I'm going to be discussing our systemic symptoms associated with breast implants bios
specimen analysis study that was funded by the Aesthetic Surgery Education and Research
Foundation. It is the first prospective blinded study with
controls to compare patients with systemic symptoms they attribute to their implants to
two control groups.
I have no disclosures.
Breast implant illness recently dubbed systemic symptoms associated with breast implants refers
to the 100+ symptoms that patients believe are caused by their breast implants.
Their medical workup is usually negative.
They have no abnormal labs or physical findings to explain their symptoms,
and there are no diagnostic criteria making this a diagnosis of exclusion.
These patients come in with very specific requests.
They want their implants and capsules removed on block or in one piece because they believe
that violation of the implant capsule will contaminate them.
They also want a photo of the pocket to make sure that their entire capsule is removed.
Their contention is that whatever toxins are in the implants are also in the capsules,
and that failure to remove the capsules would leave these toxins behind.
Concerns about implants have been around as long as implants have been around.
The literature contains case reports, small case series,
and anecdotal evidence potentially linking breast implant implants to autoimmune and
connective tissue diseases.
Rod Rorrick did a literature review on outcome studies for breast implant illness in 2022,
and he identified 11 studies.
Of those, only 4 used a comparative design and control groups were inconsistent.
All the studies had selection and sampling bias.
So to date, the published data on breast implant illness are mostly retrospective case
studies with poor follow-up and no control groups.
What do we know for sure?
We know that breast implant illness has been reported in patients with all types of implants.
We know that these patients have a lot of symptoms and no specific configuration.
We know that a lot of these symptoms occur in patients without breast implants and that some
patients symptoms will improve after implant removal.
We know that social media groups promote implant illness explant surgeons,
and unblocked capsulectomy, but also growing are groups of women who've had explantation for
breast implant illness without improvement in their health who are left with physical and
psychological scarring.
What do we need to know?
Do implants cause symptoms? What are the potential ideologies?
Does implant removal improve symptoms? And if it does,
for how long is unblocked capsulectomy or any capsulectomy required for treatment?
And what are the potential roles of illness, anxiety disorders and the nocebo effect?
Our study was designed to prospectively study women with self-reported systemic symptoms as
well as control groups.
We wanted to evaluate bios specimens for quantitative differences between cohorts and
then look at capsulectomies and whether they made a difference in these patients in terms of
symptom relief.
There were 3 age matched cohorts. The first was self-described breast implant
illness patients undergoing implant removal.
The second were women with implants undergoing implant removal and replacement without
symptoms they attributed to their breast implants.
And the third were women who never had any implanted medical device undergoing a cosmetic
mastopexy.
The team included multidisciplinary investigators.
We use detailed symptom surveys and the NIH uh patient reported outcomes measurement
information systems or POMIS to measure anxiety, fatigue, cognitive function,
and sleep disturbance.
The bios specimens were collected the day of surgery and were sent within 24 hours to the
various labs blinded with only site and study number recorded in the peripheral blood,
we looked at thyroid function, blood count, C-reactive protein and vitamin D levels.
We looked at 12 cytokines.
And IgG and IgE antibodies to staph enterotoxin, which is a known super antigen.
The capsules were photographed as soon as they were removed.
We swabbed the surface of the implant and sent them to Microgen DX lab for next generation
sequencing microbial.
DNA diagnostics. We took 10 grammes of capsule tissue and sent
it in a metal-free container to Eurofin's labs for analysis of 22 heavy metals,
and the remainder of the capsule was sent to the Brown University Department of Pathology
for histologic evaluation.
Part one of the study looked at the impact of capsulectomy type on systemic symptom
improvement, and this was published in December 2021.
In the demographic data, the BII cohort had a higher BMI,
more reported allergies, a higher number of smokers and marijuana users.
They used more pain medications, antidepressants, herbal supplements,
hormone replacement therapy, and had a higher number of tattoos.
In the BII cohort, 64% of patients had uh saline implants.
90% was smooth surfaced, 88% were intact, and 84% had grade 1 or 2 capsules.
66% of the BII cohort listed social media as their source of medical information compared to
less than 10% of the controls.
The BI the.
The BII cohort, wait, yeah, I'm, I'm sorry.
The BII cohort reported significantly more symptoms than the two control cohorts.
There was no statistical significance in symptoms between the non-BII and mastopexy
cohorts. The implants were in for 14 years in both
groups, so there was no statistical difference there.
We had a robust follow up with 94% of the BII group responding at one year.
At one year, 94% of the BII patients had at least partial symptom improvement with a 68%
reduction in the number of symptoms.
Most of the improvement occurred in the first six weeks and remained stable after that.
We defined our capsulectomies as either total intact, total or partial.
We found that symptom improvement was independent of the type of capsulectomy
performed. Part two of the study looked at whether there
were heavy metals in the breast implant capsules.
This paper was published in April 2022.
Why did we perform?
Why did we perform heavy metal analysis?
The BII websites post this table from the FDA summary of safety and effectiveness for each of
the breast implant manufacturers.
Actually, this is volatile and extractable testing that is required on any implantable
medical device. This table is taken out of context by the BII
proponents. These are all trace metals and not ingredients
of the implants.
We sent capsules as well as breast tissue from the control group for analysis.
We wanted to know whether there were heavy metals in the capsules around the breast
implants and whether there was a statistical significance in the type or level of these
metals between women with and without symptoms.
We did find some metals in the capsules of both cohorts as well as in the breast tissue of
patients who had never had implants, but all were in levels well below what is considered
safe levels of exposure.
Concerns about platinum levels in breast implant shells have been voiced for over 20
years. Only 2 of our capsules contain low levels of
platinum, 1 in each cohort.
Silicone bleed has also been suggested as a cause of BII.
However, 64% of our subjects in the BII cohort had saline implants,
and these have a 100 times less of the low molecular weight siloxanes.
So this does not appear to be the aetiology of BII.
The aim of part three of the study was to determine whether or not there were any
quantifiable laboratory findings identified in the blood capsule tissue or microbes that would
differentiate women with breast implant illness from the other two control groups.
This paper was published in August 2022.
We used. We use next generation sequencing.
To explore the possible role of microorganisms in the development of BII.
We examined blood specimens for inflammatory markers.
We explored the possibility of an allergic or inflammatory response by looking at serum
cytokine levels and evidence of synovial metaplasia or Eosinophils on histology.
We found no difference in vitamin D levels, thyroid function,
or complete blood counts between the cohorts.
There was no statistical difference in NGS positivity between the cohorts.
Symptom improvement, uh, was symptom improvement after explanation explantation was
the same regardless of the next generation sequencing positivity,
and 99.5% of the capsules in both cohorts were negative for fungi.
Synovial metaplasia was more common in the non-BII cohort,
which had more textured implants, and eosinophils were found in only 2 of 96 capsules
in both cohorts, making it unlikely that an allergy to breast implants was responsible for
the symptoms.
Three of the 12 cytokines were slightly statistically higher in the BII cohort in a
minority of patients.
When this data was further reviewed, it was found that these patients had Hashimoto's
thyroiditis, irritable bowel syndrome, or other systemic illnesses that could explain their
slightly elevated cytokine levels.
With respect to the enterotoxins, 18 subjects were identified in the BII cohort with elevated
IgG, but only 3 of these patients had evidence of bacterial DNA in the capsule or on the
implant surface, and all identified bacteria were cut a bacterium and not staph,
so it's presumed that the elevated IgG levels were the result of a staph infection elsewhere
in the body and not related to the implants.
