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Aesthetic Surgery Journal
2017, 1–12
© 2017 The American Society for
Aesthetic Plastic Surgery, Inc.
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DOI: 10.1093/asj/sjx150
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Supplement Article
Preliminary 3-Year Evaluation of Experience
With SilkSurface and VelvetSurface Motiva
Silicone Breast Implants: A Single-Center
Experience With 5813 Consecutive Breast
Augmentation Cases
Marcos Sforza, MD; Renato Zaccheddu, MD, MSc;
Angelo Alleruzzo, MD; Adriano Seno, MD; Domenico Mileto, MD;
Arnaldo Paganelli, MD; Hassan Sulaiman, MD; Michael Payne, MD;
and Lajos Maurovich-Horvat, PhD
Abstract
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 contrac-
ture. 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
Editorial Decision date: July 14, 2017.
Prof. Sforza is responsible for the elective internship in plastic
surgery, Dolan Park Hospital, Bromsgrove, UK; and is an Examiner
of the Royal College of Surgeons of Edinburgh. Drs. Zaccheddu,
Alleruzzo, Seno, Mileto, Paganelli, Sulaiman, and Payne are
Consultant Surgeons, Dolan Park Hospital, Bromsgrove, UK.
Dr Maurovich-Horvat is a Consultant Medical Statistician, University
College London, London, UK.
Corresponding Author:
Prof Marcos Sforza, Dolan Park Hospital, Stoney Lane, B60 1LY,
Bromsgrove, England, UK.
E-mail: marcos@marcossforza.com
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S2 Aesthetic Surgery Journal
The development of the first silicone breast implants in
1962 marked a pivotal advancement in plastic surgery.
However, since Tom Cronin and Frank Gerow developed
the first silicone breast implants with Dow Corning in that
year, a debatable technological progress has been lacking
in the ensuing 50 years. This shortcoming becomes even
more apparent when it is contrasted with the advance-
ments in other fields of medicine.
Silicone is a biomaterial that has been very widely uti-
lized in medicine since before World War II. However, with
the preponderance of research and novel developments in
medicine, the original Dow Corning thick silicone elasto-
mer outer shell device, filled with a silicone gel, does not
differ significantly from the prosthesis available today.
Silicone gel-filled breast implants have been commer-
cially available for decades, but were utilized outside
the auspices of the FDA for 14 years, until 1976, when
they were classified as a class III medical device. In 1992,
the FDA declared a “voluntary” moratorium on the sale
of silicone breast implants in the United States. Over a
decade later, Allergan and Mentor obtained clearance to
commercialize round silicone breast implants once again,
followed by Sientra with round and shaped implants, and
then Allergan and Mentor with their shaped devices. By
2006, these three manufacturers were free to operate in the
U.S. market again. However, these devices have remained
largely unmodified from their original technologies and
carry the same risks for complications today as they did
a decade ago.
In the same year of the FDA reintroduction of silicone
breast implants (2006), a group of lead engineers from
the silicone industry, along with experts from the field,
embarked on developing new and improved silicone breast
implants. These advanced concepts would incorporate a
series of new features designed to update the technology
and improve the safety and efficacy of silicone implants.
The objective of this paper is to evaluate the safety of
Motiva Implants (Alajuela, Costa Rica) for breast aug-
mentation, a group of surgeons at a single plastic surgery
center analyzed the safety outcomes of nearly 6000 consec-
utive breast augmentation cases. Two surfaces of Motiva
Implants were evaluated: SilkSurface and VelvetSurface.
This article presents a preliminary report of 3 years of
experience with over 11,000 units of Motiva Implants.
METHODS
This retrospective study evaluated the experience with
Motiva Implant silicone breast implants for breast augmen-
tation in consecutive patients over a 3-year interval. All
procedures were performed in a single center (Dolan Park
Hospital, Bromsgrove, England) by a group of 16 plastic
surgeons. All patients provided written informed consent,
and this study was designed utilizing the principles of
the Declaration of Helsinki. The primary outcomes of this
study were the rates of complications and reoperation fol-
lowing breast augmentation utilizing Motiva Implants.
