Charite Survivor

[Rocky D]

I have just now stumbled across this site.
I had the Charite implanted Jan 2005 and then it slipped out of place within 2 months, resulting in a failed attempt at revision by Dr. Spann (initial surgen) here in Austin Tx. After a few days in ICU ,when they could get me into a wheelchair, I flew to Baltimore MD. and Dr. McAfee and Dr. Saidy were able to go back in from the lower groin and up to the L4-L5, remove the Charite, place in the BAK fusion device and then flip me over to go in from my backside and insert rods.
To add insult, I incurred a torn rotator cuff and Brachial Neuritis in my right shoulder, severed Illiac vein in my left leg, requiring wearing compression hose, and permanent, shall I say, "romantic" dysfunction. All this liked to have killed me. I sure wish I had opted for fusion, it's a hard road but I am lucky and still able to hold a job. It's a struggle to get through the week and keep my pain hidden until I can get home, but I do.
Walking has been my salvation and rehabilitation.
I am wondering if there are any other Charite survivors on this site.
From reading other stories here, my heart goes out, I could just cry, I am not the only one traumatized, violated, and then just cast aside.
I am angry at the Charite people for what I am now discovering about their greed guided attempt to be the first to market, not doing the proper amount of research to optomize this ADR before marketing it to the public.
I haven't seen many Charite listings so I hope this means others are not being duped by them.

Thanks for listening, I feel a bit better.

[dshobbies]

Hi Rocky,

I'm so sorry for your circumstances but welcome to the forum. I know other Charite recipients who have done fine but some consider this an inferior product, you among them.

I really have no words of comfort, usually my specialty. Living in constant pain wears you down but instead of giving up, you use your job as a successful distraction which works for you. This can be an inspiration to others who find themselves also living in pain. Please keep posting your story to inspire others to find their 'life' when they feel like throwing in the towel.

Sharing horror stories can be cathartic too. Pain seems to separate us from the rest of the living. Listening to others who share similar fates makes us feel not so alone. Personally, I feel computers and the internet have depersonalized humanity but forums such as this, are a huge exception where it actually brings people together from around the globe. You have a lot to offer.

Dale

[Maria]

Welcome to the forum and sorry to hear what brought you here.

I'm a double discectomy old time spiney with failed back as my "regal diagnosis" as well as some other things that contribute to a generally degenerated spine! Failed back surgeries~ yep.. whatta pain!

I too have found walking to be my salvation altho it took me a long while to be able to feel good enough to really walk alot and then about a year ago or so I suffered something called "posterior tibial tendonitis" and plantar fascitis and man that stuff is nasty re foot pain and trying to recover from it ..

I thought it pretty much under control until my father recently went into the hospital since the 25th and I've been there 6 hours/day on my feet mostly which has ruined them again tho saved my back from torture as sitting too much is something the low back doesn't tolerate well tho better since the autofusion of L5S1 (just taking years and years and years to finally fuse on it's own).

Ok this has nothing to do with ADRS tho just sharing some of my own stuff. I was advised to have more spine surgery numerous times from 3 level global fusion to 2 level ADR to hybrid surgery with ADR and fusion and I have just been too too chicken to do anything else to date since my failed L4 percutaneous discectomy back in '92. You have no idea how often I had wished I never had that surgery done or that technique for the surgery tho hindsight is 20/20 like they say!

I hope you will be able to continue to progress w/o more surgical intervention and it does sound like the fusion has been helpful as you're able to walk and work (I haven't worked for nearly 10 years now).

Wishing you the best~ Maria

[Katie]

Hi Rocky,

Another welcome and condolences that you are in this mess.

May I ask though, why the disc is to blame and not the surgeons who did the work? This is a sincere question, not a snide remark. I think more Charite discs have been implanted than any other kind, because of the length of time it has been available. (I certainly could be wrong about this, but the numbers must be high) The device is only as good as the person putting it in.

Quite often patients are reluctant to put the blame on the surgeons as their lives are literally in their hands, and they don't want to tick them off We don't often have many options for back-ups.

Of course, this may have been the completely wrong disc for you, and that caused all your issues. I wish there were more choices in North America. The limitation really puts us in a bad spot at times, forcing us to take second best, when another appliance that is available in Germany for example, would be much better.

I am facing a similar situation. The M6 would be perfect for me, or at least as good as it gets. But it will not be approved in Canada for at least another two years, too long for me to wait.

I wish you well.

[Crystal33]

Concerns raised by Dr.Charles Rosen, Clinical Professor of Orthopaedic Surgery, University of California.

