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Process of Breast Augmentation
not only immediately but over time, as the trend positively impacts the global breast augmentation market.
In the end, the biggest “winner” in the process of breast
augmentation is the patient … as it should be.
William P. Adams, Jr., M.D.
Department of Plastic Surgery
University of Texas Southwestern Medical Center
6901 Snider Plaza, Suite 120
Dallas, Texas 75204
prs@dr-adams.com
REFERENCES
1. Mentor Corp. Silicone gel and Saline Implant PMA Clinical
Trials. Available at: http://www.fda.gov/cdrh/breastim
plants/index.html. Accessed February 25, 2008.
2. Inamed Corp. Silicone gel and Saline Implant PMA Clinical
Trials. Available at: http://www.fda.gov/cdrh/breastim
plants/index.html. Accessed February 25, 2008.
3. Tebbetts, J. B., and Adams, W. P., Jr. Five critical decisions
in breast augmentation using five measurements in 5
minutes: The high fiv
Reconstr. Surg. 116: 2005, 2005.
4. Bengtson, B. Experience with 410 implant. Presented
at the American Society for Aesthetic Plastic Surgery
Meeting, New Orleans , La., April 30, 2005.
5. Jewel
American Society for Aesthetic Plastic Surgery Meeting,
New Orleans, La., April 29, 2005.
6. Tebbetts, J. B. An approach that integrates patient education and inf
Reconstr. Surg. 110: 971, 2002.
7. Tebbetts, J. B. Dual plane (DP) breast augmentation:
Optimizing implant-soft tissue relationships in a wide
range of breast types. Plast. Reconstr. Surg. 107: 1255, 2001.
8. Ad
patient outcomes in aesthetic and reconstructive breast
, M. S8 Breast Education Course. Presented at the
ormed consent in breast augmentation. Plast.
ams, W. P., Jr., Rios, J. L., and Smith, S. D. Enhancing
e decision support process. Plast.
surgery using triple antibiotic breast irrigation: 6 year pro-
spective clinical study
9. Tebbetts, J. B. Achieving a predictable 24 hour return to
normal activities after breast augmentation: Part II . Patient
preparation, refined surgical techniques and instrumentation. Plast. Reconstr. Surg. 109: 293, 2002.
1 0 . Adams, W. P., Jr. Consequences of implant-soft tissue mis-
match in b re ast augmentation. M anuscript in preparation.
1 1 . Adams, W. P., Jr., Conner, W. C. H., Barton, F. E., Jr., and
Rohrich, R. J. Optimizing br
vitro study and clinical implications . Plast. Reconstr. Surg.
105: 334, 2000.
1 2 . Adams, W. P., Jr., Conner, W. C. H., Barton, F. E., Jr., and
Rohrich, R. J. Optimizing br
postbetadine era. Plast. Reconstr. Surg. 107: 1596, 2001.
1 3 . Adams, W. Optimizing results in breast augmentation.
Presented as Instructional Course S8 at the American
Society for Aesthetic Plastic Surgery Me
Orleans, La., 2005.
1 4 . Adams, W. Optimizing breast augmentation recovery.
Presented at Beauty thru Science, Stockholm, Sweden,
2007.
1 5 . Bengston, B. P., Van Natta, B. W., Murphy, D. K., Slicton,
A., and Max
Group. Style 410 highly cohesive silicone breast implant
core study results at 3 years. Plast. Reconstr. Surg. 120: 40S,
2007.
1 6 . Cunningham, B. The Mentor study on contour profile gel
silicone MemoryGel breast implants. Plast. Reconstr. Surg.
120: 33S, 2007.
