Sleep Apnea Dental Device Warning - FDA investigating Claims Over Grievous Harm Concerns

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  • เผยแพร่เมื่อ 13 ต.ค. 2024
  • Link to the FDA announcement - cpap.review/fd...

ความคิดเห็น • 100

  • @jonchalk3855
    @jonchalk3855 ปีที่แล้ว +15

    I am glad I followed my gut instincts. I did not get this procedure done. I felt that this was too good to be true. So, my final decision was the CPAP option.

  • @alp6244
    @alp6244 ปีที่แล้ว +17

    How very sad. Her livelihood has been taken away permanently and there’s significant psychological damage.

  • @toscatattertail9813
    @toscatattertail9813 7 หลายเดือนก่อน +4

    This is not an apnea appliance.
    That is not her jaw growing forward that is her teeth being shove out of place . This appliance is used with children who are still growing not adults.

  • @RodneyThomasII
    @RodneyThomasII ปีที่แล้ว +8

    Before having something like this done, you should ask for proof that it’s FDA approved.

  • @jamesivan2877
    @jamesivan2877 11 หลายเดือนก่อน +13

    This is absolutely not about a sleep apnea device. A sleep apnea oral appliance is completely different than what this video is talking about. Don't let the title of this video confuse the two. Very sad all around.

    • @LeighPeterson330
      @LeighPeterson330 7 หลายเดือนก่อน +1

      No it was not. It was marketed as helping breathing though

  • @aminemansouri4903
    @aminemansouri4903 ปีที่แล้ว +20

    I am a dentist and can’t understand how colleagues can even think you can grow an adult jaw… it just does not make any sense. Please don’t confuse agga treatment and mandibular advancement devices… Cpap is the gold standard treatment. For those that have difficulty to get used to cpap, mad can be a suitable alternative with its limitations. And yessss mad will move teeth. Even tough we use exercises and other appliances to lower that risk teeth can move. A little teeth movement is the price to pay for your health.

    • @telemario85
      @telemario85 26 วันที่ผ่านมา

      I'm a dentist too, and I can confirm it is NOT a mandibular advancement device...

  • @Fiawordweaver
    @Fiawordweaver ปีที่แล้ว +7

    So tragic that this creative talented person lost her dreams and the future pain and potential surgeries in the future by the rip off device criminal inventor that also ruined other people’s lives. He needs to be imprisoned. Thank you for alerting people that might not of known of this device. I didn’t know.

  • @Sparklepumkin27
    @Sparklepumkin27 ปีที่แล้ว +5

    Thank you! What a devastating surgery to have done!!!

  • @JGKohlenberg
    @JGKohlenberg ปีที่แล้ว +6

    This is so disturbing! I feel bad for these people. Thanks for posting this !

  • @joelhooton2215
    @joelhooton2215 ปีที่แล้ว +12

    I tried a proper mandibular device for a year, so much pain each day and my dentist was legit worried about teeth and jaw issues over time. After a year it brought my AHI from 30 down to 15 so I quit and went back to cpap.

    • @NotMyActualName_
      @NotMyActualName_ ปีที่แล้ว +1

      I'm so glad I turned down an MAD and went with a cpap. At best it would have maybe eliminated half of my apneas, which would have left me still with moderate sleep apnea.

  • @Aurleis
    @Aurleis ปีที่แล้ว +7

    So I'm not a dentist, but I could surmise exactly what would happen if you put this device in an adult's mouth (from the picture inside the mouth). Naturally the teeth are going to flare out. What did this snake oil salesman expect would happen from this dental appliance?!! This chap might be looking at some prison time for [possibly] defrauding at least 20 patients with this device. I'll stick with my Bipap and soon to be ASV machine. Simple is best.
    Thank you for sharing this video, and all of the other videos you've posted. You've been a big help on my sleep apnea journey.

  • @BootStrapTurnerVideography
    @BootStrapTurnerVideography ปีที่แล้ว +6

    I'll stick with my CPAP, my teeth are in great shape and I don't want to risk this type of result.

  • @SEast-ej8ml
    @SEast-ej8ml ปีที่แล้ว +6

    The title of this video is misleading. If you read the FDA statement, it is for the FIXED devices, those that cannot be removed from the patient's mouth by the patient and are not approved by the FDA. If you are considering an oral appliance for sleep apnea, there are FDA approved devices that have been researched, reviewed, and tested for safety.

  • @poeterritory
    @poeterritory ปีที่แล้ว +12

    1:07 Wow. People mistook this used car salesman for someone who they could trust?

    • @Relativecalm2
      @Relativecalm2 ปีที่แล้ว

      Thought the same thing - absolute snake oil salesman. Just the way he was speaking showed a complete lack of integrity.

