13
COSMETIC Late Seromas after Breast Implants: Theory and Practice Scott L. Spear, M.D. Steven J. Rottman, M.D. Caroline Glicksman, M.D. Mitchell Brown, M.D. Ali Al-Attar, M.D., Ph.D. Washington, D.C.; Sea Girt, N.J.; and Toronto, Ontario, Canada Background: Late seromas surrounding breast implants are becoming an in- creasingly important issue in breast surgery. The authors report their experience with late seromas and describe their previous management options. Methods: A multicenter retrospective review of patients who developed late seromas (clinically presenting seromas without evidence of overt or documented infection more than 1 year after implant operation) was performed. Manage- ment, surgical technique, outcomes, complications, culture findings, and cy- tology results were recorded. Results: Between 2005 and 2010, 28 late seromas were identified in 25 patients. The average interval from the patient’s last surgery to seroma onset was 4.7 years; 27 of 28 breasts (96 percent) had a Biocell textured device in place at the time of seroma development. The late seromas in the series were managed as follows: 15 (53.6 percent) by complete capsulectomy, seroma drainage, and new implant placement; three (10.7 percent) by seroma drainage and new implant place- ment but without capsulectomy; two (7.1 percent) by complete capsulectomy and seroma drainage but without implant replacement; five (17.9 percent) by only ultrasound-guided seroma drainage without the need for surgical inter- vention; and three (10.7 percent) by antibiotic therapy alone. All cultures and cytology studies were negative for malignancy or infection; 27 of 28 seromas (96 percent) were treated successfully by one of the described approaches. Conclusions: Biocell textured implants were more likely to be associated with late seromas than were smooth shell implants. The overwhelming majority of late seromas appear to be idiopathic, without clear evidence of infection or malignancy. A graduated approach, including several different management strategies, was used to successfully manage these patients. (Plast. Reconstr. Surg. 130: 423, 2012.) CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV. T he occurrence of late seromas surrounding breast implants is arousing increased interest in both cosmetic and reconstructive breast sur- gery. Late seromas are often theorized to be related to some sort of trauma or low grade, subclinical infections (e.g., mycobacterium or biofilm). 1–3 The interest surrounding late periprosthetic breast sero- mas is now even greater given the recent reports of a possible rare connection between breast implants and anaplastic large cell lymphoma, as these tumors often present as late seromas. 4,5 This study is not a theoretical algorithm but rather is a look back at a large experience with late seromas and describes those findings. We define a late seroma as a clinically symptomatic seroma that develops at least 12 months after the most recent breast implant surgery. These cases all presented with clinically evident breast swelling. We do not specify the volume amount but rather require that the presentation of the patient be clinically evident swelling. We believe, in fact, that in many other cases fluid might be an incidental radiographic or ultrasound finding From the Department of Plastic Surgery, Georgetown Uni- versity Hospital; private practice; and the Division of Plastic and Reconstructive Surgery, University of Toronto. Received for publication August 3, 2011; accepted February 14, 2012. Copyright ©2012 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0b013e3182589ea9 Disclosure: Drs. Spear and Brown are paid con- sultants for LifeCell (Branchburg, N.J.) and Aller- gan (Irvine, Calif.). Dr. Glicksman is a paid con- sultant for Allergan. Drs. Rottman and Al-Attar have no financial interests in any of the products or devices mentioned in this article. This study was not supported by any external funding. www.PRSJournal.com 423

Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

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Page 1: Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

COSMETIC

Late Seromas after Breast Implants: Theoryand Practice

Scott L. Spear, M.D.Steven J. Rottman, M.D.

Caroline Glicksman, M.D.Mitchell Brown, M.D.

Ali Al-Attar, M.D., Ph.D.

Washington, D.C.; Sea Girt, N.J.; andToronto, Ontario, Canada

Background: Late seromas surrounding breast implants are becoming an in-creasingly important issue in breast surgery. The authors report their experiencewith late seromas and describe their previous management options.Methods: A multicenter retrospective review of patients who developed lateseromas (clinically presenting seromas without evidence of overt or documentedinfection more than 1 year after implant operation) was performed. Manage-ment, surgical technique, outcomes, complications, culture findings, and cy-tology results were recorded.Results: Between 2005 and 2010, 28 late seromas were identified in 25 patients.The average interval from the patient’s last surgery to seroma onset was 4.7 years;27 of 28 breasts (96 percent) had a Biocell textured device in place at the timeof seroma development. The late seromas in the series were managed as follows:15 (53.6 percent) by complete capsulectomy, seroma drainage, and new implantplacement; three (10.7 percent) by seroma drainage and new implant place-ment but without capsulectomy; two (7.1 percent) by complete capsulectomyand seroma drainage but without implant replacement; five (17.9 percent) byonly ultrasound-guided seroma drainage without the need for surgical inter-vention; and three (10.7 percent) by antibiotic therapy alone. All cultures andcytology studies were negative for malignancy or infection; 27 of 28 seromas (96percent) were treated successfully by one of the described approaches.Conclusions: Biocell textured implants were more likely to be associated withlate seromas than were smooth shell implants. The overwhelming majority oflate seromas appear to be idiopathic, without clear evidence of infection ormalignancy. A graduated approach, including several different managementstrategies, was used to successfully manage these patients. (Plast. Reconstr. Surg.130: 423, 2012.)CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

The occurrence of late seromas surroundingbreast implants is arousing increased interestin both cosmetic and reconstructive breast sur-

gery. Late seromas are often theorized to be relatedto some sort of trauma or low grade, subclinicalinfections (e.g., mycobacterium or biofilm).1–3 Theinterest surrounding late periprosthetic breast sero-mas is now even greater given the recent reports ofa possible rare connection between breast implantsand anaplastic large cell lymphoma, as these tumorsoften present as late seromas.4,5 This study is not atheoretical algorithm but rather is a look back at a

large experience with late seromas and describesthose findings. We define a late seroma as a clinicallysymptomatic seroma that develops at least 12months after the most recent breast implant surgery.These cases all presented with clinically evidentbreast swelling. We do not specify the volumeamount but rather require that the presentation ofthe patient be clinically evident swelling. We believe,in fact, that in many other cases fluid might be anincidental radiographic or ultrasound finding

From the Department of Plastic Surgery, Georgetown Uni-versity Hospital; private practice; and the Division of Plasticand Reconstructive Surgery, University of Toronto.Received for publication August 3, 2011; accepted February14, 2012.Copyright ©2012 by the American Society of Plastic Surgeons

DOI: 10.1097/PRS.0b013e3182589ea9

Disclosure: Drs. Spear and Brown are paid con-sultants for LifeCell (Branchburg, N.J.) and Aller-gan (Irvine, Calif.). Dr. Glicksman is a paid con-sultant for Allergan. Drs. Rottman and Al-Attarhave no financial interests in any of the products ordevices mentioned in this article. This study was notsupported by any external funding.

www.PRSJournal.com 423

Page 2: Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

around many implants, but that would not fit ourcriteria.

