FDA says it never inspected lab that made controversial device intended to fix patients' jaws

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  • Опубликовано: 12 май 2024
  • Documents show a dental lab that made a device that was supposed to help patients with TMJ jaw disorder was never inspected by the FDA before a CBS News and KFF Health News investigation. Numerous patients have said the "anterior growth guidance appliance," or AGGA, damaged their mouths. The device's inventor, dentist Dr. Steve Galella, claimed it could cure TMJ jaw disorder and sleep apnea. The device and its inventor are under criminal investigation. They have denied wrongdoing. Anna Werner reports.
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Комментарии • 132

  • @askew9976
    @askew9976 Месяц назад +77

    Being a dental lab technician for 26 years, none of this story shocks me. Right down to the illegally operating lab.

    • @TheMpo1986
      @TheMpo1986 27 дней назад +2

      You should find another line of work. It has aged you. Find something that brings you peace. Your wasting your youth and life.

    • @Chad-Giga.
      @Chad-Giga. 25 дней назад +2

      @@TheMpo1986wtf?

    • @raeraebadfingers
      @raeraebadfingers 25 дней назад +2

      You know you said something dumb when even Chad-giga says wtf😢

    • @luke14946
      @luke14946 25 дней назад +2

      ​@@TheMpo1986what the hell are you talking about?

  • @LoganGraceHope
    @LoganGraceHope Месяц назад +37

    The entire dental industry needs an overhaul

    • @lovepet4565
      @lovepet4565 27 дней назад +1

      Its a rip off

    • @xx133
      @xx133 25 дней назад +4

      This device was never part of the industry. For profit healthcare will always yield these outcomes

    • @Chantalan
      @Chantalan 23 дня назад

      Not really, just say you can't afford it

  • @emma_s.234
    @emma_s.234 Месяц назад +60

    Thank you for your investigative work CBS, I'm sure you spared many other people from this device!

  • @bojanakragulj
    @bojanakragulj Месяц назад +53

    It’s the best kept secret in orthodontics, yet they marketed this only to dentists…

  • @sallyintucson
    @sallyintucson Месяц назад +24

    I’ve tried to complain to the FDA about side effects of medications that weren’t listed. The system makes it impossible.

    • @pamelas9
      @pamelas9 Месяц назад

      It's pretty easy to go to FDA.gov/medwatch to file adverse reports. After you file this, FDA forwards it to the manufacturer who has to open a complaint and add it to the database. Complaint handling is routine review during periodic inspections.

    • @user-xy6gm6ug5c
      @user-xy6gm6ug5c 29 дней назад +5

      Because it's all about money not helping people

    • @misseselise3864
      @misseselise3864 22 дня назад

      i think businesses reporting problems is different than patients reporting problems. i’ve done the same thing and i was shocked it took me over 20 minutes

  • @joec.9591
    @joec.9591 Месяц назад +12

    I've been in drug/device Regulatory Affairs for over 20 years. This is horrific.

  • @Boutys_mom
    @Boutys_mom Месяц назад +30

    This guy apparently knew more about dental loopholes than dental devices.

  • @BanFamilyVlogging
    @BanFamilyVlogging Месяц назад +20

    The fact that he’s a dentist, rather than an orthodontist, explains it. He doesn’t know what he’s doing.
    It’s like a dermatologist pretending to be a bone doctor. Of course things are going to go wrong

    • @mezmerizer0266
      @mezmerizer0266 Месяц назад

      Or the reporters wrote their story incorrectly.

    • @BanFamilyVlogging
      @BanFamilyVlogging 29 дней назад +1

      @@mezmerizer0266 did they?

    • @bojanakragulj
      @bojanakragulj 27 дней назад +3

      I agree. This appliance was marketed exclusively to dentists. But dentists are allowed to practice orthodontics in the USA.
      And that should likely change.
      But all that aside, the claims on this appliance were that they were beyond orthodontics…that it was growing the jaw…

    • @OptimusSatanas
      @OptimusSatanas 24 дня назад +2

      @@mezmerizer0266 Dude, stop being a contrarian unless you actually have information backing your assertion. Comment looks dumb.

  • @natara658
    @natara658 Месяц назад +8

    As someone with diagnosed sleep apnea and having had suffered for years with chronic pain due to TMD and even gotten to the point of researching specialist doctors to help me.. this is truly diabolical.
    Turns out an acupuncturist has been the most helpful for me.

  • @Caldenor328
    @Caldenor328 Месяц назад +5

    “Best kept secret in the industry” usually means fake.