    • @jellybeansi
      @jellybeansi ปีที่แล้ว +2

      I agree, it's disturbing. He's fixated on repeating a dozen different iterations of "people with nice smiles make more money!", with little emphasis on health benefits, it's bizarre... It doesn't seem like he's actually out there to help people at all. Sadly, I have a funny feeling that most people who used this product never saw that video. :(

    • @LeighPeterson330
      @LeighPeterson330 7 หลายเดือนก่อน

      There were dozens of dentists involved, we never met the inventor galella.

    • @poeterritory
      @poeterritory 7 หลายเดือนก่อน

      @@LeighPeterson330 Can't say I've ever trusted dentists. They tend to find things to do, even when they don't need to be done.

  • @robertduransongcovers4401
    @robertduransongcovers4401 ปีที่แล้ว +5

    Damn, can't trust anyone. Always get a second or more opinions.

  • @kerrig2471
    @kerrig2471 ปีที่แล้ว +3

    this is such a tragic outcome for people just wanting to improve their jaw issues and sleep apnea. I am thankful I decided not to go this route and continue with my BIPAP

  • @riceburner4747
    @riceburner4747 ปีที่แล้ว +4

    Thats her living, thats wrong! I hope she perseveres.

  • @othsasaa5386
    @othsasaa5386 5 หลายเดือนก่อน +1

    For adults it needs surgical assistance to split the maxila suture

  • @ranatlas
    @ranatlas ปีที่แล้ว +2

    Omg. I play the clarinet too! Thank you for this!

  • @StrongDreamsWaitHere
    @StrongDreamsWaitHere ปีที่แล้ว +15

    For all the flaws of CPAP, everything else is worse.

    • @CPAPReviews
      @CPAPReviews  ปีที่แล้ว +9

      I think that's a fair point mate

    • @kerrig2471
      @kerrig2471 ปีที่แล้ว +1

      my tracheostomy which I'm using BIPAP to get rid of, is better than this sham device.

  • @adterpandrea
    @adterpandrea ปีที่แล้ว +4

    This is horrible. Hope I can find part two!

  • @MsSgent
    @MsSgent ปีที่แล้ว +2

    I wish I could give you an extra upvote. Also telling how they charged 15k for this but a MA device with proper study (and imperfect) is ~600.

  • @shellym79
    @shellym79 11 หลายเดือนก่อน +1

    Not a doctor or a dentist but I feel like it's obvious only the teeth would shift when your are kissing something against them. Like how could they possibly think you'd grow jaw bone? Like what? I...

  • @thabreaka
    @thabreaka 2 หลายเดือนก่อน

    Oh my lord, this is insane.

  • @Angel200929
    @Angel200929 ปีที่แล้ว +3

    Will you be uploading the part 2 After Thursday? As watching from UK

  • @commanderosis435
    @commanderosis435 ปีที่แล้ว +1

    I had head gear and neck gear. I'm pretty sure it moved my soft pallet and closed off my airway

  • @creatorex1
    @creatorex1 9 หลายเดือนก่อน

    Go for a certified and safe device and a good profesional to evaluate if you’re elegible to use it: protusion and occlusion … and use the minimal advance possible to remove obstruction. Exercise your jaw and tongue and take control on what’s going on everyday. In example Nora device it’s completely different to this videos .

  • @Chronically_JBoo
    @Chronically_JBoo 9 หลายเดือนก่อน

    Does she have a GoFundMe to get the best dentist who could possibly give bone grafts or implants?

  • @hammerain93
    @hammerain93 9 หลายเดือนก่อน

    That was the worst thing I've ever seen too.

  • @CaneFu
    @CaneFu 8 หลายเดือนก่อน +1

    uh....I think I will stick with my CPAP machine

  • @SandySmith-ww6gq
    @SandySmith-ww6gq ปีที่แล้ว +1

    This is SO sad.

  • @jellybeansi
    @jellybeansi ปีที่แล้ว +1

    2:38 So much tooth death. :( I feel so bad for these folks. Hopefully everyone receives proper compensation.

    • @jellybeansi
      @jellybeansi ปีที่แล้ว

      Also, I've heard that if a certain new device/treatment is very similar to a previously-FDA approved one, it doesn't necessarily need to go through all the checks and red tape before being approved. Not sure if this is true or not, but if it is, that might explain the last part of the video.

  • @TaliaCastilleja
    @TaliaCastilleja 27 วันที่ผ่านมา

    @CBS what about the Vivos mRNA device?

  • @Somnology666
    @Somnology666 ปีที่แล้ว

    GOT DAYUMMMMMMMMM !!! that is AWFUL!

  • @Blingem14
    @Blingem14 หลายเดือนก่อน

    What about the tongue suction bulbs?

