• Report: #448010

Complaint Review: The Pure Sleep Company

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  • Submitted: Fri, May 01, 2009
  • Updated: Sat, July 14, 2012

  • Reported By:Tomball Texas
The Pure Sleep Company
900 Larkspur Landing Cir., #207 Larkspur, California U.S.A.

The Pure Sleep Company damaged ligaments in jaw, causing migraines and painful jaw Larkspur California

*General Comment: PureSleep Problems

*Consumer Comment: good morning

*Consumer Comment: Poor design and terrible customer service

*Consumer Comment: Pure Sleep

*Consumer Comment: PureSleep: The 'Mengele' Approach

*Consumer Comment: similar problems

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The Pure Sleep company (located in Larkspur, CA.) promotes a device that stops snoring, which is why my husband purchased it for me. This device has caused me to have severe problems with my jaw, and has caused me to have migraine headaches EVERY DAY for the past 5 months. Prior to the use of this product I did NOT have either of these issues. I have had to quit my job as a direct result of this product. I have seen 7 doctors trying to figure out what is wrong with me, and have had numerous x-rays (MRIs, as well as soft tissue x-rays). Finally I went to my dentist for my regular cleaning and my dentist asked me what was going on (I had to wear my sunglasses in his office because I could not handle the light) I told him that I have been having severe headaches and jaw pain, and that after all of the testing I have had, I wondered if all of these problems stemmed from the Pure Sleep device Dr. Slatton said that he was in disbelief that this dentist who came up with the Pure Sleep device has not already been sued. We have mounting medical bills and are living on one income now. We had to trade in both of our cars, and have had to cut our budget down to where there is nothing else that we can cut out. Dr. Slatton referred me to a cranial facial pain doctor who is also a dentist, Dr. Ron Prehn, and I am currently under his care. Dr Prehn. Both my dentist and the cranial facial doctor say the Pure Sleep device is very unsafe, as you are supposed to GRADUALLY move the splint forward over a period of time. The Pure Sleep device instructions state that you are to boil water and submerse the device for a few minutes - then push your bottom jaw forward and mold the device, I now have to take 8 meds a day as a direct result of all of this.

After doing a website search it would appear that this company is selling a dangerous device, not only for the damages I have listed, but for thousands of others out there that have severe sleep apnea - which I was also diagnosed with by the doctor who is currently treating me.

Marcella
Tomball, Texas
U.S.A.

This report was posted on Ripoff Report on 05/01/2009 09:46 AM and is a permanent record located here: http://www.ripoffreport.com/r/The-Pure-Sleep-Company/Larkspur-California-94939/The-Pure-Sleep-Company-damaged-ligaments-in-jaw-causing-migraines-and-painful-jaw-Larkspu-448010. The posting time indicated is Arizona local time. Arizona does not observe daylight savings so the post time may be Mountain or Pacific depending on the time of year.

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#1 General Comment

PureSleep Problems

AUTHOR: Brian A. - ()

I too have started having problems using the PureSleep device. While the device has worked, according to my wife, I am starting to have really bad jaw pain. The manual states that when you mold the device to your mouth to move your lower jaw forward. I woke up the first few mornings with an uncomfortable feeling in my jaw.

But now, I am in pain now, and the pain has persisted despite stopping using the device. I apparently started grinding my teeth when the device is in, yet don't do it when I don't have it in my mouth. I am now one week past when I stopped using the device and am worried I have ligament damage in my jaw.  

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#2 Consumer Comment

good morning

AUTHOR: freetz - ()

Thanks for warning us. Might want to try good morning snore solution. They have positive reviews at this site http://www.websitesreviewer.com/goodmorningsnoresolution-com-good-morning-snore-solution-reviews/

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#3 Consumer Comment

Poor design and terrible customer service

AUTHOR: Jay - ()

I ordered this product. It was too bulky for the mouth to close. As a result it caused dry, irritated throat and did not prevent snoring.