So the DNA and antibody data generated failed to support an infectious theory as a primary
cause for the systemic symptoms caused in BII.
Our conclusions were that there was a lack of consistent identifiable biomarkers that
differentiated subjects with self-described BMI from control groups.
So what was left, we went back and looked at our promised data which demonstrated
significant differences between the BII and non-BII cohorts.
This paper was published in April 2023.
We looked at anxiety, fatigue, cognitive function, and sleep disturbance before surgery
and out to one year after surgery.
As Roger showed you before, we found that the base at baseline,
the BII cohort reported significantly higher levels of anxiety,
fatigue, and sleep disturbance and lower cognitive function than both control cohorts
within the 3 to 6 week. Period after surgery we saw a rapid improvement
in these symptoms and although the BII subjects had a significant decrease in anxiety from
baseline they still remained numerically elevated as compared to control cohorts at all
time points. We looked at
each cohort by time interactions to understand the trajectory of BII and how the cohorts
differed over time.
The higher number of symptoms reported by the BII cohort followed rapid improvement after any
explantation method.
Why did the symptoms improve?
Previous literature has investigated the validity of DSM-5,
illness, anxiety disorder and somatic symptom disorder.
And their relationship to patients with medically unexplained symptoms.
BII as a diagnosis of exclusion with a wide variety of symptoms and no abnormal values or
physical findings to explain symptoms falls under the category of medically unexplained
symptoms. The high number of self-reported symptoms and
high anxiety at baseline followed by the rapid improvement in symptoms and reduction of
anxiety after explantation suggests that psychological factors may be at play.
How does this work? Negative emotions and negative expectations
amplify body sensations.
Patients perceive these symptoms as threatening, then add the social media platforms.
They have negative expectations that impact the increasing number of symptoms reported.
The hallmark of the nocebo effect is the rapid improvement in symptoms once perceived threats
have been removed. Patients have called me the evening after their
explant surgery to tell me that they feel much better and are cured.
There is really not a biologic problem that would have have a response rate that fast.
So in conclusion, patients experience rapid symptom improvement after explantation by any
method. There is a lack of bios specimen findings to
differentiate the cohorts. Systemic symptom data and promise data
demonstrate increased anxiety in the BII cohort, and consistent similarities between the non-BII
cohort and the mastopexy control make it unlikely that the implant is the cause of
systemic symptoms in this population.
We are now prospectively studying BII and non-BII patients undergoing implant removal
without capsulectomy.
We presently have 35 subjects in this study, and this is our early data.
The yellow line is the data from no capsule being removed and it parallels our data from
the earlier study.
So what does this mean for our patients?
We are board certified plastic surgeons. We should be practising evidence-based medicine.
BII remains a diagnosis of exclusion.
These patients have real symptoms and require a full medical evaluation prior to explant.
It is likely that the BII patients will have at least partial symptom improvement with implant
removal, and the symptom improvement is independent from the type of capsulectomy.
This is good news for our patients. We can give them educated choices using
scientific data, including removal with or without a capsulectomy based on individual
risks and benefits.
Heightened anxiety and negative expectations may contribute to symptoms and symptom
improvement, and further prospective research is required to determine which patients are at
risk and how best to treat them, and this study should be starting soon.
These are the 4 papers.
These are the 4 papers that I've discussed today.
They're all published in the aesthetic surgery journal.
Please feel free to contact me if you have any questions, thoughts,
or uh comments regarding my presentation, and I thank you for your time.
Thank you Marisa for that beautiful clear lecture.
Next speaker is Doctor John Kim from the states.
The stage and the floor is yours.
OK, so I'm gonna talk a little bit about a kind of a novel hypothesis,
somewhat heretical, but the, the idea is can breast implants actually protect against breast
cancer? So these are my disclosures.
We did receive research funding from this from several sources including the Plastic Surgery
Foundation, uh, unrestrict grants from Dixon Foundation, and Allergan.
So when we go back to the history of implants, almost 2 years after the implantation by Cronin
and Girou, we're already seeing issues related to inflammatory processes and throughout that
spotty history and saltatory fashion we've seen that there have been issues related to cancers
and autoimmune diseases that have plagued the question of implants and their safety.
So what is precisely the epidemiologic basis for talking about breast implants and cancers
if you talk to a patient who walks into your office, oftentimes they have this lay opinion
that's shared by many members of the public that to some degree there's a low level of risk
with implants that are associated with breast cancer.
So we did an updated review, uh, a literature review that was based upon another study that
was done about 10 years ago, and we identified 19 studies that totaled over
100,000 patients with an average follow up of 12 years in our systematic review.
So some of the select studies, there are a number of good uh Scandinavian studies that are
population based that are good because the population some demographics are homogeneous
and what what these studies looked at specifically was the relative risk of getting
breast cancer in. The implant population relative to the expected
risk in the population at large and in all of these studies they found that this this ratio
this relative risk was was lower than actually seen in the regular population.
There were some additional control groups which were helpful because these were internal
controls. This is a very large series 24,000 plus
patients who had had implants and then uh a control group which had other types of cosmetic
surgery. So if you're thinking about, well this is an
issue of socioeconomics and this helps to at least in some degree mitigate that,
uh, confounding factor and what was found was with a.
Very long follow up over 20 years was that there was no heightened risk now with all of
these studies it was interesting they didn't even though the actual ratio was less than one
suggesting that the implants patients had a lower risk what they concluded was there was no
greater risk because at the time there was no possibility in their view that this could
actually be um uh a tenable and sustainable lower risk.
What was also interesting here we can talk about this later,
was that polyurethane implants did seem to have a higher risk in the 1st 5 years and then
subglandular implants had a lower risk of breast cancer.
Now that's kind of interesting because if you think about the difference between subglandular
and sub pectoral, you might argue that the subglandular implants have more surface area in
contact with the breast tissue than a sub pectoralite.
So this is the graphical form these forest plots as some of you know just as a way to
represent the risk if the risk is one equal risk in the dash line here,
then anything to the right would be higher risk of cancer anything would be lower,
and you can see that in these studies where there were actual controls all of them were
lower. When we look at the same situation when they
were comparing it to the population at large, you can see that again the risk is
lower. So, um, we did an additional analysis looking
at the SER database which is a very, um, well populated granular database of all cancer
patients in the United States, and we looked specifically at patients who had had
mastectomies and who had had mastectomies with implant reconstruction and without and the key
thing here was they were extremely well matched with respect to their initial oncologic staging.
And what we found was that patients who had had uh implant reconstruction had a lower risk of
breast cancer specific death in this setting than patients without so this is again in a
slightly different population, um, not just cosmetic implants,
but we're now talking about patients with active breast cancer.
So the question is this, you know, how does this fit in?
So, um, I was attending a lecture um in Chicago at the Lin Sage Cancer symposium,
and this surgical oncologist Mary Deus was talking.
I was just here just like Charles is just zoning out on the talk and waiting for my.
Turn to come around and then something kind of caught my eye.
One of the slides she showed was basically saying that for some breast cancers they were
investigating the idea that the same mechanism by which these cells responded to
infection and biofilm.
Was similar to how they the these uh the breast was fighting uh actual
specific breast cancer subtypes so that that in some cases there was an alignment along the CDA
positive pathway.
So that got me thinking that wait a second every implant putatively has this sort of
foreign body response initially and could it be that there is something along those
epidemiologic studies that could um be related to the uh immune response so we know in
general if you have a weakened immune system you're at higher propensity for cancers,
opportunistic cancers specifically in the transplant population well documented.
