ArticlePDF Available

Six-Year Prospective Outcomes of Primary Breast Augmentation With Nano Surface Implants


Abstract and Figures

Background Motiva Implants (Establishment Labs Holdings Inc.) are a novel family of silicone breast implants using cutting-edge technologies engineered to optimize aesthetic and safety outcomes. Objectives The authors sought to prospectively evaluate the safety and effectiveness of SmoothSilk/SilkSurface Motiva Implants over long-term follow-up. Methods Surgeons at a single plastic surgery center undertook a 10-year follow-up study of SmoothSilk/SilkSurface Motiva Implants in women who underwent primary breast augmentation. Safety was assessed through identification of complications on follow-up and through magnetic resonance imaging (MRI) in a representative sample. Effectiveness outcomes were assessed by surgeons and patients using Likert scales and a Quality of Life tool. Results This article reports the 6-year safety and effectiveness outcomes. A total of 35 patients were implanted between September and December 2010, and 71.9% of implants were placed submuscularly using inframammary incision. During the 6-year follow-up, there were no occurrences of capsular contracture, rupture, double capsules, or late seroma. MRI evaluation identified no signs of implant-related complications. Three revision surgeries were performed, all for aesthetic reasons; there were no implant replacements for medical reasons. The level of satisfaction for both patients and surgeons was high at all follow-up visits. Patient quality-of-life scores increased following breast augmentation by an average of 0.89% at 72 months. Conclusions The results of this prospective long-term follow-up study demonstrate the excellent safety and effectiveness of SmoothSilk/SilkSurface Motiva Implants in primary breast augmentation through 6 years of follow-up. Level of Evidence: 4
Content may be subject to copyright.
Aesthetic Surgery Journal
2018, 1– 14
© 2018 The American Society for
Aesthetic Plastic Surgery, Inc.
This is an Open Access article
distributed under the terms of the
Creative Commons Attribution-
NonCommercial-NoDerivs licence
licenses/by-nc-nd/4.0/), which permits
non-commercial reproduction and
distribution of the work, in any
medium, provided the original
work is not altered or transformed
in any way, and that the work is
properly cited. For commercial
re-use, please contact journals.
DOI: 10.1093/asj/sjy196
Breast Surgery
Six-Year Prospective Outcomes of Primary
Breast Augmentation With Nano Surface
Manuel Chacón Quirós, MD; Manuel Chacón Bolaños, MD; and
Jeffry James Fassero, MD
Background: Motiva Implants (Establishment Labs Holdings Inc.) are a novel family of silicone breast
implants using cutting-edge technologies engineered to optimize aesthetic and safety outcomes.
Objectives: The authors sought to prospectively evaluate the safety and effectiveness of SmoothSilk/SilkSurface Motiva Implants over long-term
Methods: Surgeons at a single plastic surgery center undertook a 10-year follow-up study of SmoothSilk/SilkSurface Motiva Implants in women who
underwent primary breast augmentation. Safety was assessed through identification of complications on follow-up and through magnetic resonance
imaging (MRI) in a representative sample. Effectiveness outcomes were assessed by surgeons and patients using Likert scales and a Quality of Life tool.
Results: This article reports the 6-year safety and effectiveness outcomes. A total of 35 patients were implanted between September and December
2010, and 71.9% of implants were placed submuscularly using inframammary incision. During the 6-year follow-up, there were no occurrences of capsular
contracture, rupture, double capsules, or late seroma. MRI evaluation identified no signs of implant-related complications. Three revision surgeries were
performed, all for aesthetic reasons; there were no implant replacements for medical reasons. The level of satisfaction for both patients and surgeons was
high at all follow-up visits. Patient quality-of-life scores increased following breast augmentation by an average of 0.89% at 72 months.
Conclusions: The results of this prospective long-term follow-up study demonstrate the excellent safety and effectiveness of SmoothSilk/SilkSurface
Motiva Implants in primary breast augmentation through 6 years of follow-up.
Level of Evidence: 4
Editorial Decision date: May 30, 2018; online publish-ahead-of-print November 13, 2018.
More than 310,000 breast augmentation surgeries were
performed in the United States in 2016, making it the
most commonly performed cosmetic surgical procedure.1
Silicone breast implants were used in 87% of those aug-
mentation procedures.1
Silicone gel-filled breast implants have been commer-
cially available for decades but were not approved by the
FDA until 2006 for use in all women over the age of 21.
Since their inception, silicone breast implants have evolved
significantly to improve safety and aesthetic outcomes.
Indeed, the use of breast implants is associated with a
variety of potential complications, such as hematoma,
seroma, infection, altered sensation, rupture, leakage,
and capsular contracture.2 Poor aesthetic outcomes, such
as asymmetry, rippling, double capsules, rotation, and
Drs Chacón Quirós and Chacón Bolaños are plastic surgeons and
Dr Fassero is an anesthetist in private practice in San Jose, Costa Rica.
Corresponding Author:
Dr Manuel Chacón Quirós, European Center of Surgery, 3rd Avenue,
Sabana, San José 10108, Costa Rica.
Breast Surgery
Downloaded from by guest on 14 November 2018
2 Aesthetic Surgery Journal
malposition can also occur and may require reoperation
and possibly implant replacement to optimize cosmesis.3
Technical developments designed to reduce these risks
include procedural and device-related innovations. For
example, newer generations of silicone implants often use
cohesive or form-stable silicone gels to limit the risk of
leakage and surfaces designed to improve biocompatibil-
ity. Differences in the design and manufacture of available
silicone breast implants can significantly affect safety and
aesthetic outcomes.
Motiva Implants (Establishment Labs Holdings Inc., NY)
represent a novel family of breast implants that incorporates
a variety of cutting-edge technologies engineered to opti-
mize aesthetic and safety outcomes while providing patients
and surgeons with a diverse range of implant choices.
These implants are form-stable, silicone-filled devices with
a unique surface designed to minimize reaction with host
tissues. Rheological features of the silicone gels used in
Motiva implants provide patients and surgeons with multi-
ple options to promote specific aesthetic outcomes.
To evaluate the safety and effectiveness of SmoothSilk/
SilkSurface Motiva Implants, surgeons at a single plastic
surgery center undertook a prospective 10-year follow-up
study in women who underwent primary breast augmen-
tation. This article reports the 6-year safety and effective-
ness outcomes of this ongoing study.
This report presents the 6-year outcomes from an ongo-
ing, prospective, 10-year follow-up study to confirm the
safety and effectiveness of Motiva Implants silicone breast
implants in patients who underwent breast augmentation
surgery between September and December 2010.
Thirty-five patients were operated on for mammary
hypotrophy and hypotrophy plus ptosis grade I or II and
implanted with SmoothSilk/SilkSurface Motiva Implants.
The study was conducted at a single private plastic sur-
gery center, accredited by the American Association for
Accreditation of Surgery Facilities, by board-certified Plastic
and Reconstructive Surgeons trained at the University of
Paris. Written informed consent was obtained from all sub-
jects following the principles of the Helsinki declaration.
All patients were informed about their options to refuse
to participate or to choose a different device, and they all
accepted to be part of this single arm study.
Implants Studied
Per protocol, the implants used in this study were Motiva
Implants. These devices are gel-filled, form-stable silicone
breast implants with a unique surface architecture. The
implants used in this study were SmoothSilk/SilkSurface.
These implants are available in a range of sizes, base
diameters, and projections. The manufacturer also offers
an optional feature consisting of a Radio Frequency
Identification Device embedded in the implant that was
not available when this study was designed. Therefore, all
patients were implanted with devices without the Radio
Frequency Identification Device technology.
Unlike textured silicone breast implants, which are
produced with a secondary process that uses crystals or
polyurethane foam to create surface texture, the surface of
Motiva Implants is manufactured using 3-dimensional (3D)
inverted negative imprinting technology directly on the
mandrel. Another surface that is not manufactured with
salt crystals is found in the Siltex textured implants (Mentor
Corporation, Santa Barbara, CA) in which the silicone is
imprinted in a secondary process by pressing a polyure-
thane foam prior to curing, creating a negative contact
stamp that produces a nodular surface of varying depths
and widths and a greater amount of surface area for cellu-
lar ingrowth.4 What makes SmoothSilk/SilkSurface unique
is the controlled dimensions of its architecture based on
very low statistical roughness and the presence of cell size
features in the topography of the implant that reduce the
movement and proliferation of ingrowth breast tissue.5
This implant has an average of 49,000 contact points
per cm2 with a roughness of 3600 nanometers ±400 nm,
measured by means of a noncontact profilometer (μsurf
Mobile profilometer (Nanofocus, Oberhausen, Germany),
an instrument that traces the surface topography and
quantifies the roughness using the optical light interfer-
ence principles, defining it as an exceptional surface with
roughness at a subcellular level where tissue ingrowth is
not possible.5 According to ISO 14607:2018, SmoothSilk/
SilkSurface is considered a smooth surface.6
Study patients were healthy women aged 18 years or older
who presented themselves for aesthetic primary breast
Inclusion Criteria
Females 18 years of age or older with an appropriate health
condition for breast augmentation and adequate tissue
available to cover the implants, which has been used as
an inclusion criterion for other device studies as stated
by Bengston et al (2007) in the Style 410 Highly Cohesive
Silicone Breast Implant Core Study,7 were included. These
women were asked to complete the screening visits and
sign the informed consent form, which gives informa-
tion about the breast implants and confirms the patient
commitment to follow this evaluation’s requirements and
acceptance of the potential risks involved, according to the
Declaration of Helsinki’s guidelines.
