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Artificial Disc ProDisc. R. Bertagnoli. ProSpine Germany
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Findings Regarding Lumbar Artificial Disc "ProDisc-L" Implantation In Germany with Dr.Bertagnoli
A GRAVE ERROR IN TREATMENT Two years later, through a German investigation from TKK, an independent MDK medical doctor presented to us a report stating that the spine surgery that occurred in Straubing with Dr. Bertagnoli was a Grave Error on multiple factors and (translation) "for completely incomprehensible, medically not understandable reasons, it has been contravened grossly against the indication criteria for implantation of spinal disk protheses". This report collaborated with at least a dozen other written statements from top ADR surgeons all over the world. |
Straubing Germany. ProSpine. Dr. Rudolf Bertagnoli.
By referral from "YESS" (Spine Clinic in Phoenix, June 2005), through research and through reading certain adr forums, we heard about the spine surgeon Rudolf Bertagnoli in Germany Straubing.
Dr. B. was claiming over 98% success rate in his Prodisc-L artificial disc surgeries.
He was advertised as one of the best world-wide on two spine forums.
He seemed to be an academic and researcher which meant for us: not "there" for money.
He was an investigator of Spine
In May 2006, we met Dr. Bertagnoli in his Straubing office. Later, we were told that it was a miracle that we even got an appointment with him: "He is a very busy man." We felt that we were very lucky. But it was also a red flag for us as we already encountered one "very busy man" at Alpha Klinic: Through that business, I ended up not seeing the AK surgeon even after 4 painful visits with appointments, and ended up with an undisclosed and undiscussed surgery done on my healthy knee. The knee is destroyed for life... Alpha Klinik went into insolvency after 25 German citizens sued Dr.Dekkers in spine department apparently for alleged not indicated back surgeries. Main doctors were investigated for embezzlement (german newspapers). As we learned later, Dr. Bertagnoli joined Alpha Klinik, Dr. Dekkers department in October 2006.
In May 2006, Based on MRI and Xray images from December 2005 (less than 6 months old, from the AK), Dr. Bertagnoli found me a perfect candidate for ProDisc-L,: young, healthy, only one disc bad with all the rest of my spine in nearly perfect shape. The surgery was scheduled for October 2006.
From May to October, my back had gradually gotten better. I was totally off pain meds. I could limp on my destroyed knee at least 1km. I could sit longer. We didn't know why I had such a drastic change. I wanted to postpone the artificial disc replacement. We communicated the changes in my pain or rather almost no pain to ProSpine and we hoped to talk with Dr. Bertagnoli about my new conditions. But ...he was very busy...We were promised in email that the day before the surgery, I will be able to talk with my surgeon. In the appointed day, the day before the surgery, he was not there. He was in Munich (an announcement was made by the AK that he had joined Dr. Dekkers
I had a new MRI the same morning but we didnt get to see it...If we have seen it, we would have ran out of the hospital praising Lord and knowing the answer for my low level pain and slow self recovery. The new MRI shows my prolapse has disappeared! I was bone on bone...self fusing.
Dr.Bertagnoli was not in the town, so he couldnt have seen it either. On the phone, he assured me I was a good candidate....without seeing the latest MRI. As it turned out: I was.not. Not by any measure!
After my ProDisc surgery, I was bed ridden and disabled (23/24 hours in bed) without any help from my surgeon. He is the ONLY doctor I have ever met who has never answered an email from one of his patients.
We gathered numerous written reports from doctors saying that:
- My device was 1.5-1.7x higher than my normal biological disk
- That at this level it was locked in extreme hyper-extension and device was hardly moving (extreme pelvic tilt), crushing my facet joints like a watermelon (leakage of toxic liquid out of facets seen on one of my MRIs).
- The
cause of segmental hyperlordosis were my facets that had END STAGE
ARTHROSIS and were nearly FUSED BEFORE ADR! Facet Arthrosis is an absolute contraindication for ADR.
- Two previous surgeries were a contraindication as well, due to the scar tissue.
- According to Synthes' own web page, less than 5mm of natural disc height left is a contraindication to ADR. I was bone on bone.
- Xrays from the day-before the operation
showed that my prolapse, that persisted for over a year, was totally
self absorbed and the level was basically fused! That would explain
why months before the op I started feeling so much better: the disc had collapsed and by self fusion it was self stabilizing.
I can accept a mistake...Everyone does it at one point of time or another. We are all humans. BUT to leave the patient with no help for a year in bed, to conveniently "lose" her films, to deny that there IS a problem, to cover up and treat her as a legal case?...
Ask yourself "WHY"?
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PRODISC CENTER OF ROTATION
Red: Prodisc Rotation arc
Furthermore, the Prodisc
translates A/P 1mm for every 3° of rotation. Thus, for a total possible 20°,
we see 6.6mm shear added to the already double arc. A natural disc has 15° AP arc. As well, the Prodisc allows 20° lateral rotation, compared to 10° natural. And, the Prodisc is totally unconstrained in 360° Axial rotation, compared to 6° in natural discs! ALL forces are only restricted by the Facet joints!.