And that conversely, there are certain cancers, quite a few of them,
that respond to general immune stimulation therapies.
So the question was, is it possible that when these implants are placed that we are getting.
Inflammation and we know this to be true, but that inflammation is essentially immune cells
there's a migration of immune cells and to some degree immune cells are also involved in
surveillance against infection but also against cancer.
So does it not seem reasonable that there might be with this increased immune surveillance
because of inflammation that you could get this downstream effect where you could potentially
get some protective or surveillance response against breast cancers.
So that was the new hypothesis. So this is a paper that we published a year ago.
This is an ongoing study that we've had and, uh, several different arms.
So one arm is looking at, and these were all patients of mine who were um non-breast cancer
cosmetic patients, but we looked at patients who were about to get primary breast
augmentation. So these were implant naive patients,
no implants at all, about to get breast augmentation, and then a second cohort were
patients who already had implants who were getting a revision.
So we took basically did serologic tests and looked at antibodies against specific breast
cancer antigens and what we found was interesting again um a larger sample size each
of these dots represents a different patient and we found that for some of these breast
cancer antigens that the antibody response was higher in patients who had implants versus
patients who were about to get implants.
The other thing interesting was.
You know, maybe this is just inflammation and it's just temporary and what we found is when
we stratified some of these patients by how long they had had their implants in,
interestingly, patients who had had implants for a longer period of time had a more
sustained higher response so this wasn't just inflammation in the perioperative stage there
was something else more ongoing.
So the um an antigens that we talked about are are MU1 mammoglobin,
these are transmembrane proteins they're actually targets of vaccine therapy now active
ongoing trials in which they're targeting um uh breast cancer cells with these uh
vaccines. So a second part of this study was to take
these same patients who were implant naive before who were in my clinic before surgery and
and getting antibodies and then to follow them over time.
And then we had the benefit there of longitudinal internal controls,
and we followed these patients for a period that we have actually more than 1 year data now
but this is an interim analysis at 6 months and what we found was across the board again after
a time period where we would assume that surgical perioperative inflammation has died
out there's still a sustained response of these antibodies, um.
Some immunohistochemistry but also um we did uh uh the next phase we started looking at gene
expression so we did uh RNA um RNA sequencing and RNA sequencing is a fairly complex
process but the bottom line is it allows you to see what genes are expressed by different
cohorts. And so we can look at uh different subgroup
analysis within these patients who have had implants.
So one of the things that, um, patients will come in to talk to me is if they have a
ruptured implant they're afraid that the implants are leaking and that they're gonna get
some sort of disease process. They're concerned about cancer and whatnot.
Doc, please get these implants out of out of me because they're leaking.
Uh, they're getting into my lymph nodes, etc. etc.
So the question was what's the immune reaction from this,
uh, RNA sequencing perspective between ruptured and non-ruptured implants,
and we looked at both our traditional antibodies.
We also did, um, tissue analysis. So we got both blood and um uh breast tissue
and we did the uh subsequent analysis now when we looked at the antibody response similar to
um Doctor Glickman and Lawrence's uh presentation before we found that when you had
uh these um.
The surgery after sorry when you compared the rupture versus non-ruptured that there was no
difference, no statistical difference in the um.
Uh, antibody response to breast cancer antigens between ruptured and non-ruptured.
The second thing we looked at, and this is a busy slide,
of course, but this is looking at the gene pattern with ruptured versus non-ruptured
patients. So if there is a pattern or if there's a
difference in how these genes are expressed, we would expect something like this a pattern
sequence in which there's clustering of the genes, and what we found instead was with
ruptured versus non-ruptured there was no clustering.
So actually we looked at over 28,000 genes in that RNA sequencing analysis and only
12 of them were differentially uh expressed and ruptured and non ruptured and that's fairly
definitive that the immune reaction at least to to not only inflammation but to breast cancer
antigens is not differentiated um in terms of ruptured versus non-ruptured.
So another question we had part of our ongoing kind of trying to plumb the uh mechanism as
well as doing the subgroup analysis what happens with textured versus non-textured now
we did not distinguish texturing by types, so we just group them into one category,
although with larger sample size we'd be able to do the same thing.
And we did basically an analysis, so this is similar to the heat map,
but what you're looking for is clustering of these points and so smooth red is relatively
clustered we did find clustering here, uh, and that's in contrast to the ruptured versus non
where everything was intermixed, suggesting that there's no response and more prominently
when we compare textured versus non-textured we found a distinct difference in gene expression.
And what we found was some of these genes were not only pro-inflammatory but also pro tumour
um and a lot of inflammosome reactivity.
So in, in, in these situations we found that there were more than 20-fold
increased gene expression differentially out of those 28,000 genes.
So in conclusion we see that the epidemiologic studies which have been uh updated with our
systematic review all show a lower instance of breast cancer,
uh even in situations where you would expect some degree of control,
internal control.
Our hypothesis is that it's possible that in some of these patients we're getting a
heightened inflammatory reaction and that this reaction itself can potentially have a
protective effect. And what we need are further studies with
larger sample sizes to help confirm these results.
Thank you. So I asked
Doctor Salabian. To join us thank you very much.
Uh, these are my disclosures, um, of relevance again Abby is the parent company of Allergan
that, um, as we know, developed the biocell texture devices that we were called.
So it's, uh, a very broad topic. I'm gonna, uh,
move quickly and try and beat the 12 minute time here,
but starting here with how did we end up getting to this,
and this was a snippet of the news headings, uh, in 2017,
um, in the US outcry after that, uh, FDA update on their safety communication with regards to
ALCL. And for the purposes of this talk, um,
I'm gonna focus on the history, the pathophysiology, um,
and the types of implant associated malignancies and the evidence that we have now,
um, for the risk estimates, diagnosis, treatment, and outcomes,
and I'll spend most of the time, um, on anaplastic large cell lymphoma because that's
really what we have the most data on.
Um, I'll touch upon B cell, um, and then finish with squamous cell carcinoma as well.
Uh, so how did we get here? Um, in 1995, Duvial reported three cases of
cutaneous T cell lymphoma, and these were in young breast augmentation patients.
And just two years later, Keats reported the first case of ALCL.
It was in a patient with a McGann textured saline implant treated with total capsulectomy,
radiation, chemo, and was reported to be disease-free 2 years later.
Since then, we've had multiple case reports going into the early 2000s of ALCL.
Um, and in 2008, a matched case control study out of the Netherlands looking at non-Hodgkin's,
um, lymphoma of the breast made this connection.
So there were 11 patients with breast ALCL that were identified,
of which 5 had prior breast augmentation, matched to 35 control patients,
of which 1 had breast implants, and the odds ratio they found for ALCL was 18.2,
though the absolute risk remained low.
Fast forward to 2011, um, the FDA issues a safety communication about a warning about a
possible association between breast implants and ALCL.
There was not enough data at the time to correlate with texturing,
but Gary Brody at the AAPS meeting in 2010, um, had discussed this,
and the recommendations then were just to look out and report more cases.
2017 update as I had mentioned confirms an increased risk of ALCL in patients with breast
implants and then describes that increased incidence and textured implants and as we know
in 2019, uh, was the worldwide recon of the biocell detection implants and expanders.
So taking a little bit of a dive into the disease process and just focusing
chronologically on the evidence, 2015, Brody at Al reviewed the global literature.
Um, and the conclusions that they drew that this was a likely a multifactorial process due
to indolent inflammation isolated textured devices.
In 2016, Huweel reinforced the potential infectious aetiology and biofilm contributions
when they compared BIA ALCL capsules to non-pathologic capsules,
and they identified the higher bio burden of Ralstonia in the ALCL capsules.
