Thank you, Jean, and many, many compliments to you, Malan and Jame for this meeting.
Really outstanding from all points of view.
Thanks a lot for inviting me.
I am really, really happy to be here.
And we're talking about the polyuretin implant and I just want to focus some aspect of the
polyuretine implant by disclosure, I'm temporary consultant for polytech.
Why polyuretine first of all?
And if you try to see on long term, the pollutant advantages are
the capsular contracture rate that is very low.
As all of you know, the, um, the taxo implant was born just to
emulate the pollution one. Then, uh, from this point of view it is
fantastic. And the second great advantage of,
uh, pollutant implants is long term stability.
What about the disadvantages?
A very strong tissue adhesion that could be an advantage in some cases,
like for instance in breast reconstruction where the pocket is bigger than than we need
actually because when you do the mastectomy you have a pocket that is really large
and more than you need it.
Then when you have a strong tissue lesion, the problem is a mal positioning very often,
especially in aesthetic.
It could be happen that there's a slightly different in infra memory fall.
One is a little bit higher than the other one. This is a problem,
actually. And the second one is an implant visibility.
Unfortunately, when the patient lies down.
You don't see Mpomposition and visibility because
it's it's perfect. Also if it's semi sitting is you,
you don't see the defence actually and there is some, some tips and tricks that you have to
learn in your learning curve to know how to, to fix this,
this problem, uh, why there is an implant visibility because the.
Like in this case, you know, you can see in the upper portion,
this the, when you re-drape the skin, the, the, the grip is so strong that comes
up from the chest wall, and you have this kind of defects,
you know. In uh in the upper portion and it's,
it's really impossible to fix it, um, forget the, the lapofiing no possibility.
You have to go back in the OR and to fix the problem, then uh you have to try to avoid it.
It is, it's really a pain in the neck actually.
Another. point very important talking about the
pollution implant is a legend, this capsule removal.
It is so difficult to remove a capsule.
I think that it is true just between 3 and 9 months.
Just when you arrive at 1 year, you remove the capsule exactly as you remove all other capsula,
no great problem. Between 3 and 9 months in the time in which you
have the integration of the implant, then probably it is a little bit tougher,
but actually, uh, the, the, the problem related to the,
to the pollutant implants are this one.
I want to add some something else and misleading information when we talk about
uh BALCL.
For a long time, the classification pulled the uh pollutant implant as a
macro texture implant is wrong because it's just a coverage.
It's not a macro text implant and the number actually says that it's true.
It's not um it's true that it's not a um a macrot text or implant because the,
the problem or the majority of problem with BALCL are related to the.
Other company and actually it was a different way to vulcanize the polyurine uh um
around the, the implant.
Then, The in recon is definitely very, very,
very nice and we go and see another kind of surgery anyway,
it's always 2 centimetres away from the central line, it's always 7 centimetres,
um, lower, uh lower plane than with electrocautery,
helping with long tip and fiberli retractor just to go up.
To the, to the upper quadrant, and the 1st 2 centimetres to look for the plane and the
direct vision, and then inside, without using electrocautery, just,
uh, the left hand, it, it actually, it needs, I don't do any solution,
any infiltration.
I just, uh, want to be sure that I have 3 figures of blood pressure.
I do under direct vision to remove the, the tissue behind the nipple and and do the,
um, I cut the bridge just to cut to.
To bring out the, the, the all the land tissue and I put a
referral point on the axilla and then I go and check, according to my measurement,
the implant that I I would like to, to use.
Again, the bleeding, the sizes for the pollutants are just more implant then it's good
for um just for the, for the dimensions actually.
If everything is OK, I go in and I open my.
My box doing exactly what I do with the texture implet that I use regularly.
I don't use only polyure actually and Isha them I changed my
gloves. I put new towels on the.
On the field and uh I don't use any sleeves. 7 centimetres is,
is so huge and so uh big door that I don't have any problems.
But I use a spatula just to help myself to avoiding the problem that I showed before.
Just to redrape the skin with one hand, the implant is down,
and with the spatula, I redrape the skin, and I avoid any kind of possibility of grip between
implant and subcutaneous tissue.
Just a couple of uh of clinical cases in in all projection um in a short
time, then 6 months, no animation, very, very nice results and uh
the um one more case I want to show you also something different from,
from the one that I showed yesterday.
Uh, a very skinny patient with pollin implant. And uh you can use poin also
for this patient after a mastectomy without having any kind of problem.
You can see long-term results better than short.
And again, To 6 months and 2 years and
slightly wrinkling after 2 years, but very, very good.
And a very skinny patient, 3 years full stop in front of you.
And 5 years now, actually it's time to do the labour filling,
and we did it actually and just before summer and then I don't have
the picture because it's too early.
You can see after 5 years, 3 years, the, the upper pole is a little bit,
um, I can say it's empty uh if you compared to the um early results.
Talking about cosmetics, I want to show you just some three different situations which the
pollutant implant could be very, very good.
This is the not so young patient actually was 50 years old and asked for a press
recommendation. It's quite unusual actually.
How our patients are a lot younger than this, and I prefer to use it was one degree of ptosis,
and I just did a breast augmentation and.
2 years. The result is stable, it's very good,
just good redraping of the skin without any other problem.
One patient, and I want to show you, it, it's looked this mole.
I looked mole in a post op two years later.
I Look at the difference between the sorry, the infra mama is all,
sorry, you go back just a second.
That's it. Where is the where is the.
The lights. That's it.
1 and 2. The difference, look the difference between
inframammary fall and the mole in the poll stop.
And anyway, no double bubble, no problem.
Uh, the, the implant, if you put it in the right position,
it works perfectly with no problem at all.
No with a full deformity, nothing. And one young patient with a very constricted
lower pole, and again, the mole in, in a pre-op.
And in post op, look the the distance that you have.
is 1 inch more or less with no double bubble, no problem,
then the pollutant can be very reliable in a lot of situations.
And if you put this kind of advantages to the one that I I mentioned before,
I think that could be a great option for our reconstructive anaesthetic surgery.
Thanks a lot.
Our next uh Our next speaker, uh, this will be an interesting presentation,
uh, Edna Henry, who's gonna be talking about medical grade silicone and its application in
breast implants.
Good, good afternoon and thank you for inviting me.
It's great to be here and thank you for allowing me to inhabit your world for the last
3 days. I've certainly learned a lot and.
When I see the spectrum of views, you know, it's, it's interesting,
you know, because we maybe haven't seen the exposure to the art versus science before,
but seeing that spectrum of views and how we're able, you know,
as an engineer now to see things differently, I just really appreciate the different views and
how that created that sharing atmosphere.
So just talking about um medical grades, silicon is breast applications.
I'm hoping you'll leave this room with 4 new things that you'll know about silicone and
breast implants. You're all seeing them on your operating table,
some of you're using them every day, some just every week.
Um, so, so just a disclosure, I do work for a company called Newsil.
Um, they make silicone for medical devices. We do,
we do not make medical devices that that's not the business we're in.
Um, but I think the more relevant are disclosures for,
for this group are perhaps that I've known before, during,
or after photos.
Uh, I'm not a plastic surgeon and I don't have a suave Italian second name.
Uh But, but, but I do have a lot of relevant experience because I
have spent 10 years of my life as an engineer on medical devices,
and that's been on minimally invasive technology, but also actually on breast
implants, I've spent over 6 years working on manufacturing technologies on how to make the
breast implants, how to make them in 5 years' time, how to improve things,
and that's before joining a company and operating in a technical role,
and then moving into a commercial operations role.
And one of the things you, you may not be aware is is there is,
there is actually a technical breast implant standard.
So I have represented Ireland, uh, without that suave Italian second name,
I am actually Irish and we've represented Ireland on that ISO 14607 standard for breast
implants and it really is, you know, it's relevant, you know,
to, to the product that you use.
So, so Newsil is part of a broader group called Avantor, and Avantor,
that's the parent company, um, but just as you think about Newso,
as I think about the silicone, you know, we operate in,
in medical devices effectively where the silicon touches the human body.
And the other part is, is outer space.
And I guess what's the commonality between those two.
You know, it's about, you know, purity for one, you know,
if, if you don't have pure material, you're going to have cost of significant issues.
But it's also about the cost of failure, you know, if you have an issue in the human body or
an issue in outer space, that's really where you need some,
some different types of, of silicone that can meet those demands.
So a common question we get asked is, is silicone made in Silicon Valley?
Um, and you know, first we need to know there's a distinction.
So silicon is a metalloid and that's just found in the earth.
That's naturally occurring silicone, that's that stretchy thing you have on your shower at
home, and that's, that's manmade.
And so if you think silicon, think tech, think microchips, think Facebook,
think Google, silicone, as as a lot of, you do think breast implants,
and that's a distinction.
Um, but the irony is that actually it's not made that far away from Silicon Valley.
So our, our, our headquarters is in Carpenteria, California, and that's around 400 kilometres to
600 kilometres away from Silicon Valley.
Um, but it's, it's it's all made in the US, all of that medical grade silicone is US made.
And so you're most familiar with with with silicone because of its use in breast implants,
but it's in a variety of different devices.
It's, it's in, it's in those robotic robots that they're in the or it's in,
you know, testicular implants, it's in heart implants, it's,
it's coatings on the needles that pierce you when you get your your vaccine.
It's just in a variety of different products, and that's because it can do a variety of
different functions. Um, so, you know,
biocompatibility, that that's, you know, everybody knows that.
