[Artificial Disc Replacement / Lumbar] "A Grave Error" with Prodisc Implantation in Germany

[Keano16]

Job13, thanks for sharing great results and facts of your research, especially about surgeons relations with their own FBSS patients.

[Job13]

The Artificial Disc Replacement(ADR) was developed to overcome the shortcomings of older fusion technology, which is associated with ... adjacent segment syndrome. Also, any degenerative process will likely continue [ adjacent segment syndrom], therefore problems in other areas of the spine may appear at a later time.”

My research shows this statement is, as you say, a theory. I provide articles which are not all Pro ADR, and give the patient a chance to see other opinions. Dr. McAfee says there is no proof of the theory. Another article points out that the Prodisc actually increases stresses on other segments due to extra motions. So, fusion also puts more stress on other segments.
So, which method puts more stress on adjacent segments?
What is the rate of ASD in normal people who have DDD, vs those who have Fusion, vs. those who had a Prodisc, for example?

If that information is not available, then it is irresponsible, deceptive and cruel to give people the impression that Fusion is bad, Prodisc is good.

Thanks,
Anastasia

[Justin]

My research shows this statement is, as you say, a theory. I provide articles which are not all Pro ADR, and give the patient a chance to see other opinions. Dr. McAfee says there is no proof of the theory. Another article points out that the Prodisc actually increases stresses on other segments due to extra motions. So, fusion also puts more stress on other segments.
So, which method puts more stress on adjacent segments?
What is the rate of ASD in normal people who have DDD, vs those who have Fusion, vs. those who had a Prodisc, for example?

The data is still being complied as artificial disc replacement is a "young" field as opposed to fusions 50+ year history.

If that information is not available, then it is irresponsible, deceptive and cruel to give people the impression that Fusion is bad, Prodisc is good.

Thanks,
Anastasia

From my personal research over the last 15+ years, fusion is a great procedure in properly selected Spine Patients. Every new device tries to "one up" old devices & procedures. Unfortunately, that is the medical world as we know it. However, there have been many great strides with new devices in almost every speciality of medicine.

Also, all devices in medicine have some sort of financial relationship with the investigators to some degree (stents, pacemakers, etc.)

I wish you the very best and I hope you are making great strides.

[Hooch]

Yeah the jury is still well and truly out on the degree or even if present adr's reduce adjacent segment syndrome. But the truth is the process of spinal degeneration is not fully understood, or even poorly understood, and the variable surgical outcomes reflect this.

Here's an interesting one I came across a while back:

Charite at 10 years minimum, no case of spontaneous arthrodesis.

Clinical and Radiological Outcomes With the Charite(TM) Arti... : Journal of Spinal Disorders & Techniques

Charite at 17 year avg, 60% rate of spontaneous ankolysis. 17% had functional implants, but were significantly less satisfied than the autofused patients.

SpringerLink - European Spine Journal, Volume 15, Number 2

But of course none of this is going to matter if a hotshot surgeon shoves an oversized disc into a severely degenerated spine.

Hi Anastasia, good to see you back.

Chris.

[Job13]

I saw a very interesting post by 'runagain', but my reply would seem to be more appropriate here.
Lumbar L4/L5 ADR, Lumbar L5/S1 ADR/ALIF

On another topic, related to backs...
Had the opportunity to hear Dr. Larry Khoo speak. His speech was in part about scoliosis, fusion and minimally invasive back (lumbar surgery)...So of course, I asked him about ADRs....
As i understand it, he was a principal investigator for the Charite. I am slimming down his answer but he said that they were good for the right patient and that there were a lot of people with DDD but only a few comparably who qualified for ADRs.
And he spoke highly about them and then he said, but there is a caveat (remember, I am paraphrasing about what I remember) and that is that they come with an expiration.
I did not tell him I had an ADR. But he said, the warranty is up in 6-8 years (something pretty close to that, may have been 6-10)...