And really it was in 2017, Locke Wilkinson looked at 55 cases of BIA ALCL in Australia and
New Zealand. And they demonstrated that higher surface area
texture correlated with an increased risk of ALCL.
The biocell macro-textured implants generated by salt loss,
as we know, compared to the micro-textured siltex implants by imprint stamping,
had an odds ratio of 14.1 for developing ALCL.
And from this, the ongoing hypothesis was developed about bacterial contamination and
chronic antigen uh stimulation leading to that T cell conversion.
Subsequently in 2018, this important study reclassified the surface characteristics of
implants and also importantly confirmed significantly higher bacterial growth rate with
those type 3 and 4, salt loss and polyurethane foam, um,
textures. And I'm not gonna dwell on this aspect too much
though it is also very important, but genetic components have also been elucidated over this
time. This was first described in 2016, um, and it's
been linked mainly focused on this jackstat interrelated aberrant signalling,
um, and those, uh, reports continue to go on.
Uh, another important risk factor I think that really has to be emphasised is the length of
exposure. Um, this 2017 review in JAMA demonstrated that
the time the onset of ALCL on average was 10 years after implantation.
So naturally there's been a concern over textured expanders as well.
Um, there has been one isolated case report of a patient with smooth implants and temporary
textured expanders.
Importantly, she had the expanders in for a prolonged period of time,
12 months, which is a little bit long, as well as issues with infection that could have led to
inflammation, and she developed ALCL at 5 years.
Nelson Nadal, um, in this July, a couple of months ago,
2023 article looked at the risk of textured biocell expanders alone.
This was in 3300 patients, 5200 textured biocell TEs with a median exposure of 6 months,
um, and a median follow up of 7 years with an event rate of zero.
so this suggests that the shorter exposures, the textured devices,
these are macro textured devices, has a much lower risk than the prolonged implant exposure.
So as of August 1st, 2023, there are 1,358 suspected cases of BIALCL worldwide,
and that's been greatly been aided, um, in reporting with this profile database.
But if you just go back a few years, um, in our conferences and our publications,
I think you'd find some great relevance in Mr. Dillon's 1964 quote,
uh, and hit the times are changing.
2017, lifetime prevalence of ALCL in women with textured implants is estimated to be 1 in
30,000. Fast forward 3 years, and we heard earlier
today, Peter Coder reports a rate of almost 1 in 300 cases of biocell implants in a single
surgeon analysis of 3500 patients.
So where do we stand?
Um, in 2019, Coletta Al reviewed the literature on BIA LCL.
Um, importantly, they looked at the challenges with identifying these things which have been
reported previously in, um, in depth in this other 2017 paper,
and they reported an incidence of around 1 in 2800 based on the review of the global
literature. A more recent study looking at multi-surgeon
data, um, this is out of this year in over 900 patients with almost 10,000 textured implants
identified 11 cases of BIALCL, and this gives you an incidence of around 1 in 600.
Again, I think it's important to note that the length of exposure is a risk factor.
They had an incidence of 0 at 6 years, 4 in 1000 at 10 to 12,
and that increased to 9 in 1000 when you went out to 14 to 16.
Jumping a little bit to um clinical presentations, what these patients look like,
we know most of this information, but to review, the most common presentation is a spontaneous
periprosthetic fluid collection, usually again delayed, less common presentations but can
occur masses lymphadenopathy, systemic symptoms.
When AL cell is suspected, um, you need to get a high resolution ultrasound or an MRI,
and that's to assess for a periprosthetic fluid, um, or mass that must be either aspirated or
biopsied and what we test for, um, cytology, flow cytometry for T cells,
and immunohistochem chemistry for CD30 positivity.
Um, if a diagnosis is confirmed, the next step is to get a pet to look for,
um, distant mets, lymphadenopathy, and masses.
The staging is actually relatively simple. tumours confined to the capsular stage 1A 1C.
Those extending beyond the capsular stage 2A, and when you have lymph node involvement,
um, or distant mets, that's 2B to 4.
Treatment is multidisciplinary, um, as all things oncologic and a plastic surgery team,
primary treatment on block resection with total capsulectomy and a contralateral prophylactic
capsulectomy is also indicated because there is a 4.6% incidence of contralateral,
um, unrecognised disease, as well as removing any masses.
Um, incomplete capsulectomy has been shown to significantly decrease survival and when
patients do have a mass that they present with, which is unusual,
um, it also has a lower overall survival.
Adjuvant therapies are indicated for isolated cases where you can't do a complete
capsulectomy when you have masses that can't be resected or obviously advanced disease,
and these include um anthraccycline-based cytoxic agents,
um, as well as branttuximab which is directed against that CD30 um positivity and radiation
for local disease that can't be controlled.
Outcomes do tend to be favourable for early stage disease.
Um, Tevasal reported on 52 cases. Um, the majority were confined to the capsule.
51 had M block capsectomy.
Um, a decent percentage had adavant therapies, and there were 2 cases of local regional
recurrence that were handled, and they all um achieved complete remission.
In July of this year, O'Connell published a series of 18 cases.
All had M block capsectomy and no patients had recurrence at a medium follow up of 45 months.
And finally, what about reconstruction after you do an explantation?
Um, the MD Anderson Group looked at 18 patients, 40% had immediate reconstruction,
60% had delayed.
The majority of these patients received smooth implants.
One patient had implant regret, and they developed this algorithm,
um, in which disease confined to the capsule could be offered immediate reconstruction,
uh, and patients with advanced disease would obviously get,
um, delayed reconstruction if desired.
Moving on to B cell lymphoma, um, a lot less data, uh,
a little bit more confusing. Um, there are multiple different types of B
cell lymphomas, and again this is not new.
Reports date back to the mid 1990s. Presentations are a little bit all over the
place, but they tend to be this late, um, onset classic seroma.
There are around 30 documented cases, um, that span these different subtypes with similar
delayed presentations, um, and recently there have been.
Reports of a growing number of Epstein EBV positive B cell lymphomas,
um, which have an interesting presentation. This is,
uh, a comparative series of 8 cases compared with 14 cases of ALCL B cell versus ALCL.
Um, they were all in textured implants. They had delayed onset,
but these typically instead of presenting as a seroma, they present with discomfort and
symptoms more similar to capsular contracture.
Again, all were successfully treated those short follow up,
um. Moving on to squamous cell carcinoma, um,
this has also been reported for some time in 1992, Paleta et Al reported findings of SEC in
a woman that had bilateral uh um, silicone breast augmentation 15 years after placement.
There's also been many recent small case reports and series,
and in March of 2023, the FDA released another safety communication based on accumulated data,
um, from 19. Cases these are not just isolated two textured
implants um they tend to present with delayed, um, breast swelling and pain and though it's
rare they are quite aggressive. A recent review of the literature from 2023
identified 16 cases. 11 already had extracapsular involvement and
due to this, they often not only undergo capsulectomy, but they have to have mastectomy
and even chest wall resection, and 5 of these, um, succumbed to their disease.
Management of SEC again includes getting a diagnosis.
The markers are a little bit different here, CK 5 and 6 P 64,
but it's the same thing imaging, diagnosis, and the multidisciplinary management.
Um, I'll touch on a few other capsular abnormalities quickly.
This is a great paper, um, from January of this year, um,
that goes over some of these more rare abnormalities, two other ones worth mentioning
breast cancer asso associated within the implant capsule,
and then mesenchymal tumours, but these are all extremely rare.
