Hi, I'm Dr.
Rajani.
Thanks for joining me today.
Extremely important video for everyone today.
I'm in the aesthetic training center today.
Little different background for some of you, but I wanted to
get this out very important.
Issued by the FDA for dermal fillers delivery and where you
get them, understand the FDA has whole lot going on right now.
This is something they don't need to get involved in, unless it was very important.
When did you hear about it?
For me many years ago, you can see the videos here.
And I talked about these high Elion pens, but they didn't just talk about the pens.
It also had to do with the product and the reason.
As I tell you about these and other procedures, there have been some
disasters outcomes with people losing their lips, not a lot of
blindness that they talked about here.
Billers at irregular levels, side effects.
People cannot remove things from their face and that's why they issued the.
I'm going to add that the warning should also include, this is my opinion,
fibroblasts and fibroblasts pens, both to what we're going to talk about today.
I was on Amazon looking around today.
eBay, you can find these kinds of devices that they do mention in their
warning for 15 25, 30, $40, including the products that are going into the body.
Let's see what the FDA said today.
If you own a car.
Please take this video and share it in an email blast or
share it on your social media.
So people see why they're coming to your clinic for the education
knowledge and the expertise.
If you're a home gamer, this is when things go south.
When the tears come, this is what we're trying to avoid.
If you don't do fillers, if you don't do any of these procedures, if you were
considering buying something online, Even, including our F devices, all the devices
that are unregulated, it's worth watching.
And some people might just be interested.
But I talk about this quite a bit.
Let's see what the FDA said.
Okay.
So here is the exact warning and do not use needle free
devices for injection of dermal.
FDA safety communication though.
They don't just talk about the devices, but they talk about the fillers.
I talk about this all the time because of these dangers.
So if we scroll down, so the U S food and drug administration, the
FDA is warning the public health care professionals, not to use needle free
devices, such as high Eleron pens for injection of hyaluronic acid.
Or other lip and facial fillers notice they focus on lift because that is
the number one driver to practices other than Botox like products.
But everyone wants a large lip and when they get it large, they want even larger.
You saw my post recently on the shorts and the reels, uh, they're
commonly referred to as durable.
The FDA is aware of serious injuries.
I talk about all the time.
I don't think people listen to me, but maybe they'll listen to the FDA.
This is serious stuff in some cases, permanent harm.
So what we're talking about is necrosis loss of skin, inability to dissolve.
I did a reaction video to a botched segment where they lost the motor nerve
facial nerve seven, trying to remove some of this stuff and to the skin and the.
And the eyes, the eyes are the next driver, because it's the number one
area to age people first because of the thin skin that doesn't surprise us.
Here's the recommendation.
Do not undergo any filler procedure with needle free devices.
That's the high alley on pen.
I have two videos at least up here from a few years ago, talking about it.
I unboxed one.
And then I talked about the problems and I showed it being used.
So go back and watch them if you want, but they go on and there's more here.
Do not buy or use.
Or facial fillers sold directly to the public.
And I think this is one of the most important parts of this, because if you're
in practice, you know, we see it a lot.
People come in, they don't know what's in their face, or they went somewhere for
the $400 lip injections, lip injections costs more than $400 in the United States.
Products are cheaper in Canada, some European places, but I'll
tell you I travel the world and I don't see places where legitimate
product is less expensive.
A lot of times it's more expensive.
I was just in Germany, Dubai, uh, France, uh, Monica.
So I know the prices from around the world, Thailand as well, and, um, Jakarta
in Asia, a lot of places, it's not like.
Cheap filler injection locations in a lot of the world, you will find some do not
inject yourself or others with lip filler.
You know, my videos of people going to houses, they look like
haunted houses, getting fillers.
That's your first clue.
Something's not right.
What do I say that people need to inject before they know
how things are going to react?
What a product or device does?
The number to me is 200.
Only if people are working with their colleagues and sharing knowledge
on the other thousand procedures, because until someone's done a
thousand, you just don't know.
And it's not a thousand in one day, it's over time because you
have to see people back over years.
