Did I open Pandora's box?
Did I intrigue your curiosity?
What is an ideal breast, and can we achieve all of that that I said?
And we can Today we can perform surgery under local anaesthetic
with small scars.
Having the patients go back to work the next day or the family life without antibiotics,
sub glandular.
With no capsA contractual rate.
I know what the the the scientific articles tells us.
But there is an evolution, a development with devices and products,
so. We know what we know today.
We know what was written yesterday, but we don't know what's tomorrow.
But the last step in the 3-step journey that I had working with these 4 micron is
what I'll share with you now.
So With that said, If we'll put my slide on, do I need to do something?
You you're showing signs to me?
I need to do. Well, I'll just keep on talking.
So, so, for basically the concept was born 19 years ago and for
the last 9 years.
Uh, I've been working strongly with uh a concept called Mia.
And it took us 6 years to develop the Mia products.
And the tools and based on that preservation concept.
We developed not just a reproach, oh, you see, I'm so dumb.
I didn't know that.
Maybe not. And since 2.5 years we're doing this.
Hydro dissection, balloon assisted, blunt.
Tissue preservation augmentation.
When we go through the axilla, we call it enhancement.
Why? Because we work with small implants ranging up
to 195 ccs.
Now with the MA, there's a special device called the diamond,
and the diamond basically is what I think is the future because we all try to make small
incisions with the help of funnel, we're pushing implants through that,
but there is a risk for flipping.
The diamond is developed in a way where it's uniform, so it doesn't matter if it flips,
but beyond that, it has the properties with less volume to give more lower pole volume
pushing out, so it actually looks very much like an anatomic implant.
So The ideal breast implant stabilisation by tissue preservation.
These are my disclosures.
So the question one should ask, what might I know that you don't?
Why am I changing a successful practise based on anatomical implants,
having had a role internationally, meaning in training a lot of you surgeons in these
concepts. Transitioning from sub muscular.
The way I started doing using these devices.
However, having a map position rate of 2.9%, which in my practise was unacceptable,
trying to find solutions.
To sharp subfascial subglandular, and then to hydro assisted aromatic blunt
subglandular tissue preserving breast augmentation, that's a long word.
But that basically Incorporates everything that I'm doing today.
And today 95% of our surgeries is precisely this.
The woman walks into the OR, has the surgery done while I'm talking to her,
and she walks out and goes back home after one hour regardless if we do it through the axilla,
Mia, or the preservation through the IMF.
And it's it's about understanding that the stability of a breast shape is related and
depends on the elastic quality of the coopers and fascial ligaments,
because that's the secret.
And it's not the holy grail, but we haven't fully understood.
But when you looked at that photo where I took away 1.5 kg,
how much that breast was able to retract, then you understand the power of the Cooper's
ligaments. They're there.
Why? Because a woman.
should be able to breastfeed, have indulgement over breasts without having those breasts.
Too far down and most women do. Yes, there is some sagging.
But most of women can breastfeed several children and still have a nice shape of their
breast. What we see as surgeons are the outliners.
We see those who seek our advice, but most women actually have beautiful breasts prior to
surgery, and most women actually still have beautiful breasts after breastfeeding.
Now the interesting thing with that concept is, if we believe that we're growing the breast
surgery market the way we're doing it, it's wrong.
Most women wear push up bra and they want smaller sizes,
just to enhance that. That's the big market.
We just don't know how to address it with the surgical principles we're utilising today.
Because they don't want that downtime, they don't want to be away from the families,
they don't want the complication rates that we see with the way we've been doing surgery
previously. So the secret is preserving these Cooper's
ligaments. And if surgery is performed on the breast,
optimising the preservation of these ligaments, what we call implant stabilisation by Cooper
ligaments preservation.
And the Cooper's ligaments, by the way, were described first by British surgeon,
1840, uh, Ashley Cooper.
If we're able to do that and understand.
That these ligaments that basically are surrounding the breast,
something that was the concept behind the me.
Using a blunt balloon dissection, preserving, not cutting that.
