June 2023- Document exposes battle between FDA and Dental device used in many malpractice cases - https://www.prlog.org/12967107-as-theranos-fraudster-heads-to-prison-dentist-points-to-hoax-that-dodged-the-fda.html
May 2023- American Dental Association and various dental boards have just been alerted to a little known 2012 warning by the FDA regarding questionable health claims related to Myotronics devices used by and promoted by many 'neuromuscular' dentists. The myo-monitor and K-7 jaw tracker have been promoted by the manufacturer and certain seminars as being 'scientifically proven' for headache, migraine, TMJ(TMD), orthodontic and cosmetic procedures when independent experts state these claims are unsubstantiated. This is EXTREMELY SERIOUS as many patients have been led to believe the instruments predicted a "PERFECT BITE" which the professionals often suggested requiring expensive and irreversible full mouth crown procedures. It appears the FDA warning did not have a significant effect on changes to the promotion of these devices beyond what they actually are approved for.
LINK: https://quackwatch.org/cases/fdawarning/prod/fda-warning-letters-about-products-2012/myotronics/
QUOTE:
April 18, 2012
Department of Health and Human ServicesPublic Health Service
Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
April 9, 2012
In reply please refer to Warning Letter SEA 12-21
Mr. Fray Adib, President
Myotronics-Noromed, Inc.
5870 S 194th St.
Kent, Washington 98032
Dear Mr. Adib:
The Office of Compliance, in the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, has reviewed your firm’s print advertisements, brochures, and Internet web sites promoting the K7 Evaluation System, the J5 Myo-monitor, and the BNS-40 Bilateral Neuro Stimulator (BNS-40). FDA determined that your firm manufactures these biofeedback and goniometer products during an inspection of your Kent, Washington, facility from April 25 through May 12, 2011. These products are devices within the meaning of section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
As a result of our review and the inspection, FDA has determined that your firm is promoting and marketing the K7 Evaluation System, the J5 Myo-monitor, and the BNS-40 with new intended uses in the United States without required marketing clearance or approval, in violation of the Act.
Specifically, FDA cleared the K7 Evaluation System under K003287 for explicitly-identified uses in jaw tracking and electromyographic functions. However, your firm has been disseminating marketing material that includes medical claims that have not been evaluated or cleared by FDA. For example:
Similarly, FDA cleared the J5 Myo-monitor (K031998) and BNS-40 (K842224) devices for specific enumerated intended uses. Your firm, however, has been disseminating marketing material for the J5 Myo-monitor and BNS-40 that includes medical claims that have not been evaluated or cleared by FDA. For example:
Your firm sells a patient education pamphlet entitled, “The Benefit of TENS in Dentistry” and specifically references the J-5 Myo-monitor and the BNS-40. This pamphlet includes the following new intended use:
“To provide drug-free pain relief for your patients. Headaches. ” This text is above an image of different type of headaches: sinus, cluster, tension, and migraine.
These devices have not been cleared by FDA for treatment of sinus, cluster, or migraine headaches.
These changes to the intended use of the K7 Evaluation System, the J5 Myo-monitor, and the BNS-40 cause these devices to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to the Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, Seattle District, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact Brenda L. Reihing at (425) 483-4899.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Charles M. Breen
District Director
April 2023- The American Dental Association asks the public to report concerns with a certain dental expander (as seen in the CBS program on the AGGA):
(Dentists and the public should not assume their local dental boards and associations will alert people in their area - send a link to this to those in your state or province and include local media)
March 2023 - CBS news shares an in depth investigation into the Las Vegas Institute and the AGGA they promoted for TMJ and airway treatment:
https://www.cbsnews.com/amp/news/agga-dental-device-lawsuits-teeth-damage/
Tens of thousands of unsuspecting dental patients have been over-drilled or had the roots of their teeth literally forced out of the jaw bone with AGGA or 'Growth Appliances' by dentists warped by corrupt seminars-often pocketing $60,000 per patient. Shockingly the American Dental Association profits from certifying education programs that are known to be associated with malpractice. Regional dental boards accept the seminars for dentist continuing education based on the ADA CERP status and dentists are taught protocols that some experts suggest are 'baloney' and no better than a placebo. Some dentists have quietly stated their colleagues' 'treatment' is in many cases horrific 'butchery' and find consider it physical assault. Following the advice these seminar groupie dentists has often led to premature tooth loss and complications that keep dental malpractice lawyers very busy.
Dentist points to possibly unqualified dental investigators as reason for prolonged dental investigations: https://www.prlog.org/12932438-dentist-victims-frustrated-by-prolonged-investigations.html
A new book 'The $60,000 Dentist Headache Cure' written by whistleblower dentist Dr. Michael Zuk shows the two decade connection between a Las Vegas seminar program, Canada's largest dental lab, two dental boards - one in Alberta, Canada and another in Nevada...and patients claiming they have been hurt by the 'advanced' dental procedures. This is arguably the largest dental health fraud against the public ever orchestrated. A recent series of malpractice lawsuits are only addressing a tiny fraction of the 'over-treatment' that has occurred- most dental victims have no idea they have been scammed simply because the profession is intentionally keeping a lid on this problem to avoid the bad press and harm to their integrity. It comes as no surprise that the founder of one of the seminar programs in question is reportedly now retiring.