1 7. Jewell, M. Comparison of the form stable cohesive gel
Mentor CPG and Allergan 410 Implants. Presented at
the 41st Annual Meeting of the American Society for
Aesthetic Plastic Surgery, San Diego, May 1–6, 2008.
ebbetts, J. B. Achieving a zero percent reoperation rate
1 8 . T
at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study
118: 1453, 2006.
well, G. P.; Style 410 US Core Clinical Study
. Plast. Reconstr. Surg. 116: 1, 2005.
east pocket irrigation: An in
east pocket irrigation: The
eting, New
. Plast. Reconstr. Surg.
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D
D
COSMETIC
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Preoperative Sizing in Breast Augmentation
David A. Hidalgo, M.D.
Jason A. Spector, M.D.
New York, N.Y.
Background: Implant size selection in breast augmentation patients is one of
many variables to be determined before surgery. Few methods exist today that
allow the patient to participate in this process and accurately determine optimal
size. The authors describe a simple method of preoperative sizing using silicone
implant samples.
Methods: A total of 567 patients underwent breast augmentation: 297 had
surgery before implementation of preoperative sizing and 270 patients were
sized preoperatively. Sizing consisted of fitting the patients with various size
silicone implants in a larger bra at least twice before surgery to determine desired
size. Surveys were sent to both groups to inquire about overall satisfaction, how
many preferred a different size postoperatively, and how many ultimately underwent size change surgery.
Results: One hundred two responses (34.3 percent) were obtained from the
control group and 142 (52.6 percent) were obtained from the sized group. Sized
patients received smaller implants (average, 276.6 cc nonsized versus 246.4 cc
sized; p ! 0.001). Four patients (1.4 percent) in the control group underwent
a size change procedure compared with none in the sized group. In the sized
cohort, 69 percent believe they are the size that the process predicted, 21 percent
are smaller, 9 percent are larger, and 1 percent did not answer the question.
Conclusions: Sized patients were more satisfied than controls and fewer were
interested in having a different size implant postoperatively. Sized patients
indicated that preoperative sizing was both helpful and reasonably accurate in
predicting final breast size. (Plast. Reconstr. Surg. 125: 1781, 2010.)
atients pursuing breast augmentation have
many options to consider before surgery,
P
plane, and multiple implant factors such as filler
type, shape, profile type, texture, volume, and
sometimes manufacturer. Implant diameter is another important variable, although it is less obvious to the layperson. Some have additional factors
to consider such as the need for a simultaneous
mastopexy that can be performed by several different methods and may be unilateral, bilateral,
or require a different approach on each side. Ancillary procedures such as correction of inverted
nipples or nipple reduction in the postpartum
patient are options that add to the decision-making
process.
search, much of it Internet based, and usually see
several physicians before committing to a defini-
including surgeon, incision location, pocket
Most patients today conduct considerable re-
tive surgical plan. Arguably the most elusive factor
to settle with certainty before surgery is implant
size. Many patients have fixed notions of size based
either on cup size, celebrity or Internet photographs, the experience of friends (both good and
bad), or their personality. However, none of these
factors is of proven benefit in selecting the proper
implant size.
Verbal communication alone between the patient and physician, even if supplemented with
adjunctive information as described above, is an
unreliable method for determining implant size.
When the decision is perceived to be a unilateral
one on the part of the physician, the patient does
not feel compelled to accept responsibility for that
decision if she is disappointed after surgery. The
need for additional surgery for a size change is
associated with anxiety, urgency, and the belief
that the surgeon is at fault or at least should bear
the responsibility for the cost of replacement sur-
From the Division of Plastic Surgery, Weill Cornell Medical
College.
Received for publication June 22, 2009; accepted September
8, 2009.
Copyright ©2010 by the American Society of Plastic Surgeons
DOI: 10.1097/PRS.0b013e3181cb6530
Disclosure: Neither of the authors has a financial
interest in any of the products or devices mentioned
in this article.
www.PRSJournal.com
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Plastic and Reconstructive Surgery • June 2010
gery. Some surgeons tend to use a size larger than
may be necessary to hedge their bets and avoid this
situation, often perpetuating the folklore that patients always wish they were a little larger anyway.
