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FDA MDR: Obstetric tables (also: Pregnancy low back pain/Lordex Spine Institute)



 
 
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Old September 30th 03, 05:49 PM
Todd Gastaldo
external usenet poster
 
Posts: n/a
Default FDA MDR: Obstetric tables (also: Pregnancy low back pain/Lordex Spine Institute)

I've just submitted an FDA Medical Device Report/MDR regarding the danger of
OBSTETRIC TABLES as MDs commonly use them.

For the text of my report, see MD BIRTH CRIME (pardons in advance for MDs)
below.

ANYONE may warn the FDA.

The more reports the better. Go to:
https://www.accessdata.fda.gov/scripts/medwatch/

I am also copying this usenet post to FDA via (Attn:
CELIA M. WITTEN, Ph.D., M.D., Director, FDA's Division of General,
Restorative and Neurological Devices, Office of Device Evaluation, Center
for Devices and Radiological Health
301-594-1184: Celia, please see my note to you below.)


Onward....


PREGNANCY LOW BACK PAIN/LORDEX SPINE INSTITUTE


The LORDEX Spine Institute says:

"All back pain can be divided into two categories, MEDICAL [3%...includes
women who are pregnant]...and MECHANICAL...[the remaining] 97% of people
with acute or chronic back pain..."
http://www.lordex.com/backprob.htm (emphasis added; text in brackets derived
from context)

OPEN LETTER (archived for global access***)

JOHN BOREN (MD? LORDEX?)
Ever Prosperous Instrument, Inc. (same phone as LORDEX)
15915 Katy Freeway
Suite 645
Houston, TX
Phone: 281-398-1700
http://www.lordex.com/contact.htm
http://www.fda.gov/cdrh/510k/sumjul03.html
via

John,

I think most back pain of pregnancy is MECHANICAL and may be relieved by
MECHANICAL THERAPY - often dramatically - at least this was my experience
while still in spinal adjusting practice.

I note that the Lordex method focuses on lumbar discs...

My hands-on mechanical method ("chiropractic adjusting") included attention
to sacroiliac joints.

My sacroiliac joint manipulation was associated with dramatic improvement in
pregnant patients *and* in NON-PREGNANT patients...

To PREGNANT LADIES and those attempting sacroiliac manipulation: An audible
pop is not necessary. This "audible-pop-not-necessary" notion was taught in
chiropractic college over 20 years ago and scientific support for it was
recently provided by the US Army - specifically by (Lt. Colonel?) Timothy W
Flynn, PT, PhD, OCS and colleagues who studied a cohort of 71 patients with
nonradicular LBP treated with (one?) "high-velocity sacroiliac (SI) region
manipulation."

Flynn et al.^^^ reported:

"Nineteen of the 71 (27%) patients improved dramatically...In 14 of the 19
dramatic responders, an audible pop occurred. However, the odds ratio (1.2;
95% confidence interval, 0.38-4.04) suggested that the occurrence of a
manipulative pop would not improve the odds of achieving a dramatic
reduction in symptoms after the manipulation."

^^^Flynn TW, Fritz JM, Wainner RS, Whitman JM. Arch Phys Med Rehabil. 2003
Jul;84(7):1057-60. PubMed abstract.

John, what I'm getting at is this: Since much back pain of pregnancy
appears to be MECHANICAL, you might want to offer your services tol PREGNANT
(and immediate postpartum) Lordex "guests." Many of them are likely
suffering BOTH disc and sacroiliac problems. See Nilsson-Wikmar et al
[2003], full cite below.

Make sure you offer pregnant (and immediate postpartum) Lordex "guests" the
option of sacroiliac manipulation (perhaps you are already doing so but just
not mentioning it at your website?).


LORDEX PREVENTION STRATEGY: "improve lower extremity flexibility and range
of motion..."