Downloaded from by guest on 14 November 2018
Quirós et al 3
Patients were requested to have a magnetic resonance
imaging (MRI) procedure performed immediately prior to
explantation, if medically advisable.
Exclusion Criteria
Women with advanced fibrocystic disease considered to be
premalignant without accompanying subcutaneous mas-
tectomy were excluded from the study. Other conditions
such as existing carcinoma of the breast (without mas-
tectomy), abscess or infection at the time of enrollment,
pregnancy or currently breast-feeding, having a disease
clinically known to impact wound healing ability including
uncontrolled diabetes, tissue damage resulting from radi-
ation, compromised vascularity, or ulceration were also
considered as exclusion criteria. Any condition or treat-
ment that may constitute an unjustifiable surgical risk (eg,
unstable cardiac or pulmonary problems) and manifesta-
tion of psychological issues such as inappropriate attitude
or motivation (eg, body dysmorphic disorder) was also
considered an exclusion criterion.
Per protocol, all patients were primary augmentation cases
with no breast reconstruction cases. Indications for aug-
mentation were mammary hypotrophy or hypotrophy plus
ptosis grade I or II.
Incision site (inframammary, periareolar, transaxillary,
T mastopexy) and site of implant placement (submuscu-
lar, subfascial, subglandular, dual plane) were selected by
the treating surgeons based on patient characteristics and
preferences. In consultation with the treating surgeons,
implant size, projection, and base diameter were selected
to satisfy the patient’s desired aesthetic outcomes.
The day before the procedure the patient received a pro-
phylactic antibiotic. All procedures were performed utilizing
general anesthesia. Once on the operatory table, the patient’s
thorax was prepped with Povidone-iodine solution, which
was allowed to dry by itself. The zone where the incision
was to be performed was properly marked and infiltrated
with 2% lidocaine plus epinephrine to minimize bleeding.
Before placing the implant inside the breast pocket, it
was checked and cleaned with saline solution in its origi-
nal package to remove the static, trying to limit its manip-
ulation as much as possible.
The implant information was written in the study’s
logbook and the traceability stickers adhered to it. Once
the implants were introduced in the surgical pocket, the
surgeon checked their position and symmetry and closed
the surgical wound in 3 planes: fascia, subcutaneous tis-
sue, and cutaneous plane. In case of submuscular place-
ment of the implants, when the subcutaneous plane was
almost closed, a catheter was placed at the distal corner
of the incision and bupivacaine hydrochloride (25 mg)
was injected periprosthetically to reduce postoperative
pain. Immediately before the cutaneous plane was closed,
the surgeon excised the contusion strip (about 2 mm) to
improve the approximation of the incision borders and
enhance the appearance of the future scar.
Patient follow-up evaluation was performed postopera-
tively at 24 hours, 4 days, 2 weeks, and 1, 3, 6, 12, 24, 36,
48, 60, and 72 months and will continue annually through
10 years.
Safety was assessed by the presence of complications,
including seroma, infection, hematoma, edema, erythema,
inflammatory signs, scarring, calcification, granuloma,
stretch marks, pruritus, or suture dehiscence. Assessment
for implant-related complications included implant expo-
sure, malposition, rupture, asymmetry, rippling, capsular
contracture, or double capsules. Patient-reported breast
pain and nipple sensitivity were also assessed. Safety was
also assessed through MRI studies performed in a repre-
sentative sample of the population (62% of patients) with
a 1.5 Tesla MR system (Software Philips Achieva: Release
2.1 Level 5 2010-02-20).
The MRI sample was planned to include >50% of
participants to acquire important imaging findings. All
patients who underwent the procedure were contacted
by the treating physician and asked if they were willing
to receive an MRI evaluation. Follow-up appointments
were scheduled to collect most of the data, and 62.5%
was obtained between April 2016 and May 2017 at 5 years
after the breast augmentation. Patients who did not want
to participate in the MRI study had either a condition that
Table 1. Characteristics of Patients, Implants, and Follow-Up in the
Treatment Group
Characteristics Treatment group (N=35)
Mean age, years (range) 31.5 (21-51)
Mean weight, kg (range) 55.8 (42.5-64)
Mean BMI (range) 21.9 (17.9-25)
Current smoker, N (%) 4 (11.42%)
Implant type SilkSurface/SmoothSilk (100%)
Incision site (N=35) Inframammary (97.15%)
Transaxillary (2.85%)
Implant placement (N=35) Submuscular (68.59%)
Subglandular (14.28%)
Subfascial (14.28%)
Dual plane (2.85%)
Mean implant volume, cc (range) 326.70 (235-400)
Length of follow-up 6years
Downloaded from by guest on 14 November 2018
4 Aesthetic Surgery Journal
impeded the use of MRI, including pregnancy and claus-
trophobia, or were unwilling to be subjected to the proce-
dure. It is important to note that the regulatory agencies
regularly require MRI studies on a small sample of the
study population.
Both surgeon and patient assessed effectiveness out-
comes. Satisfaction with aesthetic results was evaluated
by both surgeon and patient by means of Likert scales as
shown in Appendix A and Appendix B, available online
at The surgeon’s level
of satisfaction with the augmentation procedure was mea-
sured on a 5-point Likert scale (1 highest, 5 lowest); the
patient’s satisfaction was based on 6-point Likert scale (1
highest, 6 lowest). Patient quality of life was assessed using
a Quality of Life (QoL) tool shown in Appendix C (availa-
ble online at The QoL
measures were a combination of the Rosenberg Self Esteem
Scale, the Body Esteem Scale, the Tennessee Self Concept
Scale, and the SF-36. Data were collected from the identi-
fied patients before implantation and at all scheduled fol-
low-up visits and then included in their medical record.
Statistical Analysis
Self-esteem/QoL scores were compared between baseline
and follow-up time points utilizing simple linear regres-
sion. Kaplan-Meier survival rates were calculated for
implant-related outcomes, such as implant rupture, cap-
sular contracture, and implant replacement. Satisfaction
scores were analyzed using descriptive statistics, and sta-
tistical significance was defined as P < .05.
The mean age of the 35 patients was 31.5 years old (range,
21-51 years) and mean body mass index was 21.9 kg/m2
(range, 17.9-25.0 kg/m2). Demographic characteristics of
study patients and the types and placement of implants
are listed in Table 1.
Most patients requested a moderate augmentation, with
an average cup size change of one cup. The estimated
average implant size calculated by the surgeon through 3-D
scanning prior to the surgery was 317 cc (range, 180-450
cc) and the actual average volume used was 326.7 cc. The
most frequently used implant profile was the “Full” (3.5-
6.1 cm), which is in the midrange projection compared to
a market equivalent selected by the surgeon, in 74% of
patients. The average implant base diameter was 11 cm.
Projections and volumes were chosen by the patient and
the surgeon based on the patient’s anatomy and desires
and the surgeon’s professional judgment.
No drains were used and no intraoperative complica-
tions were reported. No incidents of infection, hematoma,
suture dehiscence, or implant exposure were reported
during the perioperative, intraoperative, immediate, and
postoperative periods.
Three revision surgeries were performed on 3 patients,
one each at 3, 6, and 71 months after the initial augmen-
tation procedure. The Kaplan-Meier risk rate for implant
replacement due to volume changes was 9.4% through
6 years (Figure 1). The rate of implant replacement for
safety reasons remains 0% through 6 years.
At 6 years, the Kaplan-Meier rate for capsular contrac-
ture, rupture, double capsules, and late seroma was 0% for
the primary augmentations as well as for the reoperations.
Table 2 shows the Kaplan-Meier cumulative complication
rates through 6 years.