To see what these things are doing to faces, how long they're lasting
are they migrating all sorts of things, but don't inject yourself or
others with lip or facial fillers.
The main reason also is you can get product often.
That's when I say real, um, what I mean is if I go to other countries,
sometimes they're handling.
Scott Henry Sculptra well, it's P L L a.
It might be not in a water that I'm used to see, but in hyaluronic acid,
there's nothing wrong with that.
They worked well together.
The point of it is a lot can be hidden in what you think is
hyaluronic acid, including PLM.
PDO poly dioxin own can be in there.
Um, of course, impurities things that are going to cause infection.
Uh, but also you might find permanent products in there as fillers,
such as it could be anything, but PMMA is often in their plastics
because they're not made in legit.
Maybe legitimate, wrong world word.
They're not made in factories that are controlled a lot of the time.
So don't inject yourself.
Definitely not others.
If you're a DIY, do it yourself.
Great harm yourself.
Um, but don't harm other people.
I think that's an important point.
If you experienced any problems or concerned after.
Of lip or facial fillers and listen to this using a needle free device, seek
care from a licensed healthcare provider.
Well guess what a couple of problems number one is if you just go to your
local person, your local doctor, or your even your ER, with a problem, they're
most likely not going to know what to do.
These are esoteric things in the real world.
They don't see filler necrosis or blindness in a regular hospital setting.
Uh, dermatology plastic surgery, physicians, offices, offices,
where they provided injections.
Yes.
Um, but just because you go to seek care and the second they
might not know what to do.
The second thing is they might not take care of you because they
don't know what's in the face.
So report any problems.
There's one other point I want to make here.
Let's move to.
The page here.
And we see if you are considering a Phillip procedure talk to a
licensed healthcare provider.
One of the things I hear often on this channel, doc, we don't know where to go.
Can you recommend somebody?
So every state is different and has different rules and regulations.
There are federal laws, but it's.
Regulated as well.
So some places nurses can inject some, they can be somewhat independent.
Some they can't nurse practitioners, PAs doctors, um, and then there's estheticians
in states that are allowed to inject.
Um, obviously estheticians go to esthetician school, not
injection school often, uh, but some states that can be possible.
So it is legal.
Um, and some people are very, um, Forward thinking about getting their education
and they're studying and they know their stuff, and some people might have the
credentials, whatever they think you are.
They could be the highest level, doctor, PhD, whatever you believe.
And they don't know their stuff because they don't care.
Um, it's more of a business, so it's not just the title of the
person, but it's ongoing education.
And passion, you got to find the passion.
Um, and everyone, the injects should be scared about it.
We are scared of injecting everyday, inject them, scared, a healthy fear,
um, because they know what's going on in the face and what can happen.
So, um, it's not something we take lightly to procedure using FDA approved
dermal filler should be only performed by licensed healthcare providers.
Um, I did do a poll on our community section.
And I asked people who do you think are the number one
injectors in the United States?
The correct answer is nurses.
Nurses inject most of the products, meaning neuromodulators, Botox, like
products and fillers in the United States today, the majority of nurses will need.
Um, to have someone that can perform an independent examination, a nurse
practitioner, a physician, like an MD, something to that effect,
but each state again is different.
Um, again, it's passion, you can't buy passion and education.
That's what you're looking for.
So then they make.
Recommendations to the healthcare providers to report these things.
I told you the story when I did the high-alert Ron Penn videos prior,
uh, maybe four years ago, I was working with a representative from
a company and we're having dinner a little steak and beer at night.
That's when you learn everything and he said, Rosana, you wouldn't
believe I just lost 300 grand.
I said, what happened?
He ordered these pens.
Hi, all your own pen.
And started selling them to practices and people, uh, and they were
selling them for $1,600 a shot.
They were the high end high Eleron pens that deliver hyaluronic acid.
He bought a container full and was going to sell these, uh, he threw them out.
So after spending three or 400 grand on them, maybe selling 50
or 60, the complications that came back, he threw them out.
Not a lot of people have 400 grand to throw up.
That told me all I needed to know.
And of course I got them, tried them and went to courses on them,
just to see, and you'll see from my posts before I warned everyone of
this long ago, we talked about it.
