INTRODUCTION
Thousands of women opt for breast surgery, since well-endowed breasts are an
indicator of feminine beauty in various cultures and there is great social
appeal and media stimulation advocating these procedures1; this has recently led to a revolution in the silicone
industry, with a significant increase in the number of manufacturers offering
various models, different profiles, gel densities, and various characteristics
of envelopes for pleasant and safe results.
Breast surgery with silicone implants has off late been experiencing growing
popularity as the most commonly performed aesthetic surgical procedure
worldwide2. With aesthetic silicon
breast implant surgeries being performed worldwide only in 2016, according to
statistics from the International Society of Aesthetic Plastic Surgeons, Brazil
was responsible for 13.64% (206,250) of these.
In fact, the number of breast reconstruction surgeries is growing, with silicone
implants being used more predominantly than regional tissue flaps due to the
ability of silicone to mimic natural breasts3. Representatively, only in the United States, 300,000 new cases of
breast cancer are diagnosed every year. Of these, 118,000 patients choose to
undergo breast reconstruction, out of which 69% opt for silicone implants while
the remaining 31% use flaps4.
Alongside the increasing popularity of silicone breast implants, there is an
increased concern about their safety5,
manufacturing defects6, and the most
common complications related to the presence of synthetic material in the breast
region, such as capsular contracture, infections, biofilm formation7,bleeding, rupture8, and rarer conditions such as siliconomas9, and more recently, breast
implant-associated anaplastic large cell lymphoma (BIA-ALCL)10-13, which have been reported in several articles1.
These complications may lead to unexpected additional treatments and
reinterventions in 25 to 36% patients14.
In another study1, rates of reoperation
were compared between two brands of manufacturers 6 years after the procedure.
Reintervention rates of 28% and 19.4% were observed in aesthetic surgeries
performed with Allergan® implants and
Mentor® implants, respectively. In the same study,
reintervention rates of 51% and 33.9% were observed in repair surgeries
performed with Allergan® implants and
Mentor® implants, respectively, with a significant
increase in costs incurred during the treatment of these complications14, in addition to compromised
patient-physician relationship and uncertainty about the safety and reliability
of silicone implant surgeries.
On literature review, we identified research articles aiming at obtaining better
results and especially, minimizing complications related to silicone implants,
in both aesthetic and reconstructive surgeries.
OBJECTIVE
This study aims to review the existing technologies and technological trends
related to silicone breast implants and methods to minimize related
complications.
METHODS
We carried out a literature review of articles published in the last 10 years
related to patents, manufacturers, and new technologies and trends to reduce
complications related to silicone breast implants.
RESULTS
Initially, 78 articles were found, out of which 40 were shortlisted for
publication. All articles had a common aim of obtaining better results and
reducing complications related to silicone implants, in both aesthetic or
reconstructive surgeries.
The published studies, new implant models, and issued patents focus on research
of factors that diminish the immune response, improve the coating surface, and
nanotechnology, in addition to exploring the feasibility of implants with
acellular dermal matrix and fat grafting. Research has also been carried out to
find ways to improve the implant content.
Factors associated with complications of breast implants were studied and may be
related to the implant itself, surgical management, manufacturing artifacts, and
the response of the body to silicone8.
DISCUSSION
For ease of understanding, we have divided the discussion into four topics:
Surface of silicone implants
Latest technology in silicone implants
Association of silicone implants with acellular dermal matrix
Association of silicone implants with fat grafting
Surface of silicone implants
Most studies found in the literature were focused on the improvement of the
surface of breast silicone implants.
It is important to understand that the surface properties of the implant
impact the inflammatory cellular response, because the surface is the
interface between the implant and organic tissues, and the primary site
where the antigen-antibody reaction occurs. Development of implants is
fundamental in providing satisfactory solutions to minimize long-term
clinical complications15.
Therefore, there has been a lot of research for its improvement, especially
to avoid infection and capsular contracture.
Topical antibiotics. The use of topical
antibiotics has been mentioned in several studies, demonstrating that when
instilled or implanted into the external surface of silicone implants,
antimicrobials decrease the formation of biofilm, capsular contracture,
seroma, and infection16.