Safety Outcomes
The safety outcomes of the 6-year follow-up evaluation
are described in Appendix C. Because this is an ongoing
study, it is noteworthy that 32 of 35 patients have attended
the 72-month follow-up visit; 33 patients attended their
Figure 1. The Kaplan-Meier risk rate for implant replacement
due to volume changes through 6 years (N = 35).
Table2. Kaplan-Meier Cumulative Complication Rates for 6 Years
Complication Risk rates, % 95% CI
Breast implant-associated anaplastic
large cell lymphoma
0 0
Capsular contracture 0 0
Late seroma 0 0
Loss of nipple sensation 68.6 53.4-83.7
Loss of volume 6.0 0-13.0
Nipple hypersensitivity 54.3 38.0-70.6
Pain 22.9 9.14-36.8
Ptosis 54.3 37.8-70.8
Replacement due to safety reasons 0 0
Replacement due to volume changes 9.4 0-17.7
Rupture 0 0
Twinges 20.0 6.9-33.1
Downloaded from by guest on 14 November 2018
Quirós et al 5
60-month follow-up and all 35 patients completed their
24-month follow-up.
One subject who underwent revision surgery for aes-
thetic reasons was lost to follow-up after 2 years. Among
the 32 patients who did not receive revision surgery
(Table 3), no cases of edema, bruising, erythema, inflam-
matory reaction, delayed wound healing, hematoma,
seroma, infection, calcification, granuloma, stretch marks,
tightness, extrusion, necrosis, asymmetry, rippling, malpo-
sition, or irregular appearance were observed. No cases
of rupture, capsular contracture, double capsules, late
seromas, or anaplastic large cell lymphoma (ALCL) were
reported at 6 years. The 6-year Kaplan-Meier risk rate for
implant replacement due to volume changes is illustrated
in Figure 1.
Revision Surgery Cases due to Volume Changes
A total of 3 revision surgeries were performed on 3 sub-
jects. None of the revision surgeries was related to implant
safety but rather to preferred aesthetic outcomes. One
patient requested reoperation 3 months after the primary
surgery to correct an aesthetic dissatisfaction related to
larger than desired breast size. At 6 years, no adverse
events were observed and the patient’s reported level of
satisfaction was “very satisfied.”
The second reoperation patient was diagnosed with
Grade II ptosis, and her satisfaction with the augmentation
procedure decreased significantly from “extremely satisfied”
at 3 months to “satisfied” at 6 months. A mastopexy with
implant replacement was performed 6 months after the
primary surgery. The patient reported satisfaction with the
outcome at the 1-year and 2-year follow-up visits. Through
2 years, no adverse events were observed. This patient
did not attend subsequent follow-up visits (ie, 3, 4, 5, or
6 years) and is the only one lost from the original group.
The third patient requested a reoperation 71 months
after the primary surgery to replace her implants for a
larger size. This patient and the first-mentioned reopera-
tion cases continued to be monitored but were excluded
from the study. In the 3 reoperation cases, histological
analysis of the removed implants and pseudocapsules did
not show signs of contracture or any other anomaly.
At year 6, 62.5% of patients (20 of the 32 who did not
undergo revision surgery) included in the prospective,
10-year follow-up study had undergone MRI at 1.5 Tesla to
assess the Motiva Implants safety. The MRI cohort showed
excellent results (Figure 2), with no radiological signs sug-
gesting intracapsular or extracapsular ruptures, capsular
contractures Baker Grades III or IV, asymmetries, calcifica-
tions, hematomas, seromas, or any other implant-related
complication. The overall rate of complications found in
the MRI cohort was 0% for subjects and implants. By year
6, 100% of MRI cohort subjects still had an original implant
in place. Given the size of the MRI group within each indi-
cation, pooling the results provides a more accurate esti-
mate of the Motiva Implants safety and effectiveness.
Table3. Safety Outcomes
Duration of follow-up, years 6
Outcome (N=32)aValue N (%)
Changes in nipple sensitivity 3 (9.4%)
Implant rupture, capsular contracture,
double capsules, late seroma, or
0 (0%)
Inadequate scarring 0 (0%)
Pain 2 (6.3%)
Pruritus 0 (0%)
Ptosis 17 (53.1%)
Reported loss of volume 0 (0%)
Symmastia 0 (0%)
Twinges 2 (6.3%)
ALCL, anaplastic large cell lymphoma. a .
Figure 2. MRI of a 25-year-old female patient’s left breast
after primary breast augmentation done at 6 years post-op
showing no wrinkles and excellent outcome related with
total filling of the implant.
Downloaded from by guest on 14 November 2018
6 Aesthetic Surgery Journal
Effectiveness Outcomes
Patient and Surgeon Satisfaction
In general, the level of satisfaction for both patients and sur-
geons was high at all follow-up visits through 6 years. All
patients were at least “somewhat satisfied” to “extremely
satisfied” with the aesthetic results (Figure 3). The mean
patient satisfaction level was 1.75 ± 0.18 with a 95% level
of confidence, which means that the average value set of
patient satisfaction with the aesthetic results provided by
their surgical procedure was between 1 (extremely satis-
fied) and 2 (very satisfied).
The surgeons considered that patients made “very
important improvement” in 90.6% of the cases, an “import-
ant improvement” in 6.3% of the cases, and an “improve-
ment” in 3.1% of the cases utilizing Motiva Implants in
the implanted population (Figure 4). In other words, an
optimal result of the implantation was achieved in >90%
of the cases, and only 3 patients described their results as
good or very good. The mean surgeon satisfaction level was
1.25 ± 0.42, with a 95% level of confidence; hence, the
average value set of surgeon satisfaction with the aesthetic
results in the implanted population was between 1 (very
important improvement) and 2 (important improvement).
Satisfaction Following Reoperations
To date, satisfaction data are available for only 2 of the 3
reoperation cases. For these 2 cases, patients report being
at least “very satisfied” with the breast augmentation
and surgeons considered that patients had made a “very
important improvement.”
Quality of Life and Self-Esteem
Preoperatively, the patients’ average score on the 9 self-es-
teem and QoL variables evaluated was 8.86 on a scale of 1
to 10 (with 1 being lowest and 10 highest). Average scores
increased following breast augmentation (Figure 5). Overall,
a 0.89% increase in self-esteem/QoL scores was observed
72 months after the implantation compared to baseline.
The results of this long-term, follow-up study demonstrate
the safety and effectiveness of the Motiva silicone breast
implants in primary breast augmentation through 6 years
of follow-up and are also because of consciously follow-
ing the best surgical practices. There were no serious
adverse events and no cases of implant rupture, capsular
Figure 3. Patients’ satisfaction level, 6 years after primary
breast augmentation with Motiva Breast Implants (N = 32).
Figure 4. Surgeons’ satisfaction level at 6 years after
primary breast augmentation with Motiva Breast Implants
(N = 32).
Figure 5. Average scores on the self-esteem and quality of life scales (from 1 to 10, with 1 lowest and 10 highest) before
augmentation surgery and from 2 weeks to 72 months after the augmentation procedure (N = 32).
Downloaded from by guest on 14 November 2018
Quirós et al 7
contracture, double capsules, rotation, late seromas, or
ALCL. Satisfaction and QoL scores indicated very high lev-
els of satisfaction with Motiva Implants among patients
and surgeons and very low rates of reoperation. A limita-
tion of our study is that patients’ satisfaction measurement
was subjective because it was not anonymously requested.
Motiva Implants are 100% filled with highly visco-
elastic, form-stable silicone gel. They use a proprietary
TrueMonobloc configuration with similar durometer value
between patch and shell, which eliminates the gap in
the patch-shell interface and allows it to act as a single
structure with uniform tensile strength. As a result, even
pressure distribution is achieved, and the shell adjusts to
changes in position and pressure without irregularities or
deformation. In general, mechanical performance exceeds
regulatory standards in all tests performed on the shell,
such as elongation, break force, tear resistance, tensile
set, and patch joint integrity.8,9 This model also makes
insertion easier and improves implant mechanical quali-
ties when under stress. Patch joint exhibits a high level
of strength, with a very low risk of rupture. In this study,
there were no instances of rupture evidenced in the group
that received an MRI at 6 years after implantation.
The 6-year outcomes reported in this study identified
minimal adverse events and no implant-related events
(Table 3). The most commonly reported adverse events
were ptosis (53.3%) and change in nipple sensitivity
(9.4%). Other minor events were reported by almost 6.3%
of subjects. None of these outcomes led to reoperation.
Only 3 of the 35 subjects underwent reoperation. Of
these 3 revision patients, reoperation was elected by
the patient and surgeon only for aesthetic reasons. The
Kaplan-Meier risk rate for implant replacement due to vol-
ume changes was 9.4%. The main reason for requesting a
new surgical procedure was the patient’s or surgeon’s cri-
teria for possible improvement of aesthetic results obtained
with the primary surgery. The rate of implant replacement
for safety reasons remains 0% through 6 years.