Many reports in the literature specify facet arthrosis as a leading cause of
revision in disc arthroplasty [2,3,4]. There have been reports of 32% increase
in progression of facet arthrosis post-Prodisc [4] ...
Before 2005: A happy couple ... Adventurous ... studious, ..hard working ...A bright future ahead...
I had never before suffered from back pain.
In fact, I didn't know what pain really meant...
I was sooo lucky.
2.) Post Prodisc ... left to die in pain"
After 3 months post op of unbearable pain, for weeks, we were trying to get a 3 month post op review with my surgeon, begging for a meeting. My husband was posting on forums how impossible it was to get an appointment. Finally, ProSpine granted me the review but ...we were treated as a legal case, with 2 witnesses... All I wanted was to understand why I was in pain!
Was it the case that "best defense is to go on offense first"?
I was told that there is no problem, that I gained a VERY natural disk space, that device is moving well (although it was VERY clear that it was not moving at all ) and I was told that perhaps, I am just a chronic back pain patient... I reminded my doctor that I did not take any pain medications for 6 months prior to the surgery and that the pain I was experiencing happened after ADR. I also reminded him on the meeting that I was asking to postpone the surgery due to my changed pain pattern. He agreed that he remembered but only said "It doesn't matter".
At the same 3-months-post-op meeting, ProSpine asked to borrow my Xrays and MRI's (promising twice to not lose them) and after 8 months of asking them to return those, they told us that they dont know where they are! Hmmm. They never did return those films to me, even though, my life depended on them!
What were they trying to hide?
Six months post op, when things really started to go down, my husband started to analyze my Xrays before and after, writing endless emails to doctors asking to look at my images... To make it short, we were forced to go doctor-shopping, as ProSpine was completely ignoring all our pleadings for a ‘6-months’ meeting.. which, eventually, we did receive, after dozen of emails and phone calls pleading to see us. The only reason that we got that meeting, I believe, was because of my husband's perseverance. This meeting though, was with Dr. Fenk Mayer (my surgeon assistant) and not with the operating surgeon Bertagnoli.
Dr. Fenk Mayer said that after ‘thorough review’ Dr.B could find no problems, and that I needed to seek a pain management specialist. My husband asked if this is what I have to accept now, life in bed, for 50 years on heavy narcotics? The answer was "Yes".
She promised to congratulate us if we have the revision done and it will help, with a beaming smile.
I spent ALL my days in bed, for 12 months, couldnt sit for more than 3-5 min, stand, sleep...As soon as I got out of the bed, for 5-7 min tea break, my pain would escalate and was reaching at least 8 out of 10 pain in minutes. I was told by many surgeons (not Dr.B) that it is most likely due to an abnormal pelvic tilt and impinged Neuroforamina (nerve root side exits). I was literally rotting in my bed. I was told by several ADR specialists that I needed a fusion but...almost no one had an experience in 2007 in taking a ProDisk out, especially at L4/L5 level. A Prodisc revision is considered to be life threatening in every case.
I didnt mind to die at that point-it was my escape from the non ending agony, loneliness and despair.
We had been sending emails to ProSpine and directly to my surgeon for entire summer, asking either for a short appointment, or phone call, or email to talk with us about the problems found by other surgeons, and specifically about the revision strategy in my case. Just a few sentences...just a 5-10 min call... Silence. They completely denied there was a problem. WHY???
Many of doctors were clearly disturbed seeing
my facets before the surgery. They were in disbelief that I received ProDisc
with such badly degenerated facets. Many of them asked "Who did it?!"
and again, were very surprised to learn that it was the doctor who has taught 3000+ others and says over and over in his papers
to be sure to check the facets – Arthrosis is an exclusion!
At least dozen of written reports and emails from top ADR surgeons (available for proof) stated that I was not a candidate for Prodisc and why. They recommended a revision...BUT, no one knew how to revise it.
At least dozen of written reports and emails from top ADR surgeons (available for proof) stated that I was not a candidate for Prodisc and why. They recommended a revision...BUT, no one knew how to revise it.
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3.) What We Found Later...
BEFORE the surgery, we had an impression that Dr.B is a high level researcher who has a primary interest in finding the best solutions for people.
AFTER, we learned that there were big money involved all around ProDisc and that Dr.B was a co-inventor on several of the ProDisc related Patents, which were assigned to Spine-Solutions. This company was sold to Synthes for $350 Million. The acquisition price includes a $175 million payment at closing and an additional $175 million paid on the FDA approval. Spine-Solutions needed to get ProDisc approved by the FDA to get its extra $175 million. Spine Solutions, Inc. was founded in 1999 by Viscogliosi Bros., LLC and Aesculap AG & co KG. The Company was founded on the goal of commercialization of the ProDisc Lumbar, and eventually the Cervical Disc technologies. Big money on the table.
BEFORE the surgery we thought that money were not a factor that could be played in my surgeon's decisions or statistics.