But if you think of terms of levers we have designing the material,
you know, chemical stability, you know, it's been able to make it as hard or as soft as we
need to make it, you know, it's making a gas permeability, low volatility,
and that's critical when you think of outer space as well as thinking about in the body.
So a common question we get asked is, you know, what's medical grade silicone?
What's the difference between that and other silicone?
And, you know, we typically start out by saying, oh, it's,
you know, purity is important, OK, you know, it's, it's it's,
it's pure, it's got less metal.
And and then that's all people want to hear because they've got it defined.
It's now about purity.
You know, then then we talk, you know, we, we ask them not to hang up the phone.
Um, and we say, OK, well, it's actually about performance.
It's OK. What do you need the implant to do?
What, what, what's the silicone got to do in this?
We've all seen those videos of cars driving over implants.
That's made by thinking about the design of the actual product itself.
And not only creating that, you know, silicone that can stretch at 500% its original size,
but also looking at, you know, what's the application, where does it need to be
customised for an individual application or or use case?
And when you think of, you know, medical grade silicon naturally regulatory support,
you know, FDA master files, de marking as you move into a highly regulated world,
particularly as happened in the EU lately.
That it's really created a huge demand on data from our actual material.
So when you think of a breast implant, you know, you know,
um, you think of typically in terms of three core areas,
you know, so you think in terms of the shell, the shell is the outer layer,
and it's often, you know, believed to be 11 material, but it's actually a combination and
that can be from 2 up to 4 different materials or even 5 that are part of that shell.
And then you've got the gel filler within that, and that can be,
as we've heard today, soft and cohesive, different attributes.
And then you've got the patch which effectively encloses the breast implant.
And again, the patch is often thought about as one material,
but it's frequently a combination of anywhere up to 6 or 77 different materials,
and that's to give it the unique functions that that people want.
Um, and there's been a good debate on arts and science, and I think I've seen in the last hour,
we believe in science on a presentation, but very much for,
for us, for us in the silicon world is, you know, we,
we've got, it's science for us it's, it's not an art.
It is, it is completely science and I hope that's comforting to.
because obviously we're we're making that silicone in terms of understanding what the
actual product needs to achieve.
So when we hear about subjectivity, about softness, we have to frequently translate that
into attributes that we can test, take the qualitative sort of world and put that into the
quantifiable world.
So when you walk around, you know, you know, silicon lab,
you're going to see a lot of testing equipment.
And that's taking things like softness that people talk about,
you know, cohesivity and form stability are probably 3 things I've heard over these last 3
days. You know, we translate those into quantifiable
test methods and really on every attribute have 2 to 3 different test methods so we can,
you know, differentiate and show what what this gel can do versus that other gel.
And that's just an example of maybe a deep dive on gel,
you know, responsiveness is probably the one thing.
You know, I didn't hear, which is sometimes how quickly something returns to its shape in terms
of time, you know, is that 1 2nd or is that 3 seconds.
Um, so I think I promised 4 takeaways. Uh, so breast breast
implants are made from silicone, and that's an underlined E.
Um, so it is made in the US but not in Silicon Valley, um.
For us, it is all about the science and you know, I think if you get to spend some time
with us, you'll get to understand that.
Um, a medical grade, you know, it's a, it's, it's a difficult question to answer because we
we do get asked that by the press quite frequently.
Uh, it's not one thing, it's everything.
And you know, if, if you've talked to reporters, you know,
that's not what they want to hear. They want,
they want a simple answer.
You know, it's really from, you know, having our, you know,
certain trucks pick up the raw material. It's having,
you know, the length to train to get people on board.
It's that regulatory, it's the performance.
Um, so it's just, you know, it, it's, it's a lot goes in to make that happen,
but If you want to talk about uh soccer or silicone, uh feel free to give me a call,
uh, so thank you for your time.
Thank you very much. That was great, very interesting.
So we shall continue and.
You know, a, a topic which is obviously very difficult for us,
which are using these devices and uh it's a great pleasure to have Patricia.
We give her her her insights.
Thank you. I'm gonna give an update on what we have
learned about the potential aetiology of systemic symptoms associated with breast
implants. My disclosures.
So this is through our systemic symptoms in Women biospeimen analysis study.
For those of you not familiar with this, it's the first prospective blinded study to compare
women with self-described breast implant illness to two control groups.
The goal of the study was first to evaluate symptom improvement after implant removal in
these patients, and then we also. to evaluate symptoms surveys,
patient reported outcome measures, and bios specimens to see if we could find any
consistent measurable differences that could be used to make a diagnosis or point to a cause of
symptoms in these patients.
We have 4 published papers in ASJ. These are all available open access.
I encourage you to read them because I don't have time to go through everything.
So what do we know about breast implant illness or systemic symptoms associated with implants?
Well, we know this occurs with all implants saline gel,
smooth texture by every manufacturer.
We know these patients have a lot of symptoms. Over 100 symptoms have been reported.
No specific configuration.
We know social media plays a role. They're telling these patients,
your implant's gonna kill you if you leave them in, and you have to have the capsule removed
because the toxins from the implant are also in the capsule.
We also know that some of these patients' symptoms do improve after implant removal.
The literature supporting this, uh, the Asia syndrome are all retrospective case studies
with poor follow up and no control.
And we felt like these patients deserved better so we put together a team of multidisciplinary
investigators, 5 surgeon investigators, a PhD toxicologist, 2 pathologists from Brown
University, an immunologist from Johns Hopkins, and a clinical psychologist who specialises in
medically unexplained symptoms, anxiety disorders, and Semitic symptom disorders.
So the study design included 150 age. Met subjects in three cohorts women with
systemic symptoms they attribute to their implants.
Women with implants without symptoms they attribute to their implants,
and women undergoing cosmetic mastopexy who have never had any implanted medical device.
We obtained detailed demographics. We use symptom surveys and the NIHROMIS,
which is a validated patient reported outcome measure for anxiety,
fatigue, sleep disturbance, and cognitive function.
And those were administered before 3 to 6 weeks, 6 months,
and 1 year post-op. We had over 90% follow up at 1 year.
The bios specimens were peripheral blood in capsules and then some breast tissue from the
mastopexy cohort.
All the specimens were sent within 25, 24 hours to the various labs blinded with only sight and
study number. The peripheral blood, we looked at thyroid
function, CBC, CRP.
vitamin D, 12 different cytokines, IgG and IgG antibodies to staph enterotoxins.
The capsules were sent in a swab of the surface of the implant to micro DX for next generation
sequencing for bacterial and fungal DNA.
10 grammes of tissue was sent to Eoin's, uh, lab for analysis for 22 heavy metals,
and then the remainder went to Brown University for histopathology.
The implants in the symptomatic cohort majority were saline,
64%, 90% were smooth, 88% were intact, and 85% of these patients had grade 1
or grade 2 capsules.
What we found was when we removed these implants, these patients had a rapid symptom
improvement. 88% of the subjects at one year had,
uh, at least partial symptom improvement with a 70% reduction in the number of symptoms.
That symptom improvement was independent of whether part or all of the capsule was removed.
That was what was reported in the first paper.
Now we realised that there was a limitation that there was some capsule had to be removed
because of all the testing.
And our next question was, does any of the capsule have to be removed?
So we just had another study that was published in April this year where we had patients that
we did not remove capsules, just remove their implants from a symptomatic group and a control
group. They had no other indication.
for capsule removal, no caps or contractor, no extra capsular silicone,
no um abnormalities of the capsules.
And what we found is that the symptom improvement was the same.
This yellow line is the uh no capsule study, and their symptom improves the same through 6
months, which is what we published. We now have 80% in one year,
and these symptom improvement have persisted.
So we're not the only one who's found this. It's a study from the Netherlands where they
found, um, no, they say that their conclusions was there was no significant association
between the performance of capsulectomy and recovery of symptoms or improvement in general
health. This is a consensus statement between the
Aesthetic Society and the American Society of Plastic Surgeons that was published in May
saying that we need to have consistent definitions.
We're all talking about the same thing about the types of capsulectomy and specifically that
en bloc capsulectomy is a term that should only be used for malignancy and in the absence of
indications, capsulectomy is not necessary for symptom improvement.
And why does that matter? Well, capsulectomy significantly increases the
surgical risk as much as 3 times increase in surgical risk,
specifically for hematoma. The paper just published this month that I
wrote the commentary for. It's a longer operative time and it's more
expensive. But patients do they have a right to have their
implants removed. They have a right to request capsulectomy,
but this needs to be done with informed consent.
These are the other reasons that it's important. These are the patients that I see that went to
the, uh, there are plastic surgeons that promote themselves as on block capsulectomy
experts, and I'm seeing more and more of these patients, and these patients spent between $250
and $75,000 for these results.
The next thing we looked at was heavy metals in the capsules because that's what the social
media groups were saying.
So we sent capsule off and we did find some metals detected in the capsules of both of the
implant cohorts and in the controlled breast tissue, but all were well below levels that are
considered safe levels of daily exposure and some were even higher in the breast tissue of
women who never had implants.
Silicone has been implicated.
This is a paper that was published by Ellen DeNino where they looked at particles of
silicone in capsules, and they did find significant numbers of particles in silicone
capsules, but there was zero particles in the capsules of saline implants.
And remember in our study, 64% of our patients had saline implants.
The next we looked at the bios specimens, microbes, histology,
blood, and toxins, and cytokines.
I already talked about the protocol for that. We looked at all of these different things and
in the end there was a lack of consistent identifiable biomedical markers to
differentiate the symptomatic cohort from the control groups.