Understanding that if we preserve these walls.
Then we can put implants in and they will stay there over time,
even though we use smooth devices.
Not interacting by ingrowth or friction.
So This is just, this was done live 2 years ago in Dusseldorf through the IMF
preservation, and what I want to show you, this is a blunt dissection.
Hydro dissection.
And this is a blunt dissection and I want you to see those Cooper's ligaments.
So there's no, no sharp dissection, no Colorado tip, nothing.
And then what you'll see on the side here, coming in with the camera up to the right,
you see those white strokes, those are the cooper's ligaments,
and they're pushed aside.
So what does that mean?
The way we've been doing breast surgery.
is that we go in, we dissect shop, and we thin out the walls.
We have a thick mass on top that might slide down, but we've thin out on the side.
What the preservation does instead is it pushes the tissue aside,
so you can work with a less diameter but still have a nice cleavage.
When you thin out the tissue is on top, what we call might cause water form deformity.
But with the cooper ligaments, we have that stability too.
So with less width, with less volume, we can still achieve a nice proportion well balanced
result. So it's a totally 180 degree of understanding
the anatomy and the way we do surgery.
So how do we preserve the Cooper's ligaments and create a pocket for the implants without
cutting the ligaments for maximum implant stabilisation?
Well, that is the blunt concept with the help of a balloon,
specially designed.
For this purpose, where it has a drainage in it and it expands in a specific way.
So Once again, aromatic, wet hydro infiltration, blunt, non-sharp instrumental
balloon assisted precise pocket dissection.
Breast preserving, minimal incision, 2.5 centimetres, no cutting of muscle,
nerves or vessels. Augmentation, funnel assisted sub lander
implantation with ergotooth smooth plan through the IMF and with an injector through the axilla.
Keep it simple and safe and short.
Simple local anaesthesia, safe breast preserving, short because scars do matter.
They do. You ask any woman, scars do matter,
especially if they turn out to become ugly, if you have that tendency.
Now, the question that arises, OK, so this is blunt.
It's not under direct vision.
Don't you have a lot of hematomas?
We haven't had in our study, and this will of course be published,
uh 2 centres, 4 surgeons, 2.5 years, IMF.
Not one hematoma.
So, and I've done this several times, and I also do it as you can see with Master Pixars.
So this is going in with the Lifesaver, and this is coming out.
That's how they look. In general, the bleeding that will occur will
be an incision. So This is an implantation with an ergo 2 which
really has the ability with the design and super silicons to really push it.
So as you can see, the incision is a short 1, 2.5.
Now is that important? Well, scars matters, but there's another aspect.
The more you cut of the inferior pole, the more you interfere with the cooper's ligaments
stabilising that lower pole.
So with that said, I'll just showdant and move forward.
So That's a funnel which, as you can see is very narrow in the tip.
It's basically 2 centimetres and through that you have to have strong hands putting a bigger
implant through that. That's true.
But with that we're able to get that implant in without destroying the implant or the
surrounding tissue.
It's a very tight pocket.
It's actually -1 centimetre of the width of the implant.
The balloons are designed specifically to, to uh incorporate that.
So, it's a tight pocket.
And then we secure this with one stitch of the lay.
Now, our studies show that it holds up pretty well, so we're about to abandon the rib stitch
because that's basically the only thing that hurts in these patients.
So the concept of preservation surgery Mia.
A traumatic plant preserving enhancement, which is with smaller breasts,
not augmentation performed under local anaesthesia, is quite simple.
So we have this specific tool we put it on. It's designed maximum projection on top of the
the muscle, a short incision in the axilla.
We have this specific device developed for this that stabilises it.
We pump up according to what's in the plan. We have the injector,
we inject the implant.
Game over. And the patient walks out of the ward.
So I'll show you a couple of examples.
This is IMF subglandular. We started off first with smaller devices.
This is the diamond 140 before and after.
With 140 ccs with this device, you do get projection and a better look.
This is just, and this is 2 years down the road.
Sorry, uh I want to show you that.