AFTER, we learned that he was a consultant and a board member of Synthes. We learned that Dr.Bertagnoli was primary ProDisc Instructor for Synthes. According to Synthes page, student doctors can "scrub in" and even participate during the surgery: "One to two surgeries will be performed during the course. You can view the procedure via live transmission with excellent endoscopic imaging. Alternatively, participants will be invited to scrub in and assist the operating surgeon."
The disturbing coincidence: Dr.B number of training sessions were quoted as over 3000. The number of device implantations were also quoted as over 3000.
BEFORE the surgery we read that Dr.B is very critical in his patient selection process, thereby maintaining a perfect record of 94%-98.2% success.
AFTER, we learned that his success rates neither corroborated by his peers nor the FDA. The FDA trials found that only 53.4% of ProDisc ADR patients passed all criteria to be called a successful outcome, which included a very low reduction in pain levels of only 15%. Dr.Bertagnoli data was openly questioned by his own German colleagues, like Dr. Mayer.
Dr. Mayer: " Dr. Bertagnoli and Kumar have described 98.2% good and excellent results with only 1 complication in 108 patients with different indications for TDR. However, the authors [Dr.Bertagnoli and Kumar] did not provide scientific evidence for their conclusion on so-called prime, good, borderline or poor indications for TDR, nor did they describe a statistical basis on how poor indications were evaluated when almost all patients treated showed excellent results.” "In a recent report, the same author [Dr.Bertagnoli] published a similarly high success rate of 92% to 96% for multisegmental TDR and also described 4- and 5-level TDR procedures previously. However, carefully selected other studies as well as prospective randomized control trials could not confirm such high success rates, even for highly selected monosegmental cases.” FDA-supervised investigational protocol studies as well as carefully selected other studies could not confirm such high success rates.
AFTER, it turned out that the anterior revision of ProDisc at L4/5 is potentially lethal, due to the scarring of vascularity over the device and nearly impossible without incurring permanent damages. Some literature states that it is life threatening in EVERY case. Neither Synthes page nor the consultant for it, i.e. my surgeon, ever mentioned about it.
BEFORE we thought that Disc Replacement with the Prodisc-L device is safe and significantly better than Fusion on all counts.
AFTER, the controversial reports started to come out. Melissa Davis, a Senior Writer for TheStreet.com reported that Dr.C Rosen, founding director of the University of California Spine Center, officially asked the FDA to withdraw the discs from the market. He was saying that the Charite disc, for example, had been tested against a failed fusion operation.
To test an ADR procedure against an old and failed fusion technique and then tell the public that the new procedure is not worse that the old one?! On the top of that, all medical conclusions, conference proceedings and other vital data were kept secret and private only for the elite of surgeons who were members of NASS. A mere human didn’t have any access to anything and couldn’t possibly make an informed decision except to rely on the advice of doctors…Doctors, who were financially involved in their own trials and who would monetarily benefit from showing that ADR is a safe device.
In Melissa’s Devis article for TheStreet.com “Hope Slips from Disc Implants”, Charles Rosen attended North American Spine Society meeting. “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."
UBS analyst Wales, portray the prospects for artificial discs, particularly for Synthes' ProDisc, “less than encouraging after attending the same conference. He noted that one study recommended against using the ProDisc for patients over 60 and that another showed no advantages over fusion surgery, even in range of motion.”
Dr. Andre van Ooij reports were even more sobering. If there was a problem with ADR and it had to be revised, the patient had two choices: leaving it in and fusing the posterior elements or taking it out and adding a posterior instrumentation. Leaving the device in, according to his reports on 75 revisions resulted in 6.3 out of 10 pain level, while taking it out produced 5.6 out 10 pain level. In other words-a debilitating pain for the rest of the life was guaranteed. No escape, no cure, nothing else could be done.
The article by Robin R. Young was about Spine Arthroplasty Society’s first meeting that was held in 2000 in Munich, Germany. Dr.Bertagnoli name was among few founders of the SAS. The article was showing that 500,000 spine fusions were performed in the United States in one year and it generated $3.0 billion in revenue formanufacturers .
60%-70% of people with successful fusions were worth $3.0 billion.
90%-95% success with ADRs was anticipated to be worth $20 billion-$25 billion. Dr.Bertagnoli was claiming up to 98% success with no bad outcomes. What do YOU think about it?
Dr.Bertagnoli was given a presentation in front of venture capitalists and he himself was saying: “Disc Arthroplasty changed my practice completely. Today, after six years experience, Disc Arthroplasty has replaced ~90% of my fusion procedures.”
NINETY percent. 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. It was said that 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. That number was indicated as 5% to 7.7%.
If a doctor replaces 90% of his/her fusion patients with ADR, while only 5-7.7% are indicated, it means that roughly 83% of people are subjected to a severe suffering and potentially needing a life threatening revision that will likely leave them in 6.7 out of 10 level of pain for the rest of their lives. If other doctors will start integrating the same policy, the policy that will bring them financial freedom, it is easy to calculate: 500 000 fusions per year; 7% of those are indicated for ADR but 90% will receive one. It gives us 415 000 people per year that were not indicated for ADR: home bound, bedridden, incapacitated, unable to care for themselves, in severe pain and likely not getting any help from the surgeon who implanted the disc...