Study Participants
From April 2013 to April 2016, a total of 5813 consecutive
female patients had breast surgery with Motiva Implants
and were included in this analysis. The implant sizes uti-
lized ranged from 125 cc to 1050 cc. There were no exclu-
sion criteria. Study patients underwent one of four breast
augmentation procedures: primary augmentation, primary
augmentation with mastopexy, secondary augmentation
(ie, implant replacement), or secondary augmentation
with mastopexy.
This analysis included only data for the original devices
implanted at baseline; if a previous implant was changed
due to complications, the authors excluded the data of the
replacement device.
Implants and Surgical Approach
Motiva Implants are gel-filled silicone devices available
with two types of surfaces. The implants utilized in this
study were either SilkSurface or VelvetSurface. Motiva
Implants are available in a range of shapes, sizes, base
diameters, and projections. Unlike most textured silicone
breast implants, the surfaces of these Motiva Implants
are manufactured under proprietary techniques utilizing
negative imprinting with 3-dimensional (3D) technology.
Motiva Implants SilkSurface is a hierarchical micro/nano
surface that is engineered to optimize biocompatibility by
structuring a uniform topography utilizing 3D imprinting
on the polydimethylsiloxane (PDMS) material to build
the outer shell of the breast implants. The manufacturing
process for the SilkSurface is particle-free and utilizes no
projection of foreign materials to create the surface topog-
raphies, allowing a uniform and controlled shell thickness.
SilkSurface has been physically characterized utilizing the
latest technologies such as scanning electron microscopy
(SEM), 3D image topography, profilometry, and white
light interferometer, and it has proven a consistent surface
roughness of 4000 nanometers in average (Ra), a median
height of profile of 13 ± 2 µm, a kurtosis value of 3.1 ± 0.4,
a skewness value of 0.4 ± 0.2, and an average of 49,000
contact points per cm2, which shows a consistent distribu-
tion of the peaks providing increased contact points and
as a result a contact angle of 131° ± 4° (Figure 1). This
contact angle shows how the topography increases hydro-
phobicity when compared with a smooth PDMS surface
contact angle of less than 110° ± 4°.1 The chemical com-
position of the SilkSurface has been X-ray photoelectron
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Sforza et al S3
spectroscopy (XPS) analyzed to assure an atomical level at
which the production process of the PDMS does not affect
the chemical properties. All of the surface properties from
SilkSurface were designed to reduce the abrasion when the
implant is in contact with the tissue by reducing fibroblast
adhesion activity and complying with the design of micro/
nano features that is better suited to an implant inside the
body.2,3
Motiva Implants VelvetSurface is a micro surface
engineered to optimize biocompatibility by structuring
a uniform micro-topography utilizing 3D imprinting on
the PDMS material to build the outer shell of the breast
implants. The manufacturing process for the VelvetSurface
is also particle-free and utilizes no foreign materials pro-
jected or stamped, allowing a uniform and controlled shell
thickness. VelvetSurface has been physically characterized
similar to the SilkSurface and has proven a consistent sur-
face roughness of 17 ± 3 µm, a median profile height of
57 ± 15 µm, a kurtosis value of 2.6 ± 0.3, and a skew-
ness value of 0.1 ± 0.2, which shows a consistent dis-
tribution of the peaks providing increased contact points
and, as a result, a contact angle of 119° ± 3°. This contact
angle shows how the topography increases hydrophobicity
(hydrophobic surfaces have contact angles >90° and are
known to show higher biocompatibility) when compared
with a smooth PDMS surface contact angle of less than
110° ± 4°. The VelvetSurface implant has 1800 to 2200
contact points per cm2, with a mean depth of 40 to 100
microns and a profile roughness parameter (Ra) of 7001
(Figure 2).