IF YOU OR A LOVED ONE HAS BEEN HARMED WITH AN 'AGGA' DENTAL PROCEDURE (often for TMJ problems or snoring/apnea) CONTACT ONE OF THESE LAW FIRMS IMMEDIATELY:
https://www.charnaslawfirm.com/
https://www.sskrplaw.com/alan-c-milstein.html
If you have been treated with a full mouth of crowns after being told a myo-monitor or TENS device suggested a different bite for any health reason (TMJ problems, headaches, cosmetics, restoration of worn teeth, even wrinkles) it may have been an unnecessary procedure. Contact this NOW RETIRED lawyer or one in your areas that specializes in dental malpractice:
http://www.toothattorney.com/ (the website now has referral suggestions)
October 2021 - MORE lawsuits related to the one mentioned below in August is filed. Elsewhere dental boards are reviewing complaints about dentists using the same approaches taught at the SAME seminars. When will the dental profession address this???
Fall 2021- "Tongue Cutter Scam" article has 'ties' with many fringe 'TMJ' dentist approaches - don't miss this one - https://undark.org/2021/09/08/short-on-evidence-dubious-therapies-turn-to-the-tongue/
August 2021- Dentist-Author is contacted about MULTIPLE lawsuits involving procedures discussed in his recent books- patients harmed by 'AGGA' treatment should contact the law firm mentioned in the link below, a local malpractice lawyer and/or their local dental board:
ORTHODONTIST Explains dangers of AGGA Appliance Therapy (seen in recent lawsuits) - https://youtu.be/XWqKi1ldW7g
NYC Woman sues dentist for $10M after 'AGGA' device destroys her smile - https://nypost.com/2020/10/17/woman-files-10m-suit-against-dentist-after-alleged-botched-procedure/
Whistleblower Program interviews Dr. Michael Zuk- October 2020- https://youtu.be/_TMII2Otmz8
Dental Specialists warns dentist to avoid attending 'Las Vegas' seminars to reduce malpractice risk- https://youtu.be/vKEKvf9PTJ8?t=878
NEW- The $60,000 Dentist Headache Cure now on APPLE BOOKS:
https://books.apple.com/us/book/the-%2460-000-dentist-headache-cure/id1536881916
March 2021 - "$60,000 Dentist Headache Cure - 2nd edition - 300 pages of evidence that suggests dental authorities repeatedly make the same errors...and how they profit from NOT addressing the problems of overtreatment in the profession" - Now online for $19.98 US
https://www.blurb.com/ebooks/751798-the-60-000-dentist-headache-cure
2022- Alberta,Canada-VARIOUS EX-POLICE ARE BEING EMPLOYED AS 'DENTIST INVESTIGATORS'...WHY HAS AN EX-COP COMPLAINT DIRECTOR NOT USED HYGIENISTS OR DENTAL ASSISTANTS FOR THIS PURPOSE? MOST COMPLAINTS ARE NOT OF A CRIMINAL NATURE AND IF THEY ARE THE POLICE SHOULD BE INVOLVED.
What could the dental authority choose to do? A responsible authority would look at the list of Class Actions and issue an alert to all dentists in their area that there is a concern with these appliances and the claims of 'growing jaws' appear to be NOT scientifically verified. The dental labs making these appliances - who also sponsor seminars pushing these procedures - should also be warned. Dentists known to have provided this treatment should have all patients audited for treatment complications consistent with those described in the lawsuits. Seminars teaching this method could be delisted from the C Ed list -posted permanently so dentists know if they take the course it will not give then educational credits. Waiting for the complaint to come in and then taking a year or more to even check the chart is NOT protection of the public. The Alberta dental authority gets an F.
Who is qualified to evaluate the harm in these cases? A periodontist. Sadly this and many other dental authorities have NO IDEA what to do. ANOTHER Law firm is added to the list interested in assisting victims. Best advice is to demand the expert investigator should be a periodontist - if one is not assigned (and you get an ex-police officer) it would be wise to seek your own periodontist expert and submit it to the dental authority and a recommended malpractice lawyer. In Alberta the maximum the dental authority may recommend is a full refund from the dentist. In AGGA cases the harm may be so extreme that even all the money in the world (a large settlement) will not be able to restore a person back to the pre-treatment condition. The truth gets worse. In this province the dental authority's record on collecting money from the admitted guilty that ends up helping patients is under 1 or 2% of the money changing hands. Authority lawyers, consultants, investigators, career jurors and 'experts' keep almost 99%. Multiple requests to the Health Minister to request an audit have so far been ignored. On the bright side there seems to be an ongoing investigation from another agency which may provide the spark needed for change.
DONATE $100 US/Canadian funds to this cause & receive a copy of Dr. Zuk's dental authority-banned book Confessions of a Former Cosmetic Dentist (limited number) - https://www.paypal.com/donate?hosted_button_id=TQ8WZ6AMK53MY
*Compare this to aftermarket hardcover book prices on Amazon.com as high as $877 US - https://www.amazon.com/Confessions-Cosmetic-Dentist-Michael-2010-05-26/dp/B01NAO3JE1
All the fancy credentials, the celebrity patients, the online reviews and even the association with dental schools can be used to gain the confidence of the next victim. These dentists can take advantage of people in their weakest moments and then split town and mail you a box of porcelain teeth as your dental credit card starts calling for payments on 'treatment' that may have been completely unnecessary.
The public would be shocked to learn that many of the people responsible for this gross abuse of trust have spent years building layers of protection around them. They have self-awarded themselves, threatened many with lawsuits and used their positions to profit from their charade. This problem runs from the dentist down the street to the highest levels of national and state/provincial dental authorities.