Some practitioners have attempted to use a combination of chest wall measurements and “bust circumference” to determine implant size, whereas
others have constructed tables that correlate implant
1,2
volume with bra size for reference.
Others rely on
a set of specific tissue characteristics and measure-
3–6
ments to determine optimal implant size.
Although this latter method seeks to make size selection more scientific, it ultimately presents
optimal size to the patient as a fait accompli without participation beyond her anatomy. This does
not guarantee a happier patient, although it may
provide the surgeon with stronger footing for discouraging pursuit of size change surgery later.
Many experienced surgeons seek to have the
patient more actively involved in size selection in
a way that will help preview the result. Some have
described using rice or saline in a bag to estimate
7–9
the size of the implant required.
Today, there
are Web sites on the Internet that describe the
“rice test” for prospective patients to perform at
10,11
home.
A method of preoperative sizing that
the authors have been using for the past several
years and that constitutes the basis for this report
consists of fitting patients with their desired bra
size and placing various size sample silicone gel
implants in the bra to simulate the result that each
size would achieve (Fig. 1). This allows the patient
to preview final breast size and, by participating in
the sizing process, accept responsibility for the
outcome together with the surgeon. The goal is to
minimize the prospect for patient dissatisfaction
after surgery that can ultimately lead to secondary
surgery to change implant size.
PATIENTS AND METHODS
Technique of Preoperative Sizing
Preoperative sizing is performed at least two
times before surgery. The first session is generally
more time consuming and is usually done with the
nursing staff, whereas the second session is done
with the surgeon, as it is either largely confirmatory or the surgeon can give additional input to
guide the process. Patients unable to clearly state
a narrow range of preferred sizes are brought back
for a third visit if necessary. The goal is to narrow
the choice down to two sizes differing by not more
than 25 cc. Patients are advised that this narrow
range represents approximately one-eighth of a
cup size and the final selection thereafter is best
left as an intraoperative decision.
The process begins by fitting the patient with
a larger bra that has underwires but minimal padding. This is most often a C cup, althoughaDcup
may be used in some young nulliparous patients
and a B cup in some older and more conservative
postpartum patients. The chest circumference is
variable and generally the same as the patient
normally wears (even though many patients do
not necessarily wear the correct size bra for their
12
chest circumference).
the bra cup material adds volume by itself and that
this varies depending on the type of bra. In our
sizing bra, the extra volume measured 30 cc
per side (Fig. 2). This volume can be added to the
final size implant preferred by the patient during
Patients are advised that
76
Fig. 1. Breast implant sizer box containing sample implant
sizes.
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Fig. 2. A sample 34C bra is shown. The cup from one side has
been cut off, rolled, and compressed within a syringe to demonstrate a volume of approximately 30 cc. The excised cup material
weighed only 12 g.
Volume 125, Number 6 • Preoperative Breast Sizing
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the sizing process if she seeks the outside volume
that includes the bra.
The starting point in implant sample size is
somewhat arbitrarily determined by taking into
account height, weight, personality, and specific
goals. Two different sizes are placed and the combination gradually increased until the patient feels
the goal has been achieved. A common starting
point is a 225-g implant on one side and a 250-g
size on the other and working up (or less commonly down) from there. A thin form-fitting top
is typically worn to examine the effects of the
different sizes in front of a full-length mirror
(Fig. 3). Once the patient has determined the
desired size range, it is important to continue the
process, placing larger sizes until they emphatically state “that is too much.” This final step in the
sizing process can be helpful postoperatively in
preventing a patient from lamenting that maybe
she should have tried on a larger size.
It is generally best not to have friends or family
members present during the sizing process, at
least not during the first session. They may have
aesthetic values that differ from those of the patient and sometimes have a relationship that may
be competitive or otherwise emotionally charged.
Supportive spouses and significant others are usually an asset, although in some cases the partner
may harbor a different agenda regarding size.