Our fourth paper was the longevity of post-explanation.
Did they stay better at a year and what are the potential ideologies?
Well, we did so these patients did stay better through a year.
They had a rapid improvement in symptoms, but none of these objective things we looked at
were any different statistically in the symptomatic.
A cohort versus the controls. So now we're left with potentially
neuropsychiatric factors. This now fits into the category of medically
unexplained symptoms, which are physical symptoms that can't be explained by any
identifiable medical condition.
The symptoms are real and they're observable even if they are from a neuropsychiatric origin.
The more symptoms reported, the less likely a medical cause would be found.
We had between 8 and 35 symptoms in these patients with an average of 15.
These patients have a high incidence of health anxiety, and rapid symptom improvement is
consistent with the nocebo effect.
Negative emotions, negative expectations cause amplification of bodily sensations,
perceiving symptoms as threatening. I can get a headache,
it's a headache. Patients with health anxiety get a headache and
they think it's a brain tumour.
Patients with anxiety and depression do have a high sensitivity to nocebo and placebo effect.
And the hallmark is a rapid improvement in symptoms once a perceived threat has been
removed. So now we have another ongoing study where
we're still collecting data on a prospective study on sequential preoperative patients
looking at a deeper dive into these um neuropsychiatric sites and we're using the
same demographic symptom surveys that we had before.
Um, we are, we're going to get to 300 subjects enrolled.
We're looking at deeper somatic symptoms, uh, ssensory amplification,
anxiety scales, and a different.
What we're seeing so far is the um in the somatic symptom disorder,
these patients are much statistically higher, higher in catastrophizing scores,
higher in anxiety and depression from the two control groups.
So could this be a somatic symptom disorder which the DSM-5 describes.
One or more somatic symptoms that are distressing are the result in significant
disruption of daily life.
Excessive thoughts or behaviours related to somatic symptoms,
including disproportionate and persistent thoughts about seriousness and excessive time
and energy devoted to symptoms or health concerns for more than 6 months.
So the conclusion is we did find these patients' symptoms improve when you remove
their implants. There was a lack of biospeimen findings to
differentiate the three cohorts.
The systemic symptom and PROMIS data did demonstrate increased anxiety.
That was the one consistent difference between the BII cohort and the controls,
and that may contribute to their symptom perception.
The consistent similarities between the two control groups and the mastopexy the non-BI
implant cord make it likely that the implant alone is the cause of their symptoms.
When you see these patients, remember that they have real symptoms.
By the time they get to us, they are frightened, they're frustrated because nobody can tell them
what's going on. And part of what led us to this is they were
blown off by a lot of plastic surgeons. It's very important to have an appropriate
medical workup prior to having surgery. Mindy Hawes had a patient came in,
thought she had breast implant illness, and she looked sick,
so Minnie's like, I'm not operating. I'm gonna send you back to your internist.
She had metastatic liver cancer.
I had a patient that had hyperparathyroidism, her symptoms went away when that was treated,
so these patients need appropriate evaluation before they're operated on.
They have a right to have their implants removed, request a capsulectomy.
We can't tell them it's likely at least some of their symptoms will get better.
And the absence of other indications capture contracture, rupture,
textured implants, patients are concerned or requests or any capsular abnormality,
the symptom improvement is independent of whether all or any capsule is removed.
We should be practising evidence-based medicine based on the most recent scientific data,
and patients deserve choices based on scientific evidence for full informed consent,
not social media data and not surgeons promoting themselves as experts and procedures
we all do every day.
We still need further prospective research to determine who's at risk and how best to treat
them. Thank you.
OK, our, uh, next speaker is going to be Nicolo Rocco.
There he is, and he's gonna be speaking about, uh, ALCL and prophylactic explantation.
Yes, thank you, thank you again for giving me the opportunity of being part of this excellent
meeting. And let's go on with another tricky topic that
is ALCL. I have no conflicts of interest to disclose.
And let's start, starting from the basics, you know that uh BIA ALCL is an
uncommon plasia, is a T cell, uh, non-Hodgkin lymphoma occurring in women with breast
implants. Well, Looking at the numbers, you know that
from the ASPS global network we have 1,344 known cases
of ALCL and 59 deaths worldwide as January 2023.
As June 2023, the FDA received a total of 1,264 global
medical device reports for ALCL, with 63 deaths globally.
And the ASPS and the Plastic Surgery Foundation and the profile registry,
uh, reported an updated uh report about data on ALCL uh among between
2012 and 2020 on 330 cases of BA
BIALCL in the US.
If we look at literature.
And that the epidemiology of ALCL, we can say that there is a very wide range
of reported prevalence and risk estimates per patients.
This is very difficult. This is very difficult to estimate the real
incidence of ALCL because we do not know the prevalence of women with breast implants
worldwide and you can see. We range from 0.2 per
100,000 women with breast implants to
282.5 per 100,000 women with breast implants in the report by Peter Cordero from the
Sloan Kettering. So that is a risk of one out of 354 to
1 out of 500,000 implants.
So, uh, as for all rare disease, obviously we have a limit,
uh, a limited limited evidence available evidence we do not have a high quality evidence
to inform our understanding of ethiop pathogenesis of the risk of possible
therapeutic and also prophylactic approaches and outcomes of ALCL,
and I think I can tell you that we will not have.
Stronger evidence in in few years for sure as the rarity of the disease.
So looking at the Ethiopathogenesis, several assumptions have been proposed,
but nowadays we do not, we did not understand yet the true mechanisms that are behind the
aetiology and pathogenesis of ALCL.
There are several hypotheses, genetic drivers, chronic inflammation.
resulting from bacterial contamination or shell shedding of particulates or shell surface
characteristics leading to augmented friction, higher friction or implant associated reactive
compounds.
Anyway, the common underlying mechanism is the development of a chronic inflammation reaction
that will lead to the activation of the jackstat pathway which will turn to
lymphomagenesis.
Well, if we look at the scientific Committee on Health emerging an environmental risk from the
European Committee and the European Commission, we see that the Shiar reported that there is a
moderate weight evidence to support a causal relationship between taxed implants and
ALCL, and the shear.
Says that there are no known cases with smooth implant history alone,
even if we do not know the full implant history of every patient and there is a large
variability also regarding the nomenclature of different uh texteurization and different
texturing classification system use.
If you look at the FDA data, there are 37 cases of smooth implants,
but they, most of these have past history of texture disease.
Anyway, um, what about ALCL and implant texturization?
This is a very recently, just a few days ago, the American Association of Plastic Surgeons,
there is, is not the American Society of Plastic Surgeons,
there is the uh published a consensus on breast implant associated in a plastic large cell
lymphoma. This paper was online till February,
but is now have been published now.
And what are the, what does the The author, what do the author
conclude that there is currently available evidence sufficient to determine that the
association of text breast implants to ALCL meet the definition of causation based on these
redfold Hill criteria, I reported what are these breadthold Hill criteria that are 9
viewpoints by which to evaluate the evidence to determine if causation can be deduced.
So the authors conclude that the use of macro textured breast implants should be discontinued,
while no change in the use of smooth surface breast implants is warranted at this time,
as the risk of developing ALCL with a smooth implant is the same as the general population
that is 1 in 4 million.
But wait a minute.
What is the evidence behind this this assertion?
We will, I will show you later on.
Anyway, we, you know that uh there, there are guidelines and recommendations developed by the
NCCN for the diagnosis and for the treatment of ALCL.
And the, the staging is according to the TNM solid tumour staging,
not according to the uh Lugano modification of the Ann arbour staging system as for other
non-Hodgkin lymphomas, but as you can see there.
Around 70% of all ALCL are stage 1A, that is T1
and 0 and 0. That means that the tumour is confined to
diffusion to the seroma, to the periprosthetic seroma, or a layer on the luminal side of the
capsule. Well, you can see that and positive cases,
so to B3.
stage are only 59% reported in the literature. So if you look at the overall survival
rate, we can see that we can say that this is an indolent disease very
localised with an excellent prognosis when patients receive appropriate diagnosis and
surgical excision.
And you have an overall survival rate of 94% and 91% at 3 and 5 years.
Obviously there are some advanced cases of BALCL that could require adjuvant treatments,
chemotherapy, radiation therapy, also stem cell transplant, depending on pathology on the stage
of disease. Anyway, uh, for, uh, early disease,
an unblock capsulectomy, that is the, uh, the removal of the pro of the implant with the uh
intact capsule and the resection of any associated mass and excision of possibly
involved lymph node is recommended for all patients with ALCL.
And in cases of unilaterally diagnosed ALCL is advised to also remove
the contralateral, uh, the contralateral implant because there are several cases of
bilateral disease reported worldwide.
And we should also think to what to what to do with patients in which we
are removing implants for BALCL as the prognosis is excellent.
We obviously have very few data on the optimal time and mode of reconstruction for or revision
surgery for these patients. We mostly have two papers that give.
Advice one from the Royal Marsden here in London and the other one from the MD Anderson
in the United States.
The first group suggests immediate reconstruction without the use of implants for
early stage disease, while consider and propose delayed autologous tissue based reconstruction
for extensive disease after 6 to 12 months, providing there is no evidence of relapse.
Well, the group of the MD Anderson suggests the use of smooth implants,
so they suggest that also in patients that had had ALCL,
you could use smooth implants to reconstruct.
Anyway, obviously the reconstructive option uh should be offered on an individual basis
following a multidisciplinary team discussion with the oncology,
medical oncology, and the breast and plastic surgeon surgeon.