All surgeries were performed under general anesthe-
sia. The incision site (inframammary, periareolar, T mas-
topexy) and the site of implant placement (submuscular,
subglandular, dual plane) were selected by the treating
surgeon based on patient characteristics and preferences.
Implant size, projection, and base diameter were selected
by individual patients, in consultation with the treat-
ing surgeon. The most commonly utilized approach was
inframammary access, with subpectoral placement of the
implant utilizing a dual-plane technique. No insertion
device such as a plastic bag or funnel was utilized, and
no pocket irrigation with antibiotics or other solutions was
utilized. All patients were discharged with oral antibiotics
for 7 days. Postoperative management included antibiotic
and analgesic therapy for 7 days, and wearing compressive
bandages on the upper pole for 1 week, followed by sports
bras for 6 weeks, with no ventral decubitus or exercise for
3-4 weeks. No massage was recommended after surgery.
A free, 3-year postoperative care system was utilized to
ensure patient follow-up and reporting of adverse events.
Our aftercare scheme covers up to 3 years and includes
any free revisions. The patients need to return within the
first year to renew for the next 2 years; otherwise, the after-
care is voided. As previously stated, patients who fail to
attend the mandatory appointments are persistently con-
tacted and informed about the risks of losing the aftercare.
All of the patients returned for the mandatory first-year
follow-up, thus the 100% returning rate was achieved.
Statistical Analysis
The primary method of analysis for the complication
and reoperation data was survival analysis utilizing the
Kaplan-Meier product limit. To corroborate findings, the
authors estimated the confidence interval (CI) for each
complication for all types of procedures. In our analysis,
Figure 1. SilkSurface scanning electron microscopy (SEM)
image at 300 µm scale.
Figure 2. VelvetSurface scanning electron microscopy (SEM)
image at 300 µm scale.
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we utilized the Wilson score interval, which is more suita-
ble for small probabilities than the normal approximation
interval. However, we also provided the latter for com-
parison, because it is the standard technique utilized in
most studies. If our assumption is correct, a CI indicates
with a specified level of certainty that the true risk rate
in the population will likely be in the estimated range.
Whereas the standard CI or Wald interval approximates
the distribution of error around the observed risk rate,
the Wilson score interval yields an interval that is con-
sistent with the observed risk rate at the specified con-
fidence level. Therefore, no observed complication in a
sample results in a standard CI that contains only 0, but
the Wilson interval provides a no-zero upper bound of the
risk rate that could have resulted in no complications due
to randomness. This additional analysis is particularly
important, because the study only reflects a preliminary
3-year experience.
RESULTS
Between April 2013 and April 2016, a total of 5813 con-
secutive female patients had breast augmentation with
Motiva Implants. The study population included 4103
breast augmentations, 838 mastopexy augmentations,
698 implant replacements, and 174 mastopexy implant
replacements. The group’s age ranged from 18 to 72 years
old, with an average of 28.2 years old ± 10.98 (standard
deviation).
Inframammary access was utilized in 97% of the pri-
mary augmentation procedures (3980 of 4103). Axillary
access was not utilized in any cases. The dual-plane tech-
nique with subpectoral placement was performed in 79%
of all cases (4592 of 5813). No subfascial placement was
performed. The study comprises all patients operated in
a 3-year interval. The minimum interval was 12 months,
and the longest interval was 3 years and 6 months, with
a mean of 23.03 months. Because of the postoperative
care agreement, all patients had a follow-up appointment
within 1 year with the same original surgeon when they
were examined and diagnosed or not with complications.
This is a retrospective study, so at the time of the exam-
inations, surgeons were merely treating their patients to
achieve the optimal outcome and they had no intention of
collecting data for analysis.
A total of 2506 patients (43.1%) received SilkSurface
implants and 3307 patients (56.9%) received VelvetSurface
implants. Approximately two thirds of the participants
(67.6%) selected implant volumes between 300 and 499
cc. Information about smoking habits was not collected,
but smoking was not an exclusion criterion.
The numbers of patients by volume category and
implant surface are shown in Table 1.
