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www.PRSGO.com 1
For women with breast cancer requiring mastec-
tomy, breast reconstruction may improve body
image and provide significant psychosocial
benefits.1 Although autologous reconstruction tradi-
tionally has been associated with the highest patient
satisfaction in terms of aesthetic outcomes,2–4 implant-
based reconstruction is by far the most common ap-
proach to postmastectomy breast reconstruction in
the United States.5 Of approximately 92,000 breast
reconstructions performed in 2012, slightly more
than 72,000 were implant based, and of those, the
vast majority (64,575) were 2-stage tissue expander/
implant reconstructions.5 Compared with autologous
Received for publication April 3, 2014; accepted April 29,
2014.
Copyright © 2014 The Authors. Published by Lippincott
Williams & Wilkins on behalf of The American Society of
Plastic Surgeons. PRS Global Open is a publication of the
American Society of Plastic Surgeons. This is an open-access
article distributed under the terms of the Creative Commons
Attribution-NonCommercial-NoDerivatives 3.0 License,
where it is permissible to download and share the work
provided it is properly cited. The work cannot be changed in
any way or used commercially.
DOI: 10.1097/GOX.0000000000000140
From the *Assuta and Herzlia Medical Centers, Tel Aviv,
Israel; and †Division of Plastic Surgery, Massachusetts Gen-
eral Hospital, Harvard Medical School, Boston, Mass.
Background: Tissue reinforcement with allogeneic or xenogeneic acellular
dermal matrices (ADMs) is increasingly used in single-stage (direct-to-implant)
and 2-stage implant-based breast reconstruction following mastectomy. ADMs
allow surgeons to control implant position and obviate the need for submuscu-
lar implant placement. Here, we review the benefits and risks of using ADMs in
implant-based breast reconstruction based on available data.
Methods: A comprehensive analysis of the literature with focus on recent
publications was performed. Additional information regarding the proper
use of ADMs was based on our institutional experience.
Results: ADM use may improve definition of the lateral confines of the breast
and lower pole projection. It may facilitate direct-to-implant procedures and
improve aesthetic outcomes. The effect of ADMs on complication rates re-
mains controversial. Known patient risk factors such as obesity, smoking, and
radiotherapy should be considered during patient selection. For patients
with healthy, well-vascularized skin envelopes, ADM-assisted direct-to- implant
reconstruction is a safe and cost-effective alternative to 2-stage implant
reconstruction, with low complication rates. ADMs may be used to treat
capsular contracture, and limited available data further suggest the possibility
that ADMs may reduce the risk of capsular contracture. Novel synthetic or bio-
synthetic tissue reinforcement devices with different physical and ease-of-use
properties than ADMs are emerging options for reconstructive surgeons and
patients who seek to avoid tissue products from human or mammalian cadavers.
Conclusions: ADM-assisted implant-based breast reconstruction may improve
aesthetic outcomes. However, appropriate patient selection, surgical tech-
nique, and postoperative management are critical for its success, including
minimizing the risk of complications. (Plast Reconstr Surg Glob Open 2014;2:e192;
doi: 10.1097/GOX.0000000000000140; Published online 4 August 2014.)
Michael Scheflan, MD*
Amy S. Colwell, MD, FACS†
Tissue Reinforcement in Implant-based Breast
Reconstruction
Disclosure: Medical writing support for this manu-
script was funded by Allergan, Inc. Dr. Scheflan serves
as a consultant for Allergan, Inc., and a clinical inves-
tigator for TEI Biosciences Inc. Dr. Colwell is a consul-
tant for Allergan, Inc. and LifeCell Corp. The Article
Processing Charge was paid for by Allergan, Inc.
Tissue Reinforcement for Breast Implants
Scheflan and Colwell
xxx
xxx
8
Mary
Plastic & Reconstructive Surgery-Global Open
2014
2
Special Topic
10.1097/GOX.0000000000000140
29April2014
3April2014
(c) 2014 The Authors. Published by Lippincott Williams & Wilkins on behalf of The Amer-
ican Society of Plastic Surgeons. PRS Global Open is a publication of the American Society
of Plastic Surgeons.