"Following each [Lordex] procedure, patients generally undergo a stretch and
flex program designed to improve lower extremity flexibility and range of
motion...[T]he best long-term results occur when individuals take an active
part in PREVENTION."
http://www.lordex.com/backprob.htm

"Following completion of the Lordex Protocol, you will be prescribed a
Lordex Spinal Hygiene Machine. This home unit has been specially designed to
help each guest maintain the same level of improvement acquired during
in-office Lordex therapy."
http://www.lordex.com/differ.htm

John: What if most Lordex therapy and most Lordex Spinal Hygiene Machines
aren't really necessary....


THE GREAT SQUAT ROBBERY

The Lordex Spine Institute prevention strategy is improving "lower extremity
flexibility and range of motion" (see quote above)...

Surely you must be interested in stopping The Great Squat Robbery, the
culture-wide LOSS of "lower extremity flexibility and range of motion"?

In 1986, the late Arthur Guyton, MD wrote:

"Even such simple activities as sitting for a long time...can cause tissue
destruction...Cessation of blood
flow to the skin...usually...cause[s] pain...[within]...20 to 30 minutes"
(p. 594)...when the skin becomes painful as a result of the ischemia, the
person shifts weight unconsciously" (p. 592). [Guyton AC. Textbook of
Medical Physiology. 7th ed. Phil: W.B. Saunders 1986]

Whereas most humans on the planet can squat for hours nearly motionless...

CHAIRDWELLING CHILDREN SQUIRM IN THEIR CHAIRS...

Chairdwelling children (and adults) squirm in their chairs as they LOSE this
precious innate rest posture...

In 1987, Newsweek reported that children can only sit still for 15 minutes
at a time in their chairs:

"Educators say that many five-year olds really can't handle a highly
academic program. They're still learning how to sit still for more than
15 minutes at a time." [Kantrowitz B, Wingert P. The big grind in
kindergarten. Newsweek (Aug10)1987. From Gastaldo's peer review of the
AHCPR-sponsored Low Back Guideline draft.]

Eve-Line Boule, chercheur associé at CÉPAM wrote:

"[S]quatting was a regular behavior used until the end of the Middle Ages,
and after this period a progressive decrease occurs..."
[Am J Phys Anthropol 2001 May;115(1):50-6]

I replied:

The Great Squat Robbery that started in the Middle Ages starts anew in
elementary
schools every year!

Prevention is key here, John.

I *don't* think loss of squatting - loss of the ability to REST while
standing - can be rehabilitated/restored.

Remember: I'm talking here about rehabilitating/restoring loss of the
COMFORTABLE PROLONGED squatting ability.

I don't think it's possible...



MANOJAR PANJABI, PhD...

THE GREAT SQUAT ROBBERY...

AND RELATED SPINAL MANIPULATION CRIME BY MD-OBSTETRICIANS...

I recently wrote to Manohar Panjabi, PhD of Yale University...

BEGIN excerpt of Gastaldo's Open Letter to Manohar Panjabi, PhD...


[b]eing a professor in Yale's REHABILITATION department, have you guys
figured out how to rehabilitate tibio-talar "squatting" facets when they are
lost or never develop because of chronic chair-dwelling behavior? Have you
figured out a way to rehabilitate the comfortable, prolonged, flat-footed
squatting ability itself once it is lost?

I ask because Gardosi et al. indicated in The Lancet in 1989 that MDs are
closing birth canals because of (what I call) The Great Squat Robbery.
Incredibly, no one squatted in Gardosi et al.'s "randomised controlled trial
of squatting." (!)

Gardosi wrote me circa 1990 that two English randomised controlled trials
had demonstrated that sedentary women could NOT squat well enough to deliver
squatting (emphasis Gardosi's) - but Gardosi eventually changed his tune.

It turns out that squatting is not only an innate rest posture - it is an
innate DELIVERY posture - one that happens to allow the birth canal to OPEN
the "extra" up to 30%.