These safety results are comparable or superior to out-
comes reported by studies of other silicone breast implants in
Figure 6. Pseudocapsule of explanted SmoothSilk/
SilkSurface Motiva Implants Silicone Breast Implants in a
patient who requested reoperation for aesthetic reasons at
3 months.
Figure 7. Pseudocapsule of explanted SmoothSilk/
SilkSurface Motiva Implants Silicone Breast Implants in a
patient who requested reoperation for aesthetic reasons at
6 months after the primary surgery.
Downloaded from by guest on 14 November 2018
8 Aesthetic Surgery Journal
the published literature. For example, an analysis of prospec-
tively collected registry data from Denmark covering 5373
women who had primary breast augmentation between 1999
and 2007 reported a total adverse event rate of 16.7%.10 The
most common adverse events within 30 days of operation
were surgeon related such as hematoma (1.1%) and infec-
tion (1.2%); within 5 years, the most common events were
change in tactile sense (8.7%) and asymmetry/displacement
of the implant (5.2%). The rate of severe capsular contrac-
ture, a more implant-related complication, at 5 years was
1.7%. More recently, a long-term study (N = 9217 devices)
reported a 0.3% risk of nipple sensation changes at 4 weeks
and 6 months and 0.4% risk at 10 years following placement
of form-stable silicone implants.2
Qualities of the implant and operative technique have
been shown to influence complications, and both the sur-
face of Motiva Implants and surgical best-practices likely
contributed to the excellent safety results of our study. For
example, in the case series described above, utilization of
inframammary incisions and shaped textured gel implants
was associated with the lowest rates of complications.
Furthermore, textured, shaped gel implants and submus-
cular implant site were associated with the lowest rates
of capsular contracture. Other studies have also reported
lower rates of capsular contracture with inframammary
incision compared to other sites and with submuscular vs
subglandular implant placement.11 ,12
In our study, the most common incision site was infra-
mammary (96.9%) and the most common implant place-
ment was submuscular (71.9%). These characteristics of
the surgical approach may have contributed to the absence
of adverse events and of capsular contracture.
Capsular contracture and implant rupture are two of the
most important potential adverse outcomes of breast aug-
mentation, and contracture is the most common reason
for revision surgery.13 Many studies have reported rela-
tively high rates of capsular contracture, particularly with
smooth (nontextured) implants. For example, a 6-year
outcomes study of the Allergan (formerly Inamed) sili-
cone breast implants in 940 patients (half of whom were
augmentation patients, most of whom received smooth
implants) reported capsular contracture rates of 15% to
20% and an implant rupture rate of 3.5%.14 Long-term
studies and meta-analyses comparing smooth and textured
implants have reported significantly higher risk for capsu-
lar contracture with smooth vs textured implants.11,12,15,16
SmoothSilk/SilkSurface Motiva Implants used in the study
have a hierarchical micro-/nanotopographical structure on
their surface. It feels like a smooth implant, but, when
viewed under a microscope, it exhibits a complex architec-
ture of structures at the cellular scale.
Texturing was originally developed to minimize capsu-
lar contracture. However, the aggressive texturization used
in the manufacture of many implants has been associ-
ated with risk for seroma and double capsule formation.17
Furthermore, many textured implants are still associated
with a reduced but significant rate of capsular contracture.
For example, a 5-year follow-up study of 1010 textured
silicone breast implants reported a 6.6% rate of capsular
contracture in the overall study population and a Kaplan-
Meier risk of contracture of 10.7% following primary aug-
mentation.18 At 5 years, 8.5% of implants were removed
following primary augmentation. The rates of infection and
seroma in this study were 0.6% and 0.2%, respectively.
A second study reported an 8% rate of capsular contrac-
ture at 9 years following implantation of form-stable tex-
tured silicone implants.19 These studies suggest somewhat
improved risk for contracture with textured surfaces, but
many patients remained at risk for this adverse outcome.
The SmoothSilk/SilkSurface surface of Motiva Implants
differs substantially from textured implants. Rather than
being textured with the application of salt or sugar crystals
Figure 8. Pseudocapsule of explanted SmoothSilk/
SilkSurface Motiva Implants Silicone Breast Implants in a
patient who requested reoperation for aesthetic reasons at
71 months after the primary surgery. The very thin capsule
evident in this image demonstrates the positive clinical
outcome of these surfaces.
Downloaded from by guest on 14 November 2018
Quirós et al 9
onto the implant, like many other implants, SilkSurface/
SmoothSilk is manufactured using 3D inverted negative
imprinting technology. The manufacturing process is parti-
cle free and uses no foreign particle projection to create the
surface, also allowing a uniform and controlled shell thick-
ness. The resulting micro/nano surface is unique: it has
very low roughness parameters featuring an average mea-
surement of 3600 ± 400 nm, which implies low friction
coefficient and, consequently, no loose particles.20 It was
engineered to promote a cell-friendly interaction between
the implant and surrounding tissues, potentially reduc-
ing inflammation in the postoperative period and chronic
Figure 9. This 28-year-old woman with hypoplastic breasts underwent primary breast augmentation utilizing Motiva
Implant 355 cc Full Projection breast implants. (A, G, M) Preoperative, (B, H, N) 12-month postoperative, (C, I, O) 24-month
postoperative, (D, J, P) 36-month postoperative, (E, K, Q) 48-month postoperative, and (F, L R) 72-month postoperative
photographs are shown.
Downloaded from by guest on 14 November 2018
10 Aesthetic Surgery Journal
inflammation after recovery. Furthermore, this topography
seems to affect foreign body response by reducing pla-
nar arrangement of adherent cells such as fibroblasts and
promoting optimum adhesion based on stable focal con-
tacts.21,22 This improved interaction with native tissues may
limit risk for capsular contraction and allow the implant to
better adapt to the normal movement of the breast. This
surface’s unique characteristics may have contributed to
the absence of capsular contracture in the current study.
The impact of this micro/nano surface is evidenced by the
very thin pseudocapsules identified during the reoperations
performed in this investigation (Figures 6-8). In all cases, the
very thin pseudocapsule is the result of a breast implant sur-
face characterized by a multitude of contact points with low
roughness. It is significant that the surgeons participating in
this study followed a best-practices protocol for breast aug-
mentation that, in combination with these surfaces, resulted
in no capsular contracture or rupture cases through 6 years.
Figure 9. Continued
Downloaded from by guest on 14 November 2018
Quirós et al 11
Based on their experience with these implants, the authors
recommend that they should be treated like a traditional
smooth implant for surgical planning and surgical technique.
The excellent aesthetic outcomes with SmoothSilk/
SilkSurface Motiva Implants are illustrated in represen-
tative cases in the Figures 9 and 10. For the 32 patients
(64 implants) evaluated at 6 years, patients reported a
high rate of satisfaction with the aesthetic results; 100%
of the patients were somewhat satisfied, very satisfied, or
extremely satisfied with the results. The surgeons consid-
ered that patients made a very important or an import-
ant improvement in 96.9% of the cases with utilization of
Motiva Implants in the implanted population. These uni-
formly high satisfaction scores indicate the effectiveness
of the Motiva Implants for primary breast augmentation.
A recently published study with more than 5000
patients utilizing the same devices reported equiva-
lent data with no capsular contracture, late seromas,
Figure 9. Continued
Downloaded from by guest on 14 November 2018
12 Aesthetic Surgery Journal
or double capsules.23 The congruence of these findings
is reassuring because the positive outcomes from the
use of these new implants seem to be consistent and
Scores on self-esteem/QoL scales also improved from
baseline throughout the 6-year study period. A reduction
in mean scores was observed 72 months after implan-
tation compared to previous follow-up visits (except for
the 4-year value, which is the lowest in the observation
period). We believe that this reduction at 72 months was
due to individual patient variables such as weight gain,
pregnancies, and other personal situations at the time of
evaluation. In fact, 6 of the 32 evaluated patients reported
a significant weight gain and significant reductions in
their self-esteem/QoL scores, causing the average scores
to be lower.
It is of particular importance that between 2010 and
2017, the authors implanted a total of 1082 patients in
the same institution (excluding the implants belonging to
the investigation presented in this paper) with very low
complication rates (Table 4). These complication rates are
statistically consistent with those found in the 6-year out-
comes from the prospective, 10-year follow-up study to
confirm the safety and effectiveness of Motiva Implants
silicone breast implants in 35 patients who underwent
breast augmentation. Given both the prospective and ret-
rospective experience of the authors with these implants,
we believe that in the future there will be enough clini-
cal evidence that these devices can lead to more positive
outcomes for patients. Although prospective long-term
safety and efficacy in a larger series of patients has yet to
be determined for this implant, completing this extended
study will be an important contribution to draw its profile.