Breast
SPECIAL TOPIC
PRS GO • 2014
2
reconstructions, implant-based reconstructions are
simpler, take less time to perform, are less invasive,
support faster patient recovery,2,6 and avoid the need
for donor site surgery, which may cause significant
postoperative deterioration of physical well-being.7
In addition, they are believed to have more favorable
third-party reimbursement limits.8
The increasing availability of acellular dermal ma-
trices (ADMs) prepared from human or animal cadav-
ers for tissue reinforcement provides plastic surgeons
with a unique tool to improve aesthetic outcomes of
implant-based reconstruction by expanding and re-
shaping the implant pocket, while further reducing
the invasiveness of surgical intervention.9–15 The sub-
stantial pain caused by the serratus anterior elevation
necessary for total or partial muscle coverage can be
avoided, as lateral coverage is provided by the ADM.
However, results of a prospective randomized study in
70 patients who underwent immediate ADM-assisted
or conventional submuscular tissue expander/im-
plant reconstruction after mastectomy revealed no
significant differences between these patient groups
in immediate postoperative pain or pain during the
expansion phase.16 In addition to providing mechani-
cal stability, ADMs facilitate cellular and vascular infil-
tration during wound healing and tissue regeneration
through incorporation of the matrix. Since the first
publication of ADM-assisted primary breast recon-
struction in 2005,9 an increasing number of products
have become available in the United States (Table 1).
In Israel, AlloDerm (LifeCell Corp., Branchburg,
N.J.), the prototypical ADM of human dermal origin,
has been available since 2005 and SurgiMend (TEI
Biosciences Inc., Boston, Mass.), a fenestrated ADM
derived from fetal bovine dermis, has been available
since 2008. Allogeneic ADMs are not extensively used
in many European countries because of regulatory re-
strictions on human tissue products and cost consid-
erations favoring alternative products.18,19
In this review, we describe the benefits of tissue re-
inforcement in implant-based breast reconstruction,
such as improved aesthetic outcomes, provide cost
considerations, and discuss the risk of postoperative
complications. Moreover, we provide recommenda-
tions based on our own experience for how the risk
of complications can be minimized by appropriate
patient selection, surgical technique, and postopera-
tive management.
IMMEDIATE IMPLANT-BASED
RECONSTRUCTION WITH AND
WITHOUT TISSUE REINFORCEMENT
Conventional Implant-based Reconstruction
Conventional implant-based reconstruction af-
ter mastectomy requires the creation of an implant
pocket beneath the pectoralis major muscle for total
or partial muscle implant coverage (Table 2). For to-
tal muscle coverage, elevation of the serratus anterior
muscle is required for lateral coverage and support.
Total muscle coverage limits the possible anterior
and inferior projection and thus may lead to less
than optimal aesthetic outcomes. Furthermore, be-
cause the size of the implant pocket that can initially
be created with this approach is constrained by avail-
able skin and muscle tissue after the mastectomy, im-
mediate reconstruction generally requires a 2-stage
procedure, in which a tissue expander is implanted
first, then gradually expanded over several months,
and eventually replaced by a permanent implant.21
Implant-based Reconstruction with ADMs
The use of ADMs enables the formation of larg-
er implant pockets and optimal implant position-
ing without the need for serratus anterior muscle
elevation. Provided the skin is sufficiently healthy,
ADM use in 2-stage reconstruction allows for more
predictable tissue expander position, larger intra-
operative expander fill volumes, and fewer expansions
compared with submuscular placement.13,22–25
An important aspect of ADM use is that it facili-
tates immediate direct-to-implant reconstruction
Table 1. Allogeneic and Xenogeneic Soft Tissue Reinforcement Devices Available in the United States17
Product Year
Introduced Manufacturer Material Origin Sterile Hydration
Time
AlloDerm 1994 LifeCell Corp. Human dermis No (aseptically processed) 10–40 min
AlloDerm Ready To Use 2012 LifeCell Corp. Human dermis Yes ≥2 min
DermaMatrix 2005 Synthes, Inc.