Seroma following breast implant surgery is arare occurrence, particularly in the late postop-erative period, arbitrarily defined here as greaterthan 1 year. Descriptions of late seromas in theliterature have been mainly individual or smallcase reports, generally followed by speculation asto etiology. The first description of seroma fol-lowing breast implant surgery appears to havebeen in 1991,6 and for the following two decades,only a few surgeons have added their isolatedseries.7–14 Several themes have been prevalent.First, late seromas are remarkably rare. In thosereports, the incidence of late seromas among theirown primary augmentations was 1 percent orless.11,14,15 Second, the vast majority of late seromasreported in these earlier reports were in patientswho previously had Biocell (Allergan, Irvine,Calif.) textured implants, leading several authorsto speculate that the Biocell textured surfacemight play a role in the pathophysiology of lateseroma formation.11,15 Third, pocket placement(subpectoral versus subglandular) and device con-tent (saline versus silicone) did not appear to in-fluence the incidence of late seromas. Fourth, de-spite nearly uniform submission of seromasamples for microbiologic and cytologic examina-tion, the vast majority of seromas were negative forboth sets of studies. Finally, although late seromashave been reported to be managed variously bysurgery (seroma evacuation and implant ex-change), ultrasound-guided aspiration, and con-servatively (often with oral antibiotics alone), re-gardless of treatment the majority of seromas haveresolved and recurrence was uncommon.

To further study the characteristics of late se-romas, we retrospectively evaluated all clinicallyevident late seromas that presented to the prac-tices of three established plastic surgeons with dif-ferent clinical management styles. This review in-volved patients seen before the recent increasedinterest in biofilm and before the increased aware-ness of anaplastic large cell lymphoma and otherpossible lymphoproliferative disorders in womenwith breast implants. At the time these patients weremanaged, these surgeons had no preconceptionsregarding the etiology of late seroma formation.These three practices functioned independentlyand managed these late seromas empirically withoutreferring to any specific theoretical algorithm.With the study period occurring before the recentheightened concern over lymphoproliferative dis-orders, these patients were treated with a gradu-ated practical approach with the underlying as-

sumption that late seromas could be successfullytreated with more than one approach, includingantibiotics, percutaneous drainage, or more ag-gressively with surgery.

We were interested in determining whetherthe prevailing sentiment linking such seromaswith textured implants was correct and how dif-ferent seroma management techniques fared. Ourstudy was not designed to specifically estimate theincidence or frequency of late seroma formation,as we studied patients who presented to one ofthe three clinical practices with a seroma, re-gardless of where or when their previous surgerywas performed.

PATIENTS AND METHODSAn institutional review board–approved, mul-

ticenter retrospective review was carried out onpatients who developed late seromas. The reviewtook place on patients seen and treated over a5-year period between December of 2005 throughDecember of 2010 in the practices of Scott Spear,M.D., at Georgetown University Hospital, Wash-ington, D.C.; Caroline Glicksman, M.D., in SeaGirt, N.J.; and Mitchell Brown, M.D., in Toronto,Canada (Figs. 1 through 4). All patients diagnosedwith a late seroma were included in this study andcould include patients who had their implant sur-gery initially performed by one of these three sur-geons, as well as patients who were initially oper-ated on elsewhere who presented later to one ofthese three surgeons with a seroma. Data collectedincluded patient demographics, indications forinitial surgery, subsequent revision surgeries, andtime of seroma onset. Preoperative and postoper-ative photographs, management technique out-comes, complications, cultures, and cytology re-sults were recorded. Biofilm studies, includingpolymerase chain reaction–based laboratory test-ing, were not done due to the timing of this studyand the availability of those techniques. A lateseroma was defined as a seroma that first pre-sented clinically as symptomatic swelling of thebreast 1 year or longer after the most recent breastsurgery. Incidental seromas found during surgeryor reported on imaging would not qualify unlessthey were first clinically symptomatic and the ra-diologic study was performed to make the diag-nosis. Statistical analysis was performed with thechi-square test to evaluate for the probability ofdifference of sets of outcomes.

RESULTSOver a 5-year period between December of

2005 and December of 2010, 28 late seromas were

Plastic and Reconstructive Surgery • August 2012

424

Page 3: Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

identified in 25 patients (Table 1). Three patientsdeveloped bilateral seromas simultaneously. Theaverage age across all patients was 44.9 years(range, 26 to 68 years), and average body massindex was 24 kg/m2 (range, 20 to 29 kg/m2). In 19breasts (68 percent), the preceding surgery wascosmetic breast augmentation, and in the remain-ing nine breasts (32 percent), it was breast recon-struction. Three of the nine reconstructed breasts(33 percent) were previously irradiated, and one(4 percent) patient was a former smoker’s. Theaverage time from the patient’s last implant sur-

gery to seroma onset was 4.7 years (Fig. 5). At thetime of seroma development, 27 breasts (96 per-cent) had Biocell textured devices in place, andone breast (4 percent) had a smooth implant inplace (p � 0.0001). Although this review includedall patients seen and treated over the 5-year periodin the three practices, all of the seromas reportedhere developed around implants placed by one ofthe three surgeons.

Some of the seromas in this series had associatedfindings that were conjectured possible etiologies.Five breasts (18 percent) in four patients presentedwith findings of possible infection, including red-ness, swelling, and/or fever. Of these five breasts, two

Fig. 1. A 38-year-old woman underwent bilateral subpectoralbreast augmentation. She developed several right-sided capsu-lar contractures, each treated with capsulectomy and implantexchange to Style 68 high-profile smooth saline implants (Aller-gan, Inc., Irvine, Calif.); 2.3 years (845 days) after the most recentcapsulectomy, she developed a right-sided seroma and bilateralcapsular contractures.

Fig. 2. The patient shown in Figure 1 subsequently underwentbilateral capsulectomies, seroma drainage, and implant replace-ment to Style 120 textured implants (Allergan, Inc., Irvine, Calif.).Results of intraoperative cultures and cytologic analyses werenegative.