  • @scottyoung1489
    @scottyoung1489 Месяц назад +25

    Self regulating medical devices is rife with problems.

  • @laurencaulton103
    @laurencaulton103 Месяц назад +41

    And which candidate wants to eliminate federal regulations??

    • @Supernumerary
      @Supernumerary Месяц назад +3

      Lauren- Every three months, are you taking the 100% Safe and 100% Effective injection fluids?

    • @TheArgiShow
      @TheArgiShow 29 дней назад

      The same one that told people to inject bleach and stared into an eclipse without sunglasses!

    • @jetfire245
      @jetfire245 27 дней назад +5

      ​@@Supernumeraryis that a rebuttal or a friendly check in for vaccination?

  • @RussMeister70
    @RussMeister70 Месяц назад +20

    Ooopsie...forgot that FDA registration.

  • @user-qr7ee2cp4y
    @user-qr7ee2cp4y Месяц назад +39

    Govt getting out of the way... isn't that what you wanted?

    • @lynx70123
      @lynx70123 Месяц назад +7

      This. Many oppose any regulation whatsoever. Regulations have their place.

    • @OptimusSatanas
      @OptimusSatanas 24 дня назад

      @@lynx70123As the saying goes: Safety standards/regulations are written in blood...The blood of the people hurt or killed in the abscence of safety standards/regulations.

  • @rosemariebredahl9519
    @rosemariebredahl9519 28 дней назад +4

    Another "honor system" failure to consider before rolling back "nuisance" regulations & compliance oversight!

  • @thewebdiva5903
    @thewebdiva5903 Месяц назад +10

    Why are they allowing them to continue to sell this dangerous device?

    • @melodyzahradnick4440
      @melodyzahradnick4440 25 дней назад +1

      Because the FDA is a joke to begin with.
      The fact that they had never even stepped foot in the place, not even considering this product, is concerning anyway

  • @anastasiabeaverhausen8220
    @anastasiabeaverhausen8220 Месяц назад +32

    Would you buy a used car from that man? I think not.

    • @theotheleo6830
      @theotheleo6830 Месяц назад +3

      His comb over was a sure sign that he was untruthful.

    • @KatarinaS.
      @KatarinaS. Месяц назад +5

      He definitely looks sketchy.

    • @bigthunder7002
      @bigthunder7002 Месяц назад

      @@theotheleo6830😂

  • @lemontea128
    @lemontea128 Месяц назад +12

    First red flag…claim device can expand your jaw… ugh no

  • @michaelccopelandsr7120
    @michaelccopelandsr7120 Месяц назад +11

    Somebody got paid off

  • @Starfish2145
    @Starfish2145 Месяц назад +6

    Massive lawsuit needed

  • @Antilleotheclown
    @Antilleotheclown Месяц назад +7

    I feel so sorry for these people this man is modern day Frankenstein just experimenting on these poor unsuspecting people. Now on their quality of life has been ruined due to his negligence.

    • @thewebdiva5903
      @thewebdiva5903 Месяц назад +1

      The worse part is knowing he’ll make a few settlements but never pay for breaking the law.

  • @wheeljork
    @wheeljork Месяц назад +19

    So the FDA knew they were a manufacturer since 2018 and inspected them for the first time in 2023? Also, wtf is wrong with those orthodontists? The devices should have been removed at the first sign of abnormal effects.

    • @bojanakragulj
      @bojanakragulj Месяц назад

      The appliances are used by dentists who believed the claims.

    • @wheeljork
      @wheeljork Месяц назад +10

      @@bojanakragulj I question the competence of dentists unable to recognize the abnormal effects caused by them. These people should have sued their dentists as well, for deterrent effect if nothing else.

    • @mezmerizer0266
      @mezmerizer0266 Месяц назад +1

      No, they didn't know about the device until last year.

    • @MichaelDeHaven
      @MichaelDeHaven 29 дней назад +3

      ​@@mezmerizer0266Yeah, the report says the FDA knew of them as a lab not a manufacturer. I just wonder what is classified as a "device". Are things like braces and crowns both "devices"?

    • @bojanakragulj
      @bojanakragulj 28 дней назад +1

      @@mezmerizer0266 they registered as a manufacturer in 2018.

  • @TheMpo1986
    @TheMpo1986 27 дней назад +4

    I listened to that dentist for 2 seconds and I could tell he was lying

  • @nlp6082
    @nlp6082 Месяц назад +2

    Hope resolve comes quickly to the victims.