Complications
To examine complication rates arising from the differ-
ent types of breast surgery performed with the Motiva
Implants, we estimated the CIs and carried out a cumu-
lative hazard function analysis. The statistical analysis of
the overall risk rates describes the potential benefits of
SilkSurface and VelvetSurface implants, whereas the haz-
ard function provides a more detailed account of the inci-
dence of complications.
The reported complications and associated risk rates
are listed in Table 2. A total of 44 complications were
identified (0.76%). The most prevalent complication was
infection following breast augmentation (n = 7), whereas
early seroma with implant replacement had the highest
risk rate (1.51%). There was one case of implant rupture
that was analyzed, and a metal injury of the device was
verified. Therefore, there was no reported implant rupture
for device failure. There were no reported occurrences of
late seroma, persistent swelling, breast pain, rippling, cap-
sular contracture (Baker Grade III/IV) in primary cases,
or redness/rash. All patients were reviewed 24 hours and
1 week after their surgery. A low rate of hematomas was
found, which could be attributed to the experience of the
surgeons, because no special technique was applied to the
surgery. No significant difference in the hematoma rate
was found among the two types of the surfaces.
The total reoperation rate was 0.76%. The resulting
95% Wilson CI was 0.56% to 1.01%, Thus, assuming a
5% significance level, the highest rate that our result is
consistent with is 1.01%. In addition, the power of our
test to detect risk rates of 1.02% or 1.10% are 62% and
80%, respectively. Therefore, we can infer that it is highly
unlikely that the “true” complication rate of our method is
larger than 1.10%, thus we observed such a low risk rate
only by chance.
Because we have not observed any late seroma, per-
sistent swelling, breast pain, rippling, capsular contracture,
and redness, we can have confidence that the overall risk
rate of these complications across implant types and pro-
cedures is between 0.0% and 0.07%. However, for specific
procedure and implant types, it is possible that we could
observe higher risk rates in different samples (Table 2).
Table 1. Participants Receiving SilkSurface and VelvetSurface Motiva
Silicone Implants, by Implant Volume Category
Volume (cc) SilkSurface, N (%) VelvetSurface, N (%) Total, N (%)
0-299 310 (5.3) 612 (10.5) 922 (15.9)
300-499 1749 (30.1) 2182 (37.5) 3931 (67.6)
500-700 447 (7.7) 513 (8.8) 960 (16.5)
Total 2506 (43.1) 3307 (56.9) 5813 (100)
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SilkSurface vs. VelvetSurface
The overall complication rate with SilkSurface implants
was 0.36% (95% CI, 0.19% to 0.68%). By comparison,
the complication rate with VelvetSurface implants was
1.06% (95% CI, 0.76% to 1.47%). Because the CIs for the
two implant surfaces do not overlap, we can conclude that
SilkSurface implants have a significantly lower total risk
rate than VelvetSurface implants.
We also compared the risk rates for complications that
occurred with both SilkSurface and VelvetSurface implants
(Table 2). In this analysis, the CIs of the risk rates for
specific complications do overlap. Therefore, we cannot
exclude the possibility that in another sample, the compli-
cation rates with the two implant types could be the same
or that the other implant could have a lower rate than in
this sample. Nevertheless, we observed that VelvetSurface
implants had higher complication rates for each type of
breast surgery, contributing to their higher overall risk rate.
Hazard Functions and Risk Rates for
Complications
To examine the incidence of the complications over time,
we analyzed the Kaplan-Meier hazard rates for different
implant types, implant sizes, and dates of insertion. The
cumulative hazard function shows the expected number of
complications (rate times total number of patients) up to a
given postsurgical week. The increments of the cumulative
hazard function provide information about the underlying
hazard function; if the slope is increasing, it means that
the complication rate is rising, and complications are more
likely to occur during time periods with steeper slopes.
When the line is flat, no complications occur.
