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ston & List

I would like to your most recent post with further clarification.

" The FDA uses the UHMS list because it is the only list that has ever been

submitted to them. (Hyperbaric Medicine Today, Volume 1, issue 1, page 10).

The FDA has stated that it will consider other indications that are submitted

directly to them, but no one has chosen to do so yet. "

This list of indications is currently being updated by one of the IHMA's

corporate members (chamber manufacturer). Once this new reference is

accepted by one manufacturer, it should not be long before others realize the

potential for growth in our field.

" Next, the UHMS has absolutely no regulatory powers. Zip. Zero. "

This is absolutely true, just as the IHMA has no regulatory power, but the

catch comes when professional associations create standards that regulatory

powers (such as the FDA) recognize.

" The IHMA is discussed in issue 6, on page 29. It cannot spend all of its

energy

fighting regulatory issues in only one member country. "

This is a huge challenge for any new association but one we are completely

dedicated to. We will help each country as needed with whatever information

or resources we have at our disposal. By far the biggest thing we can do

(for all countries) is to get the FDA and other regulatory bodies to see that

there is little risk compared to the potential benefit for neurological

patients using HBOT and expand its use in a safe controlled manner as

prescribed by physicians.

**************************************************************************

Mr. Hartsoe

Subject: UHMS?

Thank you for your supportive comment and actions.

You wrote:

" The IHMA is fully up and running. "

We are working very hard on multiple issues in various states and at the

federal level. We will be keeping all of our members up to date as changes

are made. Please pardon the website delay as other issues have been to

pressing to complete it.

" the IHMA is working up a set of standards for free-standing centers. "

This is true and it is a big priority for the association as standards are

what will show insurance companies (Payors) that we are a professional

medical therapy delivering a quality service in consistently safe

environments. Again, this is in the back seat while we fight the major

obstacles in our way (FDA, CMS, and Insurers). Also keep in mind that any

such initiative will not be designed as a (revenue producing) cost center for

the profit of the association. Any such initiative will be done solely for

the sake of advancing the field by creating safe effective standards of care.

" It is important that everyone supports this association. I am proud to be a

founding member of the IHMA. "

The association and I thank you and all of our supporters for the

contributions they have made. We can only be as strong as our supporters.

Thank you all.

Sincerely,

R. Locklear

Editor

Hyperbaric Medicine Today journal

4500 Belvedere Road, Suite H

West Palm Beach, FL 33415

USA

www.hbomedtoday.com

hbomedtoday@...

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  • 6 months later...

Kathleen wrote:

If you have had or still have a Harrington Rod I am interested in contacting you. I am trying to set up a non-profit foundation for Flatback Syndrome.

As you may know, several present and past participants in this site -- physicians, attorneys, patients -- at one time formed a task force and advocacy group which intended to raise funds for flatback. My very best wishes for great success in your own efforts to set up what I presume will be a 501©(3) corporation. I can empathize with some of the difficulties you may be facing as you attempt to establish leadership and build a cohesive team, as well as a conscientious board. It will certainly be worth the all your persistence and hard labor, however, if you can elicit more interest in patients suffering from flatback syndrome.

You asked to be informed:

also if you have Flatback and if you still have the Harrington Rod implanted in your poor spine!

I did (past tense) have flatback, secondary to implantation of a Harrington rod with Moe hooks and sublaminar wiring. My flatback syndrome was corrected in 16 hours of staged revision surgery last December, with extension of my preexisting fusion to S-1. I am pleased with the results so far. The surgery eliminated my fixed sagittal imbalance as well as providing some unexpected coronal correction. And yes, I still have the Harrington rod implanted in my spine.

Did you know that even if you had your Harrington Rod removed years ago that you can still develop Flatback Syndrome as the Rod force on the spine may have already set Flatback into motion and it normally takes numerous years for it to develop.

