All right, well, we'll go ahead and and move right along in the interest of time,
um, so it's a pleasure to be back at the London breast meeting again and our,
uh, thanks to mentor for sponsoring, uh, this session.
So I'm gonna start out, uh, with the first part sort of on some of the,
the data and science, and then you're gonna hear the sort of the clinical applications of
this. This one? OK.
All right. OK, first of all, these are my disclosures,
consultants and mentor.
OK, so first of all, some updates on BILCL.
Um, one of the, uh, more interesting papers, uh, just appeared online ahead of print.
I don't know how many of you may have seen this. It just,
uh, was posted in July and it looked at the outcomes after treatment of these,
uh, the patients in the UK with BILCL.
And so there were, uh, a total of 18 BILCL patients
treated between 2015 and 2022. The median age was 48.5 years.
Out of those 1810 had had breast augmentation, 8 had had reconstruction.
The median time from first implant surgery diagnosis was 8.5 years,
which fits in with the standard behaviour.
All of these patients underwent an on block total capsulectomy with implant removal.
Two of them received systemic therapy.
The vast majority were early stage, stage 1 by the TNSM staging system.
And here was the key finding at median follow up of 45 months,
almost 4 years, there were no episodes of local or systemic relapse or death.
And as they concluded, the surgical management for BILC is sufficient in early stage disease
with excellent oncological outcomes, and the information is reassuring for patients when
discussing recurrence risk. So this is uh a very nice,
I think, additional literature in terms of what the latest situation is on treating these
patients. OK, um, now another thing, um, in the second
talk you're gonna hear a focus sort of on clinical selection of breast implants and so I
want to leave this in, um, this is one that's been published within the last few years out of
the Australian group and what they did is they're looking at different types of,
uh, lymphoma cells and what they responded to, what caused them to proliferate.
And they looked at both BILCL cell lines and then some tumour cells isolated from patients
and looked at what they respond to versus other types of uh ALCL and interestingly what they
found was they responded most strongly to lipopolysaccharide, but most importantly.
They didn't actually show any prolative response to the bare breast implant
cells themselves. The reason I present this is I think this is
another clue that there is something else, textures involved,
but there is some other factor, and my hope is at some point we understand what that is,
um, for better outcomes.
OK, in terms of updates, um, actually one of the things that has come up in a number of
discussions I've had with with surgeons is some data that's been put out there that I would say.
Uh, maybe deserves great scepticism and shouldn't be very considered,
um, so that relates to postmarket surveillance data.
Um, I've been working in this area for just short of 34 years now,
and I certainly analyse a lot of post-market surveillance data.
Um, but it's not clinical data, so this was at a recent meeting.
I think it's online too, uh, company was presenting different adverse events and
presenting the postmarket surveillance results as they were discussing the safety and
performance of their implant. OK, it's not clinical study data,
OK? It's actually just complaint data.
So let me ask you in the audience if you can just raise your hand.
If you have a patient with a capture contracture, no matter how many years out from
the original procedure, how many of you contact either the manufacturer or the National Health
Authority, OK?
Not too many, right? OK.
Um, that's not unusual. OK. In fact, the US FDA estimates that maybe.
Product complaints has a 1 to 10% capture rate. OK, so why do we do it?
We do it because it's surveillance, OK, and that low capture rate is pretty constant over
time. But if all of a sudden, let's say you start
seeing a number of infection reports, OK, then you know,
and there was actually a European manufacturer where that occurred,
turns out they had an issue with their sterilisation and they actually went off the
market for a period of time. So that's the purpose.
But really it was never meant to be used for data to inform surgeons or patients of
risk. Now the one exception maybe is rupture where
you have warranty coverage that data may be a little bit better,
um. But going back to this, I think it was
interesting that um we have a pointer here, yeah, that what we one of the things I noticed
first when they presented this on the postmarksurances they said device related,
OK, and if you looked at the small print, it said the following were considered technique
dependent complications, implant mal position, implant displacement,
asymmetry infection.
So those weren't included and although I certainly think those are technique dependent,
most people I know think caps are contractors technique dependent as is double capsule and
even rupture. So there's an issue of kind of full reporting
of the data don't cherry pick data, OK.
So next thing I want to uh present some uh information on briefly is what's been
termed breast implant illness.
There's a new proposed nomenclature that may or may not take hold systemic symptoms associated
with breast implants, um, just to level set.