On the subject "the warranty is up in 6-8 years (something pretty close to that, may have been 6-10) "....
The 'warranty' of Charite is 6-8 year?... Very interesting. I went and looked for the Prodisc. It says, 'limited warranty and disclaimer. Synthes Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed"

So it seems that the warranty only applies for a doctor or hospital, until they implant it in you and if it breaks afterwords, the warranty does not apply... I bet, if you go to Germany to get it implanted, your even more unlikely to have a warranty. From my experience, even if you live in Germany and pay their taxes and have German Public Health insurance, you might not have the same advantages. I was forced to leave Germany because my surgeon denied any problem; The only German surgeons who could take the device out, were not allowed to operate on U.S. Citizens (sadly discrimination against U.S. Citizens, or any 3rd nationals who is not EU citizen, is legal in Germany); While disabled and spending the whole year in bed with my Prodisc I got fired from my job in Germany ... all the above forcing us to leave because I only had a work residence permit. Of course I am not eligible for any disability here in USA due to not having enough work months, as we spent the last 3.5 years in Germany...
Luckily, the fact that I was not indicated was proven later by formal letters from several surgeons from France, the UK, USA, and finally by the German government. Although the only "luck" here is that I can openly speak about it. We are still getting more surgeons to review my Pre-Op and Post-Op MRI's, so as to spread the word.

I have some small facts to add to the 'limited warranty" subject also. Of course I am in no way saying that ADRs will fall apart. The below data is simply something to think about. What is the real life-expectancy of one of these ADRs? I imagine, most of the times it might not be presented to a patient when proposed an ADR.

=========================================

Medical Community about longevity of ADRs.

Synthes' own web page states as a potential complication of Prodisc Surgery: "Wear debris (load-bearing implants that allow motion have been shown to potentially generate wear debris over time. Early and/or long-term effects of wear debris in the human spine are not yet known)." Synthes Prodisc: Patient FAQ 2

McAfee: "Well, I hope they will last 40 years. But "honestly, to talk to the patients, 10 years is (a) pretty good outcome." http://www.ethicalspinesurgeon.com/articles/WSJRosen.htm

"Dr. Kurtz, who has consulted for Medtronic and other medical-device makers, says many younger patients who are getting artificial disks may need a life-threatening operation to remove a worn disk in 10 years or less."

AANS: "Load-bearing implants that allow motion have been shown to potentially generate wear debris over time. The long-term effects of wear debris on the spine are currently unknown.” http://www.aans.org/en/Patient%20Information/Conditions%20and%20Treatments/Artificial%20Lumbar%20Disc.aspx

John H. Peloza (Prodisc II Design): “Even though the loading environment of the lumbar spine is less severe than the hip, no polyethylene has been able to stand the degree of wear that lumbar disc replacements will require in order to avoid revision surgery.”

John H. Peloza (Name: SB Charite III/LINK) “The polyethylene core is made of non-cross linked polyethylene and is only 3mm thick at the point of maximal stress concentration. This guarantees that the implant polyethylene will fail in a short time of cyclical loading.” http://www.centerforspinecare.com/approach/minimalinvasive/lowerback/realities.html

Wyoming Spine & Neurosurgery: Load-bearing implants that allow motion have been shown to potentially generate wear debris over time. The long-term effects of wear debris on the spine are currently unknown. http://www.wyospine.com/artificialdiscs.asp

=========================================

Of course one can always find more positive points of view also, like for example:

ProSpine web page ("Myth Buster" Section):
"M. The high-density, cross-linked polyethylene core of the ProDisc is just a piece of plastic, which will easily break or deteriorate.
R. High-density, cross-linked polyethylene has been in the human body for 40 years and is chemically inert. It is extremely durable."

=========================================

But, as far as my knowledge goes, The HMWPE has not been used as ADR's in the SPINE for 40 years. Human body [is not equal] Human spine....and Prodisc, for example, was approved only in 2006.

Synthes: “The ProDisc-L implant materials have historically been used in hip and knee replacements and have been used in spinal arthroplasty procedures for two decades”. Synthes ProDisc

So... what is the expected life?
=========================================

On the subject: who actually IS indicated?
runagain: "...they [ADRs] were good for the right patient and that there were a lot of people with DDD but only a few comparably who qualified for ADRs."