When The Lancet refused to publish Brazilian obstetrician Moyses Paciornik's
report of 20,000 squatting deliveries in sedentary women, I asked Paciornik
to send his letter to the journal Birth which published it - alongside my
summary of the grisly biomechanics of semisitting delivery. [See Gastaldo
TD. Letter. Birth 1992:19(4):230; and see Paciornik M. Letter. Birth
1992:19(4):230-31]

Again Manohar, this will be my last email to you. Please do your job and
encourage members of the American Academy of Spine Physicians to do *their*
job, as in,

"[AASP p]hysicians who are employed by an institution, agency or clinic have
the responsibility to be alert of situations which may compromise the best
interest of the patient and shall make every effort to improve those
conditions."
http://www.spinephysicians.org/dr4coe.cfm

I have been alerting AASP spine physicians of BIZARRE birth conditions that
cause TERRIBLE baby spinecare. Please encourage AASP physicians to "improve
those conditions" - i.e. help STOP MD-obstetricians from routinely closing
birth canals and gruesomely manipulating most babies' spines at birth.

Do it for the babies, Manohar...

END excerpt of Gastaldo's Open Letter to Manohar Panjabi, PhD



MD BIRTH CRIME... By using semisitting and dorsal delivery - which place
women on their sacra - MD-obstetricians are CLOSING birth canals up to 30%.
In addition they are gruesomely pushing (oxytocin/Cytotec) and pulling
(hands/forceps/vacuums) - with birth canals senselessly closed up to 30%.
MDs are killing an estimated six babies per day with
vacuum-assisted spinal manipulation alone...

See MDs/MBs: If you must pull on baby's head - and sometimes you
must...
http://groups.yahoo.com/group/chiro-list/message/2132

The American College of Obstetricians
and Gynecologists/ACOG *admits* (in its
shoulder dystocia video) that OBs are routinely closing birth canals (the
video purports to show OBs how to open the birth canal when shoulders get
stuck).

Bizzarely, the ACOG method for opening the birth canal - PROPER McRoberts
maneuver - actually keeps the birth canal closed.

See IMPROPER McRoberts can save tiny lives and tiny limbs...
http://groups.yahoo.com/group/chiro-list/message/1308

NOTE: I am in favor of pardons in advance for MDs. MDs are just academic
prime cuts forced through this culture's most powerful mental meatgrinder -
medical school.


LORDEX's ANDREW RUTLEDGE, DC AND THE "LORDOTIC" SPINE...

Lordex's AASP spine physician Andrew Rutledge, DC writes of himself...

"Dr. Andrew Rutledge helped conduct ongoing research into the mechanics of
the lordotic spine..."
http://www.lordex.com/rutledge.htm

FACT: The human spine is normally NOT lordotic - not at rest at least; yet
many therapists and physicians promote "the lordotic" spine at rest - i.e. -
they blindly promote "maintaining the lumbar lordosis" inspite of the fact
that most humans on the planet obliterate the lumbar lordosis while resting!

Andrew wites in his bio,

"Working with Orthopedic surgeons, Dr. Rutledge learned..."
http://www.lordex.com/rutledge.htm

Unfortunately, orthopedic surgeons - like obstetric surgeons - aren't very
scientific.

After back surgeons received a US Public Health Service-sponsored dose of
science, they gutted the responsible federal agency (AHCPR)...

See Sen. Frist, infant penis care, dead babies - and AHRQ 'in-hospital
safety
events'
http://groups.yahoo.com/group/chiro-list/message/

I don't think most back surgeons (and Andrew Rutledge, DC) are truly
interested in conservative methods - including primary prevention.

John, if you are a back surgeon, I hope you will prove me wrong about most
back surgeons.

I mention this because currently it appears that your (?) Lordex Spine
Institute is only interested in pain RELIEF - not primary pain PREVENTION,
as in,

"Exploring non-surgical solutions to pain RELIEF is the focus of the Lordex
Spine Institute..."
http://www.lordex.com/backprob.htm (emphasis added)

WHITE ELEPHANT LOSS OF AN ACTIVITIY OF DAILY LIVING (ADL)...