And what about prophylactic surgery? So we are talking about asymptomatic patients
with macro taxoid implants. Well, according to the SHAR committee and the
report of the SER from the European Commission, in non-symptomatic patients with taxoid
implants, implant removal with or without total capsulectomy for the single purpose of
prophylaxis of ALCL is not recommended due to the very low incidence of this disease,
but we can see.
That there are some different opinions and this is the consensus conference from the American
Association of Plastic Surgeons just published on PRS.
They conclude that based on the potential risk reduction, prophylactic explantation of
macrotexus surface implant can be deemed reasonable, that is potentially to mitigate the
risk. There is a potential to mitigate the risk,
but not at. Advisable.
This is not easily understandable. Anyway.
Furthermore, after um implementing a risk classification and the surveillance plan
coupled with an informed discussion about the risk and the benefits of possible prophylactic
surgery, it may also be considered reasonable for explanation of any type of taxo implants,
not only macro taxoid implants, but.
Wait a minute. What, what is the, the evidence behind this
assertion of the American Association of Plastic Surgeons?
The authors, um, report three papers as references for their,
uh, their consensus statement.
One is, uh, this first paper by Fabio Santanelli de Pompeo published in 2023 on the
ASJ. Reporting on 248 patients who already developed
BALCL without any random randomization, no control or no comparison group.
So there are no patients without BALCL and it's not about prophylactic surgery,
not about patients who did not have BALCL.
The second paper referenced is a commentary on this article by Mark Lemmons.
The third one is a paper by Vittorietti in Italy.
That knowledge and delayed onset of ALCL by implant replacement but not risk
reduction. So none of these reference studies contain any
patient who underwent prophylactic explantation and or total total capsulectomy.
So the delayed onset in patients in the report by Vioretti of BALCL is not equivalent to
the risk reduction for those who do not have the disease.
So, and what about capsulectomy?
Yes, already Patricia McGuire mentioned for, uh, breast implant illness.
Anyway, um, there is no need for any capsule, any type of capsule resection in
pro we are talking about prophylactic surgery in this case for risk.
Reduction as there is there is no evidence for performing a total capsulectomy and there is
also evidence about disease manifestation years following capsulectomy.
So there is not a standard and there is not a standardised approach for capsulectomy
internationally. So we can conclude that the final decision for
exploitation with or without capsulect not we can conclude the authors of the consensus can
conclude that the final decision for exploitation with or without capsulectomy
should be shared between patients and surgeons following an evaluation of the patients goals
against the perceived benefits of the surgery and individual surgical risk assessment.
But again, evidence remains limited on risk reduction.
And uh as the authors acknowledged in the in the paper,
government authorities and the all national surgical Society have not acknowledged the
potential for risk reduction through prophylactic exploitation of microtex to
implants, so these procedures are not recommended.
This is the FDA that concluded that given the occurrence that of EALCL is
uncommon, prophylactic removal of taxodila is not recommended in a symptomatic patient.
Prophylactic surgery also shows some risks depending on individual patient risk factors
including the history and the anatomy.
And so there were, there was the response by the American Society of Plastic Surgeons that
concluded that based on the available evidence, the ASPS recommends following.
Uh, the, the, the FDA guidance which does not recommend the removal of breast implants for
asymptomatic women.
Anyway, obviously the ASPS support patient choice, shared decision making process again.
A woman who desire to have a breast implant removed for any reason could consult her
plastic surgeon and have a proper shared decision making.
This is another very important point reported by Glasberg in a reply to the paper
by the American Association of Plastic Surgeons about surveillance.
This is very important to note that given that the patient with taxoid implants who have had
explantation for prophylactic reason and capsulectomy could still develop ALCL,
this patient and their surgeon cannot be led to believe that such treatments leave the patient
with no further risk and no need for continued surveillance, so they should be continued to be
sur uh under surveillance.
So in conclusion. The available evidence does not indicate that
the risk of LLCL is reduced by prophylactic explantation of micro test to implants.
Prophylactic explantation is a complex individual decision and is not equally
advisable for all patients.
It's important to uh assess a personalised risk-benefit analysis to perform a personalised
risk benefit analysis, taking into account the goals of that specific patient,
risk tolerance, the health status of that specific patient.
The risk associated with different extra implants and individual surgical risk
assessment, but, uh, last but not least, it is very important,
accurate patient information and notification of the risk of developing ALCL for all patients
with breast implants. Thank you.
And, uh, our second to last speaker is going to be Lee Martin,
and he's going to be speaking on breast implant registries.
Uh thank you and uh thank you for the invite.
Um, I'm really proud to be involved with the implant registry and it's great to be able to
publicise all the work that we've done.
Um, I suppose my only disclosure is this is gonna be very UK centric,
um, and I apologise to, er, anyone who's not based in the UK,
uh, and that doesn't include Wales cos they refuse to be part of the UK,
uh, implant registry.
So the original implant registry started in 2016 following the Keogh review because of the
uh PIP scandal.
Um, like all politicians and parliament, it was only funded for two years,
and after two years we really couldn't get any money to kind of change the platform,
uh, which is kind of typical of the uh the governments.
So the original uh CAP is still open.
The annual reports are there.
We had a fantastic interactive dashboard that you could look at,
but unfortunately that's been found to be a security risk and it's been taken down because
the the Power BI that was used to to run it um had some massive big flaws and that's gonna
kind of come up a little bit later on.
I've been asked about the case ascertainment. It's probably around 80% at the moment in
2022.
Um, it's difficult because we tend to use the HESS data,
the hospital episode statistic data, uh, and the OPCS codes,
but a lot of the OPCS codes we were using actually did include implants,
which wasn't very helpful for the private sector and the.
Majority of implants are put in privately.
We tend to use the FI data, but not all hospitals are registered with Fin,
although they're kind of still entering data uh into the BCIR.
So 80% probably around, so not bad.
So since 2016, we've got 100,000 patients now that are being entered into the registry,
so very proud and hopefully we'll be able to get some kind of good data out,
uh, going forward in the future and dispel some of the myths that people have spoken about
already today. So because we had a a recent general election
in the country, this hasn't been published.
Um, so you can see the big dip of COVID, you can see the rebounds.
Um, we've had a, we've had a year on year reduction in the number of,
uh, augmentations.
I don't know whether that's secondary to health concerns.
We, we've got a big, big increase and a big problem with cosmetic tourism in this country
at the moment. So whether it's because people are going to
Turkey, etc. to go and have the surgery,
although you can see that there's a, there's been quite a big increase as well uh in
explants.
Um, and so whether those two things go together.
And for those of you that you like some figures, you can,
you can see the figures there with the drop er in augmentations and the increase in
explantations.
Um, there's been a number of problems with implants and a number of problems with drugs,
uh, with drugs as well, and that led to, uh, Jeremy Hunt,
um, commissioning the, uh, the Cumberage report, or, or it's called First do no harm.
And one of the things that uh Baroness Cumberland suggested is that we had to have a
centralised uh database, and for once they actually gave 11 million for this to happen.
Um, because the breast implant registry was already, uh,
in existence, it was decided that was gonna be one of the first with the National Joint
registry, uh, which has been going on, going, uh, along kind of quite heavy now for the last
12 years. So the outcomes and registries programme is
gonna include all implants that are used in the UK except for Wales.
Um, so 2 million implants.
Again, there's been some problems, there's been lots of patient groups being worried about
security. Uh we've just recently had to change now,
so when you log on to the new system, you've got to do a multi-factor authentication um
to ensure the safety of the patient information.
Um, as I said, we've been signed off in Northern Ireland and Scotland now.
That took absolutely ages.
Uh, and anyone who has a need to be part of the programme can register,
which is different to the old legacy database.
Uh, really grateful for all the people who volunteered to try the,
the test system out, uh, and the people who gave feedback.
Um, What's really good is anyone can get access to it to put data in.
So if you're a registrar and you get you go into a new job,
you can apply for access to be able to get your own data er into the implant registry.
We try to make it as easy as, uh, easy as possible, uh,
and as intuitive based on, on the previous one.
You can do bulk uploads.
We've added the second operating surgeon, as we've just said,
we've added, uh, added some patient risk factors, uh,
so we can do outcomes analysis going forward.
Uh, added in BIA SCC. There hasn't been one case that I know of at
the moment and, uh, in the UK that's been reported.
Again, other implant capsule malignancies, er, and the use of dermal slings with an implant
because we think that they probably do increase your risk of er periprosthetic infections and
and potential loss.
Uh, gender questions, um, again, apparently it's really important to make sure that the
pronouns are, are correct on any kind of correspondence which is,
which is sent out.
Um, there are a number of surgeons using meshes with mastopexy,
so we've included that now.
Patient preference for a revision and explantation, we've separated that now for
cosmetic and health concerns to try and see if we can get any data from that.
Two stage surgery is not a complication anymore, which it wasn't in the original,
and again it would be mandated that any implants which are inserted overseas have to be
recorded now. We've still got paper forms, um,
I would hope that people don't use the paper forms because one thing from the uh Cumbridge
report is that the surgeons have to take responsibility and they will have to validate
their own data.
Um, as I say, the, the dashboard is, is pretty, um, straightforward.
So add a record, you put the NHS number in, uh, and the date of birth,
press save, uh, and that's it, it's all done.
Uh, we're hoping to be able to get kind of auto-population as well,
uh, going forward, but again it's quite difficult.