The company implies a risk-free trial period and money back guarantee. In practice, they refused to reverse their billing to my credit card, even though I had complained in the first week about the device not working. Because I did not follow up and specifically ask them not to bill me, they billed my credit card and then refused to consider my complaint because the 30 day trial period was over.

This felt like a bait and switch to me.

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#4 Consumer Comment

Pure Sleep

AUTHOR: HelloMsPolly - (United States of America)

A person might think the owner of PURESLEEP is related to me because I have nothing but wonderful things to say about the product.

First I believe there are certain "buyer bewares" issued in their advertising and if I were her would have been suspicious of "PURESLEEP " early in her malady.

For me, having been diagnosed with SLEEP APNEA and not being able to stand wearing the pressurized breathing mask, PURESLEEP is a God send,. I had been told that I choked so bad in my sleep "they" were concerned I would choke to death.

I have been using PURESLEEP for at least two years, I am told that when I snore it is very soft and unannoying.

I feel amazingly better when I am wearing it, which is almost always.
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#5 Consumer Comment

PureSleep: The 'Mengele' Approach

AUTHOR: CPS-91935 - (U.S.A.)

Are FDA and NIH ignoring UNDISCLOSED risks of Sleep Science Partners' OTC marketing!?' The FDA or at least its advisory panel has lost its collective mind. Or maybe FDA (commerce) and NIH (basic-science) are so enamored by the medical device industry and its big money that they see nothing else . . . like the very life of the citizens for whom they have been engaged to protect.

[NOTE: The following is not for the faint-hearted, technical and historical references provided are a must! It would behoove those unfamiliar with industry's academic terms, to look them up! Should the FDA and or CA Board of Dental Examiners happen to pass this way, you dropped' and fouled' the ball in the 1980's, i.e., G. Singleton, DDS, Office of Medical Devices and L.C. Ballard, Supervising Investigator, respectively. ]

July 4, 2009

An Open Letter to Marcella, via the EDitor:

You are the first victim, in the course of an almost three decade search, with matching initial' complications, (i.e., TMJ (jaw joint) ligament damage, migraine headache and light (photo) sensitivity), resulting from the application of a mandibular repositioning appliance, currently being sold under the guise' of an anti-snoring device. The potential' for your sustained injuries were well anticipated' by the industry. The depth and breadth of the heart and soul goes out to you.

We are 'Trustee' to one whom, at the age of 28, sustained permanent and irreparable damages which to date, has resulted in the amassing of ninety (90) document boxes containing federal/state agency and judicial records (inclusive of a restraining (gag) document, coerced at the federal level in 1996), and over two-million dollars ($2,000,000.00) worth of medical/dental work records and university research findings. Added to an extensive library of authoritative medical and dental texts donated by many a licensed professional and, thanks to the internet, over five-hundred (500) gigabytes of clinical trials and reports have been collected. In reviewing this victim's files, we have witnessed many a Cardiologist, Chiropractor, E.N.T., General Dentist, Internist, Neurosurgeon, Orthodontist, Orthopedist and Respiratory Specialist, etc. responding, in a state of pallor', with a resonant OMG.

TO THE ISSUES UNDER CONSIDERATION, FDA provides the following conciliatory gratitude: Medical Devices - Alerts and Notices (Devices) Problems with medical devices may be caused when devices malfunction. But problems also may arise when users--either health professionals or the general public--do not understand or follow proper use instructions. FDA issues alerts and warnings to explain why problems may be occurring and clarify proper procedures to ensure safe and effective use of devices. Feel better?

It is true, correct and by the book, as stated by your dentist and cranial facial specialist, that the mandible (jaw) should be gradually brought forward [from its natural physiological functioning position] over a period of time. When one is under the care of a licensed professional receiving anti-snoring therapy and or 24/7 permanent' mandible repositioning from a Class II symptomatic' [mal] occlusion, such would be the case. Interestingly, PureSleep is promoted to the consumer as a SIMPLE over the counter' (OTC) nocturnal (night-time) device for a potential resolution to snoring. It is plausible for licensed professionals to liken the PureSleep approach to a nightly (cyclical) pseudo jumping the bite. Dislocating' the jaw 2-10 plus 1 or 2 mm, per USPN 5499633, doing so in a finite space is known to provoke deleterious consequences!