The Lordex Spine Institute says:

"Mechanical back pain may develop from...an acquired condition such as a
repetitive stress injury or an impact trauma...."
http://www.lordex.com/backprob.htm

Westerners "acquire" the condition called loss of the squatting activity of
daily living (ADL)...

The Institute also says:
"When your back goes out, the pain can take your breath away. Any of the
normal activities of daily living - coughing, sneezing, lifting or
bending -- can trigger a painful spasm or regional instability that
negatively impacts your overall health and quality of life."
http://www.lordex.com/backprob.htm

When your back "goes out," the activity of daily living (ADL) called
squatting has long since been robbed...

It *may* be that lumbar discs "go out" far more frequently after years of
being deprived of a natural way to efficiently squeeze fluid out of the
lumbar discs during the day (full lumbar flexion/flat-footed squatting)...

This last is Canadian orthopedic surgeon W. Harry Farhni's hypothesis as
amplified by Adams and Hutton...

See Sarah Key's huge balls (also: Kids can SQUAT motionless for hours)...
http://groups.yahoo.com/group/chiro-list/message/2084

REGARDLESS whether we can prevent back pain by stopping The Great Squat
Robbery...

WHY are back pain professionals remaining silent as this culture robs
children of a fundamental human rest posture?!

Pardon my English but...

It don't make sense!!





FURTHER LORDEX QUOTES...

"By 'reeducating' the nerve fibers through subtle movement..."
http://www.lordex.com/program.htm

"'Lord' for the Lordosis region of the spine. 'Ex' for exercise...the Lordex
Lumbar Spine System...targets the lumbar muscles to reintroduce kinetic
activity...then comfortably tractions the spinal joint, decompressing the
disk and reducing pain. Unlike conventional traction that stretches the back
only, the Lordex Decompression procedure aids in reconstitution and disc
healing, allowing increased circulation to the damaged area."
http://www.lordex.com/program.htm

"[Physical therapist, Chiropractors and medical physicians perform a variety
of techniques that are done in earnest to reduce pain but]...seem to provide
little long-term relief... If the condition becomes too extreme and the pain
intolerable, the back pain sufferer may attempt surgery as a final attempt
for relief. Almost half of all spine surgeries have less than satisfactory
outcomes."
http://www.lordex.com/backprob.htm

"Fortunately, less than 1% of all low back pain sufferers are surgical
candidates. But just because you don't need surgery doesn't mean you don't
need treatment. Lordex is the logical choice."
http://www.lordex.com/differ.htm

86%....or 90% SUCCESS?

"Lordex guests have been able to enjoy a clinical success rate of 86%..."
http://www.lordex.com/program.htm

"While some patients' conditions exceed the limitations of any procedure,
the 86% success rate of the Lordex procedure makes it promising for most
people suffering from acute or chronic low back pain. We have saved
thousands from low back pain without surgery."
http://www.lordex.com/contact.htm
"Non specific acute or chronic low back pain, with a biomechanical
non-disease origin, have an astounding 86-90% success."
http://www.lordex.com/addyour.htm


SACROILIAC - LUMBAR SPINE

LOOK AT ***BOTH***...

Nilsson-Wikmar et al.+++ write:

"Perceived pain and self-estimated activity limitations in women with back
pain post-partum....Based on pain provocation tests, four different back
pain pattern groups were identified. Pain could be provoked in the area of
the posterior pelvic/sacroiliac joints, in the lumbar spine, both in the
posterior pelvic/sacroiliac joints and in the lumbar spine, and in none of
the above areas...There was no significant difference (p = 0.12) in pain
intensity (range of medians 19.5-10 mm) between the four groups. However, on
average, most areas in the lower back (median 5 mm (range 2-14 mm)), were
marked in the group with pain in both the posterior pelvic/sacroiliac joints
and in the lumbar spine...It seems important to pay special attention to the
women where pain could be provoked in the lower back areas. The women should
be identified early in the post-partum period to initiate adequate
treatment."

