INTRODUCTION
Silicone implants have been available on the world market since the mid-1960s, and,
since then, many studies, questions and uncertainties have been in the air, from the
silicone moratorium in the United States to the bankruptcy of Dow Corning and the
worldwide scandal of PIP. Despite obstacles over the years, in 2019 alone, approximately
280,000 surgeries were performed with breast implants in the United States, totaling
approximately 50 million women with silicone implants worldwide1,2.
Despite more than 60 years of history, dozens of studies, and large population samples,
many patients have returned to the plastic surgeon’s office recently. They have doubts
about silicone, some due to recent reports of BIA-ALCL (Anaplastic Large Cell Lymphoma),
but the vast majority due to the possibility of systemic symptoms related to implants
that arouse the desire to remove them. The procedure is known as explant. This phenomenon,
whose doubts are numerous and the answers are minimal, is known in the world literature
as Breast Implant Illness (BII)1,3,4.
ASIA syndrome
Due to the increase in the prevalence and incidence of autoimmune diseases in the
world population, Yehuda Schoenfeld described in 2011 the ASIA syndrome (Autoimmune
Syndrome Induced by Adjuvants), in which certain adjuvants (nonspecific stimulating
agents of the immune system), such as alum, pristine, infection and also silicone
would act as inducers of autoimmune symptoms in genetically predisposed patients.
Thus, BII would be a subtype of the ASIA syndrome5,6.
Based on this publication and the diagnostic criteria proposed by the author, some
studies with small series have tried to relate silicone implants to the presence of
systemic symptoms directly. However, the association between silicone implants and
symptoms is uncertain. It is unclear whether these symptoms would not have developed
even if the implants had not been placed7-9.
The important thing to consider from these epidemiological studies is that, although
an increased risk of implant-related connective tissue disease was excluded, the sample
sizes were too small to exclude an increase in extremely rare connective tissue diseases5.
Silicone is not considered an inert material, as several immunological effects have
been reported. Silicone gel can migrate through the rupture of the elastomer or even
with its membrawne intact - a phenomenon called gel bleed, which clinically may be
detectable through axillary and mediastinal adenomegaly, with well-described characteristics
of silicone gel accumulation (siliconomas), regardless of cohesiveness and elastomer
type2,10.
Silicon particles can be phagocytosed by macrophages and trigger an immune response
through the activation of B and T lymphocytes. The mechanisms by which an autoimmune
phenomenon develops are numerous and include dysregulation of innate and adaptive
immunity in those patients genetically predisposed to autoimmunity. It is currently
difficult to identify such patients at risk. However, the silicone implant should
be carefully analyzed in those patients with a previous history of disease induced
by another adjuvant, established autoimmune disease, severe allergies or important
family history of diseases. autoimmune5,10.
Breast Implant Illness
Although the ASIA syndrome was described a decade ago, we are experiencing a new moment
in recent years. There is a great demand for patients who already have silicone implants
and report systemic symptoms. Today, the reach and influence of TV have been reduced
by the Internet, especially social networks, where discussion groups on various medical
problems have become popular. While some forums may indeed be fruitful, others may
promote the sharing of incorrect information by unqualified people11.
With the “boom” - or “viralization” - of the subject on the Internet and social networks,
hundreds of signs and symptoms have been related to silicone implants, usually nonspecific
(Chart 1). According to Lee et al.12, the most common symptoms reported by patients are chronic fatigue, arthralgia, mental
confusion, myalgia, memory loss, difficulty concentrating and dry eyes.
Chart 1 - BII-Related Symptoms
| Anxiety |
Depression |
Weight gain |
| Loss of hair |
Chronic fatigue |
Visual changes |
| Sleep disorders |
Tinnitus |
Premature aging |
| Drop in libido |
Arthralgia |
Myalgia |
| Urinary urgency |
Fibromyalgia |
Skin rash |
| Palpitations |
Fever |
Raynaud’s Syndrome |
| Panic Syndrome |
Irritable bowel syndrome |
Lactose intolerance |
| Thyroiditis |
Memory loss |
Dry mouth |
Chart 1 - BII-Related Symptoms
There are no diagnostic tests for BII, no scientific evidence-based method to differentiate
it from other conditions that share similar symptoms (irritable bowel syndrome and
fibromyalgia, for example) and very little knowledge about its onset, course, risk
factors, causes and appropriate management.
A small study analyzed capsules after explantation and showed that there seems to
be a relationship between the presence of biofilm - mainly due to the P. acnes bacteria.