It's the emergence of a group of women who present with a collection of systemic symptoms
thought to be related to breast implants.
That was a definition Mark Magnuson came out with back in 2019.
I think it still works well, but the important thing is there's no validated or accepted
diagnostic criteria or diagnostic test.
Now in the next session, uh, Marissa Lawrence, uh, surgeon,
one of the key surgeons involved in the study that I was also involved in will be presenting,
uh, some updates on that. So I'm, I'm just gonna touch on some highlights
and a little bit different information, I think, so there won't be too much overlap.
So in terms of implant selection, which is the focus of the second half of the symposium,
um, the BII cases have been reported from all manufacturers gel filled,
saline filled, textured and smooth breast implants.
So in terms of patient selection, that isn't really a factor.
So I presented as four key recent findings in terms of communicating to patients about
BII or SSBI, and the first one, the question has been out there for quite some time,
how frequent does does this occur? If you look on social media,
you might think it was quite common. Others have said it seems extremely rare,
but very nice study um out of the. Netherlands involving over 62,000 patients and
they came up, came up with the number 0.1% of inserted implants were removed uh due
to systemic signs and symptoms of patients attributed to their implants.
OK? And at the bottom of the screen are the
references. Those are PMID numbers you can just type in on
PubMed.gov and pull up the reference.
Same thing with another study, this is actually from the Netherlands as well,
indicating that the personality characteristics of cosmetic surgery patients certainly seems to
be correlated um with patients who have more significant symptoms and then whoops.
What happened there? OK.
And then the third finding is that patients, uh, with BII and SSBI,
and this is one of the key findings of a prospective controlled clinical study that
Marisa Lawrence was involved with, as was Caroline Glickman.
Uh, Pat McGuire, myself and others that they are are likely to experience reduction both the
number and severity of systemic symptoms, um, with total capsulectomy,
partial clapsectomy, and the latest data is it turns out you see the same symptom improvement
if you do no capsulectomy if you just leave the capsule in.
And those results are sustained.
The studies go out in Australia out to 6 months in the US,
out to 12 months.
So this was the 4th paper from our study.
You'll hear more about this in the next session 50 women in 3 groups,
the BII group, the non-BII group, the first group, although there isn't a diagnostic
criteria, women who are reporting symptoms or attributing to implants is a group you can
study. 50 women have their implants out we're not
reporting symptoms in 50 mastopexy patients, and you'll see some more results in the next
presentation, but here you can see from baseline to 1 year out,
um, they start out with a lot more symptoms and then it reduces over time in the overwhelming
majority of patients, although it generally never approaches the other two comparative
groups. And the last one is what I'd like to spend the
remaining few minutes of my talk on, and that is the fact that analysing this data and
bringing in a couple of psychologists from Australia to analyse some of the patient
reported data, it may be attributable to reduction of negative expectations and a
potential nocebo effect.
OK, so what's the nocebo effect? Well, if you look in the Cambridge dictionary
as a great definition, a bad effect on someone's, whoops,
on, on someone's health.
OK, caused, for example, by them expecting a treatment not to work or to have side effects.
Another way of putting it is the power of negative suggestion.
And in the Cambridge Dictionary they gave a great example,
and it was a real example where they had a group of volunteers and they were told that a
mild electrical current would be passed through their head,
didn't actually happen, but 2/3 of them got a headache.
OK, so one of the issues in medicine and that is you have an ethical
ethical obligation to provide informed consent, but if you do something like what the FDA did,
you put a black box warning on breast implants where you tell patients that they may
experience X, Y, and Z symptoms, they're actually more likely to experience those
symptoms than if you just stayed quiet, but you do have the ethical obligation.
Same thing holds true for a range of different drugs and medical devices.
So how can you avoid activating that nocebo effect?
Well, here's a very interesting study from just a couple of years ago,
um, and that that shows how we may be able to do that,
not just for breast implant illness, but for other, um,
adverse effects of the breast implants and other devices.
So again, as I mentioned, if you provide these warnings, you actually through the power of
suggestion are making it more likely to happen and in some sense harming them while providing.
Uh, that consent, so they tested a method of avoiding that,
and what they did is they 99 volunteers and they had them wear those virtual reality
headsets and that, and they told them they were focused on on studying spatial awareness and
then they divide them into 4 groups. One group,
they didn't say anything about whether they would experience nausea.