415 000 people per one year: forgotten suicidal people in agonizing pain with no hope. But none of it matters for the device makers, for the doctors who decide to affiliate themselves with the above for the sake of a ‘golden calf’, and for organizations that allow those devices to pass into the free market and be implanted into innocent unaware people.
Should we start calling it “medical holocaust”?
It was devastating to read. Even though, those articles were written in NY Times and Street. Com News, common people still had to know what exactly they were searching for, in order to find them.
We, patients, accustomed to the old school, where you go to your doctor and he will find the best solution for you.
So many times we heard the phrase on spine forums: “trust your doctor”.
AFTER, we learned that there were big money involved all around ProDisc and that Dr.B was a co-inventor on several of the ProDisc related Patents, which were assigned to Spine-Solutions. This company was sold to Synthes for $350 Million. The acquisition price includes a $175 million payment at closing and an additional $175 million paid on the FDA approval. Spine-Solutions needed to get ProDisc approved by the FDA to get its extra $175 million. Spine Solutions, Inc. was founded in 1999 by Viscogliosi Bros., LLC and Aesculap AG & co KG. The Company was founded on the goal of commercialization of the ProDisc Lumbar, and eventually the Cervical Disc technologies. Big money on the table.
BEFORE the surgery we thought that money were not a factor that could be played in my surgeon's decisions or statistics.
AFTER, we learned that he was a consultant and a board member of Synthes. We learned that Dr.Bertagnoli was primary ProDisc Instructor for Synthes. According to Synthes page, student doctors can "scrub in" and even participate during the surgery: "One to two surgeries will be performed during the course. You can view the procedure via live transmission with excellent endoscopic imaging. Alternatively, participants will be invited to scrub in and assist the operating surgeon."
The disturbing coincidence: Dr.B number of training sessions were quoted as over 3000. The number of device implantations were also quoted as over 3000.
Were patients used as a life exhibit? If yes, were they informed and asked their consent?
Was I used for training too & was it the reason that my surgeon didn't want to postpone the surgery?
Was I used for training too & was it the reason that my surgeon didn't want to postpone the surgery?
BEFORE the surgery we read that Dr.B is very critical in his patient selection process, thereby maintaining a perfect record of 94%-98.2% success.
AFTER, we learned that his success rates neither corroborated by his peers nor the FDA. The FDA trials found that only 53.4% of ProDisc ADR patients passed all criteria to be called a successful outcome, which included a very low reduction in pain levels of only 15%. Dr.Bertagnoli data was openly questioned by his own German colleagues, like Dr. Mayer.
Dr. Mayer: " Dr. Bertagnoli and Kumar have described 98.2% good and excellent results with only 1 complication in 108 patients with different indications for TDR. However, the authors [Dr.Bertagnoli and Kumar] did not provide scientific evidence for their conclusion on so-called prime, good, borderline or poor indications for TDR, nor did they describe a statistical basis on how poor indications were evaluated when almost all patients treated showed excellent results.” "In a recent report, the same author [Dr.Bertagnoli] published a similarly high success rate of 92% to 96% for multisegmental TDR and also described 4- and 5-level TDR procedures previously. However, carefully selected other studies as well as prospective randomized control trials could not confirm such high success rates, even for highly selected monosegmental cases.” FDA-supervised investigational protocol studies as well as carefully selected other studies could not confirm such high success rates.
If
it was true that I was the only one with such a devastating outcome -
why would he ignore my outcome and refuse to help? As an academic who
cared deeply for people, wouldn’t he want to find the source of the
failure so that it will not be repeated with someone else in the
future?
Why did he want to cover up a failure? The truth is - I am not the only bad outcome as I learned later.
BEFORE the surgery, Dr. Fenk Meyer at ProSpine told us that if a plastic
core wares out, it would be easy to replace it. Why did he want to cover up a failure? The truth is - I am not the only bad outcome as I learned later.
AFTER, it turned out that the anterior revision of ProDisc at L4/5 is potentially lethal, due to the scarring of vascularity over the device and nearly impossible without incurring permanent damages. Some literature states that it is life threatening in EVERY case. Neither Synthes page nor the consultant for it, i.e. my surgeon, ever mentioned about it.
BEFORE we thought that Disc Replacement with the Prodisc-L device is safe and significantly better than Fusion on all counts.
AFTER, the controversial reports started to come out. Melissa Davis, a Senior Writer for TheStreet.com reported that Dr.C Rosen, founding director of the University of California Spine Center, officially asked the FDA to withdraw the discs from the market. He was saying that the Charite disc, for example, had been tested against a failed fusion operation.
To test an ADR procedure against an old and failed fusion technique and then tell the public that the new procedure is not worse that the old one?! On the top of that, all medical conclusions, conference proceedings and other vital data were kept secret and private only for the elite of surgeons who were members of NASS. A mere human didn’t have any access to anything and couldn’t possibly make an informed decision except to rely on the advice of doctors…Doctors, who were financially involved in their own trials and who would monetarily benefit from showing that ADR is a safe device.