Volume 130, Number 2 • Late Seromas after Breast Implants

425

Page 4: Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

resolved with ultrasound-guided drainage of the se-roma and antibiotics. Two breasts (in the same pa-tient) were successfully treated with capsulectomy,seroma drainage in the operating room, and im-plant replacement. One patient whose breast pre-sented with erythema and swelling consistently re-fused recommended surgical intervention; she wastreated on three occasions with oral antibiotics thateach time resolved her symptoms; on her last visit,she had no symptom recurrence 4 months after thelast episode of swelling and erythema. None of thesepatients had purulent fluid found on drainage (ei-ther ultrasound-guided or open surgical), and all of

the cultures were sterile, suggesting either no infec-tion, subclinical infection, or seroma fluid sterilizedby antibiotic therapy.

Three of the seromas (11 percent) were associ-ated with precedent overt trauma that on clinicalexamination did not appear to be hematomas. Twoof these three seromas were managed with ultra-sound-guided drainage that successfully resolved theseromas. The third seroma was treated with capsu-lectomy, open drainage, and implant exchange,which also successfully treated the seroma. Sepa-rately, two of the breasts (7 percent) had dark fluidthat resembled a resolving hematoma. This findingwas observed during capsulectomy and implant ex-

Fig. 3. A 60-year-old woman underwent bilateral subpectoralbreast augmentation. She developed bilateral capsular contrac-tures, each treated with capsulectomy and implant replacementto Style 120 textured devices (Allergan, Inc., Irvine, Calif.); 1.5years (545 days) after the capsulotomy procedure, she developeda left-sided seroma.

Fig. 4. The patient shown in Figure 3 subsequently underwentleft seroma drainage, capsulectomy, and implant replacementwith Style 20 smooth round implants (Allergan, Inc., Irvine,Calif.). Results of intraoperative cultures and cytology studieswere negative.

Plastic and Reconstructive Surgery • August 2012

426

Page 5: Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

Tab

le1

.P

atie

nt

Dat

a

Pat

ient

No.

Surg

eon*

Age

(yr)

Pre

viou

sO

pera

tion

sP

revi

ous

Impl

ants

Eti

olog

yD

evic

eat

Tim

eof

Sero

ma

Tim

eto

Sero

ma

(day

s)U

ltra

soun

d-G

uide

dD

rain

age?

1S.

L.S

.38

Cos

met

icau

gmen

tati

on,

revi

sed

twic

eM

ento

rH

P350

Idio

path

icA

llerg

anSt

yle

68H

P(s

moo

th,

salin

e),

subp

ecto

ral

845

Not

atte

mpt

ed

2S.

L.S

.51

Cos

met

icau

gmen

tati

on,

revi

sed

once

300–

340

doub

lelu

men

Idio

path

icA

llerg

anSt

yle

110

(tex

ture

d,ge

l),

subp

ecto

ral

2733

Not

atte

mpt

ed

3S.

L.S

.51

Cos

met

icau

gmen

tati

on,

revi

sed

once

300–

340

doub

lelu

men

Idio

path

icA

llerg

anSt

yle

110

(tex

ture

d,ge

l),

subp

ecto

ral

2733

Not

atte

mpt

ed

4S.

L.S

.56

Stag

edbr

east

reco

nst

ruct

ion

wit

hex

pan

der

then

impl

ant,

no

radi

atio

n

McG

han

131

Poss

ible

subc

linic

alh

emat

oma

Alle

rgan

Styl

e15

3(t

extu

red,

gel)

,su

bpec

tora

l

4342

Not

atte

mpt

ed

5S.

L.S

.60

Cos

met

icau

gmen

tati

on,

revi

sed

once

Silic

one

gel,

subg

lan

dula

rC

apsu

lar

blee

din

g/po

ssib

lesu

bclin

ical

hem

atom

a

Alle

rgan

Styl

e12

0(t

extu

red,

gel)

,su

bgla

ndu

lar

545

Col

lect

ion

deem

edto

osm

all

todr

ain

perc

utan

eous

ly(b

ased

onM

RI)

6S.

L.S

.68

Stag

edbr

east

reco

nst

ruct

ion

wit

hex

pan

der

then

impl

ant

�ra

diat

ion

Tis

sue

expa

nde

r(M

cGh

an)

Impl

ant

rupt

ure

Alle

rgan

Styl

e15

3(t

extu

red,

gel)

,su

bpec

tora

l

6689

Not

atte

mpt

ed

7S.

L.S

.52

Stag

edbr

east

reco

nst

ruct

ion

wit

hex

pan

der

and

Allo

Der

mth

enim

plan

t;n

ora

diat

ion

(exp

ande

rst

age

com

plic

ated

byea

rly

sero

ma)

Tis

sue

expa

nde

r(1

33M

V)

15–5

75Id

iopa

thic

Alle

rgan

Styl

e41

0MF

(tex

ture

d,ge

l),

subp

ecto

ral

1102

Ult

raso

und-

guid

edas

pira

tion

perf

orm

ed;

sero

ma

recu

rred

thre

ew

eeks

late

ran

dth

eref

ore

pati

ent

was

take

nto

surg

ery

8S.

L.S

.48

Stag

edbr

east

reco

nst

ruct

ion

wit

hex

pan

der

and

Allo

Der

m,

then

impl

ant;

no

radi

atio

n;

prev

ious

revi

sion

Tis

sue

expa

nde

r(1

33)

363L

FU

ndo

cum

ente

dsu

spec

ted

infe

ctio

n

Alle

rgan

Styl

e41

0MF

(tex

ture

d,ge

l),

subp

ecto

ral

509

Not

atte

mpt

ed

9S.

L.S

.48

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edbr

east

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nst

ruct

ion

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der

and

Allo

Der

m,

then

impl

ant;

no

radi

atio

n;

prev

ious

revi

sion

Tis

sue

expa

nde

r(1

33)

363L

FU

ndo

cum

ente

dsu

spec

ted

infe

ctio

n

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rgan

Styl

e41

0MF

(tex

ture

d,ge

l),

subp

ecto

ral

649

Not

atte

mpt

ed

10S.

L.S

.63

Stag

edbr

east

reco

nst

ruct

ion

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hex

pan

der

then

impl

ant;

no

radi

atio

n

Tis

sue

expa

nde

r(1

33M

V)

Impl

ant

rupt

ure

Alle

rgan

Styl

e41

0MF

(tex

ture

d,ge

l),

subp

ecto

ral

2716

Not

atte

mpt

ed

11S.

L.S

.63

Stag

edbr

east

reco

nst

ruct

ion

wit

hex

pan

der

then

impl

ant;

no

radi

atio

n

Tis

sue

expa

nde

r(1

33M

V)

Impl

ant

rupt

ure

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rgan

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e41

0MF

(tex

ture

d,ge

l),

subm

uscu

lar

2716

Not

atte

mpt

ed

12C

.G.