A limitation of this study is the number of patients, which
is inadequate to make final claims on capsular contracture
or seroma rates.
Figure 10. This 31-year-old woman with hypoplastic breasts underwent primary breast augmentation utilizing Motiva Implant
325 cc Corse Projection breast implants. (A, F) Preoperative, (B, G) 24-month postoperative, (C, H) 36-month postoperative,
(D, I) 48-month postoperative, and (E, J) 72-month postoperative photographs are shown.
Downloaded from by guest on 14 November 2018
Quirós et al 13
Moreover, the authors would expect that additional
studies will further validate the hypothesis that these
implants amalgamate the best characteristics of a smooth
implant with the positive expectations of a textured
The SmoothSilk/SilkSurface Motiva Implants used in this
study demonstrated an optimal safety profile and excellent
aesthetic results in both the MRI and non-MRI cohorts. At
6 years, there were no cases of implant rupture or malposi-
tion, no cases of capsular contracture, and a very low rate
of reoperation, which was performed only for aesthetic
reasons. This ongoing study will continue to evaluate out-
comes with these patients, but the clinical results to date
are promising for this innovative technology.
Supplementary Material
This article contains supplementary material located online at
Editorial support for manuscript development was provided by
Joshua Kilbridge of Kilbridge Associates (San Francisco, CA).
Figure 10. Continued
Table4. Complication Rates for Motiva Breast Implants Between 2010
and 2017
Complication % (N)*
Capsular contracture 0.27 (3)
Implant replacement for aesthetical reasons 0.64 (7)
Implant rupture 0.09 (1)
Postsurgical hematoma 0.55 (6)
Postsurgical seroma 0.09 (1)
Wound necrosis 0.09 (1)
Downloaded from by guest on 14 November 2018
14 Aesthetic Surgery Journal
Dr Manuel Chacón Quirós and Dr Manuel Chacón Bolaños
are relatives of the CEO of Establishment Labs. Dr Chacon
Quirós has been a member of the Medical Advisory Board
of Establishment Labs since 2015. Dr Fassero declared no
potential conflicts of interest with respect to the research,
authorship, and publication of this article. Patients received
the implants free of charge from Establishment Labs S.A. All
reports from every patient’s visit were independently audited
by Dr. Alfredo Vargas, Plastic Surgeon from the Plastic and
Reconstructive Surgery Department, Hospital Mexico (San
Jose, Costa Rica).
Establishment Labs Holdings Inc. (New York, NY) funded the
manuscript development in terms of medical writing, editing
assistance, and statistical analysis.
1. Cosmetic Surgery National Data Bank Statistics. Aesthet
Surg J. 2017;37(Suppl 2):1-29.
2. Lund HG, Turkle J, Jewell ML, Murphy DK. Low risk
of skin and nipple sensitivity and lactation issues after
primary breast augmentation with form-stable silicone
implants: follow-up in 4927 subjects. Aesthet Surg J.
3. Somogyi RB, Brown MH. Outcomes in primary breast
augmentation: a single surgeon’s review of 1539 consecu-
tive cases. Plast Reconstr Surg. 2015;135(1):87-97.
4. Mathur A. Nanotechnology in Cancer. Amsterdam,
Netherlands: Elsevier Science and Technology Books;
5. Barr S, Hill EW, Bayat A. Functional biocompatibility test-
ing of silicone breast implants and a novel classification
system based on surface roughness. J Mech Behav Biomed
Mater. 2017;75:75-81.
6. ISO 14607:2018. Non-active surgical implants – Mammary
implants particular requirements. Geneva, Switzerland:
International Organization for Standardization.
7. Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell
GP; Style 410 U.S. Core Clinical Study Group. Style 410
highly cohesive silicone breast implant core study results at
3 years. Plast Reconstr Surg. 2007;120(7 Suppl 1):40S-48S.
8. Establishment Labs. Technical Study Report Surface
Characterization Method Motiva VelvetSurface®, Motiva
SilkSurface®, and Eurosilicone: TS-15-003.R. 2017.
9. Establishment Labs. Technical Study Report: Roughness
Test Metrology with µsurf Mobile TS-16-011.R. 2017.
10. Hvilsom GB, Hölmich LR, Henriksen TF, Lipworth L,
McLaughlin JK, Friis S. Local complications after cos-
metic breast augmentation: results from the Danish
Registry for Plastic Surgery of the Breast. Plast Surg Nurs.
11. Namnoum JD, Largent J, Kaplan HM, Oefelein MG,
Brown MH. Primary breast augmentation clinical trial
outcomes stratified by surgical incision, anatomical place-
ment and implant device type. J Plast Reconstr Aesthet
Surg. 2013;66(9):1165-1172.
12. Stevens WG, Nahabedian MY, Calobrace MB, et al.
Risk factor analysis for capsular contracture: a 5-year
Sientra study analysis using round, smooth, and textured
implants for breast augmentation. Plast Reconstr Surg.
13. Forster NA, Künzi W, Giovanoli P. The reoperation cas-
cade after breast augmentation with implants: what the
patient needs to know. J Plast Reconstr Aesthet Surg.
14. Spear SL, Murphy DK, Slicton A, Walker PS; Inamed
Silicone Breast Implant U.S. Study Group. Inamed silicone
breast implant core study results at 6 years. Plast Reconstr
Surg. 2007;120(7 Suppl 1):8S-16S; discussion 17S.
15. Wong CH, Samuel M, Tan BK, Song C. Capsular contrac-
ture in subglandular breast augmentation with textured
versus smooth breast implants: a systematic review. Plast
Reconstr Surg. 2006;118(5):1224-1236.
16. Barnsley GP, Sigurdson LJ, Barnsley SE. Textured surface
breast implants in the prevention of capsular contrac-
ture among breast augmentation patients: a meta-anal-
ysis of randomized controlled trials. Plast Reconstr Surg.
17. Hall-Findlay EJ. Breast implant complication review:
double capsules and late seromas. Plast Reconstr Surg.
18. Duteille F, Perrot P, Bacheley MH, Stewart S. Eight-year
safety data for round and anatomical silicone gel breast
implants. Aesthet Surg J. 2018;38(2):151-161.
19. Stevens WG, Calobrace MB, Harrington J, Alizadeh
K, Zeidler KR, d’Incelli RC. Nine-year core study data
for Sientra’s FDA-approved round and shaped implants
with high-strength cohesive silicone gel. Aesthet Surg J.
20. Munhoz AM, Santanelli di Pompeo F, De Mezerville R.
Nanotechnology, nanosurfaces and silicone gel breast
implants: current aspects. Case Reports Plast Surg Hand
Surg. 2017;4(1):99-113.
21. Barr S, Hill E, Bayat A. Current implant surface technol-
ogy: an examination of their nanostructure and their influ-
ence on fibroblast alignment and biocompatibility. Eplasty.
22. Barr S, Bayat A. Breast implant surface development: per-
spectives on development and manufacture. Aesthet Surg
J. 2011;31(1):56-67.
23. Sforza M, Zaccheddu R, Alleruzzo A, et al. Preliminary
3-year evaluation of experience with silksurface and
velvetsurface motiva silicone breast implants: a sin-
gle-center experience with 5813 consecutive breast
augmentation cases. Aesthet Surg J. 2018;38(Suppl
Downloaded from by guest on 14 November 2018
... To date, previous studies have shown that incidences of CC range between 0.0% and 2.10% in a cohort of patients receiving the Motiva Ergonomix Round SilkSurf ace. 13,19,22,23,46 We found that CC occurred at an incidence of 1.4%; it was within the previous range and higher as compared with that reported during a 1-year period (0.0%). 13 Limitations of the current study are as follows: First, we included a small series of the patients under the retrospective design. Second, we conducted the current study in a cohort of the patients who visited a single local clinic in Seoul, Korea. ...
Background The Motiva Ergonomix™ Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is one the representative brands of the fifth-generation of a silicone gel-filled breast implant with a microtextured surface. Objectives In this study, we describe preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women. Methods We performed a retrospective analysis of medical records in a total of 69 women (n=69) receiving an implant-based augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface between September 26, 2017 and December 31, 2020. We analyzed incidences of postoperative complications. Results A total of 6 cases (8.7%) of postoperative complications occurred; these include 2 cases (2.9%) of early seroma, 1 case (1.4%) of capsular contracture, 2 cases (2.9%) of alterations in the shape and 1 case (1.4%) of foreign body sensation. Time-to-events were estimated at 266.81±273.17 days. Conclusions We describe our preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix TM Round SilkSurface in Korean women. But this deserves further large-scale studies with long periods of follow-up.
