April 5, 2022
Understanding The FDA’s New Breast Implant Regulations And Black Box Warning
Breast augmentation is one of the most popular cosmetic surgery procedures in the United States. Still, controversy surrounds breast implants and their safety. In October, 2021, the FDA issued new regulations regarding breast implants and their use. Dr. Bass lays out the new regulations and some of the motivations that led to them. What is a black box warning? What should you know before deciding if breast augmentation or breast reconstruction with a breast implant is right for you? Dr. Bass helps you to understand the process you would work through during a consultation with a plastic surgeon when it comes to implants and their safety and performance.
Links
- Read the official black box warning announcement
- Read about breast augmentation
- Read more about the subject of breast implants, breast augmentation and the FDA in Dr. Bass’s blog
About Dr. Lawrence Bass
Innovator. Industry veteran. In-demand Park Avenue board certified plastic surgeon, Dr. Lawrence Bass is a true master of his craft, not only in the OR but as an industry pioneer in the development and evaluation of new aesthetic technologies. With locations in both Manhattan (on Park Avenue between 62nd and 63rd Streets) and in Great Neck, Long Island, Dr. Bass has earned his reputation as the plastic surgeon for the most discerning patients in NYC and beyond.
To learn more, visit the Bass Plastic Surgery website or follow the team on Instagram @drbassnyc
Subscribe to the Park Avenue Plastic Surgery Class newsletter to be notified of new episodes & receive exclusive invitations, offers, and information from Dr. Bass.
1
00:00:00,260 --> 00:00:04,390
Welcome to another episode of
Park Avenue Plastic Surgery Class,
2
00:00:04,391 --> 00:00:08,670
the podcast where we explore controversies
and breaking issues in plastic
3
00:00:08,671 --> 00:00:11,070
surgery. I'm your co-host Doreen Wu.
4
00:00:11,490 --> 00:00:15,990
And I'm excited to be here with Dr.
Lawrence Bass Park Avenue plastic surgeon,
5
00:00:16,590 --> 00:00:18,390
educator, and technology innovator.
6
00:00:18,930 --> 00:00:23,700
The title of today's episode is
understanding the FDA's new breast
7
00:00:23,701 --> 00:00:26,180
implant regulations and black box warning.
8
00:00:27,740 --> 00:00:32,280
Breast augmentations are one of the most
popular and commonly performed surgical
9
00:00:32,720 --> 00:00:36,560
cosmetic procedures in the United
States when considering breast implants,
10
00:00:36,740 --> 00:00:41,630
people often have many questions such
as whether to get silicone or saline
11
00:00:41,670 --> 00:00:44,550
implants, what size to get, which style,
12
00:00:44,940 --> 00:00:49,390
what the aftercare looks like and the
long term risks associated with implants.
13
00:00:49,770 --> 00:00:52,510
So, Dr. Bass, what is the
news about breast implants?
14
00:00:52,780 --> 00:00:55,270
What do I need to know to
make an informed decision?
15
00:00:56,910 --> 00:01:01,270
Well, the FDA was concerned that, uh,
16
00:01:01,390 --> 00:01:05,830
a lot of the information about
the performance of breast
17
00:01:05,990 --> 00:01:10,990
implants and some new things that we're
learning about the behavior of certain
18
00:01:11,040 --> 00:01:15,710
types of breast implants were
not being communicated adequately
19
00:01:16,480 --> 00:01:21,300
to every patient that was considering
whether or not they wanted to have
20
00:01:21,301 --> 00:01:22,780
breast implants placed.
21
00:01:22,781 --> 00:01:27,700
The first important thing to
remember is breast implants are used
22
00:01:27,880 --> 00:01:32,020
for cosmetic use. That's about three
quarters of the breast implants.
23
00:01:32,640 --> 00:01:37,450
And the other 25% is for breast
reconstruction after breast
24
00:01:37,451 --> 00:01:38,410
cancer surgery.
25
00:01:38,411 --> 00:01:42,530
So breast implants are
an important part of,
26
00:01:42,531 --> 00:01:45,130
of medical care for those patients.
27
00:01:46,070 --> 00:01:48,450
And we want them to be around available,
28
00:01:49,030 --> 00:01:53,560
and we want to know everything
about what's involved in their use.
29
00:01:55,060 --> 00:01:59,920
So we can adequately communicate that to
patients. And FDA was wondering though,
30
00:01:59,921 --> 00:02:01,440
what are patients being told?
31
00:02:01,980 --> 00:02:05,960
How much of that information did the
average surgeon tell them how much
32
00:02:06,110 --> 00:02:07,200
variation was there?
33
00:02:07,220 --> 00:02:12,070
And there were some new
developments like anaplastic large
34
00:02:12,460 --> 00:02:15,750
cell lymphoma, or ALCL, uh,
35
00:02:15,800 --> 00:02:20,750
which is a new development
that we became aware of over
36
00:02:20,850 --> 00:02:22,190
the last several years.
37
00:02:23,610 --> 00:02:28,230
And they wanted to be sure that
information about that was available
38
00:02:28,410 --> 00:02:29,550
to patients as well.
39
00:02:30,370 --> 00:02:34,260
In response to this concern,
what did the FDA decide to do?
40
00:02:34,530 --> 00:02:36,580
What did they put on
this black box warning?
41
00:02:38,250 --> 00:02:43,110
So the FDA decided to in
their recent regulation,
42
00:02:43,800 --> 00:02:48,550
which came out the very end of
October in 2021 and fully went into
43
00:02:48,551 --> 00:02:50,260
effect. 30 days later,
44
00:02:51,050 --> 00:02:53,860
they decided to take several steps.