44Pr

evio

usco

smet

icsu

bgla

ndu

lar

augm

enta

tion

,fo

llow

edby

stag

edbr

east

reco

nst

ruct

ion

wit

hex

pan

der

(com

plic

ated

byde

laye

dw

oun

dh

ealin

g)th

enim

plan

t,n

ora

diat

ion

Salin

esu

bgla

ndu

lar

impl

ant;

tiss

ueex

pan

der

(133

MV

)

Idio

path

icA

llerg

anSt

yle

410F

X(t

extu

red,

gel)

,su

bpec

tora

l

1295

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

(Con

tinue

d)

Volume 130, Number 2 • Late Seromas after Breast Implants

427

Page 6: Late Seromas after Breast Implants: Theory · Seroma following breast implant surgery is a rare occurrence, particularly in the late postop-erative period, arbitrarily defined here

Tab

le1

.(C

on

tin

ued

)

Pat

ient

No.

Surg

eon*

Age

(yr)

Pre

viou

sO

pera

tion

sP

revi

ous

Impl

ants

Eti

olog

yD

evic

eat

Tim

eof

Sero

ma

Tim

eto

Sero

ma

(day

s)U

ltra

soun

d-G

uide

dD

rain

age?

13C

.G.

60St

aged

brea

stre

con

stru

ctio

nw

ith

expa

nde

rth

enim

plan

t,re

vise

dtw

ice,

no

radi

atio

n

Tis

sue

expa

nde

r(1

33);

Men

tor

Silt

ex15

3–45

0

Un

docu

men

ted

susp

ecte

din

fect

ion

Alle

rgan

Styl

e41

0FX

(tex

ture

d,ge

l),

subp

ecto

ral

1034

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

14C

.G.

44C

osm

etic

augm

enta

tion

,re

vise

don

ceM

ento

rSi

ltex

354–

2712

Tra

uma

Alle

rgan

Styl

e15

3(t

extu

red,

gel)

,su

bpec

tora

l

1778

Not

perf

orm

ed

15C

.G.

34C

osm

etic

augm

enta

tion

Non

eT

raum

aA

llerg

anSt

yle

115

(tex

ture

d,ge

l)su

bpec

tora

l

468

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

16C

.G.

48C

osm

etic

augm

enta

tion

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vise

don

ceSm

ooth

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dsa

line

(sub

mus

cula

r)

Un

docu

men

ted

susp

ecte

din

fect

ion

Alle

rgan

Styl

e15

3(t

extu

red,

gel)

subp

ecto

ral

2526

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

17C

.G.

28C

osm

etic

augm

enta

tion

Non

eU

ndo

cum

ente

dsu

spec

ted

infe

ctio

n

Alle

rgan

Styl

e11

0(t

extu

red,

gel)

subp

ecto

ral

1031

Not

atte

mpt

ed

18C

.G.

39C

osm

etic

augm

enta

tion

Non

eId

iopa

thic

Alle

rgan

Styl

e11

0(t

extu

red,

gel)

subp

ecto

ral

2651

Col

lect

ion

deem

edto

osm

all

todr

ain

perc

utan

eous

ly(b

ased

onM

RI

and

ultr

asou

nd)

19C

.G.

36C

osm

etic

augm

enta

tion

Non

eE

xerc

ise-

indu

ced

trau

ma

Alle

rgan

Styl

e15

3(t

extu

red,

gel)

subp

ecto

ral

1041

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

20M

.H.B

.38

Cos

met

icau

gmen

tati

onm

asto

pexy

Non

eId

iopa

thic

Alle

rgan

Styl

e41

0MF

(tex

ture

d,ge

l)su

bgla

ndu

lar

865

Ult

raso

und-

guid

edas

pira

tion

perf

orm

ed;

sero

ma

recu

rred

and

ther

efor

epa

tien

tw

asta

ken

tosu

rger

y21

M.H

.B.

45C

osm

etic

augm

enta

tion

Non

eId

iopa

thic

Alle

rgan

Styl

e11

5(t

extu

red,

gel)

subg

lan

dula

r

635

Not

atte

mpt

ed

22M

.H.B

.42

Cos

met

icau

gmen

tati

onN

one

Idio

path

icA

llerg

anSt

yle

410M

F(t

extu

red,

gel)

410

MF

subp

ecto

ral

840

Not

atte

mpt

ed

23M

.H.B

.32

Cos

met

icau

gmen

tati

onN

one

Idio

path

icA

llerg

anSt

yle

115

(tex

ture

d,ge

l)su

bgla

ndu

lar

970

Ult

raso

und-

guid

edas

pira

tion

perf

orm

ed;

sero

ma

recu

rred

and

ther

efor

epa

tien

tw

asta

ken

tosu

rger

y24

M.H

.B.

39C

osm

etic

augm

enta

tion

Non

eId

iopa

thic

Alle

rgan

Styl

e41

0FF

(tex

ture

d,ge

l)su

bpec

tora

l

955

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

(Con

tinue

d)

Plastic and Reconstructive Surgery • August 2012

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change, with successful resolution in both. Finally,four breasts (14 percent) were found to have rup-tured implants or gel bleeding associated with theseromas; all four breasts were successfully managedwith capsulectomy, open surgical drainage of theseromas, and implant exchange.

The late seromas in our series were managedin a variety of different ways (Table 2). Twenty ofthe 28 seromas (71 percent) ultimately underwentopen surgical treatment, whereas eight (29 per-cent) did not. Fifteen of the 28 patients (54 per-cent) underwent a complete capsulectomy withsimultaneous drainage of their seroma and place-ment of a new implant. Nine textured devices andsix smooth devices were used to replace these 15explanted implants. Three patients (11 percent)had their implants replaced with simultaneousdrainage of their seroma, but without capsulectomy.Two of these new devices placed were smooth, andone was a Biocell textured implant. Two breasts (7percent) underwent complete capsulectomy with se-roma drainage but did not have implant replace-ment. Thus, 15 seromas (54 percent) were treatedwith capsulectomy with or without replacement, and16 seromas (57 percent) underwent implant re-placement with or without capsulectomy.

Four of the 20 patients ultimately treated sur-gically initially had percutaneous seroma drainageprocedures without resolution of the seroma ei-ther because of recurrence or intentionally in-complete drainage. This led to open surgicaldrainage of the seroma, capsulectomy, and im-plant replacement. The average follow-up lengthwas 401 days for those five seromas successfullytreated only with ultrasound-guided drainage, 439days for those treated with antibiotics alone (n �3), and 364 days for those treated with surgery(n � 20). The average follow-up duration afterseroma treatment for all patients was 12.8 months.

Fig. 5. Scatter graph of onset of late seroma formation. Note thetwo clusters of onset, the first between 600 and 1100 days, andthe second between 2500 and 2700 days.