Um, You go through, um, again, very intuitive.
er if all the fields are being filled in which are mandatory,
you get a yellow or an amber, um, button.
Uh, if everything's been filled in, you get a green, and if not all the mandatories,
and then you can't submit or you can save.
Um, so, as you can see on the, on your left there, there's,
um, some which have been filled in all the fields and some are mandatory sections and some
which haven't been filled in and which will need to be filled in before you can actually
submit. I think this is the best thing now, so when you
actually go in um to your implant it automatically defaults that you can use a
barcode scanner um just for the USB.
Um, and that will give you the lot number, serial number,
the UDI, uh, everything about the implants.
Uh, otherwise there is a backend database now.
Um, so you can actually just put the serial number, the lot number in,
and then it will auto populate, uh, without having to put the 14 figure UDI number in,
which is actually quite difficult.
As I say, all clinicians will have to validate their data.
Uh, and if they don't validate it, it won't be formally submitted,
so you will get an email to say that you haven't validated your data.
We're just trying to decide what will happen if you don't,
whether that'll go to the medical director or or whoever.
So we started the new um we started the new cap in March and at the moment only
18.4% of cases have been validated.
NHS is doing slightly better than the independent sector.
So we're gonna try and get all the data from the legacy cap um uploaded.
Uh, we've got a mobile phone, um.
Scanner called Scander Express that kind of can scan the barcode again and auto populate
the cap, which is quite exciting.
You'll get your own individualised hospital surgeon, manufacturer reports working with the
manufacturers, as was mentioned before.
There will be a live dashboard which will be updated as you go every day so you can see how
many implants are being performed, who's doing them, etc.
And we're hoping going forward to integrate the implant registry into the NH app,
uh just like the, like the COVID vaccines that we had.
One of the big things is about proms.
I stopped um mandatory consent to go into the implant registry when I first took
over. um, so it's an opt out as opposed to an opt in,
but for proms it will have to, you'll have to get consent if you want proms doing.
So I think that's gonna give us quite a few challenges, but hopefully it will give us some
really important information.
We've also been in contact with Keith Tucker, who shares the orthopaedic data evaluation
panel and the Beyond compliance. So again,
looking to the industry about after things have been seenmark and looking to see how,
how can we get better or the centres of excellence that we can learn from.
So thank you for listening. I hope everyone who's a UK will actually kind
of just fill it in online, it is dead easy.
Thank you.
Thank you very much. So, and now to the very,
very, very last.
Talk of this meeting and um given this time because he was just sitting around
doing nothing for 3 days, so he also needs to give a talk.
OK, thank, thank you very much. Uh, always it's an honour to be the last one.
And the good thing about the, the Barcelona meeting and the London meeting is we try to
don't put too much work and but you know Jen always put me a little bit of a drop of work
and honestly with with a very strange, you know, um, titles that uh
it's much easy to talk about anything la flap, DF flap or any kind of things.
Uh, he asked me to talk about what's on the horizon in the breast surgery.
And um you know, after to be in the gala dinner, I have been all night just watching this
crystal ball trying to find what can I say about the horizon in breast surgery.
There is no disclosure in my presentation.
And obviously when you see a little bit about the breast cancer,
you realise that you don't need to to to to watch in the crystal ball.
Just you need to remember what Humberto Veronei said, you know,
more than, than, than 30 years ago.
The best cancer treatment is based in that in this minimal effective treatment and quality of
life, and this is what we are going to find in uh in the close future.
01:00:00.570 --> 01:00:04.530 And obviously when you see what the patients they need is simple.
01:00:04.899 --> 01:00:09.620 The first thing they need the right information. This is still the the patients they are,
01:00:09.739 --> 01:00:13.379 they are missing that in many peoples in the world in Spain,
01:00:13.419 --> 01:00:18.179 in the UK, in Italy and you can. Imagine in some other places in the world and
01:00:18.179 --> 01:00:22.899 obviously the people they want the best, the best technique and the best technique is simple
01:00:23.139 --> 01:00:28.929 is, you know, natural and permanent breasts, no mobility in a very easy way.
01:00:29.139 --> 01:00:33.379 This is the the the the base of what the people expect.
01:00:34.189 --> 01:00:41.020 When you see what is uh coming new in uh in this new paradigm on on on breast surgery is
01:00:41.020 --> 01:00:44.939 again it's quite simple, more personalised oncological treatment,
01:00:45.149 --> 01:00:50.379 all these genomic biomarkings, you know, innovations, more breast conservative,
01:00:50.389 --> 01:00:56.060 better oncoplastic minibus techniques, robotics, endoscopic surgery,
01:00:56.310 --> 01:00:58.149 faster recovery protocols.
01:00:58.649 --> 01:01:02.290 The wonderful, you know, tissue engineer regenerative medicine,
01:01:02.360 --> 01:01:07.370 and obviously everybody likes to talk now about the artificial intelligence,
01:01:07.459 --> 01:01:10.060 you know. Nobody knows what it means, but everybody likes
01:01:10.060 --> 01:01:11.209 to talk about that.
01:01:11.459 --> 01:01:13.489 Probably that they will be arrive very soon.
01:01:14.310 --> 01:01:20.389 But at the end I am, I am sure I am going to, to jump in this field making a wonderful
01:01:20.389 --> 01:01:27.340 breasts from this regenerative medicine may may maybe um some of you
01:01:27.580 --> 01:01:33.139 like Ramou is going to do, but I am still, you know, I am not a scientist.
01:01:33.219 --> 01:01:38.979 I am a surgeon and at the end what I like is go to the OR and do something for my patients.
01:01:39.500 --> 01:01:46.110 And uh honestly what uh is really is really becoming more and more important is
01:01:46.439 --> 01:01:51.889 to listen to the patients, you know, the, the breast care is based on what the patients want
01:01:52.120 --> 01:01:56.840 and this is sometimes uh is what we are, you know, for we forgot,
01:01:56.959 --> 01:02:01.479 you know, to listen to the patients and we are going to see more and more this holistic care
01:02:01.479 --> 01:02:04.760 approach and and shared decision making.
01:02:05.169 --> 01:02:10.090 Because the patients, they want to take the decision about what they want to do about their
01:02:10.090 --> 01:02:14.350 life. When you see what uh we can do now after,
01:02:14.489 --> 01:02:18.850 you know, all this, you know, surgery, we can see that these patients,
01:02:18.860 --> 01:02:24.250 they need probably now not only surgeons, we need also a little bit science beside we need
01:02:24.250 --> 01:02:30.689 to be more combining, you know, these uh crazy things about the stem cells growth factors and
01:02:30.689 --> 01:02:33.500 these kind of things, but still the knife is going to be ci.
01:02:34.830 --> 01:02:41.260 And uh this is what we have been doing for the last 25 years and we can achieve amazing
01:02:41.260 --> 01:02:45.040 results. That that case is from 2001 and I am very proud
01:02:45.040 --> 01:02:49.969 and when I see what they are doing now, I say wow, there are no many different things in the
01:02:49.969 --> 01:02:54.739 last 25. Yes, but obviously this is what we do in
01:02:54.739 --> 01:03:00.860 Barcelona that we see that everybody is doing in everywhere all the fancy fancy peo flaps,
01:03:00.939 --> 01:03:06.379 the, the DTI, the new expanders for grafting meshes, all these,
01:03:06.459 --> 01:03:08.330 you know, but at the end.
01:03:08.909 --> 01:03:13.840 Uh, what we are doing better and better, we are squeezing more of our brain to get the best
01:03:13.840 --> 01:03:19.030 thing for our patients, and this is why we are also, we can improve,
01:03:19.399 --> 01:03:24.360 uh, our surgery and this is what I really believe this is going to be very close,
01:03:24.520 --> 01:03:29.495 very close in this. The horizon for the next 3-5 years and then you
01:03:29.495 --> 01:03:34.695 will see that this is what going to talk in the London press meeting and and probably in the
01:03:34.695 --> 01:03:39.294 Barcelona press meeting and in some other, you know, meetings that they are following London
01:03:39.294 --> 01:03:41.975 and Barcelona meeting because everybody's following us.
01:03:42.629 --> 01:03:47.719 And uh the thing about uh autologous tissue, we are going to move more to this perforator to
01:03:47.719 --> 01:03:52.370 perforator DAPSA fla. We are going to in fact,
01:03:52.520 --> 01:03:57.280 we are going to avoid opening the fascia. We are going to take only a little piece of
01:03:57.280 --> 01:04:03.520 vessel under the skin and with the help of the robots we can do that in a very comfortable way.
01:04:03.679 --> 01:04:08.580 This is going to be a reality and you will see that very soon we are not going to dissect
01:04:09.060 --> 01:04:13.350 anything. I don't believe in in going and harvesting the
01:04:13.350 --> 01:04:16.780 flap from inside abdomen, but you know with this, you know,
01:04:17.040 --> 01:04:22.979 wonderful, you know, super microsa robots you can take on a little piece and then do the
01:04:22.979 --> 01:04:24.659 asstomosis in a very nice way.
01:04:25.510 --> 01:04:31.459 I believe more and more in breast sensation restoration and Andrea so a wonderful work and
01:04:31.459 --> 01:04:37.449 the idea to, to keep sensation in all the tissue and even to keep sensation in the nipple
01:04:37.449 --> 01:04:39.770 is going to be a reality very soon.
01:04:41.110 --> 01:04:47.169 And what is going to happen behind the implants? Honestly I think implants they are going to
01:04:47.169 --> 01:04:51.310 disappear. You know, it's a limited time for the implants.