45
00:02:54,490 --> 00:02:56,500
They did put a black box warning,
46
00:02:57,400 --> 00:03:01,920
or what's called a boxed warning
officially at FDA on breast
47
00:03:02,080 --> 00:03:06,640
implants. They required that there be
48
00:03:08,570 --> 00:03:13,210
a patient decision checklist that's
followed as part of the consent
49
00:03:13,610 --> 00:03:18,480
process to provide patients a step
by step process for considering all
50
00:03:18,680 --> 00:03:23,520
of the important information
in FDA's view about breast
51
00:03:24,120 --> 00:03:26,520
implants before they decide
whether to go ahead or not.
52
00:03:28,520 --> 00:03:31,320
They provided, uh, regulation on
53
00:03:33,100 --> 00:03:37,810
presenting information on the materials
that are in breast implants and device
54
00:03:38,690 --> 00:03:42,570
description, so that people understood
what they're putting in their bodies,
55
00:03:43,010 --> 00:03:45,610
what the materials are. Uh,
56
00:03:46,010 --> 00:03:50,770
they added a patient device
card regulation that was
somewhat updated from the
57
00:03:51,250 --> 00:03:53,250
existing device cards. Um,
58
00:03:54,130 --> 00:03:59,120
they wanted patients presented with
manufacturers specific performance
59
00:03:59,520 --> 00:04:03,040
data after the initial approval studies,
60
00:04:03,520 --> 00:04:07,680
which look at the patients
out to a typical length of
time and many FDA studies
61
00:04:08,040 --> 00:04:09,200
that six months or a year.
62
00:04:09,660 --> 00:04:12,880
But these implants of course
remain in patients for decades.
63
00:04:15,050 --> 00:04:19,990
So FDA required each manufacturer
to complete a post-approval
64
00:04:20,160 --> 00:04:24,750
study following patients
for years and years after
65
00:04:24,751 --> 00:04:26,070
implants had been placed.
66
00:04:26,690 --> 00:04:31,510
So they wanted patients to see some of
that performance data to understand what
67
00:04:31,511 --> 00:04:36,060
kind of problems developed with breast
implants down the line. And finally,
68
00:04:36,200 --> 00:04:41,020
the FDA updated some of their
screening recommendations for
69
00:04:41,680 --> 00:04:45,740
how to perform surveillance on breast,
70
00:04:45,741 --> 00:04:48,220
on silicone gel, breast implants,
71
00:04:48,800 --> 00:04:53,370
to determine if there's a hidden
rupture of the implant or not.
72
00:04:54,540 --> 00:04:58,790
Earlier, you mentioned
anaplastic large cell lymphoma.
73
00:04:59,380 --> 00:05:02,670
What is the story behind
ALCL? Is it breast cancer?
74
00:05:03,750 --> 00:05:06,870
Uh, so ALCL is not breast cancer. Uh,
75
00:05:07,110 --> 00:05:11,900
it is a form of cancer that can form in
76
00:05:12,380 --> 00:05:16,860
the capsule or scar tissue
that heals around a breast
77
00:05:17,460 --> 00:05:19,980
implant. At this point in time,
78
00:05:20,260 --> 00:05:25,060
it has only been identified
in patients who have received
79
00:05:25,300 --> 00:05:29,610
the textured breast implant
or who had one point in time,
80
00:05:29,930 --> 00:05:32,170
had a textured breast
implant in their body.
81
00:05:33,250 --> 00:05:37,050
Patients who have only had
smooth breast implants, uh,
82
00:05:37,690 --> 00:05:41,130
currently have not
identified a case of ALCL
83
00:05:42,650 --> 00:05:44,410
although theoretically,
it might be possible.
84
00:05:46,570 --> 00:05:49,200
So this tumor develops in the capsule.
85
00:05:49,960 --> 00:05:53,280
It may show as a lump or, uh,
86
00:05:54,120 --> 00:05:57,240
hardening of the breast
overlying skin rash,
87
00:05:57,840 --> 00:06:01,040
or sometimes there's a fluid
collection around the implant,
88
00:06:01,480 --> 00:06:03,440
which could produce breast enlargement.
89
00:06:04,240 --> 00:06:08,800
So if any of those signs are seen in
anybody who has a breast implant in,
90
00:06:09,000 --> 00:06:11,680
they should see their plastic
surgeon to be evaluated.
91
00:06:12,270 --> 00:06:17,030
Typically this is treated by
removing the implant and the capsule.
92
00:06:19,090 --> 00:06:23,830
And if that's caught early, that's
all the treatment that's required.
93
00:06:24,010 --> 00:06:28,870
If it is found very late in the game,
sometimes other treatments are required.
94
00:06:29,490 --> 00:06:33,430
So this is something that we've just seen
in the last several years. It's very,
95
00:06:33,770 --> 00:06:34,603
very rare,
96
00:06:35,440 --> 00:06:40,340
but FDA felt that this new finding
needed to be part of the consent process.
97
00:06:40,760 --> 00:06:41,900
The current risk,
98
00:06:42,080 --> 00:06:46,820
as we understand at the time
of this recording is that the
99
00:06:47,140 --> 00:06:51,180
lifetime risk of getting
breast implant associated ALCL
100
00:06:52,280 --> 00:06:56,250
is somewhere between
one in 2,200 and one in
101
00:06:56,251 --> 00:07:01,130
86,000. So very uncommon, very low risk,
102
00:07:01,390 --> 00:07:04,410
but certainly something to
factor into decision making.
103
00:07:05,630 --> 00:07:10,200
What are the big items on risks
and outcomes that the FDA wants
104
00:07:10,201 --> 00:07:15,070
patients to consider and be aware
of in deciding whether or not to get
105
00:07:15,071 --> 00:07:15,990
breast implants?
106
00:07:17,210 --> 00:07:19,990
So ALCL was, was one of them.