The second visit with the physician serves to
confirm the size preferred and allow for a conversation on how anatomy may either impose
some restrictions regarding the size selected or
suggest the use of a larger size than previously
considered. Patients with either a narrow breast
base (such as tubular breasts), poor postpartum
skin elasticity, or a sharply defined inframammary
crease located close to the areolar margin may
require a smaller implant size than they prefer. In
contrast, tall patients and those with a wide chest
may benefit from greater volume and diameter
than they thought was ideal. This meeting is also
useful to decide which incision will be best. Sometimes, for example, the patient preferring a somewhat larger silicone implant may no longer be a
candidate for a periareolar incision if her areolar
diameter is small. An inframammary crease incision usually proves necessary in such a case.
Although sizing is performed with silicone implant samples, the process is the same for patients
using saline implants. The saline implant size selected is one size smaller than the silicone sample.
This allows overfilling to the desired volume to
minimize the prospect of ripples and possibly premature deflation. For example, a patient who likes
a range between 275 and 300 g would be well
suited for either a 250-cc implant or a 275-cc implant overfilled to achieve the same final volume
range. As a practical matter, saline implant size is
assumed to correspond in cubic centimeters to the
size selected in grams of silicone.
Data Collection
A questionnaire was sent to a control group
consisting of patients operated on between March
3, 2003, and October 6, 2005, and a sized group
operated on between October 10, 2005, and July
16, 2008; all procedures were performed by the
senior author (D.A.H.). The goal was to assess
satisfaction with the procedure in general and
with size specifically, at an interval of at least 6
months after surgery (Fig. 4). Patients who were
sized preoperatively were sent a second questionnaire that inquired specifically about the sizing
process (Fig. 5). Nonresponders to mail inquiry
were called by phone to maximize the response
rate.
Statistical Analysis
A two-sample independent measures t test was
performed to analyze implant volume in breast
augmentation patients treated with or without our
preoperative sizing device. Cohen’s d was reported
to show the size of the treatment effect (by convention, 0.2 ! d ! 0.8 corresponds to a medium
effect size). Fisher’s exact test was used to evaluate
wanting smaller or larger breast augmentations
following surgery in patients treated with or without our preoperative sizing device. The Wilcoxon
rank sum test was performed to assess the data
obtained from the questionnaires. Results for ratio data were reported as mean " SE and those for
ordinal data were expressed as median and corresponding interquartile range. In all cases, the
level for statistical significance was set at p ! 0.05.
RESULTS
The control group consisted of 297 patients
and the sized group contained 270 patients. One
hundred two responses (34.3 percent) were obtained from the control group and 142 (52.6 percent) were obtained from the sized group. Fourteen percent of surveys in the control group and
12 percent in the sized group were returned because of change of address with no forwarding
address available. The median interval between
surgery and the survey response was 21 months in
the control group (interquartile range, 9 to 71
months) and 12 months in the sized group (in-
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Plastic and Reconstructive Surgery • June 2010
78
Fig. 3. A patient is shown preoperatively (above, left), with a 275-g implant used as a sizer on the right and a 300-g implant on
the left in the sizing bra (above, center), and with an overlying garment (above, right). Postoperative views show the patient with
300-cc submuscular saline implants filled to 305 cc on the right and 320 cc on the left (below, left) and wearing the same sizing
bra (below, center) and outer garment (below, right).
terquartile range, 6 to 36 months) (Table 1). The
average implant volume was 276.6 " 53.4 g/cc in
the control group and 246.4 " 49.5 g/cc in the
sized group, corresponding to a statistically significant difference and a medium effect size (p !
0.001, d # 0.6). Twenty-one respondents (7.1 per-
cent) in the control group preferred either a
larger or smaller size than they had, whereas 11
respondents (4.1 percent) in the sized group felt
the same way, corresponding to no statistically
significant difference. Overall procedure satisfaction was measured on a scale of 1 (not helpful) to
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Volume 125, Number 6 • Preoperative Breast Sizing
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Fig. 4. Initial questionnaire sent to patients in both study arms.