... Some authors have revealed that the new texture adapts better to biological tissues, allowing its permanence in the surgical site, the growth of granulation tissue surrounding the biomaterial (9). In contrast, the nanotextured breast silicone implant was introduced in 2004 using three-dimensional (3D) inverted negative printing technology on the implant surface to provide a surface that could better adapt to the organism, decrease fibroblastic adhesion activity and, at the same time, decrease the incidence of capsular contracture, according to information provided by the manufacturer (10). ...
Background/aim: The aim of this study was to investigate cytotoxicity, inflammatory response, and angiogenesis induced by silicone gel breast implants with different textured surfaces in vitro and in vivo. Materials and methods: In the in vitro study, murine fibroblast cells (L929) were cultured for 1, 3, and 5 days with silicone membranes of three different textures: nanotextured, microtextured, and silicone foam. In the in vivo study, a total of 30 male rats (Rattus, norvegicus, albinos, Wistar) were distributed into three groups (10 animals per group), with 2 implants in each rat: nanotextured silicone gel breast implants group, microtextured silicone gel breast implants group, and silicone gel breast foam implants group. Results: The Alamar Blue assay detected higher viability of cells cultured in the presence of nanotextured silicone surface for 1 and 3 days. The MTT assay showed higher cytotoxicity of silicone foam after 1 and 3 days of exposure. Nanotextured silicone breast implants induced a more prolonged inflammatory response, denoting a delay in the healing process and subsequent organization of the fibrous capsule as depicted by the collagen fiber types found. VEGF expression did not differ between experimental groups. Conclusion: Gel foam breast implants are more biocompatible when compared to micro- or nano-textured silicone breast implants.
Objective. To study the impact of augmentation mammoplasty on some aspects of body image-related quality of life, motivation and self-esteem. Materials and methods. Seventeen women were surveyed 6-14 months after augmentation mammoplasty using the BIQLI and ASI-R questionnaires. Results. The aspects of body image-related quality of life associated with physical activity and desire to change one's appearance were higher in younger people with lower body weight. The volume of installed breast implants was inversely proportional to the feeling of confidence and happiness in everyday life (R = 0.6). The larger was the volume of implants, the less was the responsibility for life events (R = 0.8). In the long-term period after mammoplasty, a subjective level of the quality of life increased in 53 %, on average by 0.2 (p0.05), significantly only for the motivation scale and the question "feelings of personal dignity and self-respect". Negative dynamics was found for the following aspects: "When I meet new people", "At work (study)" and "Relationships with friends", for all other answers positive one. The older the patients were, the more attention they paid to their appearance (R = 0.7) and compared themselves with the others (R = 0.6), thought about what the others think about their appearance (R = 0,6), more often thought about how they look like in different situations (R = 0.6). Conclusions. Preoperative studying of motivation allows more differentially determining the indications for surgery and risk of postoperative dissatisfaction. Augmentation mammoplasty often improves the body image-related quality of life, motivation and self-esteem.
Background: Inferior implant malposition after breast augmentation is the second most common reason for revision surgery. This article introduces the new concept of dual-plane pocket formation in transaxillary breast augmentation to prevent inferior implant malposition by preserving the continuity of the superficial layer of the deep pectoralis fascia. Methods: Patients who underwent transaxillary endoscopic breast augmentation performed from January of 2017 to December of 2019 were retrospectively reviewed. With the aid of the endoscope, dissection proceeded. During pectoralis muscle origin detachment, the superficial layer of deep pectoralis fascia was preserved. After making pocket, silicone gel implants were inserted. Retrospective chart review was done to collect data on the postoperative complications. Results: A total of 251 patients were performed and the mean follow-up time was 20.6 months. In a total of 28 cases of complications (9.6%), there were 2 cases of reoperations. In a total of three patients (1.2%) of implant malposition, one patient (0.4%) developed mild bilateral bottoming-out deformity. Conclusions: Meticulous dissection by endoscopy could avoid destruction of the superficial layer of the deep pectoralis fascia during pocket dissection and produce an intact fascial system with its own continuity at the IMF. A well-controlled envelope over the implant and supporting structure underneath it are important in breast augmentation to prevent inferior implant malposition.
Background: Breast augmentation is one of the most commonly requested and performed plastic surgery procedures. In order to prevent early postoperative complications such as seroma or hematoma, surgical drains could be useful. The aim is to perform a systematic review of the literature on the use of surgical drains in primary breast augmentation. Methods: This review was performed following the PRISMA guidelines. PubMed, SCOPUS, Web of Science and Cochrane Library databases were queried in search of clinical studies describing the use of surgical drains in women undergoing primary breast augmentation with implants and documenting seroma and/or hematoma formation rate and/or infection rate. Results: Initial search identified 2596 studies, and 162 were found relevant. Full-text review and application of our inclusion criteria to all retrieved papers produced 38 articles that met inclusion criteria. Among the included studies, 16 papers reported the use of surgical drains in breast augmentation, while in the remaining 22 articles drains were not used. Only 5 studies specifically investigated the role and effectiveness of surgical drains in augmentation mammaplasty and its possible relationship with complication rate such as seroma, hematoma or infection. Conclusions: Despite similar complication rates emerged from the analyzed articles, because of the heterogeneity of the studies, we were not able to demonstrate specifically whether drain use affects the rate of early postoperative complications such as seroma, hematoma and infection. Additional randomized controlled trials are strongly advocated in order to provide the necessary scientific evidence. Level of evidence iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors .
Full-text available
Background Simultaneous association of autologous fat grafting (AFG) with silicone implants, defined as a hybrid procedure, has been proposed for breast augmentation (BA). In some patients, larger-volume implants may result in larger incisions, with long-term effects including implant palpability, soft tissue atrophy, and secondary ptosis. Some patients do not want large volume implants, or have insufficient soft tissue coverage. Recent improvements in AFG have led to new surgical options in BA for addressing these cases.Objectives This study combines AFG in BA using small-volume implants, known as the SWEH (soft weight hybrid) approach, and evaluates aesthetic advantages and outcomes following primary/secondary BA.Methods25 patients (50 breasts) underwent SWEH procedures; this approach was indicated when the overlying tissue was insufficient to adequately cover the implant and patients refused large-volume implants. Three-dimensional images were obtained using a Divina 3D scanner system (AX3 Technologies, Miami, USA) to assess breast volume (BV) and intermammary distance (IMD) during follow-up.ResultsMean patient age was 29.3 years (range: 21–42) and mean body mass index was 19.3 kg/m2 (15.3–27.2). The most common implant (SmoothSilk surface Round/Ergonomix style) volume was 180 cc (175–215), and patients received a mean volume of 125 cc of fat (89–168)/breast in the subcutaneous tissue. Preoperative average BV measurements were 236.85 cc (170–335). At 3 and 12 months post-procedure, the average BV values were 488.82 and 478.73cc, respectively (p=0.475). The average preoperative IMD was 31.76 mm (range, 22–43); at 3 and 12 months post-procedure, the average IMD was 20.47 and 20.94 mm, respectively (p=0.61). Postoperative complications included subcutaneous banding in the axilla (n = 1; 4%) and hypertrophic scarring (n = 1; 4%). Breast imaging exams were performed; in 2 breasts (8%) localized oil cysts were observed; no cases of suspicious calcifications, fat necrosis, or lumps were seen. Fat retention rate (1 year) was calculated by the difference between the BV expected with 100% fat intake and the real BV observed. In our sample we observed an average of 72.7 (range: 69.2–77.3, SD: 2.63) and 76.7 (range: 72.3–79.9, SD: 2.18) percent of fat intake on the right and the left breast respectively. No rippling, implant malposition, or infection was observed during a mean follow-up of 22 months (6–40).ConclusionsSWEH is a useful surgical alternative that combines the benefits of AFG and implant-based augmentation, particularly with regard to soft tissue coverage, and avoids the limitations of larger-volume implants. The association of small-volume gel implants and smaller scars can yield satisfactory aesthetic outcomes.Level of Evidence IVThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors
Silicone gel-filled implants exist in a wide range of shapes and textures, and yet there are relatively few long-term large-scale studies, particularly on recently developed “semi-smooth” implants. The present study fills in this gap by presenting the 3-year findings from an ongoing 10-year multicenter prospective study on breast implants with four different surface types: smooth, semi-smooth, microtextured, and macrotextured. A total of 908 patients were recruited in 15 investigational sites across Europe and divided in three groups: 653 primary augmentations in Group 1, 144 revision augmentations in Group 2, and 111 reconstructions in Group 3. All 4 types of implant shells were manufactured by the same company using the same silicone material. Surgeons were free to choose their preferred technique and implant surface, but data was collected using a standardized software and included all complications, and satisfaction levels reported by the patients at each visit. The incidence of post-operative complications was estimated based on Kaplan-Meier risk rates, on a per patient basis. At 3 years post implantation, capsular contracture (Baker grade III/IV) was the most common complication, with a per-patient risk rate of 1.5% in Group 1. Interestingly, there was no capsular contracture in this group when semi-smooth implants were used. The risk of implant rupture in Group 1 was 0.2%. The preliminary findings of this 10-year prospective study indicate that, 3 years after the operation, the four types of silicone gel-filled implants investigated were safe, with a low complication rate in comparison with the most favorable results published in other similar studies.