107
00:07:20,370 --> 00:07:23,790
And there's also some
concern nowadays, uh,
108
00:07:24,210 --> 00:07:28,950
in some patients that the implants
have produced sort of a brain
109
00:07:29,170 --> 00:07:33,380
fog or fatigue, other
kinds of systemic symptoms.
110
00:07:33,381 --> 00:07:36,500
This is called breast implant illness,
111
00:07:37,230 --> 00:07:38,700
which is controversial,
112
00:07:38,840 --> 00:07:41,900
but they wanted patients to
at least be aware that their,
113
00:07:42,530 --> 00:07:47,500
that some people believe that the
implants themselves can cause some of
114
00:07:47,501 --> 00:07:48,610
these symptoms.
115
00:07:48,611 --> 00:07:53,170
The other really important features
116
00:07:53,480 --> 00:07:56,050
that FDA was keying into was
117
00:07:58,300 --> 00:08:03,160
the following that the
implants are not expected to
118
00:08:03,161 --> 00:08:06,640
be a lifetime implant,
119
00:08:07,620 --> 00:08:11,710
like any device it can
wear out and fail and that
120
00:08:11,990 --> 00:08:16,390
necessitates more surgery,
anesthesia, recovery, time,
121
00:08:16,860 --> 00:08:19,670
more money out of pocket. Um,
122
00:08:20,050 --> 00:08:22,270
and I've always told
my patients, you know,
123
00:08:22,290 --> 00:08:24,990
if you like the idea of
having bigger breasts,
124
00:08:26,440 --> 00:08:30,740
but you never want to think about the
implants again, this is not a good idea.
125
00:08:31,600 --> 00:08:36,060
If you like the idea of adjusting
your breast size and you
126
00:08:36,560 --> 00:08:40,140
accept that, it means
somewhere in the future,
127
00:08:41,250 --> 00:08:45,610
more surgery, more
tinkering with the implants,
128
00:08:45,680 --> 00:08:50,490
potentially implant, removal,
or replacement, then, you know,
129
00:08:50,491 --> 00:08:55,170
patients love their breast implants
and typically are very satisfied,
130
00:08:55,420 --> 00:08:59,960
but you have to understand
what you're signing up for. Uh,
131
00:08:59,961 --> 00:09:04,600
they also wanted patients to understand
that you should undergo regular
132
00:09:05,240 --> 00:09:07,480
surveillance, plastic surgeons,
133
00:09:07,481 --> 00:09:11,520
typically like to see their breast implant
patients once a year and at any time,
134
00:09:11,580 --> 00:09:13,710
if there's a change in the implant.
135
00:09:14,850 --> 00:09:19,670
And they wanted patients to understand
that the screening for possible
136
00:09:19,820 --> 00:09:24,110
rupture of silicone gel
implants, not saline implants,
137
00:09:25,430 --> 00:09:30,150
uh, involves more testing,
more out of pocket expense.
138
00:09:30,290 --> 00:09:31,270
In most cases.
139
00:09:32,890 --> 00:09:35,990
The term black box warning sounds ominous.
140
00:09:36,410 --> 00:09:40,670
Should it make patients afraid or does
it mean that the product is dangerous?
141
00:09:41,830 --> 00:09:45,000
It's not so much that the product
is dangerous, but you know,
142
00:09:45,001 --> 00:09:49,840
there are some significant
considerations with implants as I
143
00:09:49,841 --> 00:09:54,310
just described, as well as other
things that can happen, uh,
144
00:09:54,500 --> 00:09:58,630
rupture, capsular
contracture, and, you know,
145
00:09:58,631 --> 00:10:03,470
these are important and because of
the importance and because this is
146
00:10:03,850 --> 00:10:08,590
in the case of cosmetic breast surgery,
a completely elective treatment,
147
00:10:09,340 --> 00:10:13,820
they wanted to be sure that patients
factored this into their decision making
148
00:10:14,080 --> 00:10:18,820
and by highlighting it in,
in a boxed warning, uh,
149
00:10:18,920 --> 00:10:23,540
it makes sure that that
information is part of what
150
00:10:23,720 --> 00:10:28,290
all patients are notified about prior to
151
00:10:28,650 --> 00:10:33,530
deciding they, they think it's a good
idea to go ahead and get breast implants.
152
00:10:34,510 --> 00:10:38,880
There's a lot of complexity here.
I can see how confusing it can be.
153
00:10:39,380 --> 00:10:43,000
Are these regulations a good thing?
Are they worth the time and effort?
154
00:10:44,280 --> 00:10:49,170
So I think anything that standardizes care
155
00:10:49,270 --> 00:10:53,010
and makes sure nothing slips
through the cracks is a good idea.
156
00:10:54,250 --> 00:10:58,530
I typically have a very extensive
discussion with my patients about breast
157
00:10:58,610 --> 00:11:02,170
implants, because I think they really
need to know what they're signing up for.
158
00:11:02,590 --> 00:11:07,000
And as I said, you know, my patients
love them. They have a great time,
159
00:11:07,020 --> 00:11:09,120
but if you get into
trouble with an implant,
160
00:11:09,180 --> 00:11:14,040
it can be a very frustrating experience
and can really put people through
161
00:11:14,041 --> 00:11:15,720
the ringer. And out of fairness,
162
00:11:15,790 --> 00:11:18,640
it's important to recognize
that like everything in life,
163
00:11:18,641 --> 00:11:23,520
there are risks and the
FDA's new requirement
164
00:11:23,690 --> 00:11:28,510
to show for the individual
manufacturer's implant exactly what
165
00:11:28,530 --> 00:11:30,510
the performance is like,
166
00:11:31,200 --> 00:11:35,950
which put another way means
exactly what the frequency or
167
00:11:35,951 --> 00:11:40,950
incidence of different kinds of problems
and complications are as the implant
168
00:11:41,340 --> 00:11:44,660
ages is a really good idea, uh,
169
00:11:44,690 --> 00:11:47,660
because this isn't supposed
to be an impulse decision.