Importantly, recent clinical studies17-19 reported
that infections due to breast silicone prostheses can be treated at a single
time using both aesthetic and repair surgery, with subsequent resolution of
the infection.
Povidone-iodine solution. At the end of 2017,
the Food and Drug Administration(FDA) approved the use of Betadine
(povidone-iodine) to prevent the formation of biofilm and infection, as it
has a broad spectrum against Gram+ bacteria, which are related to capsular
contracture, and Gram-, more related to BIA-ALCL. Previously, since 2000,
the FDA believed that povidone-iodine could degrade the silicone implant
capsule, and this change represents a major advance in the prevention of
complications.20
Recently, a controlled experimental study has demonstrated decontamination of
infected breast silicone implants after brushing povidone-iodine for 1
minute and removing excess saline solution21. This leads to a heightened expectation of the treatment of
infection in one surgical stage, as described in other studies17-19.
Surface texture. It is generally known that
capsular contracture is more frequent in implants with a smooth surface and
less frequent in microtextured and macrotextured surfaces. Some recent
studies22-24 sought to minimize this complication
but could not completely avoid it.
More recently23,24, there is evidence of increased
bacterial contamination in silicone implants with macrotextured surfaces due
to more space being available for bacterial growth.
Moreover, scientific evidence10-13 shows
that BIA-ALCL is more likely to occur in macrotextured silicone
implants.
Alternative surfaces of silicone breast implant
Novel surfaces aimed at preventing complications related to the textured
surface of conventional implants are being developed.
A study reported the development, manufacture, and evaluation of an implant
surface obtained from human tissue aimed at biomimicking, with increased
compatibility and decreased capsular contracture25. This in vitro experimental study
used a treated and prepared fat surface of 3 patients fixed with gold and
palladium and demonstrated a decreased inflammatory response that was
evaluated by cytokine and C-reactive protein levels.
Another study described a modification of the surface with implantation of
carbon ions26 tested in 3 different
doses in order to increase biocompatibility. This implantation reduced
surface roughness, bacterial adhesion, and capsule formation in an
in vitro and in vivo experimental
study in 16 rats. The results were more evident with higher doses of carbon
ions.
A patent issued in 2017 (registration No. US2017/0049549 A1 by Bayat and
contributors - University of Manchester, UK) describes a new biomimetic
textured surface topography, with roughness control on macro, micro, and
nanoscales simulating the topography (basement membrane and papillary
dermis) of human skin. No experimental or clinical trials analyzed this
patent.
Another patent (registration No. US0209618 A1 by Mark Anton, 2017) describes
a second outer layer of polytetrafluoroethylene (PTFE) to decrease capsular
contracture, acting as a reservoir. It utilizes PTFE, rifampicin, verapamil,
α-tocopherol (Vitamin E), and methylprednisolone to reduce the risk
of infection and biofilm formation, thus forming a third layer with slow or
late release, promoting cellular adhesion. It would be used to confer a more
natural appearance, similar to natural skin and lighter, because PTFE has a
lower density than silicone. It makes use of nanotechnology that repels
water (hydrophobia) helping in biocompatibility, with less possibility of
capsular contracture. We found no clinical trials analyzing this patent as
well.
Nanotechnology in breast silicone implants
Nano and surface microtopography aim at influencing cell polarization,
alignment, migration, coupling, adhesion, proliferation, and morphological
nature at the nano and micro levels, thus leading to cells reacting more
naturally to surrounding structures27.
Recent studies suggest that the inflammatory response in these new models is
lower, with better scattered and spindle-shaped fibroblasts and milder
surface reactions by macrophages, thus indicating a more favorable foreign
body reaction1,27.
In the technological line, some studies describe a breast silicone implant
coated with halofuginone nanofibers28, inhibitors of collagen synthesis type I that interferes with the
synthesis of transforming growth factor β (TGF-β) which, in an
experimental study using the submuscular plane of 28 rats, showed no
systemic reaction; a decrease in histiocytes, CD68 marker (type I collagen),
TGF-β, fibroblasts, type I and III collagens; and capsular
thickening.