(West Chester, Pa.) Human dermis No (aseptically processed) 3 min
FlexHD 2007 Ethicon, Inc. Human dermis No (aseptically processed) None
AlloMax ≥2009 Davol Inc. (Warwick, R.I.) Human dermis Yes “Rapidly”
Repriza 2010 Specialty Surgical Products,
Inc. (Victor, Mont.) Human dermis Yes None
Strattice 2008 LifeCell Corp. Porcine dermis Yes ≥2 min
Veritas Collagen Matrix 2001 Synovis (St Paul, Minn.) Bovine pericardium Yes None
SurgiMend 2006 TEI Biosciences Inc. Fetal bovine dermis Yes 60 s
Scheflan and Colwell • Tissue Reinforcement for Breast Implants
3
(Table 2, Fig. 1) in appropriately selected patients
by allowing precise positioning of a full-sized per-
manent implant, with favorable aesthetic outcomes
and minimal risk of implant displacement, visibil-
ity, rippling, or extrusion.10–12,20,26–28 Moreover, ADM
materials that are not completely resorbed help
prevent pectoralis muscle retraction and offer addi-
tional soft tissue coverage in the lower pole of the
breast. Experience from 331 consecutive immediate
direct-to-implant reconstructions performed with
AlloDerm at the Massachusetts General Hospital
suggests that this approach is associated with favor-
able aesthetic outcomes and low complication rates
in patients with thick, well-vascularized skin flaps
after skin-sparing or nipple-sparing mastectomy.20
Similarly, the use of a SurgiMend in 341 consecutive
Table 2. Surgical Techniques of Total and Partial Muscle Coverage and of ADM-assisted Direct-to-implant
Reconstruction
Total muscle
coverage The pectoralis major muscle is elevated lateral to medial by electrocautery after the lateral edge has
been identified. The inferior and medial origins are maintained. The serratus anterior muscle is
elevated over the fourth, fifth, and sixth ribs by electrocautery. The superior portion of the rectus
abdominis fascia or muscle may be included in the dissection of the muscular pocket to facilitate
positioning of the tissue expander and help prevent superior malposition. One or 2 closed-suction
drains are placed to facilitate drainage and help prevent seroma.
Partial muscle
coverage The pectoralis muscle is elevated and partially released inferiorly to allow greater lower pole expan-
sion. The medial most sternal origin should be released inferiorly to allow the implant to fit medially
and obtain cleavage. This typically corresponds to the 4 and 8 o’clock positions on the chest wall but
may be advanced to the 3 or 9 o’clock positions if necessary. Sutures are typically used to prevent
retraction of the pectoralis muscle, and the serratus muscle is often elevated to help cover the
expander laterally and prevent lateral malposition
ADM-assisted
direct-to-implant
reconstruction
In one technique, the pectoralis major muscle is elevated from the chest wall inferiorly up to the 3 or
9 o’clock position medially, and a tailored ADM is placed in the pocket and sewn to the pectoralis
muscle. In another technique, the pectoralis major muscle is elevated up to the 4 or 8 o’clock
position medially, and a rectangular ADM is sewn to the inframammary fold, if present and well
preserved, or to the thoracic fascia to create a new fold. After placement of the implant into the
subpectoralis/sub-ADM pocket, a drain each is placed into the pocket along the inframammary fold
and into the lateral pocket margin.10,20
Fig. 1. Use of ADM in implant-based breast reconstruction. Shown are the techniques prac-
ticed at the Assuta Medical Center (AMC), Tel Aviv (A)17 and the Massachusetts General Hospital
(MGH), Boston (B).10,20 The inferior origin of the pectoralis major is released on the aponeurosis
of the external oblique and on the inferior sternum, with pectoralis elevation up to the 3 and
9 o’clock position (AMC) or the 4 and 8 o’clock position (MGH). A tailored fenestrated semioval
(AMC) or a standard rectangular (MGH) ADM sheet is sewn inferiorly to the thoracic fascia or
inframammary fold (if intact) and laterally to the thoracic fascia to form the implant pocket. In
the AMC technique, the semioval ADM is split, and the medial and lateral tails are sutured to
the pectoralis major with deep overlap of the tails underneath the muscle (A). In the MGH tech-
nique, the rectangular ADM is sewn edge to edge to the pectoralis major without overlap (B).