170
00:11:47,810 --> 00:11:51,500
It's supposed to be something that's
well thought out it is elective.
171
00:11:51,600 --> 00:11:55,960
So there's the luxury of time to make
sure you're making the right decision.
172
00:11:55,961 --> 00:12:00,760
So it doesn't mean that implants are
bad or intrinsically problematic,
173
00:12:02,340 --> 00:12:06,280
but we do have enough experience to
be able to say what the problems are
174
00:12:07,380 --> 00:12:12,110
and people can decide
before they're in trouble
175
00:12:12,420 --> 00:12:16,790
with an implant, whether this is
a risk they'd care to take or not.
176
00:12:17,900 --> 00:12:22,760
It is reassuring to know that the FDA
has taken a number of steps to address
177
00:12:22,761 --> 00:12:25,960
the risks and strengthen
their safety requirements.
178
00:12:26,660 --> 00:12:29,280
Can you give us some important
takeaways before we close?
179
00:12:30,730 --> 00:12:35,260
So I think the concept
that this could be a
180
00:12:35,460 --> 00:12:37,660
lifetime implant is disingenuous.
181
00:12:37,890 --> 00:12:42,340
I've always told patients that the
implant will wear out eventually,
182
00:12:43,100 --> 00:12:47,340
uh, typically implants replaced in
people who are going to be alive for many
183
00:12:47,341 --> 00:12:51,930
decades. And so the likelihood
is high that eventually,
184
00:12:52,350 --> 00:12:56,410
and it often does take
decades on multiple decades,
185
00:12:56,710 --> 00:13:01,610
but eventually the implant will probably
wear out and need to be either removed
186
00:13:01,670 --> 00:13:06,290
or replaced. And interestingly,
almost every patient,
187
00:13:07,400 --> 00:13:11,800
even if they're now well into
their senior citizen years,
188
00:13:12,670 --> 00:13:16,760
typically requests to
have the implants not just
189
00:13:17,470 --> 00:13:18,720
removed when they fail,
190
00:13:18,860 --> 00:13:23,600
but also replaced because this is
part of their self image that they're
191
00:13:23,720 --> 00:13:26,630
accustomed to now, and they
don't want to give that up.
192
00:13:27,050 --> 00:13:31,670
So I think that's a very telling
detail about the experience
193
00:13:31,780 --> 00:13:36,470
with breast implants, despite the fact
that there can occasionally be problems.
194
00:13:37,710 --> 00:13:38,543
Um,
195
00:13:38,850 --> 00:13:43,830
the other takeaway is it's important
to get the surveillance have a really
196
00:13:44,070 --> 00:13:47,140
an ongoing relationship with the
plastic surgeon who placed it,
197
00:13:48,460 --> 00:13:50,940
get the imaging, if you
have silicone gel implants,
198
00:13:51,700 --> 00:13:56,640
but even though FDA made many
of these new recommendations and
199
00:13:57,320 --> 00:13:59,040
requirements, um, more demanding,
200
00:13:59,800 --> 00:14:04,710
the surveillance actually became more
liberal based on the post-approval
201
00:14:05,190 --> 00:14:10,070
study data and based on improvements
in ultrasound technology where
202
00:14:10,790 --> 00:14:15,310
ultrasound can be used as
well as MRI to screen for
203
00:14:16,230 --> 00:14:18,190
hidden or occult implant rupture,
204
00:14:19,310 --> 00:14:23,900
although MRIs still the most
sensitive test and still
205
00:14:24,500 --> 00:14:28,780
probably the right move for someone
who's symptomatic. If the, uh,
206
00:14:29,500 --> 00:14:32,460
ultrasound is equivocal or
does not find to rupture,
207
00:14:33,180 --> 00:14:34,820
but that ability to do the ultrasound,
208
00:14:35,100 --> 00:14:39,420
which increasingly can be done in
the plastic surgeon's office is a,
209
00:14:39,620 --> 00:14:44,210
a way that reduces the inconvenience
and expense of doing the surveillance.
210
00:14:45,530 --> 00:14:46,170
Well,
211
00:14:46,170 --> 00:14:50,380
this was certainly an informative episode
for people who are considering breast
212
00:14:50,381 --> 00:14:51,214
implant surgery.
213
00:14:51,600 --> 00:14:55,440
I hope today's episode provided some
valuable information and insight.
214
00:14:55,940 --> 00:14:58,560
If this episode sparked
any unanswered questions,
215
00:14:58,700 --> 00:15:02,600
please contact us and we would be happy
to discuss them in a future episode.
216
00:15:03,770 --> 00:15:04,820
This is Doreen Wu,
217
00:15:04,940 --> 00:15:09,460
thanking you for joining Dr. Bass and
me for this discussion of the FDA's new
218
00:15:09,610 --> 00:15:14,170
rules and regulations for breast
implants. Be sure to join us next time.
219
00:15:14,270 --> 00:15:18,290
And don't forget to subscribe to our
podcast to avoid missing all of the
220
00:15:18,530 --> 00:15:20,410
exciting content that is coming your way.
221
00:15:21,380 --> 00:15:25,330
Thank you for joining us in this episode
of the Park Avenue Plastic Surgery
222
00:15:25,420 --> 00:15:30,080
Class podcast with Dr. Lawrence
Bass Park Avenue plastic surgeon,
223
00:15:30,920 --> 00:15:32,760
educator, and technology innovator.
224
00:15:33,100 --> 00:15:35,560
The commentary in this
podcast represents opinion.
225
00:15:35,790 --> 00:15:38,200
This podcast does not
present medical advice,
226
00:15:38,540 --> 00:15:42,480
but rather general information about
plastic surgery that does not necessarily
227
00:15:42,540 --> 00:15:45,560
relate to the specific conditions
of any individual patient.