01:04:51.350 --> 01:04:55.419 I don't know how going to take 5 years, 6 years, 10 years,
01:04:55.629 --> 01:04:57.419 but unfortunately it's going to disappear.
01:04:58.520 --> 01:05:02.310 Not the concept, the implants like the we believe and we know now.
01:05:02.520 --> 01:05:08.320 It's something new coming probably they are going to be more this kind of concept of 3D
01:05:08.320 --> 01:05:13.080 printed custom by several scaffolds. It's going to be something that is not going to
01:05:13.080 --> 01:05:17.639 be a foreign body in the body. It's something that is going to help to create,
01:05:17.760 --> 01:05:20.629 you know, this volume that we are looking for.
01:05:21.290 --> 01:05:26.739 And we are going to have more and better fat transfer, the stem cell enriches and,
01:05:26.810 --> 01:05:32.169 and, and I believe strongly believe in this fat banking transfer that you can do it,
01:05:32.419 --> 01:05:36.500 you know, on the, on the office and the local anaesthesia and,
01:05:36.530 --> 01:05:40.419 and, and then do it in a very easy way and this is going to be very,
01:05:40.459 --> 01:05:44.179 very soon. And in fact following this concept you have
01:05:44.179 --> 01:05:50.419 already some people working doing uh uh I think this is a great concept is this kind of uh what
01:05:50.419 --> 01:05:56.459 Lati Medical is doing that in fact was presented here in London press meetings 4 or 5
01:05:56.459 --> 01:06:01.709 years ago. And now I am joining in this trial all the
01:06:01.709 --> 01:06:04.949 hospitals are French hospital because it's a French technology.
01:06:05.030 --> 01:06:09.219 The only who I am not uh French is me. I don't know why,
01:06:09.550 --> 01:06:12.149 but, uh, probably, you know, from time to time the French people,
01:06:12.229 --> 01:06:18.469 they make mistakes and they put us also in the in the trial and the concept I like it.
01:06:18.919 --> 01:06:25.000 It's a kind of scaffold absorbable that is creating a kind of dome and then you need just
01:06:25.000 --> 01:06:28.629 to take a little piece of tissue, very little, and this,
01:06:28.669 --> 01:06:35.100 this tissue is going to multiplicate, it's going to increase the volume 34 times and then
01:06:35.100 --> 01:06:41.239 you are going to get even in a very skinny people enough volume to recreate a natural
01:06:41.239 --> 01:06:44.639 breast. And I think that is going to work and this is
01:06:44.639 --> 01:06:47.729 why I, I am joining in this uh clinical trial.
01:06:47.989 --> 01:06:54.320 And this obviously they are going to be new versions and and better but this is going to to
01:06:54.320 --> 01:06:58.790 probably open a new window in the sight of this, you know,
01:06:59.120 --> 01:07:01.760 not completely autologous tissue reconstruction.
01:07:03.540 --> 01:07:07.840 And this is what I'm going to tell you, you know, there is place for all techniques,
01:07:07.850 --> 01:07:14.649 but for sure this is going to change and we are going to go at the end uh uh about that a more
01:07:14.649 --> 01:07:20.370 personalised medicine and at the end at the same that we are doing in our normal life we
01:07:20.370 --> 01:07:27.169 are looking for, you know, cloth products, you know, organic food and this is the same
01:07:27.169 --> 01:07:31.229 in surgery. Why you are going to take fast food when you
01:07:31.229 --> 01:07:35.659 have a wonderful, you know, organic food that is made in this,
01:07:35.719 --> 01:07:38.870 uh, for example, wonderful country that is Italy.
01:07:38.929 --> 01:07:43.979 You you need to take to take some plastic food and this is what is going to happen.
01:07:44.310 --> 01:07:50.350 But we will see, we will see in probably in the next few years in the London and in the
01:07:50.350 --> 01:07:52.280 Barcelona meeting. Thank you very much.
01:08:00.399 --> 01:08:04.560 OK, we can open it up for questions. I think we got about 10 or 15 minutes before we
01:08:04.560 --> 01:08:09.479 have to wrap up. I think I'll kind of lead things off and maybe
01:08:09.479 --> 01:08:14.800 talk to Patty first, uh, and we can bring in the ALCL things and the systemic symptoms,
01:08:14.840 --> 01:08:20.950 but I think it's fair to say at this point that the systemic symptoms associated with breast
01:08:20.950 --> 01:08:23.470 implants is solely because they have a breast implant.
01:08:23.509 --> 01:08:29.220 It's not because of any physiologic problem, but one of the things that kind of
01:08:29.790 --> 01:08:34.740 really confirms the psychosomatic nature of this is when you look at women who have these
01:08:34.740 --> 01:08:39.839 symptoms of Lyme disease or symptoms of Lyme without having Lyme,
01:08:40.109 --> 01:08:44.419 the symptoms are almost identical, and there was a New York Times article about this a few
01:08:44.419 --> 01:08:47.199 years ago. And they really pointed out, but it really kind
01:08:47.199 --> 01:08:49.438 of points out how there's probably certain.
01:08:50.290 --> 01:08:56.870 Personality types or whatever that are going to maybe be more affected by these sorts of things
01:08:56.870 --> 01:09:00.319 if they have something exogenous then maybe they'll blame it on that.
01:09:00.649 --> 01:09:02.390 I don't know any any comments?
01:09:02.649 --> 01:09:06.729 Yeah, I mean the the problem with this, you don't have 100 symptoms and it's one entity you
01:09:06.729 --> 01:09:11.040 know this is an adverse reaction to the presence of an implant.
01:09:11.299 --> 01:09:16.529 And whether it's psychosomatic, there may be some patients who have some odd physio like we
01:09:16.529 --> 01:09:19.450 couldn't find anything. And we look, we looked at under every rock we
01:09:19.450 --> 01:09:20.839 could look, we didn't find it.
01:09:21.250 --> 01:09:25.600 Dan Claw, who is a um rheumatologist at the University of Michigan.
01:09:26.120 --> 01:09:29.799 Um, he specialises in fibromyalgia, chronic fatigue syndrome.
01:09:29.839 --> 01:09:34.069 He thinks long COVID, sick building syndrome and all fall under this.
01:09:34.359 --> 01:09:41.200 He thinks these patients may have some sort of abnormal posterior pain pathway that causes
01:09:41.200 --> 01:09:44.370 their body to. Overreact to the presence of a virus to the
01:09:44.370 --> 01:09:49.279 presence of a foreign body, the presence of some sort of inflammatory process.
01:09:49.689 --> 01:09:54.609 Um, there have been some studies that show in fibromyalgia that their functional MRIs are
01:09:54.609 --> 01:09:57.529 different. There was a study done, um.
01:09:58.600 --> 01:10:03.359 And maybe in the Netherlands, I can't remember what they did on breast implant illness
01:10:03.359 --> 01:10:06.049 patients, they tried these and couldn't find anything.
01:10:06.279 --> 01:10:08.830 The functional MRI's were not any different, so.
01:10:09.189 --> 01:10:11.700 I mean it's hard. We're trying to prove a negative,
01:10:11.779 --> 01:10:13.459 trying to prove the implants don't cause anything.
01:10:13.540 --> 01:10:18.490 We had hoped we would find this was a biofilm, a subclinical infection on these patients that
01:10:18.490 --> 01:10:25.410 the enterotoxins were going to show something, but this is a and the other thing
01:10:25.410 --> 01:10:29.129 that we're hearing from these patients in this deeper dive we're doing.
01:10:29.810 --> 01:10:32.410 They start off with a negative connotation of their implants,
01:10:32.490 --> 01:10:35.209 and I've heard this from these patients. I really didn't want implants,
01:10:35.250 --> 01:10:37.919 but my abusive ex-husband talked me into it.
01:10:38.169 --> 01:10:41.270 I went in for a lift and I was talked into an implant.
01:10:41.490 --> 01:10:45.240 I thought I was going to get 300 cc implant and I have a 600 cc implant,
01:10:45.410 --> 01:10:51.649 so it's a negative connotation in patients who are more susceptible to these negative
01:10:51.649 --> 01:10:55.930 connotations and somatic symptoms, anxiety, illness disorders.
01:10:56.049 --> 01:10:58.660 This just gives them something to worry about.
01:10:59.270 --> 01:11:04.149 So it's a very complex problem, but it's it's the most important thing is these patients have
01:11:04.149 --> 01:11:08.939 real symptoms, and we made a big mistake when this first started by blowing these women off.
01:11:09.189 --> 01:11:11.310 That's why they went to the internet. That's why they went,
01:11:11.430 --> 01:11:15.129 you know, they've allowed these plastic surgeons to take advantage of them,
01:11:15.390 --> 01:11:21.669 you know, charges one guy charged $100,000 for a correct implant followed by hyperbaric oxygen,
01:11:21.750 --> 01:11:24.069 followed just um um.
01:11:25.220 --> 01:11:29.609 brain wave tests on them and sells them special diets and all these things.
01:11:29.740 --> 01:11:34.209 So we need to get back in control and show these patients that we care about and we want
01:11:34.209 --> 01:11:38.779 to figure out what's going on with them, and that's why we talk about these things at these
01:11:38.779 --> 01:11:44.160 meetings. Nicola, you know, ALCL, we've got a lot of
01:11:44.160 --> 01:11:46.240 information. You've brought up a lot of good points.
