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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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