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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#tmj #KFFHealthNewsinvestigation #dentalnews
Being a dental lab technician for 26 years, none of this story shocks me. Right down to the illegally operating lab.
You should find another line of work. It has aged you. Find something that brings you peace. Your wasting your youth and life.
@@TheMpo1986wtf?
You know you said something dumb when even Chad-giga says wtf😢
@@TheMpo1986what the hell are you talking about?
The entire dental industry needs an overhaul
Its a rip off
This device was never part of the industry. For profit healthcare will always yield these outcomes
Not really, just say you can't afford it
Thank you for your investigative work CBS, I'm sure you spared many other people from this device!
It’s the best kept secret in orthodontics, yet they marketed this only to dentists…
I’ve tried to complain to the FDA about side effects of medications that weren’t listed. The system makes it impossible.
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.
Because it's all about money not helping people
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
I've been in drug/device Regulatory Affairs for over 20 years. This is horrific.
This guy apparently knew more about dental loopholes than dental devices.
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
Or the reporters wrote their story incorrectly.
@@mezmerizer0266 did they?
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…
@@mezmerizer0266 Dude, stop being a contrarian unless you actually have information backing your assertion. Comment looks dumb.
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.
“Best kept secret in the industry” usually means fake.
Self regulating medical devices is rife with problems.
And which candidate wants to eliminate federal regulations??
Lauren- Every three months, are you taking the 100% Safe and 100% Effective injection fluids?
The same one that told people to inject bleach and stared into an eclipse without sunglasses!
@@Supernumeraryis that a rebuttal or a friendly check in for vaccination?
Ooopsie...forgot that FDA registration.
Govt getting out of the way... isn't that what you wanted?
This. Many oppose any regulation whatsoever. Regulations have their place.
@@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.
Another "honor system" failure to consider before rolling back "nuisance" regulations & compliance oversight!
Why are they allowing them to continue to sell this dangerous device?
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
Would you buy a used car from that man? I think not.
His comb over was a sure sign that he was untruthful.
He definitely looks sketchy.
@@theotheleo6830😂
First red flag…claim device can expand your jaw… ugh no
Somebody got paid off
Massive lawsuit needed
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.
The worse part is knowing he’ll make a few settlements but never pay for breaking the law.
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.
The appliances are used by dentists who believed the claims.
@@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.
No, they didn't know about the device until last year.
@@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"?
@@mezmerizer0266 they registered as a manufacturer in 2018.
I listened to that dentist for 2 seconds and I could tell he was lying
Hope resolve comes quickly to the victims.
That doctor needs to be in prison! Those poor patients 💔
I think I was told I needed one when I a kid but my parents couldn’t afford one. I guess I’m lucky.
That’s a palate expander, very very different from this.
@@ferretyluv Oh ok, that does sound more like it. Thanks
This is WILD 😳👀
Thank you
Tennessee and dentist should have been the first warning
Sounds like everyone should get sued and go to prison. I’m also looking at you FDA.
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.
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.
@@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.
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.
Trust me, they don’t admit they are wrong in court.
If you see why they give over in litigation, you know the truth.
scary stuff
Jersey here! We know payola when we see it!
Another one of these self-regulating companies that we hear about.
Geez, the guy sounds like quack.
Have always wondered why..when we can put men on the moon..is dentistry back in dark ages?
They let him wear those sneakers
Did they inspect the 8 mice used to enable an EUA?
White shoes?
They don't inspect numerous things! They approve anything that gives them a payout!
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.
Dentistry is A Dirty Business
Any agency starting with F ,one can bet they have sold out to big money.
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.
😮
Is this the same device I see advertised on RUclips? Still, like today I saw it.
Old advertisements are still up online for it, yes. Do you have a link?
Usual suspect!! Always trying to make a quick buck regardless of the cost on harming people.
Right. They refer to people like him as "white-collar" criminal. Key word is CRIMINAL. A criminal is a criminal.
Make this guy wear real shoes
Aga is short for agony.
.........................
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.
Sounds third world.
Can you sue the FDA?
Only if they let you
Did the device work as intended for anyone?
It literally cannot, because once you’re an adult you cannot change someone’s bones (including their jaw) without surgery (/breaking the bone).
Tennessee 😂😂
Was the person who dressed this male presenter, trying to make him look like a dork?
This is very common
In medical devises
Theres zero fda required to apprve
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.
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 😂😂
He looks like a used car salesman
Rfk !!!
FDA doing a bang up job. As usual🙄
No surprises fda lost many in 90's and rehire never happened as it should. Btdt its a mans world
Did I say the FDA sucks balls
hey sleepy joe! force health insurance companies to cover dental! and while you're at it how about making them fix eyes too!
Can we stop wearing sneakers with suits on tv? You’re not going to your prom 🫣
So many illegally operating dental labs.. especially by Chinese 😂
But the Mewing method does work, and stops sleep apnea. Mewing also reshapes the jawline so people can breath and swallow better.
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.