So this is 2 years down the road, and as you can see it's stable.
Now you could say that's a small implant, but here I'm trying out,
I'm pushing it, I'm using a slightly bigger one, but she has pseudotardic breasts.
One child 6 months, 160.
a little bit bigger, pushing the limits over time 265,
as you can see, she has an asymmetry.
How will she behave over time?
She still has somewhat of an asymmetry, but she holds up.
Creating what I think is a natural, beautiful looking breast.
This one also has a symmetry. I'm showing you the more difficult cases
because otherwise it gets boring, where I'm pushing the cooper ligaments,
but blunt.
Creating symmetry still with a smooth device 360.
Subglandular This is with
a small pixie. Two different implants,
stability over time.
This is the Mia through Dexilla.
140 cc.
That's the plan Going from this to this, just with 140 cc's,
it's not about the volume, it's about volume distribution and the design and shape of the
gel and the shell. A
140.
Pseudoic breast Not perfect, but the patient is very happy,
because sometimes we believe we have to create the perfect breast.
For the patient, it's the perfect journey.
The average patient that seeks my advice for Mia puts a 56 on her breast prior to surgery,
so she's quite happy with her breast, and she walks out after 6 months with a 10.
The average patient for breast augmentation walks in with the office,
puts herself on a baseline 3, and walks up out after 6 months with a 9.
So these are patients that are really happy with their breast.
They just want slightly bigger.
Same thing through Dexxilla IMF approach.
So summary. Adapting implant size to biological features,
avoiding violation of the IMF with maximum projection of implant on the nipple with a full
centimetre stma, no touch zone is recommended.
You don't want that because it will stretch.
A 2.5 incision followed by hydro dissection and blunt channel dissection up to 425.
That's where we've set our limits so far.
Maintaining a tight pocket minus 1 centimetre of the implant width,
preserving Cooper's ligaments, not cutting muscle, nerves or vessels for implant
stabilisation. Conservative approach of IMF.
If you do push it down, re anchor it with the lucky 8 stitch.
No antibiotics performed under local anaesthesia, returning to daily activities the
next day. What we have incorporated since many years is
the stability test.
We only measure our patients when they're standing up,
but the dilemma with Smooth is that they also lateralize.
So we do all these tests. So all our patients after 6 months,
2 years, 4 years are lying down, and that's when you really can see the stability.
Of this concept So that's not stable on the right, it's stable on the,
on the left. So if you do use smooth implants,
I would encourage you to do that testing.
Now if you do not measure, you don't know how to manage.
With fat transfers necessary, you can add that with this concept 160,
going from 310 anatomical away, smooth, changing plane 160,
and with fat we can achieve a beautiful result, basically the same volume as you had previously,
but with a smaller implant and fat.
You just have to have the right technique.
Or in this case, using it because we're doing a lipo sculpturing anyway,
using a small implant and then I'm performing a a high definition lipo sculpturing at the same
time, giving her a slightly better rest.
In Master Pixos we apply the same concepts.
Breast preserving, creating, preserving those Cooper's ligaments.
This is with a 300 cc implant and by doing that we can create results that are
aesthetic pleasing but most importantly safe, short and long term holding up,
which is the dilemma.
She had a symmetry. Getting that balance The
planning Implementing the concept
and why I use this is because the grey shows even better the symmetry that we're able to
achieve with this. And as you can see,
her, her left breast was more lateralized.
But we have a better shape and stability.
So before And after 6 months
So conclusion, my objective with this session has been to share my experience uh with the 4
micro implants, enabling surgeons to implement.
Or trying to grasp the concept of tissue preservation surgery.
For me it's not the future, it is the present.
I think that once you're able to embrace this novel concept,
you understand some of the benefits. I do believe it's a safe,
standardised, and reproducible concept with the least possible complications related to these 4
micro implants.
So what has close to 30 years taught me in private practise,
well, I don't believe there is a perfect implant for every patient,
nor nor do I believe that there's a perfect implant for every surgeon,
but I do believe you should.
Think outside the box.