MEDICAL DEVICE - LEGISLATION: In regards to specific marketing of PureSleep' and the 'apparent' legal pathway to the consumer's door, one need look to FDA's Bureau of Medical Devices and Diagnostic Products, created in 1974, and a complete' review of the Medical Devices Amendments (MDA) of 1976, in particular, the Senate Subcommittee Hearings leading up to the MDA finalization. Lobbyists' square' the legislation and subsequent amendments enlisting so-called opposition' lawmakers via compromise, to achieve their goals. Such is parallel to that of the banking and finance sector special interests group and the lobbyists which devastated our financial system and, too, in time will leave one in a state of bewildered awe. Our Founding Father's warned us doggedly about the pits of diversity and the special interests group, although in their day the term used was faction. With that said,,,,

AGENCY OVERSIGHT, HISTORY: Such begs the question, as posed in Pittsburgh Post-Gazette's August 5, 2008 article covering the marketing of PureSleep entitled, Resting uneasy: Heavy marketing of anti-snoring device worries some', by Steve Twedt: That has dental sleep specialists wondering -- how do people get a prescription without seeing a doctor or dentist? Mr. Lindsay (CEO) said Dr. Douglas Fenton, the California dentist who invented Pure Sleep, is the prescribing doctor generally. Asked if Dr. Fenton confers with doctors in the patient's home state, or if Pure Sleep follows up with patients, Mr. Lindsay declined to give specifics. I don't want to tell potential competitors how we do what we do. He also declined to provide sales figures for Pure Sleep, which came on the market in November [2007]. We believe we have a set of processes that are based on gathering the necessary information and crosschecking them in a way that is really powerful and clinically valid, he said. Apparently, unaware, thus unreported by the investigative reporter is that Sleep Science Partners, Inc.; CEO Noel Lindsay is recognized for his expertise in evangelizing new technologies!

Paraphrased: How is it that PureSleep appears to be getting away with a prescription' controlled mandibular-advancement device' being sold over-the-counter' as an oral anti-snoring device'? PureSleep's competitor, SnorBan' UK/Snoring Relief Labs', US, had its mandibular-advancement device' SEIZED.

FDA action initiated in the mid 90's concluded with the Agency's seizure of SnorBan, by 2001. The FDA's Dr. Runner concluded, that marketing SnorBan without a prescription raised two new questions about safety and effectiveness: (1) It would require the patient to distinguish between simple snoring and obstructive sleep apnea, a potentially life-threatening condition; and (2) It would require the patient to determine if she has any temporomandibular joint (TMJ) disease [symptoms] that would not permit the use of an oral appliance. If the patient advances her jaw too far forward in fitting the device, she could suffer TMJ. [Source: 210 F.3d 1081 (9th Cir. 2000) UNITED STATES OF AMERICA, Plaintiff-counterdefendant-Appellee, v. SNORING RELIEF LABS INC., Defendant-counterclaimant-Appellant. No. 99-15190 UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT Argued and Submitted February 9, 2000 Filed May 2, 2000.] FDA's subsequent May 15, 2001 letter to SnorBan (UK) and Snoring Relief Labs in California contains the following: ... FDA considers SnorBan to be a prescription device and therefore adequate directions for use cannot be written for safe use of this device by a layman. As a prescription device, SnorBan is not exempt from the regulatory requirements, as described in Title 21 of the Code of Federal Regulations, section 801.109. Therefore SnorBan is also misbranded within the meaning of section 502(f)(l) of the Act because its labeling does not bear adequate directions for use.