More recently, a clinical study29
analyzed 5813 breast implants, with a maximum of 3 years of follow-up, using
implants with nano and microtextures, built with uniform topography using
three-dimensional silicone printing to create optimized biocompatible
external surfaces. The manufacturing was described as particle-free and did
not use extrusion of foreign material to create the surface geometry, thus
allowing a surface of uniform and controlled thickness. Complications such
as seroma, infection, hematoma, dehiscence, rupture, and malposition of the
implant occurred in 0.36% of the implants with nanotexture surface and in
1.06% of the surface implants with microtexture surface. However, capsular
contracture and the eventual incidence of BIA-ALCL could not be evaluated
conclusively in a short time period.
Latest technology silicone implants
We identified 4 silicone breast implants utilizing innovative and recent
technology:
Ideal Implant®.
It is a structured breast implant approved by the FDA and Health
Canada in November 2014 which combines the benefits of saline
and gel implants with intercommunicate lumens filled with saline
solution, with frontal and posterior valves for filling. It was
subjected to screening in 502 patients, 399 undergoing primary
augmentation and 103 undergoing implant replacement and used in
35 different cities by 45 certified plastic surgeons with 6-year
follow-up in 438 cases (87.3%). The satisfaction reported by the
patients was 89.7% in primary cases and 91.6% in cases of
implant replacement, and the satisfaction reported by surgeons
was 92.6% in primary cases and 94% in cases of implant
replacement. Contractures of Baker grades III and IV were
observed in 5.7% of primary cases and 11.5% of cases of implant
replacement. Rupture/deflation were observed in 1.8% of primary
cases and 4.7% of cases of implant replacement.
Microchip or Microtransponder. Two
articles18,29 described a 9×2.1-mm sized radiofrequency
microchip or microtransponder positioned inside the silicone gel
near the center of its base, for identification and
postoperative tracking by Radio-Frequency Identification (RFID),
with a specific device of the manufacturer
Motiva®. RFID is a technological trend in
other specialties such as veterinary. In the field of breast
implants, it provides technical information about the implant.
It is expected that in the future, RFID can store data from
breast exams, hospital data from surgery, and global online
updates.
The presence of RFID raised questions about its safety in imaging diagnostic
methods, especially magnetic resonance imaging (MRI), with possible
interference in the diagnosis of breast neoplasms, because it has a
ferrite/copper antenna and iron is a material with great interference with
artifacts on MRI. Initial evaluations show that RFID is compatible with
clinical MRI, with a magnetic field of 1.5 or 3.0 Tesla, causing temperature
increase (3 °C) after 15 minutes of continuous pulse (regular exams rarely
exceed 3 minutes), and not showing any RFID displacement or torsion.
Initial evaluations show that an artifact is seen on MRI, being greater in
the inner posterior face of the implant with extension to the chest wall,
without significantly affecting the breast tissue and subcutaneous tissue.
Further studies need to be conducted to evaluate this interference,
especially if the RFID migrates to the interior of the implant over the
years, and in cases of implant rotation with the base positioned next to the
breast tissues.
B-Lite®. It refers to a light
silicone breast implant which relies on the reduction of mechanical tension
on the tissues to reduce pain in the postoperative period. It consists of
silicone gel with borosilicate crystal microspheres, chemically attached to
the silicone gel, fixed by a curing process and treated to increase the
hydrophobic property and ensure that it remains fixed to the silicone gel
without mixing and avoiding overflow of these microspheres, which leads to a
reduction in the weight of the implant by up to 30%31. In this study, conducted in 100 cases, the
B-Lite® implant was used in half of the patients and
conventional Eurosilicone® and Allergan
CUI® gel implants were used in the other half, with
access through the breast crease and the subglandular plane in more than 90%
of the cases. A statistically significant reduction in pain and shorter
recovery time was demonstrated by the Fischer’s test and Cox regression
model32.
Diagon/Gel 4Two® implant. The
Polytech® Diagon/Gel 4Two® implant
consists of an implant with polyurethane coating (macrotexture) and two
types of gel inside, a less dense posterior one and a higher density
anterior one to better position the areola and support the residual breast
tissue33.
A preliminary study with 894 cases followed for 5.5 years, showed low rates
of complications with no statistical significance, with 2 cases of late
seroma, 4 cases of hematomas, no case of capsular contracture, and having a
patient satisfaction rate of 90%. Since it is a new type of implant, further
statistically significant studies need to be conducted to better evaluate
complications, if any.