Fig. 5. Follow-up questionnaire sent only to patients who underwent preop-
erative sizing.
Table 1. Intergroup Comparison
No. of
Group
Control 297 102 (34) 276.6† 21(21) 4.2 4 (4)
Sized 270 142 (53) 246.4 11(16) 4.5 0 (0)
*On a scale ranging from 0 to 5.
†p ! 0.001.
Patients
5 (extremely helpful). The median score for satisfaction was 5 in both the control and the sized
Surveys
Received (%)
Average Implant
Volume (g/cc)
Would Prefer
Different Size (%)
Procedure Satisfaction
Average*
Had Size Change
Surgery (%)
dicted, and 69 percent believed they were the
same size as the sizing predicted.
groups. There were four size change procedures
(1.4 percent) performed in the control group and
none performed in the sized group, corresponding to no statistically significant difference.
The second survey sent only to the sized group
showed a median score of 4.5 (interquartile range,
4 to 5) for rating the usefulness of the sizing process on a scale of 1 (not helpful) to 5 (extremely
helpful). The median score for rating the correlation between the sizing preview and the actual
result achieved was 4 (interquartile range, 3 to 5)
on a scale of 1 (poor) to 5 (excellent). Twenty-one
percent of the sized group felt that they were
smaller than what the sizing predicted, 9 percent
felt they were larger than what the sizing pre-
Preoperative sizing allows the patient to participate in size selection. This imparts a sense of
responsibility for the final result that does not exist
in cases where the physician unilaterally decides
optimal volume. It also allows the patient’s spouse,
significant other, or key family member(s) to participate in the process. Although the latter has the
potential to cause confusion because of a diversity
of opinion, it more often than not is helpful in
finalizing a narrow size range from which the patient can choose.
Although no method provides a perfect simulation, this technique does allow the patient to preview
DISCUSSION
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Plastic and Reconstructive Surgery • June 2010
the result and assess her appearance in a variety of
clothing types. It also serves as a basis for dialogue
between the physician and patient to take into account other factors that influence final size selection.
For example, patients often have to be urged to
consider larger sizes because even conservative size
implant samples can initially seem to make a drastic difference. In addition, patient height, chest
width, and lower body contour are important factors that may argue for either a larger or smaller
size depending on particular anatomy and patient-
3–5
specific tissue characteristics.
Other anatomical
constraints such as a sharply defined inframammary crease that is located relatively close to the
inferior areolar margin will often impose limits on
13
implant diameter.
Placing an implant that is too
large in this particular setting is a common cause
of “double-bubble” deformity. Tubular breast
shape, although fortunately uncommon, is a more
extreme example of a situation where anatomy
limits implant choice.
Preoperative sizing allows the surgeon to properly counsel the patient on the issue of volume
versus diameter as it pertains to specific anatomical characteristics. This will minimize the possibility of creating a postoperative shape problem as
a result of using implant volume as the dominant
criterion for size selection. Moreover, it will allow
the physician to consider early on in the process
alternate implant types to arrive at the optimal
volume-to-diameter ratio. For all of these reasons,
the surgeon should be intimately involved in the
sizing process and not delegate this entirely to the
nursing staff.
Some believe that sizing underestimates the
final result because some of the volume is “lost”
when placed in a retropectoral plane, an idea that
is based on conjecture at best, not fact. It has not
proven necessary to arbitrarily increase the implant size beyond that which the patient has chosen to accommodate this notion. However, it is
important to make the patient aware that the bra
itself can add as much as 30 cc volume depending
on the type (Fig. 2).
Another common practice is for surgeons to
err on the larger side when it comes to selecting
implant size to avoid the unhappy patient who may
14
then seek size change surgery.