No, I did not know this, Kathleen. It is a very provocative and fascinating statement! Would you be so kind as to provide your scientific references? For some reason, these have not shown up in any literature review, to date, with which I am familiar.

Although the data may not be widely known as yet, I am certain this information will be of considerable interest and concern to some of our readers. Hence, I will be deeply grateful for your bibliography or list of citations (annotated if possible).

Wishing you all good things,

Eliana

---Outgoing mail is certified Virus Free.Checked by AVG anti-virus system (http://www.grisoft.com).Version: 6.0.386 / Virus Database: 218 - Release Date: 9/9/02

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According to Mina, in her artical on flatback syndrome,

" In older scoliosis fusions, Flatback Syndrome can gradually occur

from other fusion-related causes such as failing instrumentation,

pseudoarthrosis (inability of the spine to solidly fuse at various

locations), or collapse of the anterior portion of the disks in a

posterior-only fusion. "

http://www.users.nac.net/mina/flatback.html

While this reference does not specifically address Harrington rod

removal, it stands to reason that any posterior-only fusion, with or

without a rod, could be subject to collapse of the anterior portions

of the disks, very possibly more so if the progress toward flatback

has already begun while the rod was in place.

Unfortunately, Ms. Mina removed the information about her personal

case when she updated her site in 2001, but I read it before that

time, and she was among those whose non-instrumented fusions from the

pre-Harrington days did develop into flatback.

Sharon in southern New Hampshire :^)

Congenital scoliosis w/ spina bifida and other vertebral anomalies

1971 fusion T5 to L4 w/ single Harrington rod

Flatback, congenital thoracolumbar kyphosis, L5-S1 degeneration, etc.

>

>

> If you have had or still have a Harrington Rod I am interested in

contacting you. I am trying to set up a non-profit foundation for

Flatback Syndrome.

>

>

> As you may know, several present and past participants in this

site -- physicians, attorneys, patients -- at one time formed a task

force and advocacy group which intended to raise funds for flatback.

My very best wishes for great success in your own efforts to set up

what I presume will be a 501©(3) corporation. I can empathize with

some of the difficulties you may be facing as you attempt to

establish leadership and build a cohesive team, as well as a

conscientious board. It will certainly be worth the all your

persistence and hard labor, however, if you can elicit more interest

in patients suffering from flatback syndrome.

>

> You asked to be informed:

>

> also if you have Flatback and if you still have the Harrington Rod

implanted in your poor spine!

>

> I did (past tense) have flatback, secondary to implantation of a

Harrington rod with Moe hooks and sublaminar wiring. My flatback

syndrome was corrected in 16 hours of staged revision surgery last

December, with extension of my preexisting fusion to S-1. I am

pleased with the results so far. The surgery eliminated my fixed

sagittal imbalance as well as providing some unexpected coronal

correction. And yes, I still have the Harrington rod implanted in

my spine.

>

> Did you know that even if you had your Harrington Rod removed years

ago that you can still develop Flatback Syndrome as the Rod force on

the spine may have already set Flatback into motion and it normally

takes numerous years for it to develop.

>

> No, I did not know this, Kathleen. It is a very provocative and

fascinating statement! Would you be so kind as to provide your

scientific references? For some reason, these have not shown up in

any literature review, to date, with which I am familiar.

>

> Although the data may not be widely known as yet, I am certain this

information will be of considerable interest and concern to some of

our readers. Hence, I will be deeply grateful for your bibliography

or list of citations (annotated if possible).

>

> Wishing you all good things,

> Eliana

>

>

>

>

>

>

>

>

>

>

>

>

>

> ---

> Outgoing mail is certified Virus Free.

> Checked by AVG anti-virus system (http://www.grisoft.com).

> Version: 6.0.386 / Virus Database: 218 - Release Date: 9/9/02

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  • 1 year later...
Guest guest

Out of the office - I will be out of the office this week and will return on

Monday, June 7. I will reply to your message as soon as I can.

Walter A. Viali.

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