  • @cherriberri7161
    @cherriberri7161 25 дней назад +1

    That doctor needs to be in prison! Those poor patients 💔

  • @Tyler-789
    @Tyler-789 Месяц назад +4

    I think I was told I needed one when I a kid but my parents couldn’t afford one. I guess I’m lucky.

    • @ferretyluv
      @ferretyluv Месяц назад +5

      That’s a palate expander, very very different from this.

    • @Tyler-789
      @Tyler-789 Месяц назад +1

      @@ferretyluv Oh ok, that does sound more like it. Thanks

  • @lisalastnamesmith
    @lisalastnamesmith Месяц назад +2

    This is WILD 😳👀

  • @NunnayaR2B
    @NunnayaR2B Месяц назад +2

    Thank you

  • @Indy29045
    @Indy29045 Месяц назад +6

    Tennessee and dentist should have been the first warning

  • @elchamber
    @elchamber 22 дня назад

    Sounds like everyone should get sued and go to prison. I’m also looking at you FDA.

  • @LeeCourseyKY
    @LeeCourseyKY 26 дней назад +2

    For reference: Dental Labs are subject to the laws of their state. Dental Labs only complete work at the behest of clinicians. 99.999% of what we do is simply "customizing" (technically) rather than "manufacturing". This lab got in trouble because they crossed the line from "customizing" to "manufacturing" by doing a device that had no pre-existing documentation/research. If this had been a well-established device, there really wouldn't be an issue. Most Dental Labs do not "register" with any national organization, including the FDA, unless they are "manufacturing" - meaning they're making something never made before.

    • @bojanakragulj
      @bojanakragulj 23 дня назад

      Manufacturing means you are putting together parts to create a product, so many dental labs are in fact manufacturing.
      Even class 1 devices need to be registered with the fda, which means pay dental labs if not all should be registered with the fda.
      I do not doubt dental labs have essentially been operating illegally in the USA.
      Labs are subject both to the laws of the state and federal law.

    • @LeeCourseyKY
      @LeeCourseyKY 23 дня назад +1

      @@bojanakragulj According to the FDA, Dental Labs are "Customizers" (see video at 8:30s), not "Manufacturers". It's semantics, I know, but these are the rules the lab operates in. The lab didn't check registration or register the device. FDA registration is required for each new and novel "device" - this thing certainly qualified as new and novel It should have been cleared by research and then by the FDA. Neither were done. The lab failed to register the device (which costs $250,000+) for some reason: either they didn't know it wasn't registered or they chose not to go through the process.

  • @ShionWinkler
    @ShionWinkler 25 дней назад

    This is why you never settle out of court! To get them to admit they are wrong, and to stop other people from being harmed, you have to bring them to court and have them lose.

    • @bojanakragulj
      @bojanakragulj 23 дня назад

      Trust me, they don’t admit they are wrong in court.
      If you see why they give over in litigation, you know the truth.

  • @stanleycoleman
    @stanleycoleman Месяц назад +3

    scary stuff

  • @Emily-gy2ef
    @Emily-gy2ef Месяц назад +1

    Jersey here! We know payola when we see it!

  • @Renegadeproject
    @Renegadeproject Месяц назад +3

    Another one of these self-regulating companies that we hear about.

  • @bonefishboards
    @bonefishboards Месяц назад +2

    Geez, the guy sounds like quack.

  • @nancygilliland4002
    @nancygilliland4002 Месяц назад +5

    Have always wondered why..when we can put men on the moon..is dentistry back in dark ages?

  • @HarryHolland-fc8kh
    @HarryHolland-fc8kh Месяц назад +1

    They let him wear those sneakers

  • @DCGreenZone
    @DCGreenZone Месяц назад +1

    Did they inspect the 8 mice used to enable an EUA?

  • @blacksquirrel4008
    @blacksquirrel4008 Месяц назад +1

    White shoes?

  • @joycewedel9084
    @joycewedel9084 Месяц назад +1

    They don't inspect numerous things! They approve anything that gives them a payout!

  • @hailesalassierasterfari6218
    @hailesalassierasterfari6218 Месяц назад +1

    Definitely a trail lawyer had to get one of his buddies to go out there off the books and investigate because thats an inside job.

  • @hailesalassierasterfari6218
    @hailesalassierasterfari6218 Месяц назад +2

    Dentistry is A Dirty Business

  • @user-ht4pp6ly1v
    @user-ht4pp6ly1v Месяц назад

    Any agency starting with F ,one can bet they have sold out to big money.

  • @JL-uu3lv
    @JL-uu3lv Месяц назад +1

    I know a guy that makes teeth in his basement. Dentists send him moulds and he makes the teeth people buy for implants or crowns.