It could be argued
that postoperative problems such as double-bubble deformity and others may occur less commonly if implants are not routinely picked slightly
larger than what appears good to make certain that
the patient is happy with size selection. Although
downsizing implants is less common than a request
for larger implants, the former scenario does occur
and may also be a result of this practice. As this
study demonstrates, somewhat smaller implants
can be used without compromising patient satisfaction when preoperative sizing is incorporated
as an integral part of preoperative preparation.
Another advantage of preoperative sizing is
that two different size implants can be tested simultaneously in patients with volume asymmetry.
This will aid both the patient and the physician in
deciding whether or not to use different sizes in
those whose breasts differ in small volumes and
how many sizes different may be needed in those
with greater volume differences.
The average implant size used in this study is
relatively small and likely reflects the study population treated. The senior author’s breast augmentation patients reside in the Northeast, a region arguably more conservative than other (i.e.,
warmer) parts of the country. Also, most are postpartum patients seeking volume restoration more
than significantly larger breast size. There is no
reason to believe, however, that the practice of
preoperative sizing would not be of equal value in
practices where implant volumes average higher
by 100 cc or more.
Interestingly, this study shows that a similar
proportion of both sized and unsized patients wish
to be a different size postoperatively, usually
larger. Although the difference in revision rates
between groups did not reach statistical significance (potentially because the low incidence of
revisions in both groups), none of the patients in
the sized group underwent size change surgery.
This supports the assertion that patients who participate in size selection assume at least as much
responsibility for the final choice as the surgeon.
They are more willing to accept the result that they
have without indulging in an ongoing mental debate that ultimately leads to further surgery.
Retrospective studies have well-known limitations, and studies using surveys suffer from incomplete response rates. Despite these limitations and
the fact that the data did not often show statistically significant differences in patient satisfaction
or revision rates, our clinical impression remains
that preoperative sizing is quite useful. We believe
this simple technique can easily be incorporated
into the practice of any surgeon performing breast
augmentation. Routine use of preoperative sizing
in our practice has virtually eliminated the occurrence of frantic early postoperative telephone calls
from patients who feel they are too small. It has
reduced patient anxiety more than any other factor and has transformed the care of the breast
augmentation patient in our practice into a more
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Volume 125, Number 6 • Preoperative Breast Sizing
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uniformly rewarding and positive experience for
both the patient and physician.
CONCLUSIONS
Although preoperative sizing is a highly subjective process, it has nevertheless proven to be a
valuable tool in the management of a challenging
patient population. Patients tend to be happier
with their result than those who do not undergo
preoperative sizing. Although some patients are
not completely satisfied with their size despite preoperative sizing, they rarely seek size change surgery. It is expected that future improvements in
methodology and equipment will improve the precision of the technique.
David Hidalgo, M.D.
655 Park Avenue
New York, N.Y. 10065
dh@drdavidhidalgo.com
ACKNOWLEDGMENTS
The authors thank Andrew Weinstein for statistical
analysis and Paola Lisi for data management in the
preparation of this article.
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COSMETIC
Journal
e
Vie
cle
View Article
Brava and Autologous Fat Transfer Is a Safe and
Eective Breast Augmentation Alternative: Results of
a 6-Year, 81-Patient, Prospective Multicenter Study
Roger K. Khouri, M.D.
Marita Eisenmann-Klein, M.D.
Eufemiano Cardoso, M.D.
Brian C. Cooley, Ph.D.
Daniel Kacher, M.S.
Eva Gombos, M.D.
Thomas J. Baker, M.D.
Key Biscayne and Miami, Fla.;
Regensburg, Germany; Milwaukee, Wis.;
and Boston, Mass.
Background: Breast augmentation by autologous fat transfer is an
appealing alternative in need of scientific validation.