228
00:15:45,980 --> 00:15:50,830
No doctor patient relationship
is established by listening
to or participating
229
00:15:50,970 --> 00:15:51,803
in this podcast,
230
00:15:52,060 --> 00:15:56,110
consult your physician to advise you
about your individual healthcare.
231
00:15:56,370 --> 00:15:57,790
If you enjoyed this episode,
232
00:15:57,970 --> 00:16:02,030
please share it with your friends and
be sure to subscribe to our podcast on
233
00:16:02,031 --> 00:16:06,020
Apple Podcasts, Google, Spotify, Stitcher,
234
00:16:06,320 --> 00:16:08,620
or wherever you listen to podcasts.
00:00:00,260 --> 00:00:04,390
Welcome to another episode of
Park Avenue Plastic Surgery Class,
2
00:00:04,391 --> 00:00:08,670
the podcast where we explore controversies
and breaking issues in plastic
3
00:00:08,671 --> 00:00:11,070
surgery. I'm your co-host Doreen Wu.
4
00:00:11,490 --> 00:00:15,990
And I'm excited to be here with Dr.
Lawrence Bass Park Avenue plastic surgeon,
5
00:00:16,590 --> 00:00:18,390
educator, and technology innovator.
6
00:00:18,930 --> 00:00:23,700
The title of today's episode is
understanding the FDA's new breast
7
00:00:23,701 --> 00:00:26,180
implant regulations and black box warning.
8
00:00:27,740 --> 00:00:32,280
Breast augmentations are one of the most
popular and commonly performed surgical
9
00:00:32,720 --> 00:00:36,560
cosmetic procedures in the United
States when considering breast implants,
10
00:00:36,740 --> 00:00:41,630
people often have many questions such
as whether to get silicone or saline
11
00:00:41,670 --> 00:00:44,550
implants, what size to get, which style,
12
00:00:44,940 --> 00:00:49,390
what the aftercare looks like and the
long term risks associated with implants.
13
00:00:49,770 --> 00:00:52,510
So, Dr. Bass, what is the
news about breast implants?
14
00:00:52,780 --> 00:00:55,270
What do I need to know to
make an informed decision?
15
00:00:56,910 --> 00:01:01,270
Well, the FDA was concerned that, uh,
16
00:01:01,390 --> 00:01:05,830
a lot of the information about
the performance of breast
17
00:01:05,990 --> 00:01:10,990
implants and some new things that we're
learning about the behavior of certain
18
00:01:11,040 --> 00:01:15,710
types of breast implants were
not being communicated adequately
19
00:01:16,480 --> 00:01:21,300
to every patient that was considering
whether or not they wanted to have
20
00:01:21,301 --> 00:01:22,780
breast implants placed.
21
00:01:22,781 --> 00:01:27,700
The first important thing to
remember is breast implants are used
22
00:01:27,880 --> 00:01:32,020
for cosmetic use. That's about three
quarters of the breast implants.
23
00:01:32,640 --> 00:01:37,450
And the other 25% is for breast
reconstruction after breast
24
00:01:37,451 --> 00:01:38,410
cancer surgery.
25
00:01:38,411 --> 00:01:42,530
So breast implants are
an important part of,
26
00:01:42,531 --> 00:01:45,130
of medical care for those patients.
27
00:01:46,070 --> 00:01:48,450
And we want them to be around available,
28
00:01:49,030 --> 00:01:53,560
and we want to know everything
about what's involved in their use.
29
00:01:55,060 --> 00:01:59,920
So we can adequately communicate that to
patients. And FDA was wondering though,
30
00:01:59,921 --> 00:02:01,440
what are patients being told?
31
00:02:01,980 --> 00:02:05,960
How much of that information did the
average surgeon tell them how much
32
00:02:06,110 --> 00:02:07,200
variation was there?
33
00:02:07,220 --> 00:02:12,070
And there were some new
developments like anaplastic large
34
00:02:12,460 --> 00:02:15,750
cell lymphoma, or ALCL, uh,
35
00:02:15,800 --> 00:02:20,750
which is a new development
that we became aware of over
36
00:02:20,850 --> 00:02:22,190
the last several years.
37
00:02:23,610 --> 00:02:28,230
And they wanted to be sure that
information about that was available
38
00:02:28,410 --> 00:02:29,550
to patients as well.
39
00:02:30,370 --> 00:02:34,260
In response to this concern,
what did the FDA decide to do?
40
00:02:34,530 --> 00:02:36,580
What did they put on
this black box warning?
41
00:02:38,250 --> 00:02:43,110
So the FDA decided to in
their recent regulation,
42
00:02:43,800 --> 00:02:48,550
which came out the very end of
October in 2021 and fully went into
43
00:02:48,551 --> 00:02:50,260
effect. 30 days later,
44
00:02:51,050 --> 00:02:53,860
they decided to take several steps.
45
00:02:54,490 --> 00:02:56,500
They did put a black box warning,
46
00:02:57,400 --> 00:03:01,920
or what's called a boxed warning
officially at FDA on breast
47
00:03:02,080 --> 00:03:06,640
implants. They required that there be
48
00:03:08,570 --> 00:03:13,210
a patient decision checklist that's
followed as part of the consent
49
00:03:13,610 --> 00:03:18,480
process to provide patients a step
by step process for considering all
50
00:03:18,680 --> 00:03:23,520
of the important information
in FDA's view about breast
51
00:03:24,120 --> 00:03:26,520
implants before they decide
whether to go ahead or not.