PRS GO • 2014
4
immediate implant-based reconstructions after total
skin-sparing mastectomy, including 270 direct-to-
implant reconstructions, performed between 2001
and 2011 at the Assuta Medical Center in Tel Aviv,
Israel, provided superior aesthetic results and simi-
lar rates of complications compared with traditional
procedures.17
In the past, patient satisfaction tended to be lower
with implant-based rather than autologous recon-
struction,3 which may be due in part to the limitations
in shaping the implant pocket during conventional
implant-based procedures. In our experience, the ad-
vent of ADM and nipple-sparing procedures, includ-
ing ADM-assisted direct-to-implant reconstruction,
has allowed for significant improvements in overall
aesthetic results of implant-based reconstruction, with
the potential to increase patient satisfaction scores in
the future. Furthermore, evaluation of aesthetic out-
comes of 183 tissue expander–based reconstructions
performed at a single institution showed that ADM
use (58 reconstructions) was associated with signifi-
cantly higher aesthetic scores compared with total
submuscular reconstruction (125 reconstructions).29
PATIENT RISK FACTORS
FOR COMPLICATIONS AND
RECONSTRUCTIVE FAILURE
A number of database analyses consistently identi-
fied high body mass index and smoking as indepen-
dent risk factors for complications and/or implant
loss.30–32 For 1170 two-stage breast reconstructions
performed over a 2-year period, smoking, obesity, and
hyper tension each increased the odds of reconstructive
failure by factors of 5, 7, and 4, respectively.30 For more
than 14,000 reconstructions with or without ADM cap-
tured in the Tracking Outcomes and Operations in
Plastic Surgery (TOPS) database between 2008 and
2011, high body mass index, smoking, and diabetes
were independent risk factors for expander/implant
loss.31 ADM use seems to have no substantial influence
on patient-related risk factors.31,33 A recent analysis of
data from the American College of Surgeons National
Surgical Quality Improvement Program, which identi-
fied smoking and body mass index as independent risk
factors for short-term complications, found no statisti-
cally significant risk differences between immediate
ADM-assisted (n = 1717) and submuscular (n = 7442)
tissue expander reconstruction.32
ADM USE AND POSTOPERATIVE
COMPLICATIONS
A persistent concern among plastic surgeons is
whether ADMs increase the risk of short-term com-
plications, given the conflicting findings from retro-
spective studies,13,16,20,24,25,33–43 systematic reviews,23,44
and meta-analyses.22,45,46 However, although meta-
analyses (level III evidence) found increased risks
of infection, seroma, and/or implant loss associated
with ADM use,22,45,46 some recent large studies (level II
or III evidence) not included in these analyses found
similar or lower complication rates for ADM-assisted
versus traditional 2-stage reconstruction.20,25,35,37 For
example, a comparative study of 479 implant-based
reconstructions found no difference in total com-
plication rates or rates of infection and seroma
between ADM-assisted direct-to-implant reconstruc-
tion compared with 2-stage tissue expander/implant
reconstruction without ADM (Table 3).20 Similarly,
in a recent prospective cohort study, ADM use was
associated with significant reductions in expander/
implant loss (Table 2) and unexpected returns to
the operation room.35 These findings suggest that
ADM use itself is not an independent risk factor for
complications and that the large discrepancies in
findings among different institutions may be attrib-
utable to other factors. This view is supported by the
results of recent, large-scale National Surgical Qual-
ity Improvement Program and TOPS analyses.31,47
Although the TOPS analysis showed that ADM use
(versus no ADM use) was associated with a statisti-
cally significant increase in the risk of expander/
implant loss (odds ratio, 1.42; 95% confidence inter-
val, 1.04–1.94; P = 0.026), the absolute risk increase
was only 0.7%.31
In our experience, the vast majority of complica-
tions attributed to ADM-assisted reconstruction are
avoidable by appropriate patient selection and sur-
gical technique. An emerging consensus on the im-
portance of these factors is reflected in the recently
published joint guidelines from the Association of
Breast Surgery and the British Association of Plastic,
Reconstructive and Aesthetic Surgeons48 and recom-
mendations by other experts in the field.49,50 Effec-
tive coordination of mastectomy and reconstructive
surgery to ensure optimal viability of the skin en-
velope may further improve outcomes. Familiarity
of the reconstructive surgeon with optimal device-
specific techniques also is crucial for avoiding com-
plications. In 331 consecutive ADM-assisted 1-stage
implantations conducted between 2006 and 2009 at
the Massachusetts General Hospital, increasing ex-
perience of the surgeons and better communication
with the breast surgeon substantially reduced the
incidence of skin necrosis, resulting in a significant
2-fold reduction in total complication rates from
the surgeons’ first to subsequent years of perform-
ing the procedure (21.4%–10.9%; P < 0.02).20 How-
ever, if skin viability is questionable at the time of
the mastectomy, total muscle coverage (rather than
Scheflan and Colwell • Tissue Reinforcement for Breast Implants
5
Table 3. Complication Rates with ADM-assisted and Conventional Implant-based Breast Reconstruction in Controlled Studies
Source
No.