Methods: In a prospective multicenter study, 81 women (age range, 17 to
63 years) wore the Brava device, a bra-like vacuum-based external tissue
expander, for 4 weeks and then underwent autologous fat injection using
10 to 14 needle puncture sites into each breast in a three-dimensional fanning pattern (average, 277 ml volume injected per breast). Patients resumed
Brava wear within 24 hours for 7 or more days. Pretreatment and posttreatment breast volumes were derived from three-dimensional volumetric reconstruction of magnetic resonance imaging scans, and outcomes
were compared with a meta-analysis of six recent published reports on
autologous fat transfer breast augmentation without expansion. Follow-up
ranged from 12 months to 6 years (average, 3.7 years).
Results: Breast volume was unchanged between 3 and 6 months. Seventy-one of the treated women were compliant with Brava wear and had a
mean augmentation volume at 12 months of 233 ml per breast compared
with 134 ml per breast in published series without Brava (p < 0.00001).
Graft survival was 82±18percent compared with 55±18percent without Brava (p < 0.00001). There was a strong linear correlation (R 2=0.87)
between pregrafting Brava expansion and the resultant breast augmentation. There were no suspicious breast masses or nodules. Magnetic resonance imaging recognized a 16percent incidence of fat necrosis easily
identified at 1-year mammographic evaluation.
Conclusion: The addition of Brava expansion before autologous fat
grafting leads to significantly larger breast augmentations, with more fat
earch
ind a Previous Issu
w Arti
From the Division of Plastic Surgery, Florida International
University; the Miami Breast Center; Klinik für Plastische und
graft placement, higher graft survival rates, and minimal graft necrosis
or complications, demonstrating high safety and ecacy for the procedure. (Plast. Reconstr. Surg. 129: 1173, 2012.)
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
May 21 through 25, 2006; interim results presented at the Annual
Congress of the American Society of Plastic Surgeons, in Seattle,
Ästhetische Hand- und Wiederherstellungschirurgie, CaritasKrankenhaus St. Josef; Orthopaedic Surgery, Medical College of
Wisconsin; Surgical Planning Laboratory and Radiology Breast
Imaging, Brigham and Women’s Hospital, Harvard Medical
School; and the Department of Surgery, University of Miami.
Received for publication August 23, 2011; accepted November 29,
2011.
Preliminary study results presented at the Annual Congress of the
American Society for Aesthetic Plastic Surgery, in Orlando, Florida,
82
Washington, October 23 through 27, 2009.
Copyright ©2012 by the American Society of Plastic Surgeons
DOI: 10.1097/PRS.0b013e31824a2db6
Disclosure: Dr. Khouri has an equity interest in Brava, LLC,
the manufacturer of the Brava device, and is an owner of the
company that makes the Lipografter described in the article.
The other authors have no financial interests to disclose.
!"#$%&'()*+,-+.(/012"-%-3(45-(/"&6&'#"(7#$%-+$(08(!9)(:(;+-#$%(<*,1-6%#%&06
Brava and Autologous Fat Transfer
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utologous fat transfer to the breast has a long and
1,2
In 1987, a position state-
A
geons
3
controversial history.
ment by the American Society of Plastic Sur-
banned the procedure out of concern that the
grafts would not survive and could lead to calcification
believed to be indistinguishable from cancer with the
xeromammographic technology of the time. However,
radiologists today are better able to dierentiate neoplastic processes from fat necrosis.
of many technical refinements,
today holds much promise in plastic surgery.
4 – 6
Furthermore, because
7,8
autologous fat transfer
9 – 24
Therefore, in 2007, the American Society of Plastic Surgeons
commissioned a Fat Graft Task Force that concluded
that autologous fat transfer might be used for the breast
“while the techniques and the results vary…. leaving a
tremendous need for high quality clinical studies.”25 In
2009, the American Society of Plastic Surgeons lifted
PATIENTS AND METHODS
This study was designed to optimize all potential variables. This includes low-pressure atraumatic fat harvest,
minimal graft manipulation, and meticulous microdroplet grafting. Because a larger recipient has room in which
to safely graft larger volumes and because it is well proven
that Brava expansion enlarges the recipient breast, we
found it unethical to randomize Brava patients versus
nonexpanded controls and arbitrarily condemn women
to the morbidity and risks of surgery for a less eective
procedure. Furthermore, because there are multiple
recent peer-reviewed reports of autologous fat transfer
breast augmentation without expansion, we elected to
compare our Brava-expanded cohort to a meta-analysis
of this well-established baseline.