Association of silicone implants with acellular dermal matrix
More recently, acellular dermal matrix (ADM) has appeared as an alternative
especially for breast reconstructive surgery with silicone implants to
improve the positioning of the implants and tissue expansion dynamics,
providing greater intraoperative filling and lower frequency of expansion
sessions, leading to superior aesthetic results. The refinement of the
technique and accumulated experience have decreased the morbidity initially
related to ADM34.
It has now emerged as a potential tool for surgical prevention of capsular
contracture. ADMs are immunologically inert, minimizing capsular formation
in experimental models, which results in decreased inflammatory process,
proliferation of myofibroblastic cells, and capsular thickness. This
reduction is observed even in irradiated tissues.
Some surgeons modified ADMs by performing fenestrations to improve support,
and the results were similar. It has already been used for both prevention
and treatment of capsular contractures35.
Currently, there are several types of ADMs, and they have been used for
breast reconstruction with the following silicone implants: AlloDerm
(LifeCel Corp. Branchburg, NJ), DermaMatrix (Synthes Inc. West Chester, PA),
FlexHD (Ethicon Inc. Somerville, NJ), Strattice (Lifecell Corp), and
SurgiMend (TEI Biosciences Inc. Waltham Mass.). They differ in terms of the
origin of the tissues, processing, storage, sterility, and need for surgical
preparation.
A recent meta-analysis34 compared
results of several ADMs obtained from human cadavers and used in breast
reconstruction. Seventeen retrospective articles and one randomized article
were evaluated. The study evaluated complications (infection, seroma, flap
necrosis, reconstruction failure, and general complications) in the Flex HD,
Dermamatrix, and Alloderm ADMs. The authors concluded that complications
were similar in the 3 ADMs evaluated. However, the results were poorly
consolidated due to the scattered data from the various articles
evaluated.
A study published in 201336 evaluated
the costs of breast reconstruction with and without ADM and showed that the
use of ADM significantly decreased postoperative follow-ups. However, the
high cost of ADMs did not exceed the cost obtained with a lower number of
follow-ups.
The use of the fibrin silk mesh to coat the implant has been described as an
alternative to coating with acellular tissue9. It is made with silk, associated with polyethylene oxide, and
is manufactured with a technique using polymers and metal nanofibers.
Association of silicone implant with fat grafting
(lipofilling)
Autologous fat grafts have gained increasing attention and wide acceptance
due to improved results in breast reconstruction. They have limitations on
isolated use due to soft consistency. Thus, a combination of the classic
silicone implant technique with simultaneous handling of subcutaneous tissue
with fat grafting is the most versatile and powerful modality for obtaining
synergistic results37.
Many clinical studies have shown a reduction in complications including
capsular contracture38,39 with the
use of fat grafts,. An experimental study conducted in 20 sows showed
improvement in capsular contractures with autologous fat grafts, probably
due to neovascularization of the tissues around the silicone implant40. Its use in cosmetic breast surgery
is still controversial35.
CONCLUSION
The search for a breast implant that reduces the common complications, especially
the formation of biofilm, infectious processes, and immune response, is the
focus of most of the studies found. Acellular dermal matrix and fat grafting
have been reported in the literature as promising alternatives to that
effect.
We conclude that there is a trend towards continuous improvement in breast
augmentation surgery, with aesthetic or restorative purposes, with fewer
complications and better results expected in the future.
COLLABORATIONS
|
RSG
|
Data curation, investigation, project administration, writing -
original draft preparation.
|
|
EBG
|
Supervision, writing - review & editing.
|
|
HFCG
|
Supervision, writing - review & editing.
|
|
LMF
|
Supervision, visualization.
|
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1. Escola Paulista de Medicina, Universidade
Federal de São Paulo, São Paulo, SP, Brazil.
Corresponding author: Rogério Schützler
Gomes Av. Trompowsky, nº 291, Torre 1, Sala 303 - Centro,
Florianópolis, SC, Brazil Zip Code 88015-300 E-mail:
plasticarogerio@gmail.com
Article received: September 6, 2018.
Article accepted: November 11, 2018.
Conflicts of interest: none.