Second group, they said some of you will experience nausea.
That was a general warning.
The third group was negative framing.
7 out of 10 of you would be expected to experience nausea,
and I'm sorry, 3 out of 10 would be expected to experience nausea.
And then the fourth group was the positive framing.
7 out of 10 of you would be expected not to experience nausea.
And when they, when they ran the study then what they actually found was.
That OK, if you take the first group, the general warning is the I'm sorry,
the no warning where you didn't say anything, that's the control.
If you gave them a general warning or the negative framing,
7 out of 10 would be expected. Both of them had significantly higher levels of
nausea than if you didn't say anything.
But what was really neat was if you said 7 out of 10 don't experience nausea,
they had the same level as if you didn't even mention it,
OK. And there's at least one regulatory agency
that's already looking into applying this for warnings for both drugs and medical devices.
So if we stop and think about it for a minute in terms of.
Of let's say uh SSBI OK that we now have a good number that 0.1% from
the Netherlands study, so we could say, um, based on the best information we have available,
99.9% of implants put in for cosmetic breast augmentation will not be
removed due to um BII or SSBI.
Um, and as you can see, you could do the same thing for BILCL,
and a number of other adverse events. So hopefully that's something that you can take
away and maybe, uh, try out.
So with that, um, I'll leave you to Doctor Patel.
Thank you.
So, um, thank you very much for giving me this opportunity to come and speak today.
I'd like to thank the mentor team and also the London Breast um Committee,
uh, for asking me to speak on considerations of breast implant selection.
These are my declarations.
And I just want to start with a thought, any ideas how these four things might be connected?
I'll come back to this at the end.
I'm going to briefly talk about the history of breast implants,
considerations for implant selection, and present this through a journey of one of our
patients, Emma. It's incredible to think that in the 1800s,
we first saw breast reconstruction uh by Zerni, where a lipo was taken to reconstruct the
breast. We subsequently saw silicon being injected in
Japanese prostitutes to increase their bust size at a cost of $35.
And it's really these two individuals that have transformed this industry entirely.
They saw a bag of blood and thought that that looked very much like something that could
represent a breast implant.
And these are their very first patents.
And it's quite incredible to see that that invention has led to this entire industry.
Miss Lindsay was the first recipient of bilateral breast augmentation,
um, 60 years ago.
And she'd only gone in for some tattoo removal but walked out with something else as well.
So this has evolved over time.
And although, um, you know, things have changed significantly, what we need to really
appreciate is that we're no longer in the time of Lindsay,
we can't suddenly just do what we think is appropriate.
We definitely have that understanding with patients to have a mutual um understanding and
work with them to try and achieve the best outcomes for the patient.
So these are my considerations for implant selection.
There has to be good working between the patient and the surgeon,
and then also significant considerations on the implants that we use.
Should we be using longstanding implant data with implants um that have got good robust data,
how do we decide to select these?
So let me talk you through Amy's journey.
She's your sort of typical patient that may come and see you for her breast augmentation.
I typically see them for at least 2 consultations, spaced with a cooling out period,
um, and I use the um implant selection system. This is a performer,
it's a double page that contains all the information that you would require.
I typically start by taking a history, and this often involves a very open question.
What will success look like for you?
I think for me would be
And then I'd carry on with quite open questions.
Right. Bill centre um.
Exactly Now what the hell does different, authentic, too big actually
mean? It's so difficult to try and understand uh what
that might actually mean for a patient, which size implants might we use for this particular
patient. I find asking the patients to bring photos of
what they want to try and look like really helpful. Yes.
And what is it that you like about this? I quite like the cleavage on this one.
Yes. And how about this one here?
This one, I'm not too keen on this one.
I think it's as important to ask them what they want to look like,
but also what they don't want to look like and have an indication and an idea,
and a picture speaks 1000 words.
We also use this desired outcome, um, simple silhouette.
There are 4 images here and this simple silhouette can help you stratify what size
implants that the patients might require and what they're actually looking for.
And just to highlight a few examples, a type 1 is a very subtle augmentation,
and you can see that um probably most people wouldn't think that she has had implants.
Um, and then moving on to, again, still quite a natural result,
uh, for this patient.
Um, and then moving on to the category, has she had implants,
hasn't she had implants?
Um, and then getting to that stage where she probably has had breast implants put in.
That's the sort of type 4.