I do believe that the main reason for re-operations and complications are due to
decisions and surgical skills, not the devices.
The devices we're able to work with today, they have their pros and cons,
but they're very safe and predictable if you utilise the right concepts for them.
And I'm still learning constantly. I'm still measuring.
I'm a number guy, everyone knows that.
So I believe selecting the right implant for the right patient for the right reason,
applying standardised measurements, techniques, and long term follow up is key to success.
Breast preservation is, like I said, a novel new concept.
But I do believe that we've shown that it keeps the civilization over time.
And it has enabled me to go from sub muscular to sub glandular with less tissue coverage,
a softer feel through shorter scars, without any antibiotics,
and back to work the next day.
So it's about preserving the tissue, muscle, nerves, vessels,
and I don't need any measures, alloderms, or muscle slings in my practise.
So what matters is why you make your choices.
Is it data driven or is it pure emotional, do what you've always done.
The choice is yours.
But always ask yourself why.
So why not breast preservation?
Thank you very much, ladies and gentlemen.
I'm gonna give an update on the on the 4 year US FDA
clinical trials with Motiva.
I'm an investigator in the study.
Uh, I do because the FDA is in the final process of evaluating this data.
I have to be careful and, uh, use these legal dis uh disclosures.
This is an ongoing clinical trial for medical device under a FDA approved investigation
device exemption. It's not yet been approved by the FDA and it's
not commercially available in the United States. This is preliminary data.
Uh, but these devices have been used over 3.4 million devices in 85 countries.
In our study we used the smooth silk round and the ergonomics,
not the ergo 2.
There were 834 subjects, 560 in the augmentation and revision augmentation,
274 in the reconstruction, 308 of those are in an MRI cohort.
We have good follow up 3 year of 93%, 4 year 89%.
Uh, the 4 year follow up is complete. We're now seeing 5 and 6 year visits and PMAs
have been submitted.
The complication rates, uh, between 3 and 5. Years are pretty close to the same um low
capture contracture rate 0.5% low rupture rate, uh, any complication 8.8% that includes
things like breast pain if somebody spit a stitch, they counted that.
I kind of over this did not take chances with the FDA anything that was adverse was counted
as a complication reoperation rate of 6.6% at 3 years, 6.
8 at 5 years, the highest reoperation rate was for malposition,
but interestingly, uh, the malpositions were superior, uh,
in the patients, and they were from uh transaxillary placement of the implants.
We had been warned before the study about potential bottoming out of these implants.
We, uh, educated the surgeons before we started this study,
so I think we were well prepared for that.
Um, in the device used in the world, as I said before, over 3.4 million,
378,000 in the device in their own registry with 496 patients,
0.13% reporting adverse events reoperation rate, they have a very good warranty where they will
pay for any surgery, uh, which you would think would reflect uh on the true number of reoper
operations less than 1%.
Uh, the Flo uh, smooth tissue expander is available in the United States.
It was, uh, FDA cleared. First case was done at MD Anderson in October
of last year. They, um, it is an anatomically shaped implant.
It has an MR conditional, uh, magnet free port, uh, true fixation system in the smooth surface.
So I'm gonna run through some of my patients through 6 months of follow up.
I have found after 6 months the, uh, position stays very steady.
Now this was my first case that. I did because we were warned about them
bottoming out these implants are too high. I did not dissect the pocket enough and they
pretty much stayed where they are, um, with it.
Another patient breast asymmetry, um, this is with a this is a dual plan.
This was 4 weeks after surgery under dissected pocket, um,
this is her 6 year follow up.
4 weeks and 6 week follow up.
It's another patient, um, 6 years post-op.
This is the round these, um, are the, it's a firmer fuller device.
This is not my usual aesthetic. Um, this patient wanted as large as she could
get and interestingly it's held up through, uh, 6 years of follow up.
Another patient 6 year follow up. This is actually the lateral from that,
uh, round patient I showed before. These are out of order.
Uh, another round patient 6 years post op.
These are for patients who want a little firmer breast, a little bit more upper pole fill.
Thank you.