52
00:03:28,520 --> 00:03:31,320
They provided, uh, regulation on
53
00:03:33,100 --> 00:03:37,810
presenting information on the materials
that are in breast implants and device
54
00:03:38,690 --> 00:03:42,570
description, so that people understood
what they're putting in their bodies,
55
00:03:43,010 --> 00:03:45,610
what the materials are. Uh,
56
00:03:46,010 --> 00:03:50,770
they added a patient device
card regulation that was
somewhat updated from the
57
00:03:51,250 --> 00:03:53,250
existing device cards. Um,
58
00:03:54,130 --> 00:03:59,120
they wanted patients presented with
manufacturers specific performance
59
00:03:59,520 --> 00:04:03,040
data after the initial approval studies,
60
00:04:03,520 --> 00:04:07,680
which look at the patients
out to a typical length of
time and many FDA studies
61
00:04:08,040 --> 00:04:09,200
that six months or a year.
62
00:04:09,660 --> 00:04:12,880
But these implants of course
remain in patients for decades.
63
00:04:15,050 --> 00:04:19,990
So FDA required each manufacturer
to complete a post-approval
64
00:04:20,160 --> 00:04:24,750
study following patients
for years and years after
65
00:04:24,751 --> 00:04:26,070
implants had been placed.
66
00:04:26,690 --> 00:04:31,510
So they wanted patients to see some of
that performance data to understand what
67
00:04:31,511 --> 00:04:36,060
kind of problems developed with breast
implants down the line. And finally,
68
00:04:36,200 --> 00:04:41,020
the FDA updated some of their
screening recommendations for
69
00:04:41,680 --> 00:04:45,740
how to perform surveillance on breast,
70
00:04:45,741 --> 00:04:48,220
on silicone gel, breast implants,
71
00:04:48,800 --> 00:04:53,370
to determine if there's a hidden
rupture of the implant or not.
72
00:04:54,540 --> 00:04:58,790
Earlier, you mentioned
anaplastic large cell lymphoma.
73
00:04:59,380 --> 00:05:02,670
What is the story behind
ALCL? Is it breast cancer?
74
00:05:03,750 --> 00:05:06,870
Uh, so ALCL is not breast cancer. Uh,
75
00:05:07,110 --> 00:05:11,900
it is a form of cancer that can form in
76
00:05:12,380 --> 00:05:16,860
the capsule or scar tissue
that heals around a breast
77
00:05:17,460 --> 00:05:19,980
implant. At this point in time,
78
00:05:20,260 --> 00:05:25,060
it has only been identified
in patients who have received
79
00:05:25,300 --> 00:05:29,610
the textured breast implant
or who had one point in time,
80
00:05:29,930 --> 00:05:32,170
had a textured breast
implant in their body.
81
00:05:33,250 --> 00:05:37,050
Patients who have only had
smooth breast implants, uh,
82
00:05:37,690 --> 00:05:41,130
currently have not
identified a case of ALCL
83
00:05:42,650 --> 00:05:44,410
although theoretically,
it might be possible.
84
00:05:46,570 --> 00:05:49,200
So this tumor develops in the capsule.
85
00:05:49,960 --> 00:05:53,280
It may show as a lump or, uh,
86
00:05:54,120 --> 00:05:57,240
hardening of the breast
overlying skin rash,
87
00:05:57,840 --> 00:06:01,040
or sometimes there's a fluid
collection around the implant,
88
00:06:01,480 --> 00:06:03,440
which could produce breast enlargement.
89
00:06:04,240 --> 00:06:08,800
So if any of those signs are seen in
anybody who has a breast implant in,
90
00:06:09,000 --> 00:06:11,680
they should see their plastic
surgeon to be evaluated.
91
00:06:12,270 --> 00:06:17,030
Typically this is treated by
removing the implant and the capsule.
92
00:06:19,090 --> 00:06:23,830
And if that's caught early, that's
all the treatment that's required.
93
00:06:24,010 --> 00:06:28,870
If it is found very late in the game,
sometimes other treatments are required.
94
00:06:29,490 --> 00:06:33,430
So this is something that we've just seen
in the last several years. It's very,
95
00:06:33,770 --> 00:06:34,603
very rare,
96
00:06:35,440 --> 00:06:40,340
but FDA felt that this new finding
needed to be part of the consent process.
97
00:06:40,760 --> 00:06:41,900
The current risk,
98
00:06:42,080 --> 00:06:46,820
as we understand at the time
of this recording is that the
99
00:06:47,140 --> 00:06:51,180
lifetime risk of getting
breast implant associated ALCL
100
00:06:52,280 --> 00:06:56,250
is somewhere between
one in 2,200 and one in
101
00:06:56,251 --> 00:07:01,130
86,000. So very uncommon, very low risk,
102
00:07:01,390 --> 00:07:04,410
but certainly something to
factor into decision making.
103
00:07:05,630 --> 00:07:10,200
What are the big items on risks
and outcomes that the FDA wants
104
00:07:10,201 --> 00:07:15,070
patients to consider and be aware
of in deciding whether or not to get
105
00:07:15,071 --> 00:07:15,990
breast implants?
106
00:07:17,210 --> 00:07:19,990
So ALCL was, was one of them.
107
00:07:20,370 --> 00:07:23,790
And there's also some
concern nowadays, uh,
108
00:07:24,210 --> 00:07:28,950
in some patients that the implants
have produced sort of a brain
109
00:07:29,170 --> 00:07:33,380
fog or fatigue, other
kinds of systemic symptoms.
110
00:07:33,381 --> 00:07:36,500
This is called breast implant illness,
111
00:07:37,230 --> 00:07:38,700
which is controversial,
112
00:07:38,840 --> 00:07:41,900
but they wanted patients to
at least be aware that their,
113
00:07:42,530 --> 00:07:47,500
that some people believe that the
implants themselves can cause some of
114
00:07:47,501 --> 00:07:48,610
these symptoms.