You can't blow product with low.
Unstudied and all these pens are unregulated and different and get it
to the depth that you need it to go.
But let's say you own a clinic, um, and you are unlicensed,
especially you're motivated to do things that, um, bring you.
And who doesn't want to inject fillers.
It's a sexy thing.
It's like the new rock stars of the world or the plastic surgeons of the world.
Um, they're the new rock stars because everyone wants aesthetics.
So people want to get involved.
And if you're unlicensed and you can do things like the fibroblasts pen,
which is burning the skin, or you can do things like the high-alert on Penn
and be providing quote unquote fillers, um, then it, in your mind, you've
elevated yourself the way to elevate.
Is to go to school and study and get the credentials and get the licensing,
um, specific to your state billowing product in the face is not good.
Let's look at one last thing.
They know exactly what the product is they're talking about.
And that's the needle free injection devices that we've talked about.
And here are the specific risks that they are seeing.
They haven't evaluated the safety and effectiveness, and they noticed that
that needle free devices and lip facial fillers for use with these devices
sold online, directly to the public and their use is promoted on social
media, just because you see something on social media doesn't mean it's good.
Social media is great.
And I tell you the perils of social media, but people, again, you need two
or 300 treatments to know what's going to happen to someone on social media.
People do one or two and they they're an expert, or maybe they do one on
themselves and they're an expert, nothing wrong if you want to harm yourself,
but it's other people take, pick that up and they want it for increasing
lip volume, improving the appearance of wrinkles, everything people want.
Um, and FDA approved.
Dermal fillers are intended.
They're a prescription.
Device and it's a device it's considered a device, but when you get
a filler, the needle or the cannular that they come with, and in this
country, it's mainly needles that is FDA approved within the packaging.
And it should be used with that needle that comes with it.
Everything else is considered.
Label an important point here.
And then they say needle free injection devices for setup purposes,
do not provide enough control over where the injector product is place.
Where did you hear that?
Before?
In my videos, lip and facial filler products sold
directly to consumers online.
Maybe look at this contaminated with chemicals and infectious organisms.
Absolutely a hundred.
Correct.
And do you want a bloodborne illness?
Absolutely not very dangerous.
So here are the risks.
Bleeding bruising, not a big deal that happens no matter what
infection with bacteria, fungus virus from the needle free device.
This is one of the things I worry about most because it's the hardest to treat.
And there's something called delayed onset nodules.
And we've seen these and biofilm where the products in capsule.
So the antibiotics cannot get to it.
Look that up.
If you want to scare yourself, biofilm very hard transmission of disease
between people and the, we, there have been cases with microneedling,
guns, pens, everything else.
It's what I worry about the most when people don't know where they're going, or
if you're trying to save money and you're getting things for a hundred, 200, 300.
I mean, we'll go into that end of it.
But people, uh, seem to believe the one or $2 needle or the
two or $3 gloves are expensive.
Now can be reused needles and gloves can, and should not ever be reused.
You hear it all blockage of a blood vessel leading to tissue,
death, blindness stroke scars.
This is all very true and it can happen in the best of hands, but it's much
higher risk in those that aren't trained.
Or if you're blowing a product, trying to blow it into the skin,
much more common to happen and much harder to reverse, especially we
don't know what was blown into your.
It could be permanent.
You cannot reverse many of the products, only hyaluronic acid.
Can you reverse not even calcium hydroxylapatite or radius, even
though people believe so damage to eyes from the pressure lumps
in the skin, not the worst thing.
It's deep, big disfiguring, but not the worst thing.
Discoloration post-inflammatory hyperpigmentation.
Terrible hard to treat hard to treat.
And I've seen it on necks where it's lasted long, long, long time.
I'm talking years, I've seen I've lost track as invasions.
Um, but, um, post-inflammatory hyperpigmentation can be hard to
treat, especially if you don't know what went into the skin,
allergic reaction, not as common.
Please be careful with the high Allier on pen.
I put a complete list of videos up here to help keep your skin
and body beautiful, healthy.
And by.
Um,