 02/23/10 Evaluated via MRI UCSF Spine Center. Recommended two level C 4/5 & 5/6 ADR with Pro Disc or fusion. ADR denied by BC. Appealed, lost two appeals. Patient refused fusion. 2005-2008 Unknown cause of spinal stenosis at C 4/5. |
#12
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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.
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2006-Diagnosed DDD 2009- c5/6, c6/7 Herniation 2010- c5/6, c6/7 Disc Bulge 2011- Left c5/6 Discetomy & Foraminotomy 2012- MRI c5/6 Re-ruptured Current- Evaluating surgical options, 1 layer ADR or double layer fusion (here in the US) or double layer ADR in Germany. |
#13
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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...
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"Harrison" - info (at) adrsupport.org Fell on my ***winter 2003, Canceled fusion April 6 2004 Reborn June 25th, 2004, L5-S1 ADR Charite in Boston Founder & moderator of ADRSupport - 2004 Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006 Creator & producer, Why Am I Still Sick? - 2012 Donate www.arthropatient.org/about/donate |
#14
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#15
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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.
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#16
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Quote:
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*9/10: Unstable pelvis & SI joint, sore IT band. Chiro care, I would shift out hours to days after adjust *12/10: PT & chiro *4/11 to 11/11: 5 sessions prolo and 3 prolo w/ PRP *12/28/11 ESI L L4/L5 - 1/13/12 ESI R L4/L5 - 1/24/12 L SI joint capsule - 3/8/12 TPI - 3/23/12 L L5/S1 - 4/11/12 ESI caudal - 5/23/12 TPI - 7/10/12 Facet inj L3/L4, L4/L5, L5/S1 *9/12/12: 30 - DRX9000 *12/21/12 schedule. for L4/L5 fusion-CANCELLED 1/7/13 *7/16/2013: 3 level M6(S1-L3) w/ Dr. Bierstedt |
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