One German surgeon reported that "Today, after 6 years experience Disc Arthroplasty has replaced ~90% of my Fusion Procedures!"

Some time ago we found that according to PubMed report and FDA inclusion criteria,only a very small population of spine patients are indicated for ADR and can reasonably benefit from it without endangering their health and lives. That number was indicated as 5% to 7.7% by two different studies.
http://www.orthosupersite.com/view.aspx?rid=25668
"Disk replacement is appropriate during the narrow time window when degeneration is limited only to the disc and signs of instability or degeneration of the posterior elements have not yet appeared. Limited by this time window and the inclusion criteria dictated by the US Food and Drug Administration (FDA) for disk replacement, only 7.7% of patients admitted for lumbar spine fusion during the study period were found suitable for disk replacement. Similar figures have been reported by others.""

So, ultimately, is it possible that these devices are being put into people who are not indicated (ie, %90 - 7% = 83% ), and that the longevity may be somewhere between 10 to 40 years, that there is no warranty protection for patients, and there is no safe revision path?

[Job13]

.....
Here's an interesting one I came across a while back:
Charite at 10 years minimum, no case of spontaneous arthrodesis.
Clinical and Radiological Outcomes With the Charite(TM) Arti... : Journal of Spinal Disorders & Techniques

Charite at 17 year avg, 60% rate of spontaneous ankolysis. 17% had functional implants, but were significantly less satisfied than the autofused patients.
SpringerLink - European Spine Journal, Volume 15, Number 2
.....

Those links are very interesting Hooch. We indeed saw them some time ago and I recall thinking: "How many people have ADRs and because they are doing well, they dont do xrays any longer? They think that their ADR is functional, while the reason (at times) for their disappeared pain might be a spontaneous ankolysis and stopped motion altogether?" Anyways, those were my thoughts.

I posted some small research in the previous post on the longevity of ADRs. The point I want to make is: Any of us can go to med. device companies web pages that sell devices; Surgeons' web pages who use those devices; Web pages of medical travel services that make money by promoting certain devices or surgeons; Forums that might have a certain agendas - all those generally might give you a very good impressions or promises. We can read NASS publications (no mere human can attend the gatherings though, in my understanding) and read a "heart warming" assurances, I call it. Its not a secret that desperate people in severe pain, generally, want to hear good news and assuring results, and will believe anything. But, does any of us, regular patients, know whats going on behind those closed doors?

When I read some time ago Melissa’s Devis article for TheStreet.com “Hope Slips from Disc Implants”, describing Charles Rosen visit of North American Spine Society meeting, I was astounded: "HOW can patient get a truthful data then?!" (btw, I have no answer for that ) “He portrays the convention as "surreal," with participants banned from recording any sessions and literally escorted out if they tried. They didn't want any negative comments or press to come out of the meeting," Rosen says. "So there was no dissent at all. I felt like I had been transported to Communist Russia or something."

For example, I read it over and over again on posts that one of the reasons many people think ADR is more desirable is because their surgeons will tell them 'If it doesnt work, you can always revise. Fusion is forever'.If anyone only knew what revision or removal of an ADR entails... A couple months after my surgery, Dr. Regan published an article in which he wrote:..."The large central keel effectively precludes a lateral approach in the case of revision surgery..."
Revision Strategies Involving Lumbar Artificial Disc Replacement
(is that why I have 1/3 of my vertabra gone, and there is STILL a 2x normal space between the vertebrae?)

Another example: I have a friend who is trying to find a good surgeon in the area for taking her Prodiscs out... She called Synthes asking if they can refer her to a doctor with an experience of Prodisc revisions. They proposed her bunch of doctors' names who could put them IN... She clarified that she needs them OUT. They told her that they will call her back...(which they did btw).

One can always revise an ADR, right? ... Its the fusion that is forever.
Why is it so hard then to find anyone who would be willing to do a revision? ....Even a device making companies, at times, dont seem to have a good idea about revision options?!


My best to everyone