01:11:46.779 --> 01:11:49.419 You know, as we go forward in time, do you think the,
01:11:49.669 --> 01:11:52.490 the number of cases that are being reported year after year,
01:11:52.569 --> 01:11:56.250 is it increasing, decreasing? At what point do you think we're just gonna
01:11:56.250 --> 01:12:00.250 probably stop seeing it, or is this gonna be something that we're gonna be dealing with for
01:12:00.250 --> 01:12:02.850 decades? What are, what are your thoughts?
01:12:03.069 --> 01:12:09.569 Yeah, the number of cases reported cases are increasing because there is also
01:12:09.569 --> 01:12:13.919 more knowledge about the disease, so we are more sensible.
01:12:14.379 --> 01:12:18.509 and patients also to understand what are the first symptoms of.
01:12:19.500 --> 01:12:25.899 Obviously being any way a rare or uncommon disease, if we want registries are primary,
01:12:25.939 --> 01:12:31.589 of primary importance because we will not, we could not have a randomised trial obviously on
01:12:32.060 --> 01:12:35.540 on rare disease. So we will have information by prospective
01:12:35.540 --> 01:12:41.299 cohorts and registries are prospective prospectively collected data.
01:12:41.830 --> 01:12:48.459 So I think that another strange thing is that if we look at recent
01:12:48.459 --> 01:12:54.569 reports, there are some reports by Fabio Santanelli, by Tolazinski from Poland that
01:12:54.569 --> 01:12:59.370 reports 1 out of 300 cases with microtexed implants.
01:12:59.450 --> 01:13:05.229 But if we publish something on it, but if we look at past cohorts,
01:13:05.379 --> 01:13:09.720 obviously we did not have so much information about ACL,
01:13:09.770 --> 01:13:16.279 but We did not, if we report this this prevalence, these risk
01:13:16.279 --> 01:13:22.450 estimates to death cohorts, we should have had thousands of cases that we do not find.
01:13:22.779 --> 01:13:26.700 Why? Only underestimation, only underreporting under
01:13:26.700 --> 01:13:29.609 diagnosis. I, I don't know.
01:13:29.779 --> 01:13:36.620 Anyway, we, we could not make nothing else than weighting data from registries
01:13:36.620 --> 01:13:39.430 because we do not have any other weapon in our hands.
01:13:41.240 --> 01:13:46.549 The numbers should start to go down with the bio cell going off the market,
01:13:46.759 --> 01:13:48.069 but how long will that take?
01:13:48.299 --> 01:13:51.029 It will be 10 years, it will be 15 years, 20 years.
01:13:51.279 --> 01:13:53.220 You don't know. The expected numbers.
01:13:53.520 --> 01:13:57.629 There was a big dip in the numbers during COVID, but I think that was just a lack of diagnosis
01:13:57.629 --> 01:13:59.990 and we seem to have been catching up again now.
01:14:00.359 --> 01:14:03.399 Yeah, I would imagine there's in the United States.
01:14:04.290 --> 01:14:08.970 Number of textured surface devices is really down so I would expect that we would start to
01:14:08.970 --> 01:14:13.129 see a decline as those patients who are going to get ALCL get ALCL.
01:14:13.169 --> 01:14:17.850 Now Roy, you're, you're an advocate for Polytech, which is a polyurethane device,
01:14:17.859 --> 01:14:24.290 and even prior to the ALCL saga in the United States, we weren't allowed to use it for the
01:14:24.290 --> 01:14:25.890 last 30 years because of the.
01:14:26.290 --> 01:14:32.109 You know, the, uh, toluene diamine factor, which is probably not really a factor.
01:14:32.319 --> 01:14:36.959 Is there something about the polytech polyurethane device that's different than the
01:14:36.959 --> 01:14:42.609 other ones? On the markets we actually had only two
01:14:42.609 --> 01:14:48.330 companies, and um the Brazilian one and Politech.
01:14:49.049 --> 01:14:55.899 And for a while poli politech was uh the European uh
01:14:55.899 --> 01:15:02.129 distributor of silhomet, but when they divided the the the business
01:15:02.500 --> 01:15:09.049 and politech changed the way to volcanize to uh realise the pollutant
01:15:09.049 --> 01:15:10.270 around the implant.
01:15:11.040 --> 01:15:18.040 Then the um the Brazilian then now is is back on the market uh the all the the the
01:15:18.040 --> 01:15:22.660 series that we had the 7 patients with with the LCL with with polyuretine,
01:15:23.640 --> 01:15:29.799 um, they found the something um different on, on the surfaces of the autopolier.
01:15:30.229 --> 01:15:34.990 It was, uh, I, I don't have the English name actually, um,
01:15:35.029 --> 01:15:39.899 the, the, the pollutant destroyed itself in, in small particles,
01:15:40.290 --> 01:15:44.370 and, and this is related to the way how to put the, the,
01:15:44.379 --> 01:15:49.990 the, the silicon around the implant then, uh, we must say that I am the,
01:15:50.069 --> 01:15:55.149 the, the Italian guy that is seated at the, um, permanent table for ALCL in Italy.
01:15:55.959 --> 01:16:01.330 And the numbers are decreasing, uh, you know that yes,
01:16:01.339 --> 01:16:06.410 the first moment I, I didn't believe in a so huge issue,
01:16:06.899 --> 01:16:10.370 um, but it's very important to know it's very important how to detect.
01:16:11.000 --> 01:16:17.890 But I, I think that, uh, also in this last statement there is something that really uh
01:16:17.890 --> 01:16:24.520 it's really painful to read because I don't find any anything really honest from an
01:16:24.520 --> 01:16:26.390 intellectual point of view, you know.
01:16:26.959 --> 01:16:32.229 I had pos I had the possibility to talk straight to Mark Clements.
01:16:32.600 --> 01:16:37.589 um, I, I don't have any talk to Fabio Santanelli because he didn't say hello to me.
01:16:38.120 --> 01:16:44.379 Um, but, um, you know, I, I, I really think that ALCL is,
01:16:44.450 --> 01:16:49.250 is, is important to know, um, important now to detect, but,
01:16:49.959 --> 01:16:53.029 uh, is not a real problem actually.
01:16:53.399 --> 01:16:57.879 And then if you go and consider it that if you remove, if you change the classification,
01:16:58.000 --> 01:17:01.549 if you remove the, uh, the seroma only.
01:17:02.450 --> 01:17:09.009 Uh, and then you decrease the small number to something uh without any significance,
01:17:09.580 --> 01:17:15.640 and then you go and consider that, uh, the Allergan is not anymore on the market,
01:17:16.129 --> 01:17:21.089 and 85% of all cases are alleggan related.
01:17:22.169 --> 01:17:25.990 We are talking about nothing actually, that's the truth.
01:17:28.580 --> 01:17:33.779 Doctor, Doctor Heery, question, um, you know, medical grade silicones,
01:17:34.140 --> 01:17:39.049 we know that gels can fracture and shells can crack over time.
01:17:39.669 --> 01:17:44.810 Is it possible to invent something that won't crack, that's resistant to cracking?
01:17:45.520 --> 01:17:49.979 I mean, from a technology perspective, is that something that can be done or is it just
01:17:49.979 --> 01:17:51.779 impossible all devices fail?
01:17:53.089 --> 01:17:57.890 So if you think about, you know, the shell, you know, and let's say rupture and break and you
01:17:57.890 --> 01:18:01.450 know, let's, let's say it happened due to abrasion, not,
01:18:01.500 --> 01:18:02.560 you know, scalpel.
01:18:02.930 --> 01:18:06.799 So you know there's test methods to ensure that doesn't happen.
01:18:06.890 --> 01:18:10.089 So if you think of an implant that makes its way onto your operating theatre,
01:18:10.100 --> 01:18:15.129 and we mentioned that ISO standard, and you know, it sounds it sounds kind of.
01:18:15.569 --> 01:18:19.580 You know, it's abstract, but actually the detail that goes in in terms of 3 million
01:18:19.580 --> 01:18:23.729 cycles in terms of the weight they drop on that implant to start that testing,
01:18:23.979 --> 01:18:27.379 and that helps the producers off to the device level to then say,
01:18:27.470 --> 01:18:33.450 OK, you know, the standard for elongation is 450%, but do I need 600 or do I need
01:18:33.450 --> 01:18:34.660 700%?
01:18:35.100 --> 01:18:38.990 So certainly there are changes in silicon. Silicon can do different things,
01:18:39.229 --> 01:18:42.540 you know, I think to say absolutely no, this won't breach again,
01:18:42.589 --> 01:18:47.000 that that's, you know, simply not possible to say, can you make improvements?
01:18:47.029 --> 01:18:50.470 Yes, and that's in the silicone and it's in the device level.
01:18:50.899 --> 01:18:54.350 I think there was a remark, I think it goes by Abel, he was talking about cohesivity,
01:18:55.509 --> 01:18:59.310 cohesivity of gel has changed radically over the years,
01:18:59.720 --> 01:19:02.620 and there's still more we can go in terms of improving that.
01:19:03.040 --> 01:19:06.399 So but I think, you know, we've we've made a big step to getting that,
01:19:06.479 --> 01:19:09.040 but you won't, you know, I'm sure you've all heard the term,
01:19:09.080 --> 01:19:12.479 you know, you know, gel that simply can't break. You know,
01:19:13.410 --> 01:19:18.250 there's no absolute to that, but there are steps to improve in that direction and that's,
01:19:18.359 --> 01:19:21.899 that's where producers are going and that's where we're kind of enabling that technology,
01:19:22.009 --> 01:19:24.680 you know, but I'd love to say yes, it'll never happen again,
01:19:24.850 --> 01:19:29.729 but it's all about making those, those incremental improvement improvements to kind of
01:19:29.729 --> 01:19:31.970 help that. I think we've seen that over, you know,
01:19:32.290 --> 01:19:33.879 certainly over the decades before.
