Anastasia's Website
Artificial Disc ProDisc. R. Bertagnoli. ProSpine
Contact me: nastya@anastasia-scott.com
Contact me: nastya@anastasia-scott.com
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 Clinic, Dr. Dekkers department in October 2006.
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 busy. I wanted to cancel the surgery but Dr.B called me...In a few minutes talk he assured me that: Now is the best time to do the surgery, that the pain will come back, and that it will be too late if I were to wait longer. I recall my timid attempts to argue: "But doctor, I dont have pain..." There were several people in the room, a commotion. The answer was definite "the pain will come back. it comes and goes. it is a perfect time to do it". I was assured that I should still go ahead - even with my low pain. I TRUSTED Dr.Bertagnoli.
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.
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"?
__________________________________________________
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] ... read more.
MY BLOG: The Beginning of the Story.
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???
Two years later, through a German investigation from TKK (on their own initiative), an independent 'MDK' medical doctor presented to us a report stating that the surgery that occurred in Straubing with Dr. Bertagnoli was a Grave Error on multiple factors and
"for completely incomprehensible, medically not understandable reasons, it has been contravened grossly against the indication criteria for implantation of spinal disk protheses"
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!
A GRAVE ERROR IN TREATMENT
Two years later, through a German investigation from TKK (on their own initiative), an independent 'MDK' medical doctor presented to us a report stating that the surgery that occurred in Straubing with Dr. Bertagnoli was a Grave Error on multiple factors and
"for completely incomprehensible, medically not understandable reasons, it has been contravened grossly against the indication criteria for implantation of spinal disk protheses"
====================================
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. 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 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?
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?
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. 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...
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 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?
| MYTH BUSTER In progress. Coming Soon!
|