Tab

le1

.(C

on

tin

ued

)

Pat

ient

No.

Surg

eon*

Age

(yr)

Pre

viou

sO

pera

tion

sP

revi

ous

Impl

ants

Eti

olog

yD

evic

eat

Tim

eof

Sero

ma

Tim

eto

Sero

ma

(day

s)U

ltra

soun

d-G

uide

dD

rain

age?

25M

.H.B

.26

Cos

met

icau

gmen

tati

onN

one

Idio

path

icA

llerg

anSt

yle

410M

M(t

extu

red,

gel)

subp

ecto

ral

1370

Not

atte

mpt

ed

26M

.H.B

.31

Cos

met

icau

gmen

tati

onN

one

Idio

path

icA

llerg

anSt

yle

410F

X(t

extu

red,

gel)

subp

ecto

ral

1395

Ult

raso

und-

guid

eddr

ain

age

perf

orm

edan

dw

assu

cces

sful

27M

.H.B

.36

Cos

met

icau

gmen

tati

onN

one

Idio

path

icA

llerg

anSt

yle

410M

M(t

extu

red,

gel)

subp

ecto

ral

2720

Ult

raso

und-

guid

edas

pira

tion

perf

orm

ed;

sero

ma

recu

rred

and

ther

efor

epa

tien

tw

asta

ken

tosu

rger

y28

M.H

.B.

36C

osm

etic

augm

enta

tion

Non

eId

iopa

thic

Alle

rgan

Styl

e41

0ML

(tex

ture

d,ge

l)su

bpec

tora

l

765

Not

atte

mpt

ed

MR

I,m

agn

etic

reso

nan

ceim

agin

g.*T

he

surg

eon

sw

ere

Scot

tL

.Sp

ear,

M.D

.(S

.L.S

.);

Car

olin

eG

licks

man

,M

.D.

(C.G

.);

and

Mit

chel

lH

.B

row

n,

M.D

.(M

.H.B

.).

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Tab

le2

.M

anag

emen

to

fSer

om

as

Pat

ient

No.

Man

agem

ent

Cul

ture

Cyt

olog

yFo

llow

-Up

Dur

atio

n(d

ays)

Out

com

e/C

ompl

icat

ions

1C

apsu

lect

omy,

sero

ma

drai

nage

,im

plan

trep

lace

dw

ithSt

yle

120

impl

ant(

text

ured

,sili

cone

)N

egN

eg87

0Se

rom

are

solv

ed2

Cap

sule

ctom

y,se

rom

adr

ain

age,

impl

ant

rem

oval

Neg

Neg

26Se

rom

are

solv

ed;

impl

antn

otre

plac

ed3

Cap

sule

ctom

y,se

rom

adr

ain

age,

impl

ant

rem

oval

Neg

Neg

26Se

rom

are

solv

ed;

impl

antn

otre

plac

ed4

Cap

sule

ctom

y,se

rom

adr

ain

age,

impl

ant

repl

aced

wit

hSt

yle

45im

plan

t(s

moo

th,

silic

one)

Neg

Neg

275

Sero

ma

reso

lved

5C

apsu

lect

omy,

sero

ma

drai

nag

e,im

plan

tre

plac

edw

ith

Styl

e20

impl

ant

(sm

ooth

,si

licon

e)N

egN

eg19

2Se

rom

are

solv

ed6

Cap

sule

ctom

y,se

rom

adr

ain

age,

impl

ant

repl

aced

wit

hSt

yle

20im

plan

t(s

moo

th,

silic

one)

Neg

Neg

371

Sero

ma

reso

lved

7C

apsu

lect

omy,

sero

ma

drai

nag

e,im

plan

tre

plac

edw

ith

Styl

e41

0MF

impl

ant

(tex

ture

d,si

licon

e)N

egN

eg24

4Se

rom

are

curr

ence

;ev

entu

alex

plan

t8

Cap

sule

ctom

y,se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e41

0MF

impl

ant(

text

ured

,sili

cone

)N

egN

eg44

1Se

rom

are

solv

ed9

Cap

sule

ctom

y,se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e41

0MF

impl

ant(

text

ured

,sili

cone

)N

egN

eg44

1Se

rom

are

solv

ed10

Cap

sule

ctom

y,se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e41

0FX

impl

ant(

text

ured

,sili

cone

)N

egN

eg48

9Se

rom

are

solv

ed11

Cap

sule

ctom

y,se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e41

0FX

impl

ant(

text

ured

,sili

cone

)N

egN

eg48

9Se

rom

are

solv

ed12

Sero

ma

reso

lved

wit

hul

tras

oun

d-gu

ided

drai

nag

e;pa

tien

tla

ter

unde

rwen

tca

psul

ecto

my

and

impl

ant

repl

aced

wit

hSt

yle

410F

Xim

plan

t(t

extu

red,

silic

one)

Neg

Neg

179

Sero

ma

reso

lved

13U

ltra

soun

d-gu

ided

drai

nag

e,an

tibi

otic

sN

egN

eg23

3Se

rom

are

solv

ed14

Cap

sule

ctom

y.se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e41

0FF

impl

ant(

text

ured

,sili

cone

)N

egN

eg11

89Se

rom

are

solv

ed15

Ult

raso

und-

guid

eddr

ain

age

Neg

Neg

539

Sero

ma

reso

lved

16Se

rom

are

solv

edw

ith

ultr

asou

nd-

guid

eddr

ain

age;

pati

ent

late

run

derw

ent

caps

ulec

tom

yan

dim

plan

tre

plac

edw

ith

Styl

e20

impl

ant

(sm

ooth

,si

licon

e)N

egN

eg21

6Se

rom

are

solv

ed

17A

nti

biot

ics;

sero

mas

deve

lope

dtw

ice

mor

ean

dre

solv

edw

ith

oral

anti

biot

ics

Not

don

eN

otdo

ne

628

Sero

ma

recu

rred

two

mor

etim

es,a

ndbo

thtim

essu

cces

sful

lytr

eate

dw

ithor

alan

tibio

tics

(pat

ient

refu

sed

surg

ery)

18A

nti

biot

ics

Not

don

eN

otdo

ne

446

Sero

ma

reso

lved

19U

ltra

soun

d-gu

ided

drai

nag

eN

egN

eg69

2Se

rom

are

solv

ed20

Cap

sule

ctom

y,se

rom

adr

ain

age,

impl

ant

repl

aced

wit

hSt

yle

15im

plan

t(s

moo

th,

silic

one)

Neg

Neg

99Se

rom

are

solv

ed21

Cap

sule

ctom

y,se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e11

5im

plan

t(te

xtur

ed,s

ilico

ne)