+++Nilsson-Wikmar L, Pilo C, Pahlback M, Harms-Ringdahl K. Physiother Res
Int. 2003;8(1):23-35. PubMed abstract

Copied to: Nilsson-Wikmar et al. at Neurotec Department, Division of
Pysiotherapy, Karolinska Institutet, Stockholm, Sweden.


Copied to: Flynn et al. at US Army-Baylor University Graduate Program in
Physical Therapy, San Houston, Texas, 78234-6138, USA via


Enclosure
Lordex Inc.
March 27,2003
Device Name: Lordex Power Traction Unit
5 10k Pra market notification nunibex KO3 1227
Indications For Use:
Intended Use:
The Lordex Power Traction Unit provides a program of treatments for relief
from pain
for those patients suffering with low back pain. Each treatment consists of
a physician
prescribed treatment period on the JArdex Traction Unit, and is designed to
provide
static, intermittent, and cycling distraction forces to relieve pressures on
structures that
may be causing low back pain. It relieves pain associated with herniated
discs,
protruding discs, degenerative disc disease, posterior facet syndrome, and
sciatica. It
achieves these effects though decompression of intervertebral discs, that is
unloading
due to distraction and positioning.
Concurrence of CDRH, Office of Device Evaluation
Division sign off
5 10k Number KO3 1227
Prescription Use i// OR
(Per 21 CFR 801.109)
Over-The-Counter Use
" 2; ision of General, Restorative
a d Neurological Devices
--Enclosure to letter to John Boren from Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
US Food and Drug Administration/FDA
http://www.fda.gov/cdrh/pdf3/k031227.pdf

DEVICE: LORDEX POWER TRACTION EQUIPMENT
EVER PROSPEROUS INSTRUMENT INC 510(k) NO: K031227(TRADITIONAL)
ATTN: JOHN BOREN PHONE NO : 281-398-1700
15915 KATY FREEWAY SE DECISION MADE: 17-JUL-03
SUITE 645 510(k) STATEMENT
HOUSTON, TX 77094
http://www.fda.gov/cdrh/510k/sumjul03.html

Copied to: Celia M. Witten, Ph.D., M.D., Director, FDA's Division of
General, Restorative and Neurological Devices, Office of Device Evaluation,
Center for Devices and Radiological Health
301-594-1184 via

Celia: I hope you will personally see to it that the FDA warns pregnant
women that obstetric tables - as MDs use them - close birth canals and cause
gruesome spinal manipulation of most babies at birth.

One last note for JOHN BOREN/Ever Proprosperous Instrument, Inc...

The Oregon Lordex operation does not appear to be up and running - or
they've changed their phone number...

Here's a URL for the Yellow Page Ad. ("We have exclusive use of the LORDEX
system in the entire state of Oregon.")
http://www.yellowpages-ads.com/01316793

I called the number given 503-581-1508 (and 1-503-581-1508) - "disconnected
or is no longer in service" - or words to that effect.

Copied to John Boren via Ever Prosperous Instrument, Inc.
and via Tom Dunn, PT

Thanks for reading, everyone,

Sincerely,

Todd

Dr. Gastaldo



Copied to: ACA Chairman James Edwards, DC at


Copied also to: ACA Member Brian Zaleski, DC at
.


Brian, please copy this to the censored version of chirolist
) and to the ACA and CCA listservs

***This Open Letter will be instantly archived for global access on the
UNcensored version of chirolist...
http://groups.yahoo.com/group/chiro-list/message/2186

Within 24 hours it
will be in the google archive. Search
http://groups.google.com for "FDA MDR: Obstetric tables (also: Pregnancy low
back pain/Lordex Spine Institute)"



 




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