The entire dental industry needs an overhaul

@lovepet4565

4 күн бұрын

Its a rip off

@xx133

2 күн бұрын

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

@Chantalan

18 сағат бұрын

Not really, just say you can't afford it

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

@TheMpo1986

4 күн бұрын

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.

3 күн бұрын

@@TheMpo1986wtf?

@raeraebadfingers

2 күн бұрын

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

@luke14946

2 күн бұрын

​@@TheMpo1986what the hell are you talking about?

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

7 күн бұрын

Or the reporters wrote their story incorrectly.

@BanFamilyVlogging

6 күн бұрын

@@mezmerizer0266 did they?

@bojanakragulj

4 күн бұрын

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

Күн бұрын

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

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…

And which candidate wants to eliminate federal regulations??

@Supernumerary

8 күн бұрын

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

@TheArgiShow

6 күн бұрын

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

@jetfire245

4 күн бұрын

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

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.

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

@pamelas9

9 күн бұрын

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

6 күн бұрын

Because it's all about money not helping people

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

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.

Self regulating medical devices is rife with problems.

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

@lynx70123

8 күн бұрын

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

@OptimusSatanas

Күн бұрын

@@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.

Ooopsie...forgot that FDA registration.

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

@melodyzahradnick4440

2 күн бұрын

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.

@theotheleo6830

10 күн бұрын

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

@KatarinaS.

10 күн бұрын

He definitely looks sketchy.

@bigthunder7002

8 күн бұрын

@@theotheleo6830😂

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

Somebody got paid off

Massive lawsuit needed

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

9 күн бұрын

The appliances are used by dentists who believed the claims.

@wheeljork

9 күн бұрын

@@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

7 күн бұрын

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

@MichaelDeHaven

6 күн бұрын

​@@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

6 күн бұрын

@@mezmerizer0266 they registered as a manufacturer in 2018.

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

9 күн бұрын

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

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

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

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

Hope resolve comes quickly to the victims.

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

8 күн бұрын

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

@Tyler-789

8 күн бұрын

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

This is WILD 😳👀

Thank you

Tennessee and dentist should have been the first warning

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

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

scary stuff

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

4 сағат бұрын

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

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

4 сағат бұрын

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

3 сағат бұрын

@@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.

Geez, the guy sounds like quack.

Jersey here! We know payola when we see it!

They let him wear those sneakers

White shoes?

Dentistry is A Dirty Business

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

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

Sounds third world.

Make this guy wear real shoes

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

@lynx70123

8 күн бұрын

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

Aga is short for agony.

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.

Cured people of things….except gout.

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.

@lynx70123

8 күн бұрын

😮

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

@bojanakragulj

4 күн бұрын

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

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

He looks like a used car salesman

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

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.

Can you sue the FDA?

@DesertDog

7 күн бұрын

Only if they let you

FDA doing a bang up job. As usual🙄

Did the device work as intended for anyone?

@caseywotters

8 күн бұрын

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

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

@LeeCourseyKY

3 күн бұрын

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.

Rfk !!!

Did I say the FDA sucks balls

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 😂😂

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

Tennessee 😂😂

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

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

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

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

@isocarboxazid

10 күн бұрын

"Mewing" is almost as crazy as this device.

@natara658

7 күн бұрын

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.