Neg

Neg

90Se

rom

are

solv

ed22

No

caps

ulec

tom

y,se

rom

adr

aina

ge,i

mpl

antr

epla

ced

with

Styl

e15

impl

ant(

smoo

th,s

ilico

ne)

Neg

Neg

1175

Sero

ma

reso

lved

23N

oca

psul

ecto

my,

sero

ma

drai

nage

,im

plan

trep

lace

dw

ithSt

yle

15im

plan

t(sm

ooth

,sili

cone

)N

egN

eg28

5Se

rom

are

solv

ed24

Ult

raso

und-

guid

eddr

ain

age

Neg

Neg

180

Sero

ma

reso

lved

25N

oca

psul

ecto

my,

sero

ma

drai

nage

,im

plan

trep

lace

dw

ithSt

yle

410M

Mim

plan

t(te

xtur

ed,

silic

one)

Neg

Neg

110

Sero

ma

reso

lved

26U

ltra

soun

d-gu

ided

drai

nag

eN

egN

eg36

0Se

rom

are

solv

ed27

Cap

sule

ctom

y,se

rom

adr

ain

age,

impl

ant

repl

aced

wit

hSt

yle

15im

plan

t(s

moo

th,

silic

one)

Neg

Neg

80Se

rom

are

solv

ed28

An

tibi

otic

sN

otdo

ne

Not

don

e54

0Se

rom

are

solv

edN

eg,

neg

ativ

e.

Plastic and Reconstructive Surgery • August 2012

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Of the 18 breasts of 28 (64 percent) that under-went implant exchange procedures, one (6 percent)had a smooth device exchanged for a Biocell tex-tured device, eight (44 percent) had textured de-vices exchanged for smooth devices, and nine (50percent) had textured devices replaced with a newBiocell textured device.

Of the eight patients successfully treated with-out surgical intervention, five (18 percent) re-solved with only ultrasound-guided seroma drain-age, and three (11 percent) seromas resolved withantibiotic therapy alone. Overall, ultrasound-guided drainage procedures successfully resolvedthe seromas in five of the nine patients (56 per-cent) in whom it was attempted.

All patients who had ultrasound-guided or sur-gical drainage had seroma fluid sent for culture aswell as cytology. All tested specimens were nega-tive for malignancy or infection. The three pa-tients whose seromas resolved on antibiotic ther-apy alone did not have the seroma fluid evaluatedwith culture or cytology; 27 of 28 seromas (96percent) were treated successfully by one of thefive described approaches. There was one recur-rent seroma (3.6 percent) in our series. This pa-tient was initially treated with complete capsulec-tomy with drainage and placement of a newBiocell textured implant. Ten weeks postopera-tively, she developed erythema and swelling con-sistent with a seroma or infection. This was suc-cessfully managed with surgery, includingdrainage of the seroma, device explantation, andoral antibiotics. All her cultures were negative.

As a frame of reference for the type of devicescommonly used by the three lead investigators, allimplants placed in these practices for a represen-tative single year from 2005 to 2006 were reviewed.A total of 950 devices were placed in 509 patients;482 (51 percent) were smooth, and 468 (49 per-cent) were Biocell textured devices. Of the 509patients, 147 (29 percent) underwent breast re-construction, whereas 362 (71 percent) had cos-metic breast surgery procedures.

At Georgetown University Hospital, our refer-ence data on 142 patients operated on during that1-year period showed a stronger preference forsmooth devices (210 implants; 86 percent) versusBiocell textured implants (33 implants; 14 per-cent). Drs. Glicksman and Brown use a majority ofBiocell textured devices. A total of 435 (62 per-cent) of the 707 devices they placed during that1-year period were Biocell textured implants. Allthree surgeons use only the Biocell variety of tex-tured implants. Based on this ratio of usage oftextured versus smooth implants in this single

year, and assuming that the usage ratio is relativelyconstant, textured Biocell implants were statisti-cally more likely to be associated with late seroma(p � 0.0001) compared with smooth implants inthis study. This series represents the retrospectiveevaluation of three independent plastic surgeons.Each of the surgeons had his or her own specificdecision process for selecting the particular treat-ment plan for each patient. Although care is in-dividualized to each patient, each plastic surgeonhad his or her own individual thought process thatdrove treatment selection.

Dr. Spear’s decision process centered on nar-rowing the diagnosis, followed by a definitive treat-ment. Specifically, if a late swelling developed ina patient with a breast implant, the patient was firstbrought for serial examinations over several weeksto determine whether the symptoms progressed orresolved spontaneously. If there was any erythema,warmth, or malaise, the patient was empiricallystarted on antibiotics. Those patients whose swell-ing did not appear to be infectious (either no signsof infection or the swelling remained despite acourse of antibiotics) were then deemed to havelate seromas. The patient was sent for a diagnosticultrasound; if the radiologist found that it could beeasily and safely tapped, then it was drained andsent for studies; if the seroma did not recur fol-lowing such drainage, then no further interven-tion was performed. If the seroma was not percu-taneously drained, then the patient was taken tothe operating room, where the seroma wasdrained and the periprosthetic space evaluated.Seroma fluid was sent for Gram stain, aerobic andanaerobic culture, and cytologic analysis. The im-plant was removed, and if the capsule was thick-ened or appeared abnormal in any way, a surgicalcapsulectomy or capsule curretage was per-formed. The cavity was irrigated copiously withBetadine (Purdue Products, Stamford, Conn.) ir-rigation followed by antibiotic-containing saline,and then a new smooth implant was placed in thesame setting. Of the 11 breast seromas treated byDr. Spear, all underwent capsulectomy (100 per-cent), nine (82 percent) underwent capsulectomyand implant exchange, and two (18 percent) hadcapsulectomy and implant removal without place-ment of new implants.

Dr. Glicksman’s decision-making process cen-tered around avoiding the loss of an implant dueto an infection. If the patient presented with lateswelling associated with any signs/symptoms ofinfection (erythema, warmth), then the patientwas empirically prescribed oral antibiotics, whilean attempt was made to schedule a diagnostic

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ultrasound with aspiration of periprosthetic fluidas soon as possible. Fluid collected was sent foraerobic and anaerobic cultures and Gram stain;cytologic analysis was requested on all reconstruc-tive patients who presented with late seromas since2009. Not all late seroma patients were compliant,and several refused ultrasound and drainage. If apatient underwent ultrasound-guided drainageand there was no recurrence of swelling within 6months, then no further intervention was per-formed. In those patients with older generationround silicone gel or McGhan Style 153 implants,imaging studies were performed to evaluate forrupture. Patients with ruptured implants underwentexplantation, capsulectomy, and replacement witheither smooth or Biocell textured devices. Patientswith evidence of infection underwent explantationwithout replacement.