Marketers of legitimate products usually correct the problems immediately. Marketers of quack products vary. Currently, SnorBan instructs the consumer on how to get around FDA in the close of the Company's Disclaimer': The process to get the SnorBan anti-snoring mouthpiece approved for availability through a prescription is a very time consuming and costly process. This would cause the price of a SnorBan anti-snoring mouthpiece to skyrocket and then it would not be affordable to very many people. Since the SnorBan anti-snoring mouthpiece also works well as a sports mouthpiece we have decided to only sell our mouthpiece in the U.S. as a SnorBan brand sports mouthpiece and not as an anti-snoring mouthpiece. So if you need a SnorBan brand sports mouthpiece for some sporting activity we can take your order.

Although some marketers comply with the law, many stall, attempt to obfuscate, and/or continue to do as much as they think they can get away with.

CORPORATE GUINEA-PIG RESEARCH ala FDA (?): PureSleep, too, is a prescriptive mandibular-advancement device (MAD) being sold with what appears to be yet another slight-of-hand' OTC technique. Apparently, it is the materials that are FDA-cleared as safe'. This Company points to its product' as being cleared through FDA and, if so, the question is, for what purpose?

FDA ESTABLISHMENT REGISTRATION & DEVICE LISTING:
Proprietary Name: PureSleep
Classification Name: DEVICE, ANTI-SNORING
Product Code: LRK
Device Class: 2
Regulation Number: 872.5570
Medical Specialty: Dental
Registered Establishment Name: Sleep Science Partners, Inc.
Registered Establishment Num: 3006794225
Owner/Operator: Sleep Science Partners, Inc.
Owner/Operator Number: 10023348
Establishment Operations: Specification Developer Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

FDA PRODUCT CLASSIFICATION:
Device: device, anti-snoring
Regulation Description: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Regulation Medical Specialty: Dental
Review Panel: Dental
Product Code: LRK
Submission Type: 510(k)
Regulation Number: 872.5570
Device Class: 2
GMP Exempt?: No
Recognized Consensus Standard: ISO 7405:1997 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
Guidance Document: Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA
Third Party Review: Eligible for Accredited Persons Program

According to CA Dept. of Corporations, Sleep Science Partners, Inc. (C2786121) and The PureSleep Company are both located at 900 Larkspur Landing Circle, #207, Larkspur, California 94939. One of the partners possess a DDS and MS degree and is the Company's so-called medical/dental advisor. Corporate website puts forth that this individual is a FULL Professor in the Division of Diagnostic Sciences at the USC School of Dentistry and is considered [by some] the leading pioneer' in the research and development of mandibular advancement devices to treat snoring and obstructive sleep apnea. His groundbreaking work has led him to be the Principal Investigator on several National Institute for Dental Research grants. Prior to his tenure at USC, [he] was a full professor at UCLA, where he was also the Director of the Clinical Research Center, Director of the Dental Research Institute, Associate Dean of Research, Chair of the Sections of Orofacial Pain, Oral Diagnostic Sciences and Oral Medicine. Sounds authoritatively impressive, wouldn't you say?

Of interest too, is that the Company advertises Pure Sleep' as being proudly made in the United States from American-sourced materials. However, Made-In-China.com states that Pure Sleep (EF-7684). USPN-5499633 is manufactured in CHINA, available for export to over 60 countries including the USA, UK, France, Spain, Japan, Korea, Australia, UAE, Chile, etc.

It is clear, from FDA's Dental Products Panel Meeting- November 3-5, 1997' and the aforementioned action taken, that the Agency's staff knows and understands that exposing the consumer to a mandibular-advancement device (MAD) would be more than risky. At the time, Sleep Science Partners' so-called medical/dental advisor was a Guest Speaker who delivered scientific fact and thoughtful remarks that were more than simply provocative'. It is well-documented that handled even as a prescriptive device' the licensed professional, too, has fallen victim to the dangers of the predictable and' unpredictable results. And, that OTC use in the laypersons hand will never be without consequence, no matter what. Apparently, as identified by the Sleep Science Partners' medical/dental advisor, that estimated two-billion dollar anti-snoring market took precedence over the estimated thousands of dollars in cost to various consumers' who over prolonged use incur a shifting of the teeth.