Reconstructions
(Patients)* Total
Complications, % Infections, % Seroma, % Skin Necrosis, %
Reconstructive
Failure or Implant
Loss, %
ADM Non-
ADM ADM Non-
ADM PADM Non-
ADM PADM Non-
ADM PADM Non-
ADM PADM Non-
ADM P
ADM-assisted direct-to-implant versus 2-stage tissue expander/implant with partial or total submuscular placement
Colwell et al20 331 148 14.8 19.6 0.180 3.0 5.7 0.152 1.5 1.9 0.810 9.1 10.1 0.722 1.5 7.0 0.002
ADM-assisted versus non-ADM 2-stage implant-based reconstruction with tissue expanders or implants
McCarthy et al16 (36) (33) 17 15 1.00
Parks et al34 346 165 29.9 15.7 <0.001 11.9 11.5 0.88 11.6 8.4 0.35
Seth et al25 199 393 18.1 14.3 0.19 7.0 4.3 0.17 4.0 2.0 0.18 8.5† 6.6† 0.41 8.5 7.4 0.63
Peled et al35 100 90 20.0 27.8 0.04 4 4.4 0.75 6.0 11.1 0.26 7.0 17.8 0.001
260‡ 15.8 5.8 6.2 5.0
Weichman et al36 442 186 15.3§ 5.4§ 0.001 8.6¶ 2.7¶ 0.001 1.8 3.2 0.326 8.3 3.2 0.005 7.7 2.7 0.004
Vardanian et al37 208 129 29.3 40.3 0.038 1.0 2.3 0.314 2.4‖1.6‖0.593
Hanna et al24 38 (31) 62 (44) 41.9 38.6 0.814 16.1¶ 4.5¶ 0.118 19.4 13.6 0.537 6.5† 2.3† 0.566 16.1 4.5 0.118
Liu et al38 266 204 19.5 12.3 0.034 6.8 2.5 0.031 7.1 3.9 0.136 13.9 10.8 0.310
Antony et al33 153 2910 23.6 12.4 ND 3.3 1.3 ND 7.2 1.6 ND 4.6 6.5 ND 5.9 1.9 ND
Lanier et al39 52 75 46.2 22.7 0.007 28.9 12.0 0.022 15.4 6.7 0.14 15.4 5.3 0.069 19.2 5.3 0.020
Chun et al40 269** 146** 8.9 2.1 0.033 14.1 2.7 <0.001 23.4 8.9 <0.001
Nguyen et al41 75 246 5.3¶ 2.8¶ 0.291 8.0‡‡ 1.6‡‡ 0.013
Nahabedian42 100 376 5.0 5.9 ND 2.0 5.3 ND
Sbitany et al13 92 (50) 84 (50) 18 14 0.79 8.0 6.0 0.99 6.0 6.0 1.0 8.0 6.0 0.99
Preminger et al43 45 45 15.6 6.7 0.180 6.7 4.4 0.645
*Complication rates were based on the number of reconstructions, or on the number of patients where patient numbers are indicated.
†Major flap or skin necrosis.
‡Patient selected for ADM due to thin skin envelope.
§Major complications only.
¶Requiring intravenous antibiotics.
‖Seroma or hematoma.
**Reconstructions may have included direct-to-implant procedures.
‡‡Explantation due to infection, seroma, or extrusion.
ND indicates not determined.
PRS GO • 2014
6
partial muscle release with or without ADM) should
be considered even if this may negatively affect the
final aesthetic outcome (Fig. 2).
THE RISK OF CAPSULAR
CONTRACTURE
Capsular contracture is a common risk of im-
plant-based reconstruction, particularly in the set-
ting of radiotherapy.51–54 A variety of factors may
contribute to development of capsular contracture,
including but not limited to insufficient sterility
during surgery, hematoma, mechanical strain on
the inferior skin envelope, type and surface proper-
ties of the implant, and radiation therapy.55,56 It has
been suggested that the use of ADMs may minimize
capsular contracture by reducing pressure on the
inferior breast skin envelope,20 which in turn may
reduce fibroblast stimulation and inflammation.57,58
In a retrospective comparison of 2-stage reconstruc-
tion with and without ADM use during expander
implantation in 203 patients, the capsular contrac-
ture rate was significantly lower for ADM-assisted
reconstructions (3.8% versus 19.4%; P < 0.001)
at a mean follow-up after implant exchange of 29
months.37 Moreover, a remarkably low capsular
contracture rate of only 0.4% was observed in an
8-year study of 466 ADM-assisted direct-to-implant
breast reconstructions with a mean follow-up of
29 months,27 and ADM use, including complete
implant coverage, has been used successfully in
the treatment of capsular contracture.55,59 How-
ever, given that the risk of implant-related capsular
contracture increases over time,60 it remains to be
demonstrated whether ADMs reduce the long-term
risk of capsular contracture. Furthermore, it is pres-
ently unclear whether non–ADM-based tissue rein-
forcements can influence the incidence of capsular
contracture.