FREQUENTLY ASKED QUESTIONS:

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Charles Rosen, MD

[Jim M2]

His (Dr. Rosen's) two problems with the Charite, hardness and motion, are the same problems that any artifical disc or surgical fusion will have. I'm not a Charite proponent. I had one inserted in 2003. Even with perfect placement it is a failed surgery.

I agree with his conclusions that the Charite should be withdrawn from the market. I also don't doubt FDA corruption and incompetence that resulted in the flawed approval study and continues to keep data hidden.

[nomorepain]

whats unique about this site is that we are all able to tell our accounts
of our spinal situations, either good, bad or indifferent. The moderator lets us speak our truths ! We welcome you to this forum and may you find some comfort in knowing you are not all alone going through this.
I believe the account of your surgery is important to the others on this site, as it tells us that not all surgeries are a success, and there are risks involved.
Glad you shared with us your story!

[Rocky D]

Wow! I don't know what to say...
Dale , Maria , Katie , Crystal , Jim , Nomorepain , I really appreciate getting back online and reading all of your replies.
I felt good just writing about this thing, now I feel even better after reading all your kind and thought provoking replies.
Online therapy! Who would've guessed?
Thanks for the smile.

[mmglobal]

Rocky, I'm so sorry that you had a poor outcome. I have 2 Charite's that have worked well for more than 7 years now. If you look on the GPN website (linked in my sig file below), you'll see a vide of me playing tennis with the very first Charite' patient... done in east Berlin, 1984. There are some design issues with the Charite that have been improved upon over the years. However, I believe that the disc works well (when properly installed in a properly selected patient.)

The problem with the old Charite' is that with the highly mobile core, lack of a locking mechanism and the thin rim; in the presence of a significant structural issue, the failure mode can be catastrophic. Many of the other designs will have a less frightening failure mode when things like subsidence or migration of the plates occurs.

Most of the problems I see with the Charite' are related to poor implant sizing, improper location and other surgical mistakes. Sadly, with spine surgery, even when everything is done perfectly, significant failures still occur. Even though the catastropic expulsion of the core, breaking of the rim and wire and other Charite' specific problems are not likely or not possible with other prosthesis, horrible outcomes with other devices (and fusions) occur at rates similar to the Charite'. Sadly, many of the problems might have been avoided with more experienced or careful surgeons.

I know that none of this helps you at all. For you the failure rate is 100%. My heart goes out to you. I hope you can find some relief.

Mark

[Crystal33]

Regarding playing tennis, of interest I recently read there are four top professionals playing who have suffered herniated spinal discs, but chose no surgery whatsoever. Tsonga is the most high profiled of them. I never would have thought it possible to return to such high level of intensity. Are there any pro tennis players with lumbar ADR's?

[Crystal33]

I'm wondering if this report on Charité III disc replacements is bad as it sounds, or am i misinterpreting something?

Survival and clinical outcome of SB Charite III disc replacement for back pain -- Ross et al. 89-B (6): 785 -- Journal of Bone and Joint Surgery - British Volume

Journal of Bone and Joint Surgery - British Volume, Vol 89-B, Issue 6, 785-789.

Copyright © 2007 by British Editorial Society of Bone and Joint Surgery

Survival and clinical outcome of SB Charité III disc replacement for back pain

R. Ross, MBChB, FRCS(Ed), FRACS, Spinal Surgeon1; A. H. Mirza, MBChB, MRCS(Ed), Spinal Fellow1; H. E. Norris, BA(Hons), RGN, Research Nurse1; and M. Khatri, MS(Orth), FRCS(Tr & Orth), Consultant Spinal & Orthopaedic Surgeon1

1 Salford Royal NHS Foundation Trust, Eccles Old Road, Salford, Manchester M6 8HD, UK.

Correspondence should be sent to Mr R. Ross; e-mail: ersross@hotmail.co.uk

Between January 1990 and December 2000 we carried out 226 SB Charité III disc replacements for lumbar disc degeneration in 160 patients. They were reviewed at a mean follow-up of 79 months (31 to 161) to determine the clinical and radiological outcome. The clinical results were collected by an independent observer, who was not involved in patient selection, treatment or follow-up, using a combination of outcome measures, including the Oswestry Disability Index. Pain was recorded using a visual analogue score, and the most recent radiographs were reviewed.

Survival of the device was analysed by the Kaplan-Meier method and showed a cumulative survival of 35% at 156 months when radiological failure was taken as the endpoint. The mean improvement in the Oswestry disability index scores after disc replacement was 14% (6% to 21%) and the mean improvement in the pain score was 1.6 (0.46 to 2.73), both falling below the clinically significant threshold. Removal of the implant was required in 12 patients, four because of implant failure.

These poor results indicate that further use of this implant is not justified.