Zusammenfassung Hintergrund Laut aktueller Studienlage weist die einzeitige Augmentationsmastopexie (AM) geringe Komplikationen auf und ist mit einer niedrigeren Reoperationsrate verbunden, als wenn ein zweizeitiges Vorgehen erfolgt. Bei der AM kann sich die Brustdimension im Vergleich zu jenen Fällen ohne zusätzliche Straffungsindikation deutlich unterscheiden. Dabei blieben diese Unterschiede nur unzureichend untersucht. In der vorliegenden Studie sollen diese zunächst quantifiziert und im Anschluss die Auswirkung der Brustdimension auf die Implantatauswahl eruiert werden. Zudem soll der Einfluss der Mastopexie auf das Outcome von Augmentationen mit runden nanotexturierten Silikonimplantaten evaluiert werden. Patienten und Methoden Über einen Zweijahreszeitraum wurden alle Patientinnen mit primären Brustaugmentationen mit nanotexturierten Implantaten in die Studie eingeschlossen. Soziodemografische Daten, präoperative Brustmaße, Spezifikationen der eingesetzten Implantate und Komplikationen der Augmentationsgruppe ohne Straffung wurden mit jenen der Gruppe mit AM verglichen. Die Zufriedenheit der Patientinnen und der Operateure wurde mittels Likert-Skalen dokumentiert. Ergebnisse Insgesamt wurden 206 Brustaugmentationen bei n = 103 Patientinnen durchgeführt. Das mittlere Follow-up betrug 24,0 ± 4,3 Monate. Im Vergleich zur Augmentation ohne Straffungsindikation lagen bei der AM breitere Brustbasen und größere präoperative Körbchengrößen vor, p < 0,001. In der Folge wurden bei der AM Implantate mit breiteren Durchmessern und niedrigeren Volumina (p < 0,05) ausgewählt, welche mit geringeren Projektionen verbunden waren, p < 0,001. Die Gesamtrevisionsraten nach Augmentationen ohne (n = 51) und mit Straffung (n = 52) betrugen 5,9 % und 19,2 %, p < 0,05. Die AM erhöhte gewebebedingte Revisionen von 2,0 % auf 13,4 % (p < 0,05) ohne Einfluss auf implantatbedingte Revisionen (3,9 % vs. 5,8 %, p = 0,663). Die Gesamtinzidenz von Kapselkontrakturen lag bei 1,9 %. In beiden Gruppen zeigte sich eine annähernd gleichhohe Zufriedenheit. Schlussfolgerung Im Vergleich zu Augmentationen ohne Straffung führen präoperativ breitere Brustbasen und größere Brustvolumina zur Auswahl von signifikant unterschiedlichen Implantatdimensionen bei der AM. Nanotexturierte Implantate sind verbunden mit niedrigen Komplikationsraten, wobei ein erhöhtes Risiko für gewebebedingte Revisionen nach AM verbleibt. Weitere Studien sind notwendig, um eventuelle Vor- und Nachteile gegenüber etablierten Implantaten zu evaluieren.
Introduction: In plastic breast surgery minimal scar techniques are usually associated with some advantages in terms of the aesthetics associated with scar formation and scar visibility. They can also bring benefits in terms of healing and recovery time, which is why minimal scar techniques for breast reduction and mastopexy have long been established. Modern implants and new, adapted surgical techniques enable it now to use minimal scar techniques for breast augmentation with similar advantages. Method: 252 patients were included in a retrospective study, which underwent a minimal scar breast augmentation via an inframammary approach over a period of two years. The investigations included the location, the size, the shape and any postoperative complications. In addition, all patients were interviewed about their experiences before and one year after the operation using the Breast-Q Questionnaire (Augmentation Module). The focus was on self-esteem (pre- and postoperative) and satisfaction with the outcome of breast augmentation involving the scar. Results: The assessment of the surgical outcome and the scar were consistently positive. There were no complications with regard to surgical access, the scar or the implant. All patients showed a significant increase in quality of life on the Breast-Q scale from 0-100 (psychological well-being: 44 to 77) and were satisfied with the outcome of breast enlargement (satisfaction with the breasts: 28 to 80; satisfaction with the result: 89 out of 100) involving the scar. Conclusion: Minimal scar breast augmentation requires greater technical effort and operative experience. However, the results are consistently positive and promising, both clinically and psychologically.
Full-text available
Nanotechnology is defined as the design of products that interact with biological systems on the nanoscopic scale. Creating a controlled nanotexture and understanding the ways in which surface properties impact inflammatory response is of the utmost significance in designing implants that can provide satisfactory outcomes.
Full-text available
Background: Silicone breast implants have been in use for breast augmentation for more than 50 years, but technological innovation has been lacking in implant design until recently. Objectives: This study was designed to evaluate the complication and reoperation rates following breast augmentation utilizing the Motiva silicone breast implants. Methods: This retrospective study evaluated the safety of Motiva implants in 5813 consecutive cases of breast augmentation. Implants with two different textured surfaces were evaluated: SilkSurface (nanotextured) and VelvetSurface (micro-textured). Results: Implants were placed between April 2013 and April 2016. A total of 44 complications were reported, with an overall complication rate of 0.76%, and the rate of reoperation was 0.76% over an interval of 3 years. There were no late complications and no cases of primary capsular contracture. No differences in complication rates were observed because of the implant date. However, among patients who received implants 300 to 499 cc in volume, complication rates were significantly lower with SilkSurface compared with VelvetSurface implants. Advanced statistical analysis supported the validity of the low complication rate reported in this study. Conclusions: Overall, these findings suggest that Motiva silicone breast implants are associated with very low rates of complication and reoperation, and that the nano-textured SilkSurface implant is associated with fewer complications than micro-textured implants. Level of evidence 3:
Full-text available
Purpose: Increasing numbers of women undergo breast implantation for cosmetic and reconstructive purposes. Contracture of the fibrous capsule, which encases the implant leads to significant pain and reoperation. Texture, wettability and the cellular reaction to implant surfaces are poorly understood determinants of implant biocompatibility. The aim of this study was to evaluate the in-vitro characteristics of a range of commercial available implants using a macrophage based assay of implant biocompatibility and a quantitative assessment of wettability and texture. Methods: Thirteen commercially available surfaces were subjected to wettability and texture characterisation using scanning and laser confocal microscopy. THP-1 macrophages were cultured on their surfaces and assessed using Integrin αV immunocytochemistry, SEM and RT-PCR for the expression of TNF-Alpha, IL-6, IL-10 and a cytokine array for the production of TNF-alpha, IL-10, IL-1RA and IL1β; important indicators of inflammation and macrophage polarization. Results: Textured surfaces can be accurately sub-categorized dependent upon roughness and re-entrant features into four main types (macro, micro, meso and nano-textured surfaces). Significant (P < 0.0001) differences in implant hydrophobicity and texture exist. Certain surfaces promoted poor macrophage polarization and an innate potential to foster a proinflammatory response. A subgroup analysis showed that texture had a variable effect on markers of inflammation in these surfaces. Conclusions: We propose a classification of implant surfaces based on roughness and present a macrophage based assay of breast implant biocompatibility with a quantitative assessment of implant wettability and texture. The breast implant surface-cell interaction is variable and sufficient to alter healing response and capsular contracture fate in-vivo.