  • @vjr5261
    @vjr5261 Месяц назад

    Is this the same device I see advertised on RUclips? Still, like today I saw it.

    • @bojanakragulj
      @bojanakragulj 27 дней назад

      Old advertisements are still up online for it, yes. Do you have a link?

  • @ELA-dy1pt
    @ELA-dy1pt Месяц назад +4

    Usual suspect!! Always trying to make a quick buck regardless of the cost on harming people.

    • @lynx70123
      @lynx70123 Месяц назад

      Right. They refer to people like him as "white-collar" criminal. Key word is CRIMINAL. A criminal is a criminal.

  • @jbdfd8779
    @jbdfd8779 25 дней назад

    Make this guy wear real shoes

  • @JustXavier
    @JustXavier Месяц назад +1

    Aga is short for agony.

  • @user-yv9yy1fn5p
    @user-yv9yy1fn5p Месяц назад +3

    .........................

  • @Supernumerary
    @Supernumerary Месяц назад +4

    You are naive if your thought process is that a government agency will protect anyone from anything. It is up to each citizen to do their own research, become informed.

  • @aroundandround
    @aroundandround Месяц назад +3

    Sounds third world.

  • @jadedcrow6796
    @jadedcrow6796 Месяц назад

    Can you sue the FDA?

    • @DesertDog
      @DesertDog Месяц назад

      Only if they let you

  • @davidbell4986
    @davidbell4986 Месяц назад +2

    Did the device work as intended for anyone?

    • @caseywotters
      @caseywotters Месяц назад +1

      It literally cannot, because once you’re an adult you cannot change someone’s bones (including their jaw) without surgery (/breaking the bone).

  • @MayberryAIArt
    @MayberryAIArt Месяц назад +7

    Tennessee 😂😂

  • @sjordan7085
    @sjordan7085 25 дней назад

    Was the person who dressed this male presenter, trying to make him look like a dork?

  • @lovepet4565
    @lovepet4565 27 дней назад +1

    This is very common
    In medical devises
    Theres zero fda required to apprve

    • @LeeCourseyKY
      @LeeCourseyKY 26 дней назад +1

      Literally every "device" needs to be registered and approved by the FDA. that's the point of this story. Each denture or crown produced is not a "new" device: it has previously been cleared by the FDA. This device - the arch lengthened - is an FDA Class II device and should have been cleared before use.

  • @magnetohex703
    @magnetohex703 Месяц назад +1

    At 1:13 yo that white girl made me laugh she said my teeth were being pushed outward & than she got real & elaborated that her teeth were pushing forward trying to make a buckwey pose. LOL i love funny women 🥰 she might be an SNL comedy writer. LOL 😂😂

  • @pisceswit
    @pisceswit Месяц назад +3

    He looks like a used car salesman

  • @EricaAnn777
    @EricaAnn777 Месяц назад

    Rfk !!!

  • @LeviAaronx
    @LeviAaronx Месяц назад +8

    FDA doing a bang up job. As usual🙄

  • @cafebacon8974
    @cafebacon8974 Месяц назад +1

    No surprises fda lost many in 90's and rehire never happened as it should. Btdt its a mans world

  • @mitchellkrouth5083
    @mitchellkrouth5083 Месяц назад

    Did I say the FDA sucks balls

  • @screechweiner2921
    @screechweiner2921 25 дней назад

    hey sleepy joe! force health insurance companies to cover dental! and while you're at it how about making them fix eyes too!

  • @westloop446
    @westloop446 25 дней назад

    Can we stop wearing sneakers with suits on tv? You’re not going to your prom 🫣

  • @GorVala
    @GorVala 26 дней назад +1

    So many illegally operating dental labs.. especially by Chinese 😂

  • @FreemanFamilyFarm1986
    @FreemanFamilyFarm1986 Месяц назад +2

    But the Mewing method does work, and stops sleep apnea. Mewing also reshapes the jawline so people can breath and swallow better.

    • @natara658
      @natara658 Месяц назад

      Mewing can help a little with tongue and jaw placement, but it can also worsen TMD symptoms by overworking the muscles. The jaw joint (TMJ) is a synovial, condylar and hinge-type joint, it’s one of the most complex and most delicate joints in the human body. There have been no studies proving that mewing can help with TMD, much less accomplish anything that Dr Mew claimed. I’ll admit that Dr Mew had some points, but he was also a fanatic. Please don’t spread misinformation. TMD can be very serious and people have deleted themselves due to the chronic pain it causes. It’s frankly insensitive to claim that something like mewing can help.