EFFECT OF RADIOTHERAPY
A major concern with implant-based breast recon-
struction is the effect of radiation therapy on compli-
cation rates.61 Radiation therapy given before or after
mastectomy has been associated with significantly
increased rates of major complications,62 including
implant removal or replacement25,63 and capsular
contracture.51,53,54 However, a recent systematic review
found that ADM did not increase the complication
rate in the setting of radiotherapy.64 Similarly, an-
other recent literature review concluded that ADM
use essentially had a neutral effect on postoperative
complications among patients who received adjuvant
radiation therapy after implant-based reconstruc-
tion,65 and results of a recent retrospective study even
suggested that ADM use may significantly reduce the
odds of complications (including explantation) in the
setting of postmastectomy radiation therapy.25
Among patients who received a total of 479 ADM-
assisted direct-to-implant or conventional 2-stage re-
constructions at the Massachusetts General Hospital,
radiotherapy was associated with an increased rate
of early complications. Among patients who received
radiation, the highest complication rate was seen in
the setting of preoperative irradiation and conven-
tional 2-stage reconstruction (41.1%), whereas the
lowest rate was seen in direct-to-implant reconstruc-
tions with postoperative radiation (16.7%).20 The im-
portance of timing of postmastectomy radiotherapy
was also demonstrated in a prospective, controlled
study of 257 patients undergoing subpectoral 2-stage
breast reconstruction.66 Patients who received radio-
therapy on the tissue expander had a significantly
higher failure rate (40%) than those who received
radiotherapy on the permanent implant (6.4%) or
received no radiotherapy (2.3%; P < 0.0001).66
Radiation therapy also seems to affect capsular
contracture rates after ADM-assisted implant-based
Fig. 2. Algorithm for implant-based reconstruction.20 Reprinted with permission from Col-
well AS, Damjanovic B, Zahedi B, et al. Retrospective review of 331 consecutive immediate
single-stage implant reconstructions with acellular dermal matrix: indications, complica-
tions, trends, and cost. Plast Reconstr Surg. 2011;128:1170–1178.
Scheflan and Colwell • Tissue Reinforcement for Breast Implants
7
breast reconstruction. The overall rate of clinically
significant capsular contracture (grade III/IV)
among 341 reconstructions at the Assuta Medical
Center was only 2.0%. Remarkably, capsular contrac-
ture occurred exclusively in patients who previously
received preoperative or postoperative radiation
therapy at a rate of 12.3%.17 In a study of ADM-assisted
2-stage reconstruction in 289 women, radiation
therapy before mastectomy and at expander stage
resulted in dramatically increased rates of infection
(53% and 73%, respectively, versus 1.4% without
radiation) and grade III/IV capsular contractures
(41% and 61%, respectively, versus 1.4% without ra-
diation), although eventual explantation was avoid-
ed in most cases.54 Thus, although the use of ADM in
implant-based reconstruction may reduce the risk of
capsular contracture, it remains to be demonstrated
whether this benefit extends to patients who receive
pre- or postoperative radiation therapy.
COST CONSIDERATIONS
Recent cost analyses including the costs of prob-
able complications in addition to physician and hos-
pital fees estimate that ADM-assisted direct-to-implant
reconstruction may result in moderate to substantial
cost savings compared with traditional 2-stage implant
reconstruction.67,68 At the Massachusetts General Hos-
pital, overall hospital charges of the 2 procedures did
not differ significantly (P = 0.8) because the substan-
tially lower professional fees charged by anesthesiolo-
gists and surgeons for ADM-assisted direct-to-implant
reconstruction were largely offset by higher hospital
charges.20 An important cost factor when using tissue
reinforcement can be the costs of the tissue support
itself, particularly if AlloDerm is used. However, these
costs may decrease with the increasing availability of
lower cost xenogeneic ADMs18 and alternative tissue
reinforcement devices.19,69 Furthermore, overall cost
savings may potentially be larger than currently esti-
mated if future research demonstrated that the use of
ADM-assisted procedures substantially reduces the in-
cidence of implant loss, capsular contracture, time off
from work, and corrective surgery. The usage of ADM
in 2-stage reconstruction increases the material costs
for the procedure. For cost savings to be realized in
this setting, a decreased need for revisions, shorter op-
erative time, and/or lower complication rates would
need to be demonstrated in a cost–benefit analysis.