Um, so in the last 10 seconds, I'll just go through a few quick,
I think, high level bullet points.
Um, BIA SCC very rare, um, but also very aggressive.
BIALCL can be invasive but manageable surgically when caught early.
Um, 19 cases of SEC reported almost 1400 of ALCL.
We don't know the risk estimates of SEC. ALCL is gonna vary between unlikely 1 in 300,
but somewhere more towards 1 in 3000. Um, they both have delayed onset.
Uh, and, uh, the presentation is similar except SEC tends to be more advanced and the mortality
again is significantly higher with SEC.
We went over the different androgen markers and treatments, the same M block capsulectomy,
um, though this is much more effective for ALCL than SCC.
Thank you very much.
I, I don't think he took a breath.
Very impressive, Doctor, I mean, very impressive.
Roger, the stage is yours.
Now you can breathe. Very impressive.
OK, thank you. Um, so the topic I was asked to address here
was ALCL ALCL, and its impact on the industry.
Uh, disclosures are the same as I described before.
So, um, I thought before talking about, uh, the impact, uh,
this was a nice paper, um, Doctor Spiegel from Houston, um,
was the senior author on it and looked at the trends in utilisation of smooth versus texture
implants in the US versus Europe, OK, and this was based on,
uh, one manufacturer set of data and that and this was published in 2021.
Um, so actually it's changed a little bit, but I think it makes some interesting points that
that are useful. So first of all, when they looked at implant
size utilisation by region, um, and this is something that has been suggested for a long
time, but here's actual some numbers in that you see that in the mid-range categories it's
pretty much the same between the US and Europe, but if you go to the smaller size implants,
a lot more of those are used in Europe. And the much larger implants,
a lot more of those are used in the US. And if you think about the purpose for which
texture was first introduced back in the 1970s, it was for stabilisation of the implant.
You can see there would be more of a benefit where you're using larger implants.
And then at the time they were capturing the data, this was a distribution of textured
versus smooth um in the US versus Europe. OK, this is already changed so in
the US that number is probably decreased significantly from 12% utilisation of texture
it's very, very low now.
um, in Europe, um, the latest numbers I have it's probably still about 90% use of texture,
OK. So with that sort of background for discussion,
um, actually, Doctor Sliian went through some of this timeline,
um, which affects how industry responded. So first case report 1995,
196, there's.
Uh, debate on that one, Gary Brody, um, actually remember at the 2007 ASPS meeting
in Baltimore actually was that was the very first time he recognised,
um, the potential connection between BILCL and textured implants.
um, interesting story he had.
Um, uh, one of his fellows had was out of town and asked him to see a patient.
Late seroma turned out to be BILCL. He had had a case 15 years earlier of his own,
and all of a sudden he started thinking about how many late seromas he had seen over the
years, and it probably would be low incidence, but maybe we should start looking into that.
That was 2007.
De Jong is was the one that I think really caught people's attention and that relative
risk that you saw on on the previous slide that I think also is when manufacturers started
really paying attention to this and and following it very closely and following their
whether there are any cases 2011 FDA communication.
Uh, certainly had quite an impact and then the publications by Diva,
Laura Johnson in that paper I presented, they actually showed the impact on sales of textured
implants that correlated with the publication or or these announcements and that.
Um, and then you saw the, the, uh, macro protect bio cell removed from the market.
OK, so what has industry done in response? Well, as we all know,
in the one example with the biocell following first ANSM and then FDA that was withdrawn
worldwide. Uh, one of the things, and this was when I was
involved with is, you know, there's a suggestion that these textured implants may
very well reduce reoper operations for certain complications and that might have a risk
reduction benefit.
And that too, but no one had really quantified that that was something that just was sort of
discussed in general terms and there's paper from 2020 where we actually quantify that
because if you can reduce reoper operations, there is an inherent risk including a very,
very small, um, inherent risk of mortality associated with reoperation,
um. And then you had the introduction and and
actually marketing focused a lot on BILCL of nano texture breast implants first was motiva.
There's a couple other uh European manufacturers have introduced,
uh, fairly similar nano texture type breast implants, um,
but I think what we've seen and, and I think this is was a bit of a surprise there was,
um. There was a thought early on that with the
emergence of BILCL texture breast implants might disappear,
but in fact there is continued marketing and as I described earlier,
still about 90% of implant usage in Europe remains textured implants,
I think because of that risk benefit that I talked about before.
Um, what else is industry done? Well, some, but I don't,
but not all manufacturers have invested in BILCL research and supporting international
conferences and an exchange of information.
I actually hope this ramps up because there was a study out of that Australian group Diva,
where they actually looked. At what BILCL cells respond to whether it's
established cell lines or brand new isolated BILCL cells,
one interesting findings was that um although they responded to lipopolysaccharide,
which would be consistent with the uh biofilm hypothesis, so there's contrary data now.
They didn't show any proliferative response to the different breast implant surface to the
different textured surfaces, so something else is going on there and if we understood what
that something else was and could prevent it, I think that might certainly change the um
the use of textured implants going forward.
The other thing that that we saw was a lot of educational programmes um um worldwide focused
on for those surgeons who want to switch from texture to smooth how could they avoid the
increase in complications or at least minimise that that so many surgeons had experienced who
are used to using textured implants.
And then also we've seen, and this was first in the US,
seen the introduction of smooth tissue expanders.
You saw the study that Dr. Libyan presented from Memorial Sloan Kettering.
To date there's only a single case, uh, confirmed case worldwide of a textured tissue
expander followed by a smooth implant that was a bile cell one,
and you saw that pretty large data set from Memorial Sloan Kettering.
There's another paper out of MD Anderson consistent with that.
To kind of summarise this all together, the end result is in terms of the impact on industry we
do see very extensive continued sales and use of a range of textured implants,
um, combined with some increase in the sales and use of smooth device.
So both are still out there and along the lines of our discussion yesterday in the panel on
on shaped implants, uh, there is no perfect implant that's suitable for all patients and I
think we continue to see the use of both smooth and texture.
Thank you very much. Well,
um, it's time for a discussion. I, I'm waiting for my co-chairman and the other
speakers to, uh, we, we've been given time.
Yes, we are so, so I think I know that you are scared.
Please get back, get back your feelings, by the way, Charles,
why did you decide to stay.
In the front line here looking to you probably been scared about all these words cancer ALCL
and you want to face it now on the contrary, I'll take it up front anytime,
by the way, we should be scared.
Starting with you, should we be scared about this because we are talking about cancer and
something we are doing in a good way, making our life patient better but one day we
discovered that you produce this kind of.
Trouble I think you should, I think it's um wise to be concerned about the cancer risks
um I don't think we need to be concerned about systemic symptoms associated with the breast
implants. I think that as we look prospectively um.
Who we put in breast implants in will realise that there I mean even in my practise now if I
have somebody who has a history of anxiety and depression I'm less likely to recommend an
augmentation to them just and I will tell them honestly about breast implant illness in terms
of our um.
Uh, textured implants and the risk of squamous cell and B cell.
I do discuss that with my patients, but as Roger had suggested earlier,
I talk about the minimal risk and I emphasise, um, surveillance with them.
I have an ultrasound in my office that we routinely use on all of our implant patients.
And so I've over 20 years put in over 6000 implants so
and the way that patients have come to me, they are more scared uh at least in the United
States, and I think the bottom line is, uh, I, I, it,
it's about the data and so what I tell them is the truth that,
uh, all the epidemiologic data suggests that implants as a whole do not cause breast cancer.