Full-text available
Background: Natrelle 410 implants (Allergan, Inc., Irvine, CA) are approved in the United States for breast augmentation, reconstruction, and revision. Objectives: To assess the risk of nipple and skin sensation changes and lactation issues in subjects receiving implants for primary breast augmentation and ascertain whether differences based on incision site exist. Methods: We used 410 Continued Access study data to assess safety and effectiveness of devices implanted via inframammary or periareolar incision sites. Subjects were evaluated preoperatively and at 4 weeks, 6 months, and annually up to 10 years postoperatively. Lactation issues and nipple and skin sensation changes (hypersensitivity/paresthesia, loss of sensation) were assessed. Results: The inframammary and periareolar cohorts comprised 9217 and 610 implanted devices, with mean follow-up of 4.1 years (range, 0-10.1 years) and 4.8 years (range, 0-10.1 years), respectively. In the inframammary cohort, risk of first occurrence of nipple sensation changes was 0.3% (95% CI: 0.2-0.5) at week 4 and month 6, and 0.4% (0.3-0.7) at year 10. Risk of skin sensation changes was 0.0% (95% CI: 0.0-0.2) at week 4, 0.1% (0.0-0.2) at month 6, and 0.1% (0.0-0.3) at all subsequent time points. No nipple or skin changes occurred in the periareolar cohort. Incidence of lactation issues was similar to that reported in postpartum women who did not have breast implants. Conclusions: We found that the risk of nipple or skin sensation changes and lactation issues is low and provide long-term safety and effectiveness data on subjects receiving implants for primary breast augmentation. Level of evidence: 3 Therapeutic.
Full-text available
Background: Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. Objectives: The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants. Methods: The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. Results: Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. Conclusions: The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. Level of evidence: 2 Therapeutic.
Background The safety and efficacy of all medical devices, including breast implants, is important and consistent performance is best shown by undertaking long-term clinical and vigilance studies. Local complications such as capsular contracture and rupture are risks often associated with breast implant surgery. Objectives The authors investigate and evaluate the safety and performance of Eurosilicone’s (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at 8 years postimplantation. Methods In this prospective clinical study, 995 Eurosilicone textured cohesive Cristalline Paragel mammary implants were implanted in 526 women undergoing augmentation and reconstructive surgery at 17 centers across France. Complications were recorded at 3 months and annually thereafter for 8 years. Descriptive statistics were used and key complications were analysed using the Kaplan-Meier method. Results Capsular contracture was reported in 8.5% of implants across all cohorts through 8 years. The Kaplan-Meier risk of capsular contracture (Baker Grade III/IV) per implant was 8.4% in the primary augmentation cohort and 18.0% in the primary reconstruction cohort. Eight implant ruptures were identified by surgeon examination during this follow-up period. The Kaplan-Meier risk of rupture occurring within 8 years postimplantation, across all cohorts, was 1.4% per patient and 0.9% per implant. Actual implant removal rate (explantation/exchange) was 6.0% and 13.8% for primary augmentation and primary reconstruction, respectively. Actual rates of local complications including infection and seroma were low with risk rates of 0.6% and 0.2% by subject. Conclusions This multicenter clinical study involving Eurosilicone’s silicone gel breast implants in both round and shaped profiles demonstrates an excellent safety and efficacy profile through 8 years. Level of Evidence: 3
The use of implants in aesthetic breast surgery may lead to complications resulting in the need for reoperation. This study examines outcomes following breast augmentation in a single surgeon's practice and investigates the effect of implant selection and surgical technique on complications and reoperations. A retrospective review of a single surgeon's prospectively maintained database over 15 years was performed. All primary bilateral breast augmentation patients were included. Implant characteristics-including implant type, fill, shape, surface, and projection; incision type; and pocket location-were collected. Complications and reasons for reoperation were analyzed using survival analysis. One thousand five hundred thirty-nine patients with 3078 implants were included. Implant types included 596 shaped textured gel, 515 round smooth saline, 192 round textured gel, and 236 round smooth gel implants. Follow-up ranged from 0 to 155 months (average, 18 months). Total complication and reoperation rates were 6.8 and 7.7 percent, respectively. Inframammary incisions and the use of shaped textured gel implants were associated with lower rates of complications. The use of a dual-plane II or III pocket, and implant volumes over 400 cc, were associated with higher rates of complications. Full-projection round implants had rates of complications and reoperations equivalent to those of moderate-projection devices. Both textured shaped gel implants and a subpectoral pocket location were associated with the lowest rates of capsular contracture. This large series of breast implant patients demonstrates that both implant- and technique-related factors may influence complications and reoperations in breast implant surgery. Therapeutic, IV.
Although there are a few broadly agreed upon contributory factors, the multifaceted etiologies of capsular contracture have remained unresolved for decades. This study investigates a variety of potential risk factors that contribute to capsular contracture in primary augmentation patients. The data used for this analysis includes 5109 implants in 2560 primary augmentation patients implanted by 34 surgeons based on five-year results from Sientra's clinical study. Patients were evaluated at annual visits where the capsular contracture Baker Grade was recorded. Potential risk factors, including patient attributes, implant attributes, surgery characteristics, pocket irrigation, and post-surgery characteristics, were analyzed using frequency and multivariate models. A total of 265 capsular contracture events in 179 patients were reported through five years. The overall Kaplan-Meier rate for capsular contracture was 7.6 percent by device. The unadjusted analysis showed increase odds of capsular contracture in smooth devices, periareolar incision, subglandular placement, antibiotic and steroid pocket irrigation, recommended massage, and surgical bra (all p values < 0.05). Results from the multivariate analysis, adjusting for all variables in the model, found six factors to be independently associated with capsular contracture (implant placement, implant surface, incision site, hematoma or seroma development, device size, and surgical bra, all p values < 0.05). This analysis has provided evidence that submuscular placement and textured implants, in addition to other factors, are significant in reducing the incidence of capsular contracture.
Background: Clinical evidence concerning the potential risks and benefits associated with surgical incision, anatomical pocket and implant device type in primary breast augmentation is lacking. Objectives: This study assesses relative risk (RR) of adverse events stratified by surgical incision, anatomical pocket and breast implant device in primary augmentation patients enrolled in Core (NCT00689871, round/silicone devices) and 410 (NCT00690339, anatomically shaped/highly cohesive silicone devices) long-term clinical trials. Methods: RR for time-to-first-event of Baker grade 3-4 capsular contracture (CC), moderate-severe malposition, and secondary procedure were calculated using multivariate time-to-event regression analysis. Results: Risk of CC was increased with periareolar (unadjusted model only) and with axillary (adjusted model) versus inframammary incision. Risk of CC was significantly reduced with subpectoral versus subglandular placement (adjusted model), and with textured surface/round/silicone-filled devices and textured surface/shaped/highly cohesive silicone-filled devices versus smooth surface/round/silicone-filled devices (adjusted model). Risk of CC was significantly reduced with textured surface devices independent of subpectoral or subglandular placement (adjusted model). In a number-needed-to-treat analysis, 7-9 patients needed to be treated with a textured surface device to prevent one Baker grade 3-4 CC over 10 years. Risk of moderate-severe malposition was significantly increased with periareolar (adjusted model) and axillary (adjusted model) versus inframammary incision; and significantly lower with textured surface/shaped/highly cohesive silicone-filled devices than with smooth surface/round/silicone-filled devices (adjusted model). Risk of secondary procedures was significantly increased with periareolar (adjusted model) and axillary (adjusted model) versus inframammary incision; and significantly reduced with textured surface/shaped/highly cohesive silicone-filled devices versus smooth surface/round/silicone-filled devices (adjusted model). Conclusions: In primary breast augmentation, surgical incision, anatomical pocket, and device were significant predictors of clinical outcomes: capsular contracture, malposition and secondary procedure.
Breast augmentation with implants is the most commonly performed aesthetic surgical procedure. However, the risk of complications requiring revision surgery with unsatisfactory final results is often underestimated. In a 10-year retrospective study, patients receiving implant exchange or implant removal after breast augmentation were reviewed with regards to surgical technique, implant type and position, complications and follow-up interventions. As many as 230 patients were included with a mean age of 40.23 years. A total of 192 (83.5%) had primary augmentation for aesthetic reasons, 24 (10.4%) patients were transsexuals and 14 (6.1%) were treated for malformations. The median primary implant size was 260, 224 and 327 g for aesthetic, malformation and transsexual patients, respectively. Capsular contracture was the leading cause for revision in aesthetic patients whereas size and shape were the main reasons for reoperation in transsexual and malformation patients, respectively. As many as 25% of patients required more than one revision procedure. The time between operations in aesthetic augmentation patients was significantly shorter for the second revision procedure (106.2 months vs. 11.4 months, p < 0.0001). The cumulative risk for needing a second revision procedure in aesthetic patients at 12 months was 24.5%. There was no correlation between implant site, size, position or type of complication and the number of revision procedures. Our data highlight the high complication rate of revision surgery involving implant removal or replacement. We conclude that patients must be routinely informed of the high risk and arduous consequences of revision surgery, which should be stated as such in the written consent for the procedure.