NON-ADM OPTIONS FOR SOFT TISSUE
REINFORCEMENT
ADMs may vary in their chemical composition
and physical properties, with the potential to affect
the quality and timing of tissue regeneration,70–72
and the risk of complications.18,73–80 Differences in
material-associated risk of inflammation, thickness,
requirements for hydration, and sterility may affect
the handling facility of ADMs and their ability to si-
multaneously provide adequate structural support
and sufficient pliability.81 Patients who do not accept
cadaver material being part of their reconstructed
breasts would benefit from alternative products with
appropriate physical and ease-of-use properties that
are either synthetic or made from biomaterials other
than ADMs.
TiLOOP Bra (pfm medical titanium, Nuremberg,
Germany), a nonabsorbable titanium-coated pro-
pylene mesh approved for breast reconstruction in
Europe, was retrospectively evaluated in 231 breast
reconstructions. Explantation (7.8%) was the most
common major complication, with skin necrosis
and capsule fibrosis identified as significant risk fac-
tors in multivariate analysis.19 TIGR Matrix (Novus
Scientific, Uppsala, Sweden), a synthetic, long-term
resorbable surgical mesh,82 may be beneficial as tem-
porary tissue reinforcement, but clinical experience
to date is very limited.83 A retrospective review of 76
direct-to-implant reconstructions with Vicryl mesh
(Ethicon, Inc., Somerville, N.J.) in 50 consecutive pa-
tients was associated with complications in 5 breasts
(6.6%) including 1 implant loss (1.3%) consequent
to infection.69 Long-term capsular contracture rates
were not reported.69
SERI (Allergan, Inc., Irvine, Calif.), a long-term
bioresorbable, silk-derived surgical scaffold,84–86 re-
ceived 510(k) clearance from the US Food and Drug
Administration for use as soft tissue reinforcement
in plastic and reconstructive surgery. In a single-arm
prospective multicenter study of 2-stage implant-
based breast reconstruction with SERI in the United
States (NCT01256502), complications at 1-year fol-
low-up (n = 105) included necrosis (6.7%), hema-
toma (4.8%), seroma (5.7%), implant loss (3.8%),
cellulitis [minor breast infection requiring antibiotic
treatment (2.9%)], breast infection [major, requir-
ing surgical intervention (1.0%)], and capsular con-
tracture (1.9%), but were considered unrelated to
the use of SERI by the investigators.87
CONCLUSIONS
Tissue reinforcement in implant-based breast
reconstruction may reduce the invasiveness of im-
plant-based procedures and improve aesthetic out-
comes. Appropriate patient selection, proper surgical
technique, and adjusted postoperative management
are critical for the success of ADM-assisted reconstruc-
tion, including minimizing the risk of complications.
For qualifying patients with healthy, well-vascularized
skin envelopes, ADM-assisted direct-to-implant
PRS GO • 2014
8
reconstruction is a safe and cost-effective alternative
to 2-stage implant reconstruction that can provide
excellent aesthetic results. Known patient risk factors
for implant-based reconstruction, such as obesity and
smoking, also apply to ADM-assisted reconstruction
and should be considered during patient selection.
The availability of novel synthetic or biosynthet-
ic tissue reinforcement devices that have different
physical and ease-of-use properties than ADMs may
enhance the ability to refine surgical techniques to
further optimize aesthetic outcomes and minimize
complications.
Amy S. Colwell, MD, FACS
Division of Plastic Surgery
Harvard Medical School
Massachusetts General Hospital
15 Parkman Street
WACC 435
Boston
MA 02114
E-mail: acolwell@partners.org
ACKNOWLEDGMENT
Writing assistance was provided by Roland Tacke, PhD,
of Evidence Scientific Solutions, Philadelphia, Pa., and
funded by Allergan, Inc.
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