  • @travv88
    @travv88 ปีที่แล้ว +4

    If the device makes you look better why does he look like that lol

  • @piperlynne1
    @piperlynne1 ปีที่แล้ว +2

    Cpap causes teeth flaring too. You have to keep your mouth closed and the pressure from the air causes your tongue to press on the back of your teeth causing them to flare out. You end up with front teeth that don't come together anymore. So be aware that cpap isn't a perfect solution either.

    • @priyaravi1571
      @priyaravi1571 7 หลายเดือนก่อน

      Obstructive sleep apnea is a horrible condition with no easy solutions.

  • @shahnjaylaconnors1476
    @shahnjaylaconnors1476 8 หลายเดือนก่อน

    This doesn't even make sense. A device like this can't move your jaws. If that was the case, braces would make your jaws grow.

  • @anrn5303
    @anrn5303 ปีที่แล้ว

    wow, thanks for info... always for 2nd opinion...

  • @davej7458
    @davej7458 ปีที่แล้ว +1

    The only thing he undeniably cares about is that crap load of money. Same thing for the Dentists. How is it possible that a real dentist does not know that he or she is pulling your teeth out?
    The word for that is a Con Man. Now more correctly, Con Person. They find something that is cheap for them and expensive for you and. convince as many people as possible that they need to buy it.

  • @lauriehuber8048
    @lauriehuber8048 ปีที่แล้ว +1

    OMG!
    I’m no expert but even I know you can’t grow an adult’s jaw bone!!!

  • @petechavez6200
    @petechavez6200 ปีที่แล้ว

    You had sent me the address of where I can get my Cpap machine fixed. I can’t find your message could you please send me the info again? Please. I live in California. Thank you.

  • @loretta6089
    @loretta6089 ปีที่แล้ว

    Omg what a horror story 🥶

  • @myelinsheathxd
    @myelinsheathxd ปีที่แล้ว +1

    Mewing and proper posture is the way to go

    • @LeighPeterson330
      @LeighPeterson330 7 หลายเดือนก่อน +1

      I am one of the patients in this story. We all who were damaged know about "mewing," myofunctional therapy, posture, proper tongue posture, etc. that is not going to address these issues fully.

  • @frankrinaldi3520
    @frankrinaldi3520 ปีที่แล้ว

    I didn't like it and Lucky I didn't have to pay for it since my cousin was a dentist. I prefer the mask

  • @DeloresCastillo-k1d
    @DeloresCastillo-k1d หลายเดือนก่อน

    Garcia Margaret Martinez Brian Hernandez Donna

  • @andrewkoetz3933
    @andrewkoetz3933 ปีที่แล้ว

    Damn; I don't have any jaws that need "surgery"; but all the pain & the career the musician had & income lost because of this snake oil device......

  • @johnsmith-sw7ii
    @johnsmith-sw7ii ปีที่แล้ว +1

    Where is the apnea story??????

    • @RodneyThomasII
      @RodneyThomasII ปีที่แล้ว +5

      Some people had this procedure done to cure sleep apnea

  • @probuildman
    @probuildman ปีที่แล้ว

    Wow,

  • @erkut67
    @erkut67 ปีที่แล้ว

    😱😱😱

  • @ebo7310
    @ebo7310 6 หลายเดือนก่อน

    Wow

  • @davej7458
    @davej7458 ปีที่แล้ว +3

    I think the title you used Is completely misleading it has nothing to do with sleep apnea.

  • @GlendaPhillips-f8r
    @GlendaPhillips-f8r 23 วันที่ผ่านมา

    Lee Amy Smith Donna Lee Kimberly

  • @AmeliaSmith-qk9sn
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    Jones Christopher Allen Sandra Hernandez Steven

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    @PriestleyJill-d6b หลายเดือนก่อน

    Thomas Donna Lopez Kevin Jones Richard

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    @gregserussel1308 29 วันที่ผ่านมา

    Hernandez Jessica Gonzalez Robert Lopez Jeffrey

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    @beatricesykesfera3810 26 วันที่ผ่านมา

    Johnson Cynthia Anderson Elizabeth Johnson Timothy

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    @ClydeOrville หลายเดือนก่อน

    Hernandez Eric Harris Timothy Martinez William

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    @TommyPhoebe-d6b 27 วันที่ผ่านมา

    Thompson Kimberly Gonzalez Linda Anderson Laura

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    Garcia Donna Taylor Patricia Young Michelle

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  • @JS-xs5hq
    @JS-xs5hq ปีที่แล้ว

    Horrible.

  • @rapromania-zc9zh
    @rapromania-zc9zh ปีที่แล้ว

    But do you breathe better!?

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    @harrisondyson1508 28 วันที่ผ่านมา

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    @長谷川樹-y3j 28 วันที่ผ่านมา

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