WHAT IS THE ACTUAL' TOLL EXTRACTED FROM TAXPAYER FUNDED PROGRAMS APPLICABLE TO UNDISCLOSED CORPORATE HUMAN RESEARCH? Consumers' whose injuries point to iatrogenic sources, (individual and or corporate), may find that the tab for industry liabilities (externalities) are NOT handled humanely: VII. The Politics of Power: Abuse of the Somatoform Disorder Psychiatric Diagnosis, the Handling of Psychiatric Claims, and the Operation of the Houston Anti-Fraud Unit in 20013: TRCDDS apparently does not believe in certain diseases associated with chemical injury. (We believe this also extends to the Texas SSA ALJ's [Social Security Administration, Administrative Law Judge] at the OHA's [Office of Hearing and Appeals] at least in Dallas, given the number of ALJ decisions written over the past 15 years there labeling claimants who have been treated by doctors named in the October 1996 TRC MCS'' Memo as having a medical condition that is iatrogenic''caused by the doctor.) As a result, the only way that many of these desperate injured individuals can get Social Security disability is on grounds of somatoform disorder'', a psychiatric condition similar to being a hypochondriac. ..tactics included subjecting claimants including some with mental problems to ruse interviews'', including by falsely accusing some individuals of crimes in order to evaluate their mental response. [Source: Hearing Before The Subcommittee On Social Security Of The Committee On Ways And Means U.S. House Of Representatives, One Hundred Eighth Congress, First Session, September 23, 2003. Serial No. 10840. Pg. 131] Social Security Administration guidelines for Disability Evaluation Under Social Security lists Somatoform disorders for adults under category 12.00 Mental Disorders, subsection 12.07 Somatoform disorders. Physical symptoms for which there are NO demonstrable organic findings or known physiological mechanisms. [Source: SSA]

That $2,000,000.00 tab' identified in the opening to this letter includes some rather extensive and risky surgical interventions; two procedures to correct direct damages incurred from mandibular-advancement (unauthorized' bilateral insertion of Vitek-Proplast II, another FDA debacle) and, four subsequent life-saving procedures for debris removal and reconstruction as a result of defective materials placed in the prior two surgeries. Such did provide free biological materials research data, at consumer expense. More so, what that dollar amount does NOT include is the almost three decade worth of public program expense, under the disability label of Somatoform Disorder.

Accordingly, politically' coercive and/or restrictive wrong diagnosis', which equals wrong and or inappropriate treatment', incurs more than a mere industry constructed misappropriation' of the Public Trust under color of the law'. Added to the complexity of the issue is the century long manufactured' controversy amidst industry, academic and clinical infighting, everybody wants a piece of the pie which includes federal grants'. Many a consumer goes about with unassociated environmental and or manmade biomechanical or chemically induced neuromuscular-orthopedic-STRESS' symptoms which the Behavioral Sciences (BS) maintain as unrelated. Disorders involving the temporomandibular joints (TMJ), the pivotal lever within the cranio-mandibular-cervical complex, have often been referred to as The Money Junction.

WHAT IS NOT BEING DISCLOSED REGARDING THE MANDIBULAR-ADVANCEMENT DEVICE (MAD) AND OR ORAL ANTI-SNORING APPLIANCE
R.O.A., Forward Posturing. "The changes induced by these passive functional appliances are monitored by intrinsic factors for each patient." "The delicate forces, plus the gradual and sequential forward positioning of the lower jaw, will avoid the exertion of undue pressure." "Owing to the individual differences in response, results of bionator' (a pre WWII label) treatment cannot be predicted, and the prognosis may be very difficult to determine at the start of treatment." "Generally speaking, the muscle action is comparable to that of cervical headgear pull--the mandible [lower member of the appliance] acts as the outer bow of the headgear, whereas the labial arch wire [upper member of the appliance] can be compared with the inner bow. "These devices involve the masticatory' and neuromuscular system' for the correction of malocclusion and require great sublety in their management. Such potentially dangerous appliances must not be used unless the operator has had proper and full training in diagnosis and treatment technique. [Source: T.M. Graber, DMD, MSD, PhD and Bedrich Neumann, MD.] Can we say ALTERED central nervous system (CNS) processing all the way up to the pyramidal cells of Betz'!?