Kaplan-Meier analysis was conducted on the entire sam-
ple (Figure 3). The analysis reveals that the hazard function
is steepest in the first 10 weeks after implant placement,
which indicates that most of the complications occurred in
this period. By 25 weeks after implant placement, a further
increase in complications is minimal, suggesting that there
were very few complications after this time point. Following
the 45th week, the hazard rate is flat (ie, no further compli-
cations occurred). The cumulative hazard rate at this point
is 0.76%, indicating that more that 99.2% of patients did
not have any complication up to 1 year, which was the last
follow-up visit in this analysis. Although it is possible that
more complications occurred after this period, it is very
unlikely that the overall hazard rate increased significantly,
given the shape of the cumulative hazard function.
Analysis by Date of Insertion
The analysis revealed no apparent differences between
groups regarding the date of implant insertion (ie, 2013-
2014 vs 2015-2016). Therefore, the authors decided to
expand the analysis comparing these groups. Utilizing
Kaplan-Meier analysis, the complication rates were 0.81%
and 0.70% for insertions performed in 2013-2014 and 2015-
2016, respectively. The difference between these two rates
was not significant, and the incidence of complications in
the two groups was similar (Figure 4). Therefore, at the
5% significance level, we cannot reject the null hypoth-
esis that the two groups have the same risk rate. Finally,
test statistics did not identify a significant difference in
complication rates between groups (P = 0.64 in all tests).
Therefore, we statistically conclude that the risk rates and
hazard curves are the same for Group A (insertion in 2013-
2014) and Group B (insertion in 2015-2016), which enable
us to compare different cohorts of the sample.
Table2. Complication Rates Following Primary Breast Augmentation or Mastopexy Augmentation, or Secondary (ie, Implant Replacement) Breast
Augmentation or Mastopexy Augmentation Using Motiva Implants
Primary augmentation, % (95% CI),
[critical rate]
Implant replacement, % (95% CI),
[critical rate]
Primary mastopexy augmentation, %
(95% CI), [critical rate]
Mastopexy implant
replacement, % (95% CI),
[critical rate]
Implant
surface
Silk Velvet Silk Velvet Silk Velvet Silk Velvet
N 1765 2338 301 397 361 477 75 99
Early seroma 0 0.13 (0-0.27) [0.38] 0.33 (0-0.98) [1.86] 1.51 (0.31-2.71) [3.26] 0 0.42 (0-1.0) [1.52] 0 1.01 (0-2.98) [5.5]
Infection 0 0.30 (0.08-0.52) [0.62] 0 0.25 (0-0.74) [1.41] 0.28 (0-0.82) [1.56] 0.21 (0-0.62) [1.18] 0 0
Hematoma 0 0.04 (0-0.13) [0.24] 0 0.50 (0-1.20) [1.81] 0 0.42 (0-1.0) [1.25] 0 0
Wound
dehiscence
0.11 (0-0.27) [0.40] 0.04 (0-0.13) [0.24] 0.66 (0-1.58) [2.39] 0 0.55 (0-1.32) [1.99] 1.26 (0.26-2.26) [2.72] 0 0
Rupture 0 0 0 0 0 0.21 (0-0.62) [1.18] 0 0
Implant
malposition
0 0 0 0.25 (0-0.74) [1.41] 0 0 0 0
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Analysis by Implant Surface Type
In addition, we evaluated the difference in hazard rates
between SilkSurface and VelvetSurface implants for differ-
ent implant volumes. Significant differences in complica-
tion rates between SilkSurface and VelvetSurface implants
were identified only in participants who received implant
volumes 300 to 499 cc (Table 3). This result was signif-
icant even when following adjustment for significance
level with Bonferroni correction to account for multi-
ple tests (comparison of overall hazard rates between
SilkSurface and VelvetSurface implants, between different
insertion dates, and between three different implant vol-
umes). In contrast, the increments in cumulative hazard
rates for the SilkSurface and VelvetSurface implants are
very similar for the smaller and larger implant volumes
(Figures 5 and 6), whereas those in the cumulative haz-
ard functions are markedly different for SilkSurface and
VelvetSurface implants with mid-sized volumes of 300 to
499 cc (Figure 7).