In Melissa’s Devis article for TheStreet.com “Hope Slips from Disc Implants”, Charles Rosen attended North American Spine Society meeting. “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."
UBS analyst Wales, portray the prospects for artificial discs, particularly for Synthes' ProDisc, “less than encouraging after attending the same conference. He noted that one study recommended against using the ProDisc for patients over 60 and that another showed no advantages over fusion surgery, even in range of motion.”
Dr. Andre van Ooij reports were even more sobering. If there was a problem with ADR and it had to be revised, the patient had two choices: leaving it in and fusing the posterior elements or taking it out and adding a posterior instrumentation. Leaving the device in, according to his reports on 75 revisions resulted in 6.3 out of 10 pain level, while taking it out produced 5.6 out 10 pain level. In other words-a debilitating pain for the rest of the life was guaranteed. No escape, no cure, nothing else could be done.
The article by Robin R. Young was about Spine Arthroplasty Society’s first meeting that was held in 2000 in Munich, Germany. Dr.Bertagnoli name was among few founders of the SAS. The article was showing that 500,000 spine fusions were performed in the United States in one year and it generated $3.0 billion in revenue for
60%-70% of people with successful fusions were worth $3.0 billion.
90%-95% success with ADRs was anticipated to be worth $20 billion-$25 billion. Dr.Bertagnoli was claiming up to 98% success with no bad outcomes. What do YOU think about it?
Was it the case that bad outcomes like me had to be either get rid of or
ignored in order to show such a great success rate? After all, $25
billion were on the table of the ADR industry...
How many people like me are out there, lying in debilitating pain with no answers?
"Back surgery is a multibillion-dollar market, so all of these
companies are throwing their hats in the ring," Dr.Rosen was saying.How many people like me are out there, lying in debilitating pain with no answers?
Dr.Bertagnoli was given a presentation in front of venture capitalists and he himself was saying: “Disc Arthroplasty changed my practice completely. Today, after six years experience, Disc Arthroplasty has replaced ~90% of my fusion procedures.”
NINETY percent. 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. It was said that 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. That number was indicated as 5% to 7.7%.
If a doctor replaces 90% of his/her fusion patients with ADR, while only 5-7.7% are indicated, it means that roughly 83% of people are subjected to a severe suffering and potentially needing a life threatening revision that will likely leave them in 6.7 out of 10 level of pain for the rest of their lives. If other doctors will start integrating the same policy, the policy that will bring them financial freedom, it is easy to calculate: 500 000 fusions per year; 7% of those are indicated for ADR but 90% will receive one. It gives us 415 000 people per year that were not indicated for ADR: home bound, bedridden, incapacitated, unable to care for themselves, in severe pain and likely not getting any help from the surgeon who implanted the disc...
415 000 people per one year: forgotten suicidal people in agonizing pain with no hope. But none of it matters for the device makers, for the doctors who decide to affiliate themselves with the above for the sake of a ‘golden calf’, and for organizations that allow those devices to pass into the free market and be implanted into innocent unaware people.
Should we start calling it “medical holocaust”?
It was devastating to read. Even though, those articles were written in NY Times and Street. Com News, common people still had to know what exactly they were searching for, in order to find them.
We, patients, accustomed to the old school, where you go to your doctor and he will find the best solution for you.
So many times we heard the phrase on spine forums: “trust your doctor”.
After learning what is going on in the medical industry: can YOU trust your doctor?
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MYTH BUSTER ?
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I. ProSpine web page ('Myth Buster' section):
Myth. Facet arthrosis or facet hypertrophy is a contraindication for ADR surgery.
Reality. Only severe and untreated facet arthrosis or facet hypertrophy is a contraindication for ADR surgery..."
The following list is a fraction of various authoritative sources specifying the inclusion/exclusion criteria for ADR with the Synthes Spine Inc. PRODISC®. In particular, every reference states specifically that facet joint disease (degeneration, arthrosis, arthropathy, osteophytes) is a contraindication. The reasoning is patently clear: If the facet joints are arthritic (and a pain generator), then expanding the disc space and increasing mobility will significantly exacerbate the pain condition, and furthermore accelerate the facet degeneration. Furthermore, the Synthes labeling states that the remaining disc height should be 5mm or more. This prevents over-distraction damage to the nerve root, and also provides a margin of safety that there is not already significant facet Arthrosis due to a collapsed level.
MEDICAL COMMUNITY FINDINGS on contraindications
- Synthes Spine: ”Radiographic confirmation of facet joint disease or degeneration.” (note Dr.B is the main instructor for Synthes)
- Rudolf Bertagnoli: ”Care should be used to assess patients for the presence of facet arthropathy,”
- Rudolf Bertagnoli 2006, ”Patients should be screened carefully for evidence of facet joint impingement/degeneration”
- Rudolf Bertagnoli 2005, severe nondiscal central or severe lateral spinal canal stenosis associated with hypertrophic posterior facet joints,
- Synthes Spine Surgical Technique: “Radiological confirmation of severe facet joint disease or degeneration”
- FDA: ”Radiographic confirmation of facet joint disease or degeneration.”