If the ultrasound-guided drainage was fol-lowed by seroma recurrence with no evidence ofinfection, the patient was given the option of re-peat ultrasound-guided drainage or implant re-moval with cultures, Gram stain, triple antibioticirrigation, Betadine irrigation, complete capsulec-tomy, and replacement to a new implant. Of theeight breast seromas treated by Dr. Glicksman,three underwent capsulectomy and implant ex-change, three had ultrasound-guided drainagealone, and two were treated with antibiotics alone.

Dr. Brown’s approach was to initially assess for ahistory of trauma and to examine for any evidenceof infection. If a fluid wave was clearly visible, hegenerally attempted ultrasound-guided drainage,sending fluid for culture and cytology. If the seromaresolved with aspiration, he then prescribed a courseof anti-inflammatory medications and/or antibiot-ics. If the seroma recurred following ultrasound-guided drainage, then the patient was taken to theoperating room for exploration. If the capsule wasmature and thin, without evidence of infection, thenthe wound was irrigated and the implant replaced;capsulotomy was performed if necessary. If the cap-sule was thickened, then a capsulectomy was per-formed and the implant usually changed. Of thenine breast seromas treated by Dr. Brown, threeunderwent capsulectomy and implant exchange,three had implants exchanged without capsulec-tomy, two had ultrasound-guided drainage alone,and one was treated with antibiotics alone.

DISCUSSIONThe etiology of late periprosthetic breast se-

romas has been the subject of speculation withoutany clear cut consensus regarding their frequencyor likely usual cause. There have been only a hand-

ful of case and small series reports of lateseromas.6–14 Fewer than 20 cases of late seromashave been published to date. Suspected causes oflate seroma have included clinical infection, sub-clinical infection (including biofilm), malignancy(including anaplastic large cell lymphoma), cap-sule tear, microtrauma, mechanical shearing, andidiopathic. In a 2004 article, Adams and col-leagues published a comprehensive article on themanagement of a wide variety of breast implant–related issues in an effort to address the U.S. Foodand Drug Administration’s concern over reopera-tion rates, and to guide physicians and patients inthe management of certain potentially challeng-ing situations.15 They made comprehensive diag-nostic and therapeutic recommendations for thefollowing six scenarios: request for implant sizeexchange, capsular contracture, stretch deformi-ties, silent rupture, undefined systemic symptomcomplexes, and possible periprosthetic space in-fection or seroma. At that point in time, the em-phasis was mostly on diagnosing and treating in-fection rather than on seroma. Once infection wasruled out clinically and by culture, options forseroma management included, in part, doingnothing, removal of one or both implants, andremoving the affected implant and surroundingcapsule with or without replacement. There didnot appear at that time to have been any special orheightened concern regarding malignancy or acausative role for any one type of implant.

The relationship between implant type andthe development of late seroma has been unclear.Hall-Findlay recently reported her observationsthat late seromas appeared more common withcertain aggressively textured implants.16 She re-viewed 626 consecutive patients who underwentprimary bilateral breast augmentation or primarybilateral mastopexy-augmentations after the mor-atorium in 1992. A total of 105 patients (17 per-cent) in her report had Biocell textured siliconeimplants placed. She found double capsules in 14patients, all of whom had Biocell textured surfacesilicone implants. Of these 14 patients, three hadseromas. She further reports that she had no lateseromas or double capsules in her primary aug-mentations between 1983 and 2006, before shestarted using Biocell implants, and suggests thatseromas and double capsules are therefore a com-plication unique to these aggressively texturedBiocell implants.

In our current study, 27 of 28 (96 percent) ofour reported late seromas were associated withBiocell textured implants, whereas our percentageof Biocell textured implants used in our three

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practices during that overlapping year rangedfrom 14 percent (S.L.S.) to 94 percent (C.G.), withan overall mean of 49 percent. Although our se-roma data regarding texturing are dominated bythe Biocell type of textured implant, this resultcould be in part due to selection bias because onlythe Biocell type of textured implant is used in ourpractices.

The subject of late seromas after breast im-plants has received renewed interest with the re-cent description of anaplastic large cell lymphomaoccurring after the placement of breast implants.Part of the presentation of this lymphoma hasbeen its frequent association with a late symptom-atic swelling or seroma around a breast implant. Intheir systematic review of anaplastic large cell lym-phoma, Kim and colleagues were able to identify34 articles that included 36 cases of it and othernon-Hodgkin’s lymphomas involving the breast.17

Twenty-nine of the 36 (81 percent) were anaplas-tic large cell lymphoma. Fourteen of the 29 cases(48 percent) were reported as presenting with aseroma, whereas another 14 of the 29 cases (48percent) did not provide sufficient information toascertain whether a seroma was the presentingcomplaint or not. Only one (3 percent) was spec-ified as not presenting as a seroma.

Increasing concern about the management ofsuch late seromas and the heightened awarenessof the possibility of associated malignancy has ledto various new recommendations or algorithmsfor late seroma management.18 These algorithmsinclude obtaining fluid for sophisticated cytologyand culture.19 There are also more recent specificrecommendations for what sort of cytological andpathological examinations are appropriate de-pending on the fluid and capsule findings. Cur-rent routine culture techniques are not suffi-ciently sensitive or accurate for the detection ofchronic biofilm infections. In addition, biofilmevaluation techniques are not available at everyfacility. Despite these valid recommendations, it isinteresting to note that all 25 cultures performedin this report were negative, as were the 25 spec-imens sent for cytology. The potential benefit ofsuch more sophisticated and important tests de-spite their theoretical significant value may be verylow, based on our experience of successful man-agement of such late seromas without this newinformation.

All but one of the patients in our series wereultimately successfully treated for their seromas,and none had any clear evidence of malignancy ordocumented subclinical infection. The successfuloutcomes of our reported cases support the no-

tion that all or most of these late seromas wereidiopathic in the sense that we were unable todocument either a suspected infection or occultmalignancy. Although the relationship betweenbiofilm and capsular contracture has beendocumented,20,21 the connection between biofilmand late seroma has not yet.16 Biofilm does needto be at least considered as a possible etiology inthe future. However, without specifically treatingor looking for a biofilm source, 27 of our 28 casesof late seroma were successfully treated with thedescribed methods. Among the 28 seromas de-scribed in this study, 13 (46 percent) had associatedfindings that suggest an etiology or at least an ag-gravating factor. These factors include suspected(but undocumented) infection (five breasts, 18 per-cent), implant rupture or bleed (four breasts, 14percent), trauma (three breasts, 11 percent), anddark fluid resembling old hematoma (two breasts,7 percent). Although all 13 of these breasts had aclinical diagnosis of seroma at the time of treat-ment, the associated findings raise the suspicionthat these factors contributed to seroma forma-tion. All the patients with findings suggestive ofinfection had fluid sent for culture, yet the resultswere uniformly negative. Although systemic anti-biotics might have reduced many of the symptomsof infection, the inflammatory effects probablymanifested as seroma. Similarly, hematoma, gelbleeding, and trauma could have promoted aninflammatory reaction that resulted in seroma inthese cases.