The obtained results are compatible with the surgeons’
expectations in relation to minimal rates of complications
throughout the years (Figures 8 and 9).
DISCUSSION
Fifty-four years after the development of the first breast
implant, surgeons are still faced with high complication
and revision rates when utilizing most commercially avail-
able silicone breast implants. Indeed, the 3-year core stud-
ies from the FDA-approved manufacturers revealed high
reoperation rates, even for primary augmentations. For
example, Sientra’s overall reoperation risk rate in 3 years
was 12.6%,4 Mentor’s was 15.4%,5 and Allergan’s was
23.5%.6,7 These high reoperation rates signify a clear
unmet need for technological innovation to improve the
safety and durability of silicone breast implants.
The Motiva Implants are a novel breast implant technol-
ogy. The authors believe that the properties of the surfaces
of the implants were more relevant to the outcomes; how-
ever, they acknowledge that data about the gel should also
be incorporated in future studies.
The results of this 3-year experience demonstrate excel-
lent safety outcomes with the Motiva Implants in breast
surgery. There were no serious adverse events and no
cases of implant rupture for device failure, capsular con-
tracture (Baker III/IV) in primary cases, double capsules,
or late seromas. The authors presented consistent real-
world data and they strongly believe that their free, 3-year
aftercare system is a strong method for patient retention
and follow up, because the financial commitment with the
model compels the patients to return for follow-up consul-
tations if any issues occur. Anecdotally, the same group
of surgeons utilizing the same aftercare system for the
last 7 years reported substantially different results utiliz-
ing other types of silicone breast implants (ie, non-Motiva
Figure 4. Kaplan-Meier hazard complication rates for
patients with implant placement performed in 2013-2014
(Group A) and 2015-2016 (Group B).
Figure 3. Kaplan-Meier cumulative hazard rate of the entire
patient sample (N = 5813). The hazard function increases
most in the first 10 weeks following implant placement,
indicating that most complications occurred during this
period. After 25 weeks, a further increase in the complication
rate is minimal, indicating that very few complications
occurred after this time.
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Sforza et al S7
Implants). The overall revision rate for this group from
2010 to 2013 utilizing a different, macro-texture, FDA-
approved implant (N > 10,000) was 8.43%, which is more
than an order of magnitude higher than the rate reported
in this analysis.
Statistical Analysis and Confirmation
Because of the very low revision rate identified in this
analysis (<1%), we applied statistical analyses beyond
the standard Kaplan-Meier risk analysis to confirm the
clinical relevance of our results.
Survival analysis determines the expected time until
an event occurs.8 These estimates are clinically useful,
particularly when counseling patients regarding the
incidence and timing of potential complications. The
hazard function at a given time specifies the rate at
which patients experience a complication, given that
they have not had any complication up to that time. It
is usually more informative to see how the hazard rate
changes over time, which we can see from the cumu-
lative hazard. In our study, we verified that a plateau
in hazard rates occurred in every group after 25 weeks,
independent of the surgery or implant, indicating that
there was no further increase in complications after
this time.
Furthermore, we analyzed the complication rates over
the entire follow-up period. This analysis allows for the
Table3. Statistical Comparisons of Hazard Rates for Complications by Implant Surface (SilkSurface VelvetSurface) and Category of Implant Volume
Implant volume (cc) Complications, N (%) Test Chi-square P value
0-299 SilkSurface:
310 (5.3)
VelvetSurface:
612 (10.5)
Log rank (Mantel-Cox) 0.913 0.339
Breslow (Generalized Wilcoxon) 0.919 0.338
Tarone-Ware 0.916 0.338
300-499 SilkSurface:
1749 (30.1)
VelvetSurface:
2182 (37.5)
Log rank (Mantel-Cox) 12.170 <0.001
Breslow (Generalized Wilcoxon) 12.164 <0.001
Tarone-Ware 12.167 <0.001
500-700 SilkSurface:
447 (7.7)
VelvetSurface:
513 (8.8)
Log rank (Mantel-Cox) 0.185 0.667
Breslow (Generalized Wilcoxon) 0.185 0.667
Tarone-Ware 0.185 0.667
The only statistically significant difference between the Velvet and Silk surface implants was in the volume category 300 to 499 cc.