R.O.A., Head Posture & Cranial Morphology. A comprehensive set of correlations was found between craniofacial morphology and head posture, and the correlations were similar for both head positions investigated. Of the postural variables the craniocervical angulation showed the largest set of correlations with the craniofacial morphology. It is apparent that all of the muscular balance systems of the region are interconnected or perhaps part of one balance system. Apparently there is some evidence that adaptive changes will follow alterations in the muscular balance system. It is suggested that such changes may be provoked by an appliance interfering effectively with the existing muscular balance. [SOURCE: T.M. Graber, DMD, MSD, PhD and Bedrich Neumann, MD.]

R.O.A, about the principal author. Dr. Graber, DMD in dentistry', MSD in orthodontics', and a PhD in anatomy', was Professor of orthodontics at the University of Illinois at Chicago (UIC) College of Dentistry and editor-in-chief of the World Journal of Orthodontics at the time of his passing, on June 26, 2007'. At the University of Chicago, he founded and chaired the Orthodontic Section at the university's medical school and was also a visiting professor at the University of Michigan. Because of his prodigious production of 28 texts (including foreign translations) for both orthodontic specialists and general dentists, 22 book chapters, more than 200 scientific journal articles, his editorship of orthodontic journals (the American Journal of Orthodontics and Dentofacial Orthopedics and the founder of World Journal of Orthodontics), his presentation of more than 475 lectures all over the world, and his multiple faculty positions coupled with his mentorship of students and colleagues, it is not an exaggeration to claim that in some fashion he helped educate every orthodontist who entered the specialty in the last 50 years. For these efforts, he was internationally recognized and was the most decorated orthodontic specialist in the world. He founded the Kenilworth Dental Research Foundation, endowed a professorship at the University of Michigan and contributed to the UIC College of Dentistry. He was a preeminent historian of our specialty, and his passing represents one of the last live connections to some of the equally great orthodontists who established the art and science of orthodontics. [Source: WFO 06/26/2007 Memorial]

Sleep Science Partners' venture in to the mandibular-advancement device' so-called oral anti-snoring appliance' multi-billion dollar market was launched by November of 2007.

SCIENTIFIC FACT OR THEORETICAL CONTENTIONS, you be the judge: In spring of 1980, this victim, (history free of cranial, facial and cervical complaint), received an oral appliance incorporating an instantaneous 13.5mm forward dislocation of the mandible (jaw). Gradually complaints of migraine like headaches on lateral upward gaze, sensitivity to light and pain in front of the ears occurred. Within thirty days after removal of the appliance, by year end, this victim wound up in a local ER due to difficulty with breathing, he blacked out while at work. Diagnosis of possible viral flu led to diagnosis of sinusitis throughout 1981 into 1982. Injury to the usual craniofacial, temporomandibular joint, mandible and hyoid muscle/ligament/fasciae pre- vertebral attachments were identified in mid 1982. However, associated internal injuries (post- vertebral muscle and ligament attachments) were identified BUT not confirmed until almost one year later. Due to SLEEP SCIENCE PARTNERS' medical/dental advisors fingering the matter, the suppression' of a UCLA associates accurate diagnosis occurred, overturning and perverting the dentist's findings in to a diagnosis of hysterical trismus', a.k.a., somatoform disorder. To whom and or what might the benefit be?