115
00:07:48,611 --> 00:07:53,170
The other really important features
116
00:07:53,480 --> 00:07:56,050
that FDA was keying into was
117
00:07:58,300 --> 00:08:03,160
the following that the
implants are not expected to
118
00:08:03,161 --> 00:08:06,640
be a lifetime implant,
119
00:08:07,620 --> 00:08:11,710
like any device it can
wear out and fail and that
120
00:08:11,990 --> 00:08:16,390
necessitates more surgery,
anesthesia, recovery, time,
121
00:08:16,860 --> 00:08:19,670
more money out of pocket. Um,
122
00:08:20,050 --> 00:08:22,270
and I've always told
my patients, you know,
123
00:08:22,290 --> 00:08:24,990
if you like the idea of
having bigger breasts,
124
00:08:26,440 --> 00:08:30,740
but you never want to think about the
implants again, this is not a good idea.
125
00:08:31,600 --> 00:08:36,060
If you like the idea of adjusting
your breast size and you
126
00:08:36,560 --> 00:08:40,140
accept that, it means
somewhere in the future,
127
00:08:41,250 --> 00:08:45,610
more surgery, more
tinkering with the implants,
128
00:08:45,680 --> 00:08:50,490
potentially implant, removal,
or replacement, then, you know,
129
00:08:50,491 --> 00:08:55,170
patients love their breast implants
and typically are very satisfied,
130
00:08:55,420 --> 00:08:59,960
but you have to understand
what you're signing up for. Uh,
131
00:08:59,961 --> 00:09:04,600
they also wanted patients to understand
that you should undergo regular
132
00:09:05,240 --> 00:09:07,480
surveillance, plastic surgeons,
133
00:09:07,481 --> 00:09:11,520
typically like to see their breast implant
patients once a year and at any time,
134
00:09:11,580 --> 00:09:13,710
if there's a change in the implant.
135
00:09:14,850 --> 00:09:19,670
And they wanted patients to understand
that the screening for possible
136
00:09:19,820 --> 00:09:24,110
rupture of silicone gel
implants, not saline implants,
137
00:09:25,430 --> 00:09:30,150
uh, involves more testing,
more out of pocket expense.
138
00:09:30,290 --> 00:09:31,270
In most cases.
139
00:09:32,890 --> 00:09:35,990
The term black box warning sounds ominous.
140
00:09:36,410 --> 00:09:40,670
Should it make patients afraid or does
it mean that the product is dangerous?
141
00:09:41,830 --> 00:09:45,000
It's not so much that the product
is dangerous, but you know,
142
00:09:45,001 --> 00:09:49,840
there are some significant
considerations with implants as I
143
00:09:49,841 --> 00:09:54,310
just described, as well as other
things that can happen, uh,
144
00:09:54,500 --> 00:09:58,630
rupture, capsular
contracture, and, you know,
145
00:09:58,631 --> 00:10:03,470
these are important and because of
the importance and because this is
146
00:10:03,850 --> 00:10:08,590
in the case of cosmetic breast surgery,
a completely elective treatment,
147
00:10:09,340 --> 00:10:13,820
they wanted to be sure that patients
factored this into their decision making
148
00:10:14,080 --> 00:10:18,820
and by highlighting it in,
in a boxed warning, uh,
149
00:10:18,920 --> 00:10:23,540
it makes sure that that
information is part of what
150
00:10:23,720 --> 00:10:28,290
all patients are notified about prior to
151
00:10:28,650 --> 00:10:33,530
deciding they, they think it's a good
idea to go ahead and get breast implants.
152
00:10:34,510 --> 00:10:38,880
There's a lot of complexity here.
I can see how confusing it can be.
153
00:10:39,380 --> 00:10:43,000
Are these regulations a good thing?
Are they worth the time and effort?
154
00:10:44,280 --> 00:10:49,170
So I think anything that standardizes care
155
00:10:49,270 --> 00:10:53,010
and makes sure nothing slips
through the cracks is a good idea.
156
00:10:54,250 --> 00:10:58,530
I typically have a very extensive
discussion with my patients about breast
157
00:10:58,610 --> 00:11:02,170
implants, because I think they really
need to know what they're signing up for.
158
00:11:02,590 --> 00:11:07,000
And as I said, you know, my patients
love them. They have a great time,
159
00:11:07,020 --> 00:11:09,120
but if you get into
trouble with an implant,
160
00:11:09,180 --> 00:11:14,040
it can be a very frustrating experience
and can really put people through
161
00:11:14,041 --> 00:11:15,720
the ringer. And out of fairness,
162
00:11:15,790 --> 00:11:18,640
it's important to recognize
that like everything in life,
163
00:11:18,641 --> 00:11:23,520
there are risks and the
FDA's new requirement
164
00:11:23,690 --> 00:11:28,510
to show for the individual
manufacturer's implant exactly what
165
00:11:28,530 --> 00:11:30,510
the performance is like,
166
00:11:31,200 --> 00:11:35,950
which put another way means
exactly what the frequency or
167
00:11:35,951 --> 00:11:40,950
incidence of different kinds of problems
and complications are as the implant
168
00:11:41,340 --> 00:11:44,660
ages is a really good idea, uh,
169
00:11:44,690 --> 00:11:47,660
because this isn't supposed
to be an impulse decision.
170
00:11:47,810 --> 00:11:51,500
It's supposed to be something that's
well thought out it is elective.
171
00:11:51,600 --> 00:11:55,960
So there's the luxury of time to make
sure you're making the right decision.
172
00:11:55,961 --> 00:12:00,760
So it doesn't mean that implants are
bad or intrinsically problematic,
173
00:12:02,340 --> 00:12:06,280
but we do have enough experience to
be able to say what the problems are
174
00:12:07,380 --> 00:12:12,110
and people can decide
before they're in trouble
175
00:12:12,420 --> 00:12:16,790
with an implant, whether this is
a risk they'd care to take or not.