I also use our sizes, and the sizes can be used in a few different ways,
and I'm going to try and highlight them to you.
Um, I use sizes in a way in which we start with the smaller size of first.
Yeah, thank you. And this is a Which is roughly about a cup
size. You Um, so you can start getting
I think that having a full length mirror is really helpful for the patients.
Explain to the patients, don't just look at your chest,
but look at your height, you know, your shoulder width,
your, your, your all of your proportions to see what you think might be appropriate for you.
I have a selection of bras in the clinic, surgical bras that expand.
I absolutely avoid uh dark tight sports bras because your expanders won't
really give you the results, um, that the patients can be able to appreciate.
So, um, something like that um works much better.
And then move up to the next size.
Yeah, so that's about 2 cup sizes bigger.
Maybe to a deep cut something.
And then we do have a look And then she was happy with that,
but we always try one size bigger, um, and it's important to do this size.
It yourself. Please do look at your height,
your hips, your shoulders, the full, you know, all your.
Um, and then.
Definitely quite big I think. Yes.
And if that's too big, then at least you know you've tried that for the patient and then you
can combine the sizes as well, so like a 50 and a 250,
uh, to bring that size back down.
Yeah, I think that Now And then also ask them to
put on their top because actually rather than just looking at the bra,
they can see what they look like in clothing.
This is great. Now we use sizes for lots of different things,
even in significant breast asymmetry, just a uh an example to show you,
to have a good idea of the volume that you're likely to require for that patient.
The other way in which these sizes can be extremely helpful is to flip the sizes 180
degrees, um, and that gives you um a way of sort of simulating what a higher
profile implant might look like for the patient.
Um, and just to highlight highlight that with an example,
so this lady's got a significant scoliosis, um, that came to see me for breast augmentation
surgery. Uh, the right chest is recessed compared to the
left side. Um, and here you want to use those sizes,
um, you know, the correct way up and upside down to try and simulate that higher profile.
She's only bothered about looking the same profile when she looks down,
um, at her breasts.
So in this example, we used, um, a high profile implant on one side and a um moderate plus
profile implant on the other side, um, to give her an acceptable result.
We then come onto the 2nd page of the performer, and that's really um documenting your
examination findings. There are so many different um techniques that
exist and it's intentionally left very blank because everyone has their own way of selecting
implants and you can apply that to the performer.
So just to very quickly run through uh you know, of this patient's uh markings,
I usually take a step back, um, you know, chart down the differences,
and these are important in the long run.
I then mark out um our basic measurements, the midline, anterior axillary folds,
um, the inframammary fold, and then the new nipple height for an average size implant for
that patient by asking the patient to lift their arms up.
We then carry out a pinch test using the callipers, um,
and if the pinch test on the upper pole is less than 2 centimetres,
then I'd have a dual plane approach for the patients such that they don't have such a sharp
takeoff. We then measure the breast base width,
and here we know that the breast base width is about 13.
Take away our pinch test, so we've got a good starting breast base width of 11 centimetres.
You can do the same for the height of the breast implant,
and with that you're trying to aim to have um the nipple centred around the implant or trying
to achieve that 45, 55 um ratio.
So those two pages um help culminate all of your examination findings.
I then usually send the patients off, especially those patients that want extremely
large implants that might not have considered the outcome to their activities of daily living,
um, and I ask them to try that out in their bra and do all their activities of daily living,
and it's not uncommon for them to downsize subsequent to that.
Um, it also builds up a bit of a relationship between you,
um, and the patient, and they can also assess if they've got any significant size differences
too. So Emma's decided on 300 cc implants, um,
she's gone for smooth implants, and because her height and width are the same,
we've opted for round implants in her situation.
So looking at implants with a diameter of 11 centimetres, it's quite easy then to have a
good starting point for that patient, um, looking at the moderate plus extra profile and
the high profile implant for her.
So I hope over the last 10 minutes, I've given you a pressed his history,
considerations for our patient Emma.
And I'd like to leave you with these final thoughts.
Times have changed and we absolutely have to manage our patients in a different way to how
Lindsay was managed.
Our patients are much more like Emma is, um, and we must have that um in the back of our
minds. If you align your patient's expectations with
reality, they will never be disappointed.
So any ideas how these 4 things are connected?
Fantastic, yep, these are all materials that have previously been used uh as implants.
Thank you so much for listening.