Advocate For Allowing Americans the New ADRs

[mmglobal]

The m6 and neodisc are interesting designs. Whether or not they are better than other motion preservation devices remains to be seen.

I have seen many more m6 cervical discs needing explant revisions than I have of any other disc... not by just a little bit. And, this is in spite of the m6 being done in much, much smaller numbers. I like many of the design components, but questions about the materials, longevity, etc... will only be proven with time.

Mark

[ADR seeker]

Originally Posted by mmglobal

The m6 and neodisc are interesting designs. Whether or not they are better than other motion preservation devices remains to be seen.

I have seen many more m6 cervical discs needing explant revisions than I have of any other disc... not by just a little bit. And, this is in spite of the m6 being done in much, much smaller numbers. I like many of the design components, but questions about the materials, longevity, etc... will only be proven with time.

Mark

They have been proven superior. The M6 implants like a standard ball and socket ADR but once in place it cannot over rotate and it is motion limiting like a real disk. The only thing that can stop a the over rotation of a standard ADR are the facet joints.

The Neo Disc is a simple implant. Any surgeon who can do a ACDF can install a neo disk. Also there is no metal and if you have a titanium allergy they can use ceramic screws. The Neo sounds like the best design.

Both disks are tried and true and there are no valid reasons for why they are not available on American soil.

I spoke with a surgeon who did the clinical trial for the neo and he installed 13 of them. Only one went bad and that was because he used the wrong size.

Because the FDA owns my body I cannot buy a Neo Disk and get it installed. Imagine that. It is unlawful for me to own a chunk of silicone and fabric and allow a doctor to install it in my spine.

These ADRs have the C Mark and that is good enough for me. If the FDA app5oved them and C Mark didn't then they are probably junk like the Depuy hip implant.

I wish I could put a positive spin on this. I can't. It's tyranny.

[Hooch]

Originally Posted by mmglobal

I have seen many more m6 cervical discs needing explant revisions than I have of any other disc... not by just a little bit. And, this is in spite of the m6 being done in much, much smaller numbers. I like many of the design components, but questions about the materials, longevity, etc... will only be proven with time.

What sort of failures, Mark?

[Maria]

I think our healthcare system was better before insurance companies took command of everything (insurance companies and big pharm).

Our healthcare system is screwed most definately though I do not blame the physicians for that.

[ADR seeker]

Originally Posted by Maria

I think our healthcare system was better before insurance companies took command of everything (insurance companies and big pharm).

Our healthcare system is screwed most definately though I do not blame the physicians for that.

Big pharma funds medical schools and that is why doctor in the US have become pill pushers.

Mostly it the culture. They are greedy and arrogant.

Bad medicine is more lucrative and with the emphasis on managing disease rather than curing it it will be expensive and will not serve the patient. They think of us as customers and we see them as part of a industry that is about the money first and foremost. This is not to say that all American doctors are money grubbing mercenaries but IMO, based on my experience this is how it is.

[mmglobal]

ADR Seeker, I'm not sure I understand how you can deride the industry so severely and then take their word for it that something has been proven superior. There have been many technologies that were 'proven superior' and implemented widely, only to be halted or recalled later.

The marketing spin about devices is very interesting. This reminds me of the original Charite' versus Prodisc spin wars. One of the advantages constantly pointed to, of the keeled design was that it arrested rotation of the plates. (This is different from rotation you are referring to in the M6 discussion.) It is intuitively obvious that the plates cannot rotate with the keel encased in bone. However, if the Charite' plates don't rotate, then arresting rotation of the Prodisc plates is a non-issue.

IMHO, the jury is still out on the facet issue. I have seen both Charite' and Prodisc patients with poor facets going into the surgery, have good long-term outcomes. I have seen both Charite' and Prodisc patients with good facets going into the surgery, have facet problems later. This issue is so much more complicated than most of us can imagine. I have seen studies that show Charite' to be superior related to facet loading and I have seen studies that show Prodisc to be superior.