On institutional review board approval (Concordia
Clinical Research, Inc.; Breast Reconstruction and Aug-
the ban on fat grafting for breast reconstruction while
recommending cautious use for augmentation26 because
of concern for safety and ecacy, given the paucity of
scientific studies.
Breast augmentation with liposuctioned fat has suffered from two fundamental limitations: the volume of
fat that can be transferred in a single session and the percentage graft survival.
18 – 22,27
In fact, there seems to be an
inverse relationship between the two (i.e., the more fat
grafted, the lower its survival rate).28 Eorts at overcoming
this have focused on harvesting techniques, fat manipulation, stem cells, and related approaches.
13,17 – 20,23,24,27,29 – 72
Most studies report 50 to 60percent survival and an
augmentation in the 100-ml range on long-term follow-
17 – 22,27
up.
Of note, none made any attempt to improve
the quality of the recipient breast.
To preserve the graft-to-recipient interface critical for
mentation with Brava Enhanced Autologous Fat Micro
Grafting Protocol No. 2004-2, IRB COMM. No. 167),
81 women (Miami Breast Center, Key Biscayne, Fla.,
n = 59; Caritas-Krankenhaus St. Josef, Regensburg,
Germany, n = 12; Harley Medical Center, London,
United Kingdom, n=10) who desired breast augmen-
tation, were averse to implants, and who tolerated a
20-minute Brava test trial in the oce were enrolled
in the study. We performed 77 bilateral and four unilateral autologous fat transfer breast augmentations on
170 breasts. Patient ages ranged from 17 to 63 years
and body mass index ranged from 15 to 28 (average,
19.8). Smokers were excluded. All enrolled were grafted
despite wide variation in compliance with the requested
pregraft Brava treatment1 and despite the fact that four
patients were noncompliant. Six patients did not return
for follow-up magnetic resonance imaging, and although
revascularization and survival, fat grafts have to be dispersed as microdroplets. Because in the small breasts to
be augmented there is physically no room for dispersal
without crowding a large quantity of microdroplets, we
postulated that preparation of the recipient breast by
external expansion is the key missing ingredient.
The Brava device has been on the market for over
10 years as an external soft-tissue expander and has
demonstrated modest, permanent augmentation after
long-term use.
73 – 77
Short-term use of Brava, however,
causes a marked temporary increase in breast size and
generates a very large fibrovascular scaold that would
be an ideal recipient for fat grafts (Khouri RK, personal
observation). We undertook this multicenter, prospective, magnetic resonance imaging – documented study to
determine the safety and ecacy of single-stage largevolume autologous fat transfer to the breast treated with
self-reports indicate they are complication-free, postprocedure breast volumetric measurements were not taken.
Six of the earlier patients later underwent grafting a second time. However, we only analyzed the outcome of
their first graft. Figure1 shows the breakdown of the
treated and compliant patient groups.
Before Brava expansion and in phase with her menstrual cycle, every woman underwent baseline magnetic
resonance imaging with breast coils, intravenous gadolinium contrast, and fat subtraction. The patients were
asked to wear the Brava external breast tissue expander
for 10 hours/day for 4 weeks. This preexpansion period
increases the vascularity of the recipient site.
61,62,78
For
the last 36 to 48 hours, they were asked to maintain uninterrupted expansion and come to the operating room
still wearing the expander, to induce an immediate temporary three-dimensional enhanced enlargement of the
the Brava external breast expander.
83
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subcutaneous periglandular tissue matrix (Fig.2).
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