Dr Bierstedt

[jss]

Grant,

Good luck today! From everything I hear the first few days of that lumbar recovery is a son-of-a-gun. I know you're going to do great.

Jeff

[Gman88]

Thanks Jeff. Yeah the first hour after waking up was pretty brutal but mostly because I was on Percocet for almost a year at high dose and my tolerance for pain meds was so high.

My suggestion to those on pain meds before surgery is try the best you can to at least lessen the amount you normally take. I am now at an acceptable pain level but it took some time post op because of my tolerance. They have no problem giving you all the meds you need for pain. Dr showed me an X-ray of the discs and they look perfectly aligned.

My leg pain is actually totally gone but not sure if that is a result of the meds I am taking. So the only place I have some pain post op is back pain. Going for a short walk in a minute.

[MikeC]

As Dr Bierstedt once told me on the phone when I asked about the M6 being approved in Germany and not in the USA; "we are not a banana republic in Germany".

So what are we here in the USA where the FDA cannot muster up the resources to make some forward progress in approving the M6 ? How does one find out where they stand. I think I'll make a few calls and also write to my congressman. That worked for me once in the past; Senator Lieberman got my issue sorted out pronto, but this might be a somewhat bigger challenge

Are they some lobbyists in DC working to keep this device out of the hands of the US surgeons? I'll keep you posted on my new project. Mike

[Harrison]

Wow, what a trooper, Mike. Good luck with all your efforts!

[Jerry5]

Gman,
Have you had a laminectomy, discectomy, does not say, I did, and it takes 5 or 6 days, really to recover, to the point that you can move around, but in reality, it will take about 10 days to quit 'noticing' the suture.
They will teach how to move around a little differently until you adjust to the movement.
My first 5 or 6 hours were pretty bad, (the first is the worst, coming out of that anesthesia) finally got into the second day, went home 24 hours later, it is brutal, there is no other way to explain it, like an epidural, work at least part of the way, but there are benefits to these shots.

You said 'back' pain, did they do this from the front, anterior?
I believe if they have to replace a disc above the L3 level, they have to go in from the side.

Emailed Spinal Kinetics, they said this FDA approval, will not take place for several years, I am sure there are lobbyists and people at the FDA playing football with this issue.
I emailed a dr, about the auditory nerve implant, (do not hear in one ear) and he said it would take a decade or more before they get approval, to do trials in humans, if it works, let people get the benefits.

May email my Congressman as well, this is silly, it is all about the money, I am sure they spend millions to develop this (technology)/these medical devices, but they cannot and should be allowed by law, to let the lobbyists take control of this, should let the people make this decision, there are over 20,000, last I could count, of these put in people over the last 6 or 7 years, in Europe, with no failures (correct me if I am wrong, and I am talking about sublimation, not installation) so there should be no reason for other manufacturers to pay politicians to NOT allow this to be used in the USA.
Funny part about this M6, this was developed in the USA, California, by Neurosurgeons, just for this reason, mobility, and they will not allow this to be used here.


sorry for the rambling, but this has gone too far.

Jerry

[Jerry5]

The FDA is going/ has gone too far, this is not about who gets the most money, this is about providing people with the opportunity to the latest in medical equipment, and the ability to get back movement and mobility.