The Bryan disc is a non-starter for virtually all of the spine surgeons I know. You know what? Medtronic presents data that clearly shows the bryan disc to be superior. That device is clearly inferior. That's why Medtronic bought the Bristol disc and renamed it to Prestige. They knew that the Bryan disc would not be successful. Yet the data shows it to be superior.

How is it that you are absolutely certain that these devices are so wonderful when you are so very skeptical about so many other issues in this field?

Hooch, regarding M6 failures. Many of the failures I have seen are technical failures of the surgeon. Most of them from Stenum. they have the same types of failures with the M6 as they did with the prestige and other devices. You can't do a 5 hour surgery in 70 minutes and expect success. You can't take a neck with severe cord compression due to osteophytes and severe DDD at many levels; do a 3-level ADR without addressing the osteophytes. ADR surgery is more than opening, putting the disc in and closing. There is very tedious work that needs to be done. ADR surgery without performing the NECESSARY decompression is not a high success rate operation.

Gotta run... thanks all for the good discussion!

Mark

[ADR seeker]

Originally Posted by mmglobal

ADR Seeker, I'm not sure I understand how you can deride the industry so severely and then take their word for it that something has been proven superior. There have been many technologies that were 'proven superior' and implemented widely, only to be halted or recalled later.

Here is why. M6 and Neo Disk are made by small companies and they are used by the best surgeons in the world Johnson & Johnson makes the disks and other orthopedic products that fail. Johnson & Johnson have paid all sorts of fines for wrong doing. I trust C Mark. I don't trust the FDA.

The marketing spin about devices is very interesting. This reminds me of the original Charite' versus Prodisc spin wars. One of the advantages constantly pointed to, of the keeled design was that it arrested rotation of the plates. (This is different from rotation you are referring to in the M6 discussion.) It is intuitively obvious that the plates cannot rotate with the keel encased in bone. However, if the Charite' plates don't rotate, then arresting rotation of the Prodisc plates is a non-issue.

In most cases a device that acts like a real disk is best. I can't see how a ball and socket can be much better than a fusion and I don't think that they have been proven better in most patients. Charite had a ton of failures and it's made by J&J.

IMHO, the jury is still out on the facet issue. I have seen both Charite' and Prodisc patients with poor facets going into the surgery, have good long-term outcomes. I have seen both Charite' and Prodisc patients with good facets going into the surgery, have facet problems later. This issue is so much more complicated than most of us can imagine. I have seen studies that show Charite' to be superior related to facet loading and I have seen studies that show Prodisc to be superior.

Manufacturers manipulate studies. How to you think the Johnson & Johnson hip implant made it out of clinical trials. The FDA knew it was a poor design. Again, if a device acts like the real thing and the surgeon installs it properly there is a very good chance that is will function properly.

The Bryan disc is a non-starter for virtually all of the spine surgeons I know. You know what? Medtronic presents data that clearly shows the bryan disc to be superior. That device is clearly inferior. That's why Medtronic bought the Bristol disc and renamed it to Prestige. They knew that the Bryan disc would not be successful. Yet the data shows it to be superior.

In any other industry other than the medical industry people would be in jail for that type of fraud. Imagine if Lockheed said their jet fighter was better than the General Dynamics fighter and they were lying. Somebody would be in deep trouble. The medical industry is above the law.



How is it that you are absolutely certain that these devices are so wonderful when you are so very skeptical about so many other issues in this field?

I have spoken with a surgeon who did the Neo Disk clinical study. He was trained by Luis Pimenta. He had spectacular results. He told me that he saw Pimenta do a 3 level with one incision with a great outcome.

M6 and Neo both have the C Mark approval. If the FDA approves something all it means that the FDA approved it. It does not mean that it is good. If it gets C Mark approval then chances are it is good.