176
00:12:17,900 --> 00:12:22,760
It is reassuring to know that the FDA
has taken a number of steps to address
177
00:12:22,761 --> 00:12:25,960
the risks and strengthen
their safety requirements.
178
00:12:26,660 --> 00:12:29,280
Can you give us some important
takeaways before we close?
179
00:12:30,730 --> 00:12:35,260
So I think the concept
that this could be a
180
00:12:35,460 --> 00:12:37,660
lifetime implant is disingenuous.
181
00:12:37,890 --> 00:12:42,340
I've always told patients that the
implant will wear out eventually,
182
00:12:43,100 --> 00:12:47,340
uh, typically implants replaced in
people who are going to be alive for many
183
00:12:47,341 --> 00:12:51,930
decades. And so the likelihood
is high that eventually,
184
00:12:52,350 --> 00:12:56,410
and it often does take
decades on multiple decades,
185
00:12:56,710 --> 00:13:01,610
but eventually the implant will probably
wear out and need to be either removed
186
00:13:01,670 --> 00:13:06,290
or replaced. And interestingly,
almost every patient,
187
00:13:07,400 --> 00:13:11,800
even if they're now well into
their senior citizen years,
188
00:13:12,670 --> 00:13:16,760
typically requests to
have the implants not just
189
00:13:17,470 --> 00:13:18,720
removed when they fail,
190
00:13:18,860 --> 00:13:23,600
but also replaced because this is
part of their self image that they're
191
00:13:23,720 --> 00:13:26,630
accustomed to now, and they
don't want to give that up.
192
00:13:27,050 --> 00:13:31,670
So I think that's a very telling
detail about the experience
193
00:13:31,780 --> 00:13:36,470
with breast implants, despite the fact
that there can occasionally be problems.
194
00:13:37,710 --> 00:13:38,543
Um,
195
00:13:38,850 --> 00:13:43,830
the other takeaway is it's important
to get the surveillance have a really
196
00:13:44,070 --> 00:13:47,140
an ongoing relationship with the
plastic surgeon who placed it,
197
00:13:48,460 --> 00:13:50,940
get the imaging, if you
have silicone gel implants,
198
00:13:51,700 --> 00:13:56,640
but even though FDA made many
of these new recommendations and
199
00:13:57,320 --> 00:13:59,040
requirements, um, more demanding,
200
00:13:59,800 --> 00:14:04,710
the surveillance actually became more
liberal based on the post-approval
201
00:14:05,190 --> 00:14:10,070
study data and based on improvements
in ultrasound technology where
202
00:14:10,790 --> 00:14:15,310
ultrasound can be used as
well as MRI to screen for
203
00:14:16,230 --> 00:14:18,190
hidden or occult implant rupture,
204
00:14:19,310 --> 00:14:23,900
although MRIs still the most
sensitive test and still
205
00:14:24,500 --> 00:14:28,780
probably the right move for someone
who's symptomatic. If the, uh,
206
00:14:29,500 --> 00:14:32,460
ultrasound is equivocal or
does not find to rupture,
207
00:14:33,180 --> 00:14:34,820
but that ability to do the ultrasound,
208
00:14:35,100 --> 00:14:39,420
which increasingly can be done in
the plastic surgeon's office is a,
209
00:14:39,620 --> 00:14:44,210
a way that reduces the inconvenience
and expense of doing the surveillance.
210
00:14:45,530 --> 00:14:46,170
Well,
211
00:14:46,170 --> 00:14:50,380
this was certainly an informative episode
for people who are considering breast
212
00:14:50,381 --> 00:14:51,214
implant surgery.
213
00:14:51,600 --> 00:14:55,440
I hope today's episode provided some
valuable information and insight.
214
00:14:55,940 --> 00:14:58,560
If this episode sparked
any unanswered questions,
215
00:14:58,700 --> 00:15:02,600
please contact us and we would be happy
to discuss them in a future episode.
216
00:15:03,770 --> 00:15:04,820
This is Doreen Wu,
217
00:15:04,940 --> 00:15:09,460
thanking you for joining Dr. Bass and
me for this discussion of the FDA's new
218
00:15:09,610 --> 00:15:14,170
rules and regulations for breast
implants. Be sure to join us next time.
219
00:15:14,270 --> 00:15:18,290
And don't forget to subscribe to our
podcast to avoid missing all of the
220
00:15:18,530 --> 00:15:20,410
exciting content that is coming your way.
221
00:15:21,380 --> 00:15:25,330
Thank you for joining us in this episode
of the Park Avenue Plastic Surgery
222
00:15:25,420 --> 00:15:30,080
Class podcast with Dr. Lawrence
Bass Park Avenue plastic surgeon,
223
00:15:30,920 --> 00:15:32,760
educator, and technology innovator.
224
00:15:33,100 --> 00:15:35,560
The commentary in this
podcast represents opinion.
225
00:15:35,790 --> 00:15:38,200
This podcast does not
present medical advice,
226
00:15:38,540 --> 00:15:42,480
but rather general information about
plastic surgery that does not necessarily
227
00:15:42,540 --> 00:15:45,560
relate to the specific conditions
of any individual patient.
228
00:15:45,980 --> 00:15:50,830
No doctor patient relationship
is established by listening
to or participating
229
00:15:50,970 --> 00:15:51,803
in this podcast,
230
00:15:52,060 --> 00:15:56,110
consult your physician to advise you
about your individual healthcare.
231
00:15:56,370 --> 00:15:57,790
If you enjoyed this episode,
232
00:15:57,970 --> 00:16:02,030
please share it with your friends and
be sure to subscribe to our podcast on
233
00:16:02,031 --> 00:16:06,020
Apple Podcasts, Google, Spotify, Stitcher,
234
00:16:06,320 --> 00:16:08,620
or wherever you listen to podcasts.