Um, implants may have a rare instance of autoimmune issues,
um, but I'll, I'm gonna quote another, um, Danish study,
uh, tomorrow in which they found that, uh, looking at serology that there was no again
same thing that, uh, Doctor Glickman and Doctor um Marissa found.
So I tell them I wouldn't be concerned, but the problem is is that we in the United States have
a uh lower risk tolerance because of the higher sensitivity that we have to uh medical
litiginous environment so that's very real in our society that people sue doctors
routinely for small things and these suits can result in.
Issues where you you sometimes have to stop practising so when you are in that harsh
environment you have to be much more conscious and our threshold for tolerating risk is lower
and even though I feel that most of the things such as the Cordero study suggesting 1 in a few
100 risk of um.
Uh, ALCL with, with, um, the Allergan implants and that the mentor implants are much better in
general we our risk tolerance does not allow us to, uh,
granularly differentiate that so and patients will not understand so I think I speak for most
of the high volume implant surgeons in the US, um, and we don't use textured implants
even though we would like to use them, we cannot use them because of the different
environment. But you said about patient anxiety and
sensibility and patient doesn't have access to our data.
The only thing they see they see some very famous doctor coming to our meeting being on
the first page on New York Times.
And saying, OK, there is a connection between cancer.
Do you think that it's a good? So, so actually that's a great question.
Like how do I practically deal with it? I, I basically tell them exactly what I just
said here, which is, listen, I've put in 6000 implants, never had a patient of mine that had
ALCL or squamous cell, and I've had a few patients that might have had autoimmune,
and I tell them, you know, there's a risk coming to my office that you could.
Get into a car accident or some other issue or with any surgery and I tell them I think that
risk is low enough where it's safe enough to travel by plane or to put in an implant but as
part of our consent process we have to document that we talk to them so that's the way I do it.
I mention it and then I reassure them that the chances is extremely low.
And are you expressing all this data in a. An informed consent,
particularly specifically we have the FDA checklist that that it's mandatory
unfortunately Europe, it's dependent country. It's multiple pages.
I actually don't use that checklist, but I document in my note that I mentioned that to
them. Many surgeons, I think, use it's a, it's a
multiple page checklist. It's literally like pages long and the initial.
Points of ALCL black box warning and everyone signs by the way,
congratulations trying to catch my breath. Uh, you are young and not young
experienced doctor jumping in this new era where everything was changed because some
decisions, some, uh, let's say company industry, but what about us?
What should we do to really face on these fights between between companies and in the
end that are shaping our decision daily decision some of our colleagues,
I remember a few years ago in this meeting half of day was the totally with some
speakers from all over the world but very famous.
I know that James Bond one came to the the British society giving a lecture and everybody
was scared. Now where are they?
What I'm doing some colleagues decided completely to not use texture implant they move
to smooth and the reinvention rate it was higher.
Yeah, no, that's a great question. I mean, and I think relevantly said my
experience is orders of magnitude, a fraction of everyone else here,
but I think it goes back to what Doctor Kim says we're talking about us and risk tolerance
as someone that's been in practise not for very long, my risk tolerance is extremely low,
um, for.
Any complication but even potentially going down the lines of something like this so,
um, I go about the same approach um I tell them what the risks are based on the data I give a
range around 1 in 350 to 1 in 3000 is what we know, um,
but I personally because I don't have enough experience, wouldn't start flirting with that
line, um, for the other reason because it's just, you know,
the factors that Doctor Kim.
Um, talked about in the US it's different, um, and I'm mainly a breast reconstruction practise
and by the time I get done talking to them.
I end up just saying, you know, there is a type of cancer that's associated with implants that
we don't use that you never touch and then even when you say that.
They start, you know, it just, it's like something hit them,
um, so I just, I stay away whether that's the right answer or not,
it's just it's it's safety.
Yes it's true because at the end of the day we need to be to sleep well by the way,
on this panel the whole speakers are from United States.
What about Europe?
And before going the last to Roger Charles, what about Europe?
is your decision now looking to this subject.
You know, I, I addressed that during my talk earlier on um like I said there's no perfect
implant for every patient and there's none perfect for every surgeon.
I do believe that most of the issues we see today are certainly related.
The question about breast implant illness and ALCL is a topic that's very important.
This talk, this discussion is extremely important.
Does that impact on my decisions in my practise today as it did 18-10 years ago when I started
looking closer at this? No, it does not.
Um, the, the, the talks we had 10 years ago, and trust me,
they were quite heavy talks was, are we seeing the tip of the iceberg or what's happening here?
And to be quite honest, we do not know.
I mean, with all due respect, we do not know.
Because this is a time machine. We do not know if this is a ticking bomb person.
I don't think it's a ticking bomb, but it's something we need to be aware of,
all of us. I don't know how many of you have had ALCL,
but for someone who's been in practise for close to 30 years,
of course, putting in a lot, a lot of texture devices.
I've had my share of those.
We've had 2 cases within my facility.
And cancer is a very scary word, even though we know that up to date,
I think we've had 59 cases of death involved with this,
so it's quite rare and it's easy curable today and we've learned a lot during these years.
Basically surgical invention, capsulectomy heals most of them.
However, with that said, The transition I did personally and like everyone is aware of,
I'm not only using uh nano smooth, I'm using texture, of course I am.
Uh, um In certain cases.
My shift has not been the way I see today is not due to ALCL.
It's because I see other.
Good things with a nano smooth biocompatible implant because anything that's biocompatible
by per definition is nicer to tissue and if I can put something that's nice into the tissue.
Basically, I, I, I think that's good for any patient.
I don't need to add antibiotics and I have small incisions and I can put them
subglandinary. So, long story short.
Um, we all have to make our choices.
Uh, there's continuously data and excellent presentation on what's coming up.
You need to make your choices, and when you do, the most important thing really is how you
communicate those choices to your patients.
Are you selling something or are you teaching your patients and at the end of the day things
can happen all the time just be have a protocol how to take care of them if it happens,
if you decide and you can get cancer for any type of surface,
although it's rarer with smooth but have a protocol and follow your patients over time
show them that you're caring and that you're dedicated.
Don't believe that your relationship with your patients end with the last stitch,
01:00:00.189 --> 01:00:02.739 that's when you take a responsibility for the rest of her life,
01:00:02.870 --> 01:00:06.110 as long as she has that device, because based on your.
01:00:08.159 --> 01:00:12.550 Knowledge and based on your advice, she most likely will pick that implant.
01:00:13.570 --> 01:00:15.629 So that's, that's my answer.
01:00:16.090 --> 01:00:17.090 Take responsibility.
01:00:18.040 --> 01:00:21.840 Thank you Charles. It was just an intro because I want to go now
01:00:21.840 --> 01:00:26.389 to the last speaker because you are the most experienced and long in this kind of subjects
01:00:26.989 --> 01:00:30.050 involved with industry, and that was probably mentor.
01:00:30.080 --> 01:00:34.110 You studied also the capsuar contractor, the small, uh,
01:00:34.120 --> 01:00:38.989 seroma around the texture mentor implant. Now the LCL.
01:00:39.199 --> 01:00:41.840 What is your impression? It's a new subject.
01:00:42.300 --> 01:00:45.739 To make people to feel a little bit scary.
01:00:46.129 --> 01:00:50.419 Well, well, I think you know, I think one of the important things whether it's breast
01:00:50.419 --> 01:00:55.629 implants or anything else when you're deciding what medical device to use,
01:00:55.719 --> 01:01:00.639 you need to look at the whole picture and I think that reflects some of what you said and
01:01:00.639 --> 01:01:06.250 what several of the other speakers said. BIL sale is is one issue and if you increase,
01:01:06.399 --> 01:01:08.729 you know, there was the study out of um.