IMO based on common sense and some background in engineering and construction the Neo Disk is the best design out right now. I suspect that the reason Spinal Kenetics went to the keel design was for patent reasons. A better solution would be a PCM coating and a post on each end that slide into a small oval shaped holes on the top of on vertebra and the bottom of the other. A monkey could do it. There would be zero chance of migration it would fuse.

Hooch, regarding M6 failures. Many of the failures I have seen are technical failures of the surgeon. Most of them from Stenum. they have the same types of failures with the M6 as they did with the prestige and other devices. You can't do a 5 hour surgery in 70 minutes and expect success. You can't take a neck with severe cord compression due to osteophytes and severe DDD at many levels; do a 3-level ADR without addressing the osteophytes. ADR surgery is more than opening, putting the disc in and closing. There is very tedious work that needs to be done. ADR surgery without performing the NECESSARY decompression is not a high success rate operation.

No doubt that Stenum is a surgery mill. Osteophytes are a whole other issue. When they are removed they grow back with a vengeance. Bone wax which is really bees wax stops them but in 2% of cases it causes bone necrosis.

One would think by now that there would be an alternative to retard bone grown other than bees wax.

In my case I have disk material pressing on the cord and the nerve roots. The disks are ossified and if the fragments were nibbled away I'd probably be OK. What may work is what Bonati advertizes but done by a skilled surgeon and not a hack that works on volume.

Gotta run... thanks all for the good discussion!

Mark

Hang in there Mark and I will do the same for a while.

[haris]

hello everyone, My name is Suad and I am from Bosnia. 50 days ago I had a surgery at Bogen, Germany L4/L5 and L5/S1 pro disc. Dr Bertagnoli performed the surgery. First Spine surgery that I had was microdiscetomia L4/L5 back in 2000. After that surgery I had no problems until 2007. MRI showed discus hernia L5/S1. My symptoms back then were as follows: I could not stand up for more then one hour, and I coud not sit down for more then half an hour. After that time I had back pain which goes down towards my both legs. I had a same feelings in the both legs, I never had "dropped" foot, and I never had problems when I had to go to toillet (I always had control over my blodder). Hoping that I will solve these problems with sitting down and standing up I underwent new surgery L5/S1 microdiscetomia. However, after that surgery my problems become worse. After surgery I could both walk and sit down less then before the surgery. After I had consultations with many doctors, I went to Bogen, Germany at dr. Bertagnoli where I had a surgery on 15 of September 2011. They implanted two pro disc at the levels L4/L5 and L5/S1. They told me that surgery was successful. Dr. F. Mayer told me that after 6 months I could continue with my sport life style. However today, 50 days after the surgery I still can't sit down for more then 10 minutes, I can't walk for more then 20 minutes. I also feel very insecure when I want to get up when sitting down. New symptoms are: My left foot is more red then the right one. My right foot hurts during my short walks. Also when I am walking and sitting down I have a feeling that my both feet are kind of burning, I feel heat in my feet. I became very scared. I feel psyhologicly very bad. I am also worried because no one from the Pro spine clinic in Bogen Germany does not reply my emails. They did reply at the begining but they do not reply any more. I am begging all members of the forum who had similar surgery to give me their experience and to help me in any way shape or form so I can feel better. Any advice is welcome. You can also write me at my personal email suad.hadzic@bih.net.ba THANK YOU ALL.

[sahuaro]

If you're going to post average income for various medical specialties, how about also posting malpractice insurance premiums? They account for most of the difference between US and foreign docs' costs.

[Stingerlee]

Originally Posted by sahuaro

If you're going to post average income for various medical specialties, how about also posting malpractice insurance premiums? They account for most of the difference between US and foreign docs' costs.

Why don't you doc and tell the truth. US doctors are the highest paid doctors in the world. They also pay a lot less in taxes and they have a lot of undeclared income and perks.



The truth is 700,000+ doctors pay less than 2 billion in premiums but they pocket over 200 billion fixing their own mistakes. Doctors are a bunch of whiners. When a doctor is sued which is rare, they don't get punished. Legally doctors are held to a very low standard.