- Dr. Shedid: Patients with any of the following conditions should not undergo placement of this disc: infection; …; facet joint disease;
- Spine-Health.com ”clinically significant degenerative facet disease”
- Spine Universe: Prodisc Clinical Trials: Radiographic confirmation of facet joint disease or degeneration.
- Dr. Kulkarni et.al: ”Facet arthropathy has been appreciated as a major contraindication”
- Dr. Delamarter et.al.: ”severe facet degeneration were excluded from the study”
- Dr.Zigler et.al: ”The authors identify factors leading to clinical failure, including posterior facet arthritis”
- Dr.Tropiano et.al: ”Exclusion criteria included facet Arthrosis”
- David Wong et.al: #1: Facet Joint Athritis
- Dr. David Thierry: ”emphasized the importance of normal facet architecture.”
- Spine-Health.com: Facet Technologies, Facet arthritis is currently a contraindication for any type of disc replacement.
- Dr. Matthew Scott-Young: ”This is a failure of indication, in which the facet arthropathy is overlooked by the surgeon.”
- Dave Levitan: OrthoSuperSite, Interview Dr. Bertagnoli: “We know that 98% of complications are surgeon-related,” he said. “What were the reasons for these problems? No. 1 was the wrong indication. As pointed out before, indication and proper patient selection is really crucial.”
- Le Huec J.C.:”This improvement is significantly [negatively] correlated with facet arthrosis and muscle fatty degeneration.”
- M.E. Jansen: “pathology of the posterior elements. In such cases, fusion is still the first choice for treatment,”
- Balkan Cakir et al: “The inclusion criteria … absence of facet joint arthrosis confirmed by CT, no pain relief after facet joint infiltration,”
- Christoph Siepe, Michael Mayer et al: “strict policy to before surgery rule out symptomatic facet joint involvement”
- John Regan: “Posterior facets should be carefully evaluated on physical exam and on the imaging studies such as MRI and CT scans. If posterior facet disease is suspected, diagnostic injection may be used to rule out this condition as the contributing source of pain as these patients do not benefit from total disc replacement.”
- Hochschuler, McAfee: “If .. factors (such as significant degenerative changes in the facet joint) are present, then the patient may have to undergo a revision surgery after the initial surgery
- Zucherman et. al.: “radiographically documented evidence of facet joint disease”
- Weishaupt ’99:. “fortgeschrittene Facettendegenerationen II.-III. Grades“
| II. ProSpine web page ('Myth Buster' section): "Myth. ADR surgery causes facet degeneration. Reality. If the ADR is improperly placed this is true...There is one study claiming that ADR surgery leads to facet pain, but the study makes no judgment about the placement of the ADRs, hence it comes to a false conclusion. Moreover, one study is not scientific consensus." |
The 'Myths' web page criticizes some study, while Dr.B's own study is criticized by his German his peers (Dr. Mayer/Siepe) where they say "[Dr. B] described 98.2% good and excellent results”without "providing scientific evidence for their conclusion on so-called prime, good, borderline or poor indications for TDR, nor did they describe a statistical basis on how poor indications were evaluated when almost all patients treated showed excellent results.”
MEDICAL COMMUNITY FINDINGS on Facet Degeneration and ADR
ADR surgery doesnt cause facet degeneration. The ADR does, according to the literature:
According to Van Ooij (
According to Spine Center, OrthoCenter Munich, Germany (Christoph J. Siepe, MD; H Michael Mayer et.al): Fluoroscopically guided spine infiltrations confirmed that the incidence of postoperative pain from posterior joint structures was 9.1% (n = 2) for L4-L5 TDR, 28.1% (n = 16) following L5-S1, and 60.0% (n = 12) for bisegmental-TDR at L4-L5 + L5-S1, respectively.
According to Results from 5 year follow up (R.A. Kube et.al) ”Degeneration of lumbar discs and facets after disc arthroplasty”: CT/MRI saw 8/10 facet degeneration at the operative level. Improvement in 2/10 adjacent discs.
According to spine-helath.com: “There have been some reports that patients who have had artificial disc replacement surgery have accelerated posterior facet joint degeneration, and this is felt to be due to the abnormal motion provided by the artificial disc”.
According to Liu et al, “Effect of the Increase in the Height of Lumbar Disc Space on Facet Joint Articulation Area in Sagittal Plane” “The inappropriate increase of the height of disc space will result in facet joint subluxation.”
A comparative study of a minimum 3-year follow-up: Degradation of the facets was seen in 36.4% of the CHARITE and 32% of the ProDisc: CHARITÉ versus prodisc : A comparative study of a minimum 3-year follow-up “Conclusions. While clinical outcomes of both CHARITE and ProDisc groups were fairly good, the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of patients, regardless of the device used, raising concerns of possible late consequences of total disc replacement, especially regarding facet arthrosis and adjacent segment disease.