01:01:09.159 --> 01:01:12.760 Out of Stockholm with Hamdi's comment that this one group that switched,
01:01:12.800 --> 01:01:14.149 they ended up with much higher.
01:01:14.590 --> 01:01:20.659 Um, reoper operations and that and so when Roy needs to look at the whole picture and I think
01:01:21.030 --> 01:01:26.830 um another thing that's come up at some of the international BILL conferences is for patients
01:01:26.830 --> 01:01:32.469 who are getting implants now they should be the risk should be communicated for the implants
01:01:32.469 --> 01:01:38.629 that are still on the market because 91% of the cases in the last analysis of
01:01:38.629 --> 01:01:43.030 BILCL where manufacturer was known, was the ones that are no longer available on the market.
01:01:43.479 --> 01:01:46.879 If you remove those it's a different risk that you're talking about.
01:01:46.919 --> 01:01:51.860 It's not the 1 in 300 or the Kaplan Meyer when he did Captain Meyer was actually up to 1 in
01:01:51.860 --> 01:01:55.870 100, OK, because his patients, a lot of them are still early on.
01:01:56.120 --> 01:02:01.594 So I think that's, you know, that's. One important factor and I think back to what
01:02:01.594 --> 01:02:03.945 Doctor Kim said it's interesting. I remember,
01:02:04.235 --> 01:02:07.824 uh, Brad Calbra at one of the meetings he was on a panel and he was asked,
01:02:08.114 --> 01:02:10.885 so do you still see a role for textured implants?
01:02:10.895 --> 01:02:15.905 And he had an answer, well, in the US, not currently outside the US,
01:02:16.034 --> 01:02:19.715 yes, and it was for the re the exact reasons that you heard.
01:02:20.149 --> 01:02:24.399 Um, described here, I think, um, Doctor Lawrence, which he,
01:02:24.629 --> 01:02:29.649 um, communicated on, on breast implants, systemic signs and symptoms.
01:02:29.709 --> 01:02:36.139 I think now we have a much better idea we have good information to communicate to patients and,
01:02:36.379 --> 01:02:43.209 and as she said have information now to know which patients before they get the surgery done
01:02:43.209 --> 01:02:48.590 maybe need some extra counselling or you don't do the surgery on it so I think a key thing has
01:02:48.590 --> 01:02:52.280 been. You know, getting better information to make
01:02:52.280 --> 01:02:59.040 those decisions and you know we didn't have, we really didn't have that information before
01:02:59.530 --> 01:03:00.610 we have much better now.
01:03:01.850 --> 01:03:05.149 Thank you, Charles. Now it's I think it's extremely important to
01:03:05.149 --> 01:03:06.729 differentiate between.
01:03:08.800 --> 01:03:11.419 And John Tebbit stated this very well.
01:03:12.659 --> 01:03:19.020 The difference between device related complications and surgeon related complications.
01:03:19.969 --> 01:03:21.610 So if we're academic.
01:03:22.500 --> 01:03:27.010 The truth is that certain devices are more prone to this disease.
01:03:27.090 --> 01:03:30.020 That's a fact. That's just a fact.
01:03:31.689 --> 01:03:37.729 Now, does that mean that you won't have complications using different type of devices?
01:03:37.810 --> 01:03:40.770 Of course, depending on your surgical aseptic technique, you'll have that.
01:03:41.520 --> 01:03:47.600 And you're referring to an article where a surgeon shifts and has more complications,
01:03:47.679 --> 01:03:52.790 but those are not device related in regards of this disease we're just talking about.
01:03:52.919 --> 01:03:55.360 They're related to surgical.
01:03:56.449 --> 01:04:01.600 Technique and lack of experience and a learning curve like anything else,
01:04:01.649 --> 01:04:03.639 you drive a new car, you'll have problems.
01:04:04.010 --> 01:04:07.889 So I think it's important just to divide those two things.
01:04:08.870 --> 01:04:14.889 Uh, with that said, uh, I think I, I'd like, I mean, I'd like to ask a couple of specific
01:04:14.889 --> 01:04:17.290 questions to your talks. Is, is that OK?
01:04:18.290 --> 01:04:25.209 Uh So one of the things, uh, uh, John, was when you talked about subglandular,
01:04:25.370 --> 01:04:31.439 I mean those talks about women who have implants, they have less breast cancer one it's,
01:04:31.489 --> 01:04:33.159 it's been known for quite some time.
01:04:33.530 --> 01:04:37.850 I was always under the impression, well, that's because they have less tissue and they can feel
01:04:37.850 --> 01:04:44.040 the nodules, you know, earlier on, but you had a different and I like that could you,
01:04:44.050 --> 01:04:49.280 I mean, elaborate a little bit, why do you think that women with subglandular implants.
01:04:49.629 --> 01:04:54.709 And uh and women with implants in general have less uh breast cancer.
01:04:55.489 --> 01:05:00.129 Well, I, I, I think that it's an interesting finding, um.
01:05:00.989 --> 01:05:07.699 You know the problem with the one of the major kind of controversies or or push backs to
01:05:07.699 --> 01:05:14.540 this idea is that well women with smaller breasts will have implants and smaller
01:05:14.540 --> 01:05:21.540 breasts might be related to less breast tissue, less risk for cancer so the problem is that if
01:05:21.540 --> 01:05:26.500 you talk to many surgical oncologists, they'll tell you that there is not necessarily a
01:05:26.500 --> 01:05:30.469 relationship between breast size and breast cancer.
01:05:30.939 --> 01:05:36.570 And we don't have good data on that, so it's possible that some of the effect that we're
01:05:36.570 --> 01:05:40.540 seeing, which is very clear, comprehensive across all 19 studies,
01:05:40.649 --> 01:05:46.929 is maybe simply a small impact of the breast size, but the issue of,
01:05:46.969 --> 01:05:50.129 well, is it subglandular so you can detect it more?
01:05:50.189 --> 01:05:55.010 I don't think that's the case because for instance that study was 24 years if you're
01:05:55.010 --> 01:05:58.050 gonna have a breast cancer come up in that situation.
01:05:58.580 --> 01:06:01.760 I would say 24 years gives you long enough time to find it,
01:06:01.820 --> 01:06:07.060 but I think there might be something about the surface area and the contact and the
01:06:07.060 --> 01:06:10.899 inflammation. We know inflammation can be bad if you have
01:06:10.899 --> 01:06:15.860 aggressive biocell texturing you get intense inflammation, and we know that the genes that
01:06:15.860 --> 01:06:19.500 are expressed there are related to proliferation.
01:06:19.635 --> 01:06:23.615 And hyper proliferation, but we also know inflammation can be helpful,
01:06:23.825 --> 01:06:27.635 that there is good forms of inflammation so it's true of disease,
01:06:27.706 --> 01:06:32.535 it's true of life, and I think it's true of implants that we have bad and good inflammation
01:06:32.736 --> 01:06:38.266 and in rare situations some of that bad inflammation will result in a problem and but
01:06:38.266 --> 01:06:40.785 that if we look at hundreds of thousands of patients.
01:06:40.892 --> 01:06:47.271 Like that study did that in general I think you can say across the board that there may be a a
01:06:47.271 --> 01:06:53.872 slight dampening of breast cancer risk because of good inflammation that's that's what I would
01:06:53.872 --> 01:06:58.352 say but like you said you were, you have to follow the numbers you have to follow data and
01:06:58.352 --> 01:07:02.031 so we followed the data and now we're trying to explain it.