01:19:35.709 --> 01:19:40.419 Can you just tell us, is Newsil the only producer of silicon in the world?
01:19:42.330 --> 01:19:45.859 silicone, no. Uh, so there's there's a huge amount of people
01:19:45.859 --> 01:19:51.689 who produce silicone, and we're not even big on those scales in terms of implantable grade,
01:19:51.700 --> 01:19:56.330 and we talked about medical grades, but there's actually the distinction if it stays in longer
01:19:56.330 --> 01:19:57.560 than 29 days.
01:19:58.970 --> 01:20:03.935 News has got a very Significant market there and particularly in terms of breast implants
01:20:04.504 --> 01:20:08.095 because of what's gone before that a lot of companies don't want to get involved,
01:20:08.384 --> 01:20:12.254 don't have the technology to make that products. So in terms of breast implant,
01:20:12.424 --> 01:20:17.785 you know, I think, you know, in the Western world we're the only producer of silicon for
01:20:17.785 --> 01:20:23.625 breast implants. And how has changed your relationship to the
01:20:23.625 --> 01:20:24.984 implant manufacturer?
01:20:25.490 --> 01:20:28.970 When you hear all of these issues going on, or is there,
01:20:29.160 --> 01:20:33.970 or is it a clear cut off that this is your problem, or is there any No,
01:20:33.979 --> 01:20:39.640 so you know, at the end of it like we make the silicone and for the devices,
01:20:39.750 --> 01:20:44.160 you know, we want, you know, once we're working with reputable people who can make that device
01:20:44.160 --> 01:20:48.140 who are doing those scientific experiments to demonstrate that,
01:20:48.390 --> 01:20:51.589 you know, when we can't, you know, we're not the judge of everybody,
01:20:51.600 --> 01:20:56.660 every company, but we can obviously see if there's flags there if you need to,
01:20:57.250 --> 01:21:00.685 if you need to. Breast implants silicone, you will ultimately
01:21:00.685 --> 01:21:06.035 end up talking to me because we have those restrictions on new companies to make sure,
01:21:06.285 --> 01:21:10.035 OK, it's not just, you know, somebody at the back of our house doing that.
01:21:10.044 --> 01:21:14.245 They have planned to go and see Mark and we released the volumes very slowly when there's a
01:21:14.245 --> 01:21:17.805 new entrant. So again, they're going to because if they're
01:21:17.805 --> 01:21:20.365 not following it, if they're asking for 2 tonnes straight away,
01:21:20.444 --> 01:21:21.674 there's something going wrong.
01:21:22.080 --> 01:21:24.560 And they, they haven't got a validated process.
01:21:24.850 --> 01:21:29.330 So when we see the volumes, we do those inspections, we're doing those just to make
01:21:29.330 --> 01:21:32.299 sure it's, you know, it is a legitimate business with,
01:21:32.410 --> 01:21:36.759 you know, scientific approach and there is that long longevity there that,
01:21:36.850 --> 01:21:40.169 you know, we, we were, you know, they're going to be around in 10 years' time.
01:21:40.410 --> 01:21:42.089 It's not an absolute process again.
01:21:42.419 --> 01:21:47.299 But there are big restrictions that the supplier make also the controller.
01:21:47.319 --> 01:21:52.919 It's, it's quite strange because I pay you to have your,
01:21:52.930 --> 01:21:55.600 your product and you come and check me.
01:21:56.589 --> 01:22:00.049 Uh, it's quite strange anyway, yeah, but frequently we'll,
01:22:00.089 --> 01:22:01.359 we'll get calls from the US.
01:22:01.569 --> 01:22:05.330 Uh, I want to silicone that I can inject in, in my patient,
01:22:05.549 --> 01:22:07.490 you know, we're, we're not gonna, I totally agree.
01:22:07.569 --> 01:22:10.839 I totally agree that it, it must be a control but not by you,
01:22:10.850 --> 01:22:15.810 no. What you know what I mean, but I think we all
01:22:15.810 --> 01:22:20.140 have, you know, due diligence to to to the what could come to us.
01:22:20.250 --> 01:22:22.919 So, so, so certainly we should not be the absolute control,
01:22:22.930 --> 01:22:28.160 and we're not trying to say that the ISO standards are the FDA the marks notified bodies
01:22:28.160 --> 01:22:32.569 that we're not the absolute control. Do we have some stage gates to make sure this
01:22:32.569 --> 01:22:35.319 business is going through those legitimate sources? Correct.
01:22:35.450 --> 01:22:38.220 Yeah, yeah, we're not trying to be the full absolute controller.
01:22:38.919 --> 01:22:40.560 I think that's true and correct.
01:22:42.850 --> 01:22:45.720 Well, there's one more question from the audience.
01:22:48.120 --> 01:22:50.220 Australia, hopefully it's working.
01:22:50.430 --> 01:22:55.250 Um, my questions are for Pat and Nicola, um, because they kind of relate to the same thing
01:22:55.250 --> 01:23:01.629 about explanting these patients, and I think when you're talking about doing that when a
01:23:01.629 --> 01:23:05.189 patient comes to you privately, you're not dealing with what we do.
01:23:05.424 --> 01:23:10.444 with, I, I work both in Australia and the UK in a universal healthcare system where we've got
01:23:10.444 --> 01:23:15.794 to manage the resources, uh, in terms of, you know, who we can offer because we have long
01:23:15.794 --> 01:23:20.555 waiting lists for cancer, trauma, other things. So how do you reconcile that?
01:23:20.625 --> 01:23:26.674 And do you, in your countries, do they offer explantation both prophylactically for macro
01:23:26.674 --> 01:23:28.475 textured implants and for BII?
01:23:29.069 --> 01:23:35.020 Or to treat BII in the public sector, and if they do or don't,
01:23:35.060 --> 01:23:36.169 do you think they should?
01:23:36.509 --> 01:23:41.689 In the United States, the private insurance does not pay for it.
01:23:41.939 --> 01:23:44.729 Most of them have, well, some of them will if there's a rupture,
01:23:44.899 --> 01:23:49.100 if there's capture contracture, but most of them have the philosophy that you pay to take
01:23:49.100 --> 01:23:51.529 it in, you pay for any consequence to it.
01:23:52.020 --> 01:23:57.209 Medicare and Medicaid won't tell you ahead of time whether they will pay for something or not.
01:23:57.649 --> 01:24:03.609 Uh, most of the time they won't, uh, but that they'll, it just all depends,
01:24:03.859 --> 01:24:09.379 but, um, yeah, patients are paying to get their implants out mostly in the United States.
01:24:11.890 --> 01:24:18.600 Is that the same for macro textured implants for the textured implants because the FDA
01:24:18.600 --> 01:24:25.120 has not recommended, I think if the FDA recommended implant removal and capsulectomy,
01:24:25.319 --> 01:24:31.080 that might change the environment, but right now, even with textured implants now if a
01:24:31.080 --> 01:24:36.879 patient we we were having problems with the insurance companies not covering diagnosis
01:24:36.879 --> 01:24:38.919 management of patients with.
01:24:39.209 --> 01:24:45.529 Um, that develop ALCL after a cosmetic procedure, and Mark Clemens has done a lot of
01:24:45.529 --> 01:24:49.120 work to get this, to get that covered. They now there's a specific,
01:24:49.410 --> 01:24:55.529 uh, CPT code, and ICD 10 code for breast implant associated ALCL that takes out whether
01:24:55.529 --> 01:24:59.080 the implant was originally placed for cosmetic reasons or not,
01:24:59.089 --> 01:25:04.009 but that that was a that was a problem now but the patient just wants a textured implant
01:25:04.009 --> 01:25:06.080 removed, most insurance won't pay for it.
01:25:07.549 --> 01:25:11.549 Thank you very much. I think as it seems really that I think this
01:25:11.549 --> 01:25:15.990 topic of implant technology is something that we have to pick up again because I think
01:25:15.990 --> 01:25:20.310 there's still a lot to say and um well thank you very much for this session.
01:25:20.319 --> 01:25:24.779 I think it was very, very helpful, useful, and a lot of information here.
01:25:25.729 --> 01:25:28.759 Hence, I think we have reached the end of this meeting.
01:25:29.370 --> 01:25:34.180 It was 3 incentive days and um in new format, in new ways,
01:25:34.569 --> 01:25:36.490 and I think in behalf of the.
01:25:37.209 --> 01:25:38.419 Scientific team.
01:25:39.270 --> 01:25:43.640 We thank everybody that has come. We thank the industry that has supported this
01:25:43.640 --> 01:25:46.629 meeting. We thank MA Healthcare, who has done the
01:25:46.629 --> 01:25:53.229 organisation, um we thank again the College of the Royal College of Physicians that has hosted
01:25:53.229 --> 01:25:57.109 us here again and the helpers who have been supporting us.
01:25:57.270 --> 01:26:00.990 So a lot of people who have put together this, this meeting,
01:26:01.029 --> 01:26:07.950 support, and um we're looking very much forward to see you in a year's time with uh
01:26:07.950 --> 01:26:10.209 hopefully a new. And a different programme.
01:26:10.290 --> 01:26:12.770 So thank you very much everybody and safe journey homes.