Does it sound like just one study to you?
Moreover, take a look at the Prodisc specifications (oh, you cant - because they are confidential?). Well, for example, the normal human body restricts forces on the facets by the natural resistance of the disc. The Prodisc is totally unconstrained in axial rotation - with nearly zero resistance (twisting). Besides ligaments/muscles, the only thing constraining it are the facets.
Also note, the Prodisc rotates on a ball, with the center of the ball somewhere in the lower vertebra. Obviously, the natural disc does not rotate thus, but rather somewhere near the posterior of the disc. With a center of rotation close to the facets, the arc of movement at the facets is very small. That is, if you bend forward 10 degrees, the arc of motion at the facets is proportional to the radius of distance from the center of motion. Even a tiny change in rotations puts a severe stress on facets - which have about 1/10 mm aligned faces which constantly glide (or grind) against each other.
The Prodisc, however, forces the center of rotation into the center of the ball, which is thus in the lower vertebra (unless it is put in upside down). This nearly DOUBLES the radius, and thus DOUBLES the arc of rotation at the facets. One might think, maybe since most revisions are due to facet arthrosis, that perhaps the ADR might be the cause?
Furthermore, the Prodisc translates A/P 1mm for every 3° of rotation. Thus, for a total possible 20°, we see 6.6mm shear added to the already double arc. A natural disc has 15° AP arc, according to some papers. As well, the Prodisc allows 20° lateral rotation, compared to 10° natural. And, the Prodisc is totally unconstrained in 360° Axial rotation, compared to 6° in natural discs! ALL forces are only restricted by the Facet joints and muscles.
| III. ProSpine web page ('Myth Buster' section) "Myth. ADR revision surgery is life threatening. Reality. This is true in 40% of the cases, if the surgeon did not sew in a barrier between the spine and the major arteries. However, Dr. Bertagnoli does sew in this barrier." |
Does it imply that ADR revision is not life threatening, if the barrier is used?
There is a story on forums of a woman (Liz) who had Prodisc revision (it has nothing to do with the above facility). She had lateral approach btw, not frontal...She almost died. Note: She HAD a protective barrier, which apparently didn't help to make her revision safe.
MEDICAL COMMUNITY FINDINGS on ADR Revisions
AAOS. Sep. 2007. By Dennis P. McGowan, MSc, MD, and Vijay K. Goel,
“Removal of an infected or dislocated TDR is a life-threatening procedure, and several deaths have already occurred in the United States. Any reoperation places the great vessels at risk.”
eSpine. Truth in Spine Surgery. Robert Pashman MD “…Current lumber artificial disc replacement at L5-S1 is rarely indicated for the following reasons. There is no significant functional motion at L5-S1... Failure of lumbar disc herniation and need for revision can be life threatening…. Lumber artificial disc replacement will be subjected to a much steeper learning curve, the short and long-term outcomes may be marginal, and the revision for failed implants will be difficult and at times life-threatening”
http://www.espine.com/artificial-disc.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."http://www.ethicalspinesurgeon.com/articles/WSJRosen.htm
Dr Van Ooij : "revision is dangerous and sometimes impossible."
Jens FRANÇOIS et al 'Early removal of a
“Revision surgery with explantation of a lumbar TDR carries great risk to the major anterior vessels and is a potentially life-threatening procedure…"
espine.com, May 5, 2010 "If there is any type of complication from the lumbar disc, the revision surgery is always life threatening."
John H. Peloza, M.D Texas. "There are multiple European studies that show success rates for the JNJ DePuy Charite between 63% and 79%. However, revisions were necessary in close to 25% of patients in one study due to continued pain. Dr. Andre Van Ooij, from the
I.Lieberman,The
“The longevity of artificial discs is yet known… Revision disc replacement surgery will be a life-threatening operation.”
Nader M. Hebela, Paul C. McAfee et.al. ‘Revision of Lumbar Total Disc Arthroplasty and Other Anterior Instrumentation, March 2008’ “ ...careful preoperative and intraoperative planning may minimize the life-threatening risks posed by reoperation”.
http://www.semspinesurg.com/article/S1040-7383%2807%2900131-1/abstract#
Santos EG et al. ‘Disc arthroplasty: lessons learned from total joint arthroplasty’ Spine J 2004;4:182S-189S: "…Revision surgery for a failed disc arthroplasty is life threatening. Dealing with the scarring around the great vessels is the main challenge...”
Jeon, Sang Hyeop MD et al. ‘Anterior Revision of a Dislocated ProDisc Prosthesis at the L4-5 Level’:
The article highlights “the difficulties and risks associated with the use of a repeat anterior approach for the revision of a ProDisc that has failed at the L4-5 level.”