Figure 5. Kaplan-Meier hazard rates for patients implanted
with small-sized (0-299 cc) SilkSurface and VelvetSurface
Motiva Implants.
Figure 6. Kaplan-Meier risk rates for patients implanted
with large-sized (500-700 cc) SilkSurface and VelvetSurface
Motiva Implants.
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S8 Aesthetic Surgery Journal
comparison of risk rates between different groups. Because
the risk rate is a random variable, it changes from sample
to sample.5 Therefore, we estimated the Wilson CI, which
provides the upper bound of the risk rate that is consistent
with our sample.9
The Role of New Surfaces in Breast
Implant Safety
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
revisional surgery.10 Many studies have reported relatively
high rates of capsular contracture, particularly with smooth
(non-textured) implants. For example, a 6-year outcomes
study of Inamed silicone breast implants in 940 patients
(half of whom were augmentation patients, most of whom
received smooth implants) reported a capsular contracture
rate of 15% to 20% and an implant rupture rate of 3.5%.11
Long-term studies and meta-analyses comparing smooth
and textured implants have reported a significantly higher
risk rate for capsular contracture with smooth vs textured
implants.12-15
Texturing of silicone breast implants was originally
developed to optimize implant positioning and minimize
capsular contracture. However, the aggressive texturiza-
tion utilized in the manufacture of many implants has
been associated with risk for seroma and double capsule
formation.16 Furthermore, many textured implants are
still associated with a reduced but significant rate of cap-
sular 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 popu-
lation, and a Kaplan-Meier risk of contracture of 10.7%
following primary augmentation.17 At 5 years, 8.5% of
implants were removed following primary augmentation.
A second study reported an 8% rate of capsular con-
tracture at 9 years following implantation of form-stable
textured silicone implants.18 These studies suggest some-
what improved risk for contracture with implants with
textured surfaces, but many patients remained at risk for
this adverse outcome.
The Motiva SilkSurface and VelvetSurface silicone
implants utilized in this study were created utilizing
novel technologies. Rather than being aggressively tex-
tured with the projection of salt or sugar crystals onto
the implant, like many other implants, the surfaces of the
Motiva Implants are obtained utilizing negative imprint-
ing with 3D technology. The resulting surfaces have very
low roughness parameters and promote a more natural
interaction between the implant and the surrounding tis-
sues, potentially reducing inflammation in the postopera-
tive period and chronic inflammation after recovery. This
improved interaction with native tissues may limit the risk
for capsular contracture and allow the implant to better
adapt to the normal movement of the breast. When held,
these implants feel smooth. However, the high number of
contact points may act to prevent fibroblast aggregation
and capsular contracture.
Interestingly, the current study clearly identi-
fied a difference in the complication rates between
the SilkSurface and VelvetSurface implants, and a
significantly higher rate of complications with the
VelvetSurface implants in the 300 to 499 cc volume cat-
egory. In 2013, Bayat et al19 reported a significant effect
for surface texture on cell behavior, and they clearly
demonstrated that cells adhere more strongly to tex-
tured implant surfaces. This finding suggests that cells
exhibit greater adhesion in the presence of numerous
surface characteristics, such as density of points of
contact or topographies, surface roughness, and con-
tact angles. The hierarchical micro/nano-topographical
structure of the SilkSurface implant, together with its
lower roughness and increased number of points of
contact, may have helped with the significant reduction
of complications. This possibility requires confirmation
in future studies. However, Langer et al20 already estab-
lished that nano-scale roughness has profound effects
on cells, especially when designing new materials (and
surfaces) for biological interaction.