There are a variety of recently described meth-ods to manage late seromas.18,19 The literature sug-gests early acquisition of the seroma fluid to ruleout infection and malignancy with microbiologyand cytology evaluation. The physician must de-cide whether to proceed with percutaneous versusopen therapeutic drainage of the fluid collection.If the decision is made to surgically drain theseroma, the capsule needs to be inspected to de-termine whether local biopsy or total capsulec-tomy is necessary. Implant replacement also needsto be considered. In our series, the most commonmethods were implant replacement and seromadrainage (18 of 28, 64 percent), with capsulec-tomy in 15 of 28 (54 percent), or without capsu-lectomy in three of 28 (11 percent). Indicationsfor capsulectomy include but are not limited to athick, nonpliable capsule, evidence of infection orinflammation or an abnormal mass within the cap-sule, or failure of a prior drainage procedure. Itshould be noted that if biofilm is in fact part of theetiology of a late seroma, such implant replace-ment and total capsulectomy would most likely

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also be the most effective way of successfully treat-ing the problem and reducing the risk of recur-rence.

The fact that these late seromas were success-fully managed by a variety of different approachesspeaks to the possibility of trying less aggressivetreatment plans first. So, depending on the clin-ical circumstances, ultrasound-guided therapeuticaspiration with culture and cytology may often bea rational first step. If this resolves the problem,nothing further need be done. On the other hand,the more definitive and reliable approach appearsto be surgical intervention with drainage, deviceexchange, and possible capsulectomy. One sur-prising feature of this review was the equivalentand almost paradoxical success with implant ex-change whether replacing with a new Biocell tex-tured or smooth implant.

Although in an early case in our series wereplaced a smooth implant with a Biocell textureddevice at the time of seroma drainage and capsu-lectomy, the fact that 27 of 28 of our late seromasoccurred with Biocell textured implants certainlysuggests that replacement of a textured implantwith a smooth implant when possible should log-ically maximally reduce the likelihood of a recur-rence, especially in the long run. With late sero-mas seen most often with Biocell texturedimplants, replacement with a smooth implantseems logical. Also, given the fact that seromaaspiration alone was successful 56 percent of thetime, this might be an appropriate first step bothdiagnostically and therapeutically for many pa-tients. Our experience supports the hypothesisthat late seromas are most reliably treated withimplant exchange with or without capsulectomybased on success with that approach in 19 of 20breasts. Finally, it is important to remember thatthese cases represent seromas that developed late(at least 1 year) following implant placement. Ourstudy is not geared to address whether the treat-ment would prevent future late seromas, and al-though some of our patients were followed formore than 1 year, we cannot speculate on whetherthese patients might develop a new longer-termlate seroma.

CONCLUSIONSBased on our experience in this series, includ-

ing following routine microbiology and cytologystudies, the majority of late seromas seen in ourpractices remain defined as idiopathic, withouthard evidence of infection or malignancy. Theoverwhelming majority of such seromas in thisreport of 28 cases were found to involve a Biocell

textured surface breast implant. A graduated hi-erarchy of different management strategies maybe appropriate, with surgical intervention and de-vice replacement being the most definitive. Vir-tually all implant-related late breast seromas in thisseries were successfully managed by the variousdescribed techniques. The recent increased inter-est in biofilm and anaplastic large cell lymphomain association with breast implants will likely en-courage more sophisticated testing and more ag-gressive treatment of late seromas and capsules,but in the meantime, this study suggests that thesepatients can be successfully treated with less so-phisticated means.

Scott L. Spear, M.D.Georgetown University Hospital

3800 Reservoir Road, NWPHC Building, 1st FloorWashington, D.C. 20007

[email protected]

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2. Wirth GA, Brenner KA, Sundine MJ. Delayed silicone breastimplant infection with Mycobacterium avium-intracellulare. Aes-thet Surg J. 2007;27:167–171.

3. Clegg HW, Bertagnoll P, Hightower AW, Baine WB. Mam-maplasty- associated mycobacterial infection: A survey of plas-tic surgeons. Plast Reconstr Surg. 1983;72:165–169.

4. U.S. Food and Drug Administration. Anaplastic large celllymphoma (ALCL) in women with breast implants: Prelim-inary FDA findings and analyses. Available at: AccessedNovember 2011.

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10. Fodor L, Moscona R. Late post-traumatic intracapsular se-roma after breast augmentation. J Plast Reconstr Aesthet Surg.2009;62:e609–e610.

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13. Tansley PD, Powell BW. Late swelling after bilateral breastaugmentation. J Plast Reconstr Aesthet Surg. 2011;64:261–263.

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20. Tamboto H, Vickery K, Deva AK. Subclinical (biofilm) in-fection causes capsular contracture in a porcine model fol-lowing augmentation mammaplasty. Plast Reconstr Surg. 2010;126:835–842.

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New Submission Guideline: Level of EvidenceBeginning with submissions made July 1, 2011, and going forward, all manuscripts amenable to Level ofEvidence grading need to indicate the clinical question addressed by the article and the Level of Evidence.The clinical question will be one of three categories: Diagnostic, Therapeutic, or Risk. Please use the ASPSLevels of Evidence and Grading Recommendations: Evidence Rating Scales to grade the level of evidencein your manuscript.

In general, the following types of articles are not gradable for level of evidence:

• Animal studies

• Cadaver studies

• Basic science studies

• Review articles

• Instructional course lectures

• CME courses

• Editorials

• Correspondence

As far as what is or is not ratable, the standard is to exclude basic science, bench work, animal, and cadavericstudies because the information gained from these studies is not something that can be applied directly topatient treatment decisions.

See the article “The Level of Evidence Pyramid: Indicating Levels of Evidence in Plastic and ReconstructiveSurgery Articles,” in the July 2011 issue (Plast Reconstr Surg. 2011;128:311–314), for more information ondetermining the Level of Evidence of your manuscript.

NOTE: While we require authors to provide an initial Level of Evidence grade for their submissions, the finalLOE grade for accepted papers will be determined and assigned by an independent panel of LOE experts,whose determination is final.

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