TheBurton Report: “..Removal of such dislocated artificial discs is life threatening…”
http://www.burtonreport.com/infspine/SurgArtificialDiscs.htm
Kevin Daly, E.Raymond S.Ross et.al 'Vascular complications of prosthetic inter-vertebral discs' 2006
“…Five consecutive cases of prosthetic inter-vertebral disc displacement with severe vascular complications on revisional surgery are described. The objective of this case report is to warn spinal surgeons that major vascular complications are likely with anterior displacement of inter-vertebral discs…”
Wyoming Spine & Neurosurgery: "Although some patients who have undergone spinal fusion surgeries need revision surgeries, they are generally less problematic than those after artificial disc surgery…..and the [revision] surgery can be life-threatening due to the potential for blood loss and other complications"
http://www.wyospine.com/artificialdiscs.asp
Also, the article 'Complications and strategies for revision surgery in total disc replacement'
R. Bertagnoli, Zigler J, Karg A, Voigt S. Orthop Clin North Am. 2005 Jul;36(3):389-95 advises that for safer revisions a protective vein barrier should be used: "..Another strategy to make vascular dissection easier and safer is to use an anti-adhesive membrane (eg, Gore-Tex, W. L. Gore & Associates, Inc., Newark, Delaware).."
Note that this article is from 2005 July.
My surgery was done in the end of 2006. I had no protective barrier.
|
IV. ProSpine web page ('Myth Buster' section): |
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”..
As far as my knowledge goes, The HMWPE has not been used as ADR's in the SPINE for 40 years.
Human body ? Human spine....(remember, Prodisc, for example, was FDA approved only in 2006).
MEDICAL COMMUNITY FINDINGS
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)."
http://www.synthesprodisc.com/html/Patient-FAQ-2.142.0.html?&L=0&0=
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
| ProSpine web page: “The Artificial Disc Replacement (ADR) was
developed to overcome the shortcomings of older fusion ProSpine web page: “Also, any degenerative process will likely continue, therefore problems in other areas of the spine may appear at a later time.” |
Doesn't it sound like one contradicts another?
MEDICAL COMMUNITY FINDINGS on ADR and adjacent segment syndrome
"Fans of the device say that it preserves motion and, in turn, reduces wear on nearby parts of the spine. But McAfee confessed that he "cannot find a single study on any motion-preserving device" that proves this theory." http://www.ethicalspinesurgeon.com/articles/theStreetBacklash.htm
Chan Shik Shim, Lee Sang-Ho et al. Department of Neurosurgery, Seoul ‘CHARITÉ vs Prodisc: A comparative study of a minimum 3-year follow-up’. “Degradation of disc degeneration at the adjacent level above the index level was seen in 19.4% in the CHARITE and 28.6% in the ProDisc. Conclusions. While clinical outcomes of both CHARITE and ProDisc groups were fairly good, the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of patients, regardless of the device used, raising concerns of possible late consequences of total disc replacement, especially regarding facet arthrosis and adjacent segment disease". http://cat.inist.fr/?aModele=afficheN&cpsidt=18701438
PubMed,
Denoziere G, Ku DN, Georgia Institute of
Columbusregional.com Does artificial disc replacement prevent the development of adjacent segment disease? “The long-term potential benefit of maintaining spinal motion with artificial disc replacement is believed to be less degeneration and problems with the surrounding discs. However, this is only a theoretical benefit, as no good long-term medical studies have been done (these procedures and devices are too newly available). Only after a longer follow-up time and additional medical studies will we know if this believed benefit is real.”
Which is better, artificial disc replacement or spinal fusion?“The potential benefits of artificial disc replacement, including retained mobility and limiting stress on the adjacent discs, must be weighed against the potential for wearing out of the implant over time and the unknown future of the mobile facet joints and other possibilities.” http://www.columbusregional.com/media/File/Spine%20Center/Evaluating%20artificial%20disc%20replacement%20surgery.pdf
Robert
Pashman MD, eSpine. Truth in Spine Surgery.
“…Advocates of the lumbar artificial disc argue that
spinal fusion has two significant drawbacks. The first argument is that
stabilization of the spine inherently reduces the functional capacity of the
individual because of decreased spinal motion. Secondly, a transfer of forces
to the adjacent segments of a spinal fusion accelerates therefore creating the
potential for degeneration and the possibility of future reconstructive
surgery. According to their theory, motion preservation technologies for spinal
disorders would obviate these two negative consequences of spinal fusion…
…Current literature suggests
that lumber artificial disc replacement when compared to spinal fusion
does little to improve overall functional spine motion. Moreover,
the current studies indicate when lumber artificial
disc replacement is observed for a long period of time, the failure rate is
high, and there appears to be little benefit to protecting the adjacent
segment as with standard fusion.This leads to a
situation where the short-term benefit of the theoretical advantages of lumber
artificial disc replacement for motion preservation may lead to significant
long-term problems…”
"Adjacent segment degeneration has been shown to be equal between disc replacement and fusion at L5-S1. Lumber artificial disc replacement will be subjected to a much steeper learning curve, the short and long-term outcomes may be marginal, and the revision for failed implants will be difficult and at times life-threatening” ttp://www.espine.com/artificial-disc.htm