Moreover, in 2015, Bayat et al21 proposed that surfaces
with topographies closer to cellular dimensions produce
an attenuation of the acute foreign body reaction. In the
current study, the absence of late seromas and primary
Figure 7. Kaplan-Meier hazard rates for patients implanted
with mid-sized (300-499 cc) SilkSurface and VelvetSurface
Motiva Implants.
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Sforza et al S9
capsular contracture over a 3-year period was probably
demonstrated by the surfaces of the hierarchical micro/
nano topographies. The correlation of this new exclusive
topography of the SilkSurface implants and the reduction
in the foreign body reaction is a promising theory that
must be validated by long-term clinical studies.
AB
CD
EF
Figure 8. (A, C, E) Preoperative photographs of this 22-year-old woman. (B, D, F) Postoperative photographs taken at
12 months. She underwent bilateral breast augmentation surgery using VelvetSurface 315 cc implants, inserted on a dual-plane
type 2.
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S10 Aesthetic Surgery Journal
New Technology Promise and Limitations
of the Study
Motiva Implants (SilkSurface and VelvetSurface) were
engineered to optimize biocompatibility by structuring
uniform hierarchical micro/nano and micro-topographies
utilizing a proprietary 3D nanotechnology imprinting on
the PDMS material, in order to build the outer shell of the
breast implants. These surfaces were designed to improve
compatibility between implants and tissues, minimizing
AB
CD
EF
Figure 9. (A, C, E) Preoperative photographs of this 26-year-old woman. (B, D, F) Postoperative photographs taken at
12 months. She underwent bilateral breast augmentation surgery using SilkSurface 335 cc implants, inserted on a dual-plane
type 2.
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Sforza et al S11
inflammation and possibly, as this study shows, inflam-
mation-related complications such as capsular contracture,
double capsules, and late seromas. The manufacturing
process for both surfaces is particle-free and utilizes no
foreign particle projection to create the surface, allowing
a uniform and controlled shell thickness. Motiva Implants
SilkSurface and VelvetSurface have a high-performance
membrane (TrueMonobloc), which integrates all compo-
nents of the implant in the same tensile force, surpass-
ing the strictest mechanical specifications of international
quality standards.
The shell has a patented barrier layer indicator that
ensures the presence of layer-barrier technology, which
minimizes the diffusion of silicone gel to the tissues.
These devices are 100% silicone gel-filled with con-
trolled viscosity and elasticity, designed to prevent gel
fracture, simulate the appearance and natural feel of the
breasts, and reduce complications such as ripples and
furrows. A particular characteristic of Motiva implants
is the presence of an FDA-cleared radiofrequency micro-
transponder for unique device identification, which can
be accessed externally after implantation for traceability
purposes.
Prospective studies are the gold standard of research,
and the retrospective design utilized in this study is its
main limitation. We utilized advanced statistical analysis
to explore the significance of our data in an attempt to con-
firm the clinical significance of the findings. Future studies
should utilize a prospective, randomized design to prevent
the introduction of bias.
CONCLUSIONS
The Motiva silicone breast implants utilized in this
study demonstrated an excellent safety profile, with
very low rates of early complications and no late
complications. There were no cases of device-related
implant rupture, no cases of primary capsular contrac-
ture (Baker III/IV), no double capsules or late seromas,
and a very low rate of reoperation. The hierarchical
micro/nano-topographical surface of the SilkSurface
Motiva Implants appears to be associated with signif-
icantly lower complication rates.
Disclosures
During the study period, Prof. Sforza declared no potential
conflicts of interest with respect to the research, authorship,
and publication of this article. In 2017 (after the study was
completed and was submitted to this journal), Prof. Sforza
accepted a position at Establishment Lab’s Medical Advisory
Board. Drs. Zaccheddu, Alleruzzo, Seno, Mileto, Paganelli,
Sulaiman, Payne, and Maurovich-Horvat declared no poten-
tial conflicts of interest with respect to the research, author-
ship, and publication of this article.
Funding
This article was supported by Establishment Labs (Alajuela,
Costa Rica), who co-funded the development of this supplement.
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