In the aftermath, a biomechanical engineering study' was performed focusing in on the temporomandibular joints and associated intersegmental attachments of the head and neck (occipitoatlantoaxial extension capacity and compensatory extension at the subaxial regions should the occipitoatlantoaxial complex, too, be impaired): Video fluoroscopy was utilized to observe the spine and the TMJ's in motion. .. The TMJ study was done in two increments in this particular study due to the fact that opening and closing the mouth to observe motion within the TMJ caused the patient to become light headed, dizzy, and unable to follow directions. The left condylar process of the mandible demonstrated a anomalous shape. The right and left joints displayed a bizarre and aberrant motion. The heads of the mandible moved in a jerky fashion that caused motion even in the cervical spine. In addition, it was noted that the first cervical vertebra in the extremes of flexion and extension would actually tilt low on one side. This was so extreme that one could see through the spinal canal. When the patient's head was placed in the extension and flexion position and his muscles and ligaments were NOT involved, the tilting of the first cervical vertebra is NOT evident. IMPRESSION: 1. Bizarre movement of the TMJs. 2. Aberrant motion of the first cervical vertebrae. 3. Altered motoricity of the entire cervical spine. COMMENTS: The bizarre motion of the first cervical vertebra and the aberrant motion of the first cervical vertebra can only be due to ligamentous instability. Since the patient was ASYMPTOMATIC earlier, this would have to be due to traumatic insult.

In April of 1984, on order of the primary physician', bilateral temporomandibular arthrograms were performed, interpreted as left side normal, right side perforated meniscus. At the request of a consulting oral and maxillofacial surgeon', in May of 1984, the right-sided arthrogram was repeated which did not indicate perforated meniscus but did indicate an anteriorly displaced meniscus with mid-to late recapture during open and closure, an anterior dislocation far anterior to the eminence during the opening cycle, gross muscular and condylar movement incoordination was evident on the x-ray studies. The April, 1984, study was accidentally' destroyed at the facility, the perforated meniscus disappeared' by May, as well.

Neurological consult, mid 1984, uncovered the following: It is my diagnostic conclusion that the primary problem is not in a peripheral organ system but rather in the central nervous regulation of perception and motor tone. I am unable to point to a specific etiology. [Device specs were withheld from the physician.] As per our conversation it is my recommendation that he be hospitalized for a substantial dose trial of dopamine antagonist in an attempt to restore a chemical imbalance in subcortical areas. It is my opinion that diagnoses such as myofascitis or chronic pain syndrome do not do justice to the severity of this unfortunate man's problem. Otherwise, identifiable as an iatrogenic mechanical stress induced processing short-circuit'!

Fast forward to 1999, a UCSD Prof. of Neurosurgery report of findings expounds on the pathology: A review of his MRA showed that the left vertebral artery was dominant and the right vertebral artery was ectactic. The flap in his vertebral artery was not appreciated. His MRI scan, however, showed that the left vertebral artery was significantly distorting the medulla and pushing it to the right side. The MRI scan of his cervical spine showed that there is some hypertrophy of the C1-2 synovial joint. Review of the patient shows that, most likely, his difficulty lies in the lower brainstem and upper cervical cord. Pathology that could lead to this lesion includes not only vascular diseases, such as ecstatic vertebral arteries, but, more likely, occipital junction problems, such as C1-2 instability. Otherwise known as Atlanto-Axial-Instability' such is a condition usually identified with Down-Syndrome, and the post-mortem statistics are less than comforting.

BEFORE PLACING SOMETHING IN THE MOUTH OR NOSE: It would behoove the consumer (mouth-breathing, snorer' or not who complains of dry mouth and or excess salivation), to gain a better understanding of the respiratory system. Where does the general public think the fundamental idea in designing air- heating, cooling, humidifying and particle filtration system's comes from? For a quick reference:

Role of turbinates in the respiratory system - The turbinates composes most of the mucosal tissue of the nose and is required for functional respiration. The turbinates are enriched with airflow pressure and temperature sensing nerve receptors (linked to the trigeminal nerve route, the fifth cranial nerve), allowing for tremendous erectile capabilities of nasal congestion and decongestion, in response to the climatic conditions and changing needs of the body. The turbinate are also responsible for filtration, heating and humidification of air inhaled through the nose. Of these three, filtration is the most important reason to breathe through the nose. As air passes over the turbinate tissues it is heated to body temperature, humidified (up to 98% water saturation) and filtered. [Source: wikipedia]
Role of turbinates as an immunological defense - The respiratory epithelium which covers the erectile tissue (or Lamina propria) of the turbinates plays a major role in the body's first line of immunological defense. The respiratory epithelium is partially composed of mucus-producing goblet cells. This secreted mucus covers the nasal cavities, and serves as a filter, by trapping air-borne particles larger than 2 to 3 micrometers. The respiratory epithelium also serves as a means of access for the lymphatic system which protects the body from being infected by viruses or bacteria. [Source: wikipedia]
Role of turbinates in olfaction - The turbinates provide, first and foremost, the humidity needed to preserve the delicate olfactory epithelium needed to keep the olfactory receptors healthy and alert. If the epithelial layer gets dry or irritated, it may cease to function. This is usually a temporary condition, but over time, may lead to chronic anosmia. The turbinates also increase the surface area of the inside of the nose, and by directing and deflecting airflow across the maximum mucosal surface of the inner nose, they are able to propel the inspired air. This, coupled with the humidity and filtration provided by the turbinates, helps to carry more scent molecules towards the higher and very narrow regions of the nasal airways, where olfaction nerve receptors are located. The superior turbinates literally hood-over, and protect the nerve axons piercing through the cribriform plate (a porous bone plate that separates the nose from the brain) into the nose. Some areas of the middle turbinates are also innervated by the olfactory bulb. All three turbinates are innervated by pain and temperature receptors, via the TRIGEMINAL NERVE (or, the fifth cranial nerve). Research has shown that there is a strong connection between these nerve endings and activation of the olfactory receptors, but science has yet to fully explain this interaction. [Source: wikipedia]

Before the general public realizes it, the consumer will be bombarded by competing interests offering their prescription mandibular-advancement device, too, as an FDA cleared' anti-snoring appliance, but, is there really a savings? We have a crises on hand with the Social Security System, Medicare and, or, Medicaid requiring a massive overhaul. Would such be to provide health services to the mass or to reach, in unison, other targeted goals?

Eugenics, currently under the guise of Human Genetics, with its updated biometrics and IT gathering template, data previously collected via IBM, incurs or reduces more than mere monetary issues, as clearly laid out in the master race' manual leading up to WWII. Beware of those so inclined that, too, remain entrenched in the field of oral' wire-pullers (misidentified by many a [politicized] historian). TAKE TIME TO THINK our species history', one of this victims' 24/7 nursing providers engaged over a five year period, was an Eastern European WWII era escapee. As in the past, you will know them by the fruits of their cephalometric' lab[H]ours, in particular, ones whose focus is on twins. Remember, as the astute historian, the legislated' acts and or events carried out through ones shadowed' by Hitler, were LEGAL'. That man too, was strung-out on prescriptive' drugs.

Thus, it is said, that we are creatures of free will and moral choices. It is critical that those who seek reward do not take reckless risk; that short-term gains are not pursued without regard for long-term consequences. Granted, if in the opinion of the licensed professional the patient's condition would benefit from one of these neuromuscular orthopedic brain-stimulating devices, in a majority of cases, the benefit should [hopefully] far outweigh the risk.

Complaints regarding The Pure Sleep Company, its parent company Sleep Science Partners, Inc. and, or, N.I.H. and F.D.A. can be lodged with any genuine' HUMAN protection agency and or non-profit watchdog of the watchdogs' that comes to mind. Such action notifies these "watchdogs" of dangerous products on the market and will hopefully put the industry ON NOTICE.

Your lack of response to a question posed on your listing leads one to wonder if your health is preventing interaction. Hope all is well and fine with you and, that you celebrated a Happy 4th of July, 2009'.
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#6 Consumer Comment

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AUTHOR: Michele - (U.S.A.)

So sorry to hear of the drastic changes that have occurred in your life. I know of someone who used a similar device and is experiencing ailments similar to what you have described. If you don't mind me asking, how long had you been using Pure Sleep?
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