01:07:02.479 --> 01:07:07.020 Can check, there's an animal. OK, there's an animal study that's fascinating
01:07:07.020 --> 01:07:12.030 that, uh, you know, talked about for a number of years on this that again suggests it's
01:07:12.030 --> 01:07:15.719 something more than just a smaller size, and it was a study,
01:07:15.830 --> 01:07:19.659 uh, by Suid all 1995 and what he did three groups of animals.
01:07:19.969 --> 01:07:25.510 So in one group was a sham operated control. One he put little mini 2 CC gel implants.
01:07:26.419 --> 01:07:29.780 Subcutaneous on the dorsum and beneath the mammary gland.
01:07:30.929 --> 01:07:33.969 14 weeks, I mean 14 days later after they healed up,
01:07:34.090 --> 01:07:37.989 he injected them with a potent mammary tumour gen and nitrosourea compound,
01:07:38.250 --> 01:07:40.610 waited for tumours to develop. What did he see?
01:07:40.770 --> 01:07:44.080 Here is a control sham operated. You put it on the dorsum here.
01:07:44.370 --> 01:07:45.989 You put it under the mammary gland.
01:07:46.610 --> 01:07:50.010 Huge reduction and that in an animal study, OK.
01:07:50.310 --> 01:07:53.600 Um, no difference in size of breasts. So, um,
01:07:53.770 --> 01:07:57.729 there's also breasts with breast implants that are 2 °C cooler.
01:07:57.929 --> 01:08:02.800 So there's some physiological, biological need to learn more about that,
01:08:02.969 --> 01:08:05.959 but that brings me into my, my question to the two of you.
01:08:06.489 --> 01:08:13.010 Has there been any correlation between the surface by size?
01:08:13.709 --> 01:08:16.490 And these diseases we're talking about.
01:08:17.390 --> 01:08:23.810 The cancer, so what I'm basically saying, does a 600 cc textur run a higher risk than a
01:08:23.810 --> 01:08:29.290 200. Not to my knowledge, I think any relation is
01:08:29.290 --> 01:08:30.990 surface area texture.
01:08:31.209 --> 01:08:35.919 Now that would be a great question that Cordero could look at because he's got the study.
01:08:36.009 --> 01:08:42.640 He should be able to maybe stratify subs, yeah, yeah, he could great question because
01:08:42.850 --> 01:08:46.529 we, we all are in the line of this is in chronic inflammatory.
01:08:46.674 --> 01:08:51.254 Reaction that leads to mutation that leads to etc. etc.
01:08:51.504 --> 01:08:56.435 so that's why I'm asking this, OK, yeah, I mean if you believe Diva's hypothesis,
01:08:56.544 --> 01:09:01.064 which there's contrary data now, the larger implant would have a larger surface and would
01:09:01.064 --> 01:09:04.035 have more stimulating bacteria. OK with that,
01:09:04.225 --> 01:09:07.294 with that said, any questions from the audience?
01:09:10.390 --> 01:09:13.798 Yes, please, madam. I noticed is that
01:09:24.359 --> 01:09:28.669 Ways to do breast screening, um, with implants, I find it's still a,
01:09:28.680 --> 01:09:31.930 a real struggle to get these women to, to screen.
01:09:32.080 --> 01:09:36.240 Um, what, what do you advise your patients about breast cancer screening?
01:09:39.229 --> 01:09:42.100 What do you advise your patients? That's the question,
01:09:42.270 --> 01:09:46.750 pressed. Cancer, breast cancer screening.
01:09:46.759 --> 01:09:50.799 I mean they should be um screened appropriate I mean I do tell my patients that they,
01:09:50.839 --> 01:09:54.879 they're always worried that the implants are gonna be ruptured by the mammograph and I tell
01:09:54.879 --> 01:09:59.959 them that that incidence is very, very low and that they do need to that it's more important
01:09:59.959 --> 01:10:03.319 to worry about cancer risk than the um.
01:10:04.040 --> 01:10:08.779 The uh breast implant itself, breast uh the mammogram is not going to tell them.
01:10:08.819 --> 01:10:13.529 I I do um ultrasound in my office on everyone and I make sure to let them know that that's
01:10:13.529 --> 01:10:17.100 not going to detect breast cancer. That's strictly to look at the integrity of the
01:10:17.100 --> 01:10:22.714 implant, but that they need to have mammograph. A lot of them now are going to thermography
01:10:23.004 --> 01:10:26.314 which I know less about. I'm not really sure that I'm comfortable with
01:10:26.314 --> 01:10:33.104 that, um, but I do recommend that we follow the radiology guidelines for mammography and I will
01:10:33.104 --> 01:10:35.964 not operate on a patient without a mammogram.
01:10:37.569 --> 01:10:40.959 Uh, you know, I think Mara answered most of that.
01:10:41.000 --> 01:10:44.120 I have a question to the audience actually, and, and, and to the panel.
01:10:45.140 --> 01:10:50.180 Obviously, as everyone is aware, data is, is very, very important and and these amazing
01:10:50.180 --> 01:10:51.649 articles just confirm that.
01:10:52.370 --> 01:10:56.430 I've got a question to the audience and all, how long do you follow your patients?
01:10:57.299 --> 01:11:01.180 So the first question is, please raise your arms, and I know this might be a bit
01:11:01.180 --> 01:11:05.779 embarrassing, but um what strategy do you have within your hospital or in your facility
01:11:05.779 --> 01:11:06.899 following your patients?
01:11:07.100 --> 01:11:09.330 So how many follow your patients more than one year?
01:11:12.819 --> 01:11:15.140 How many follow your patients more than 5 years?
01:11:18.729 --> 01:11:21.399 How many of you follow your patients more than 10 years?
01:11:22.799 --> 01:11:27.930 If they come, if they come back, yeah, very few, so within your policies,
01:11:28.009 --> 01:11:34.120 very few, and right now we learn that some of these diseases express themselves 8 to 10 years.
01:11:34.939 --> 01:11:36.899 That shows us the weakness.
01:11:37.859 --> 01:11:43.689 Within our specialty because honestly that's where we need to work a lot more,
01:11:43.740 --> 01:11:48.419 yes sir. Deal with breast cancer.
01:11:49.120 --> 01:11:54.689 And uh we do reconstruction with implants so we followed them for 5 years,
01:11:54.729 --> 01:12:00.890 but after that um there is a survivorship uh clinic follow up,
01:12:01.009 --> 01:12:06.040 but that's probably a different what our plastic surgery colleagues do,
01:12:06.689 --> 01:12:09.640 which is essentially for cosmetic purposes.
01:12:10.129 --> 01:12:12.850 Well, it depends on which facility you're associated with,
01:12:12.890 --> 01:12:15.640 I believe, but that brings me to my second question.
01:12:15.770 --> 01:12:17.250 OK, so you follow your patients.
01:12:17.629 --> 01:12:21.310 But then, how do you follow your patients? What exams?
01:12:21.799 --> 01:12:26.640 So how many of you in this audience follow your patients with MRIs or ultrasound?
01:12:30.180 --> 01:12:34.330 So that tells us we need to work a little bit more while doing this.
01:12:34.700 --> 01:12:40.850 So with that said, I think we are on, on, yeah, I think that the
01:12:40.859 --> 01:12:46.910 the the industry and you need a rest so so let's go out and and enjoy coffee and some tea.
01:12:47.060 --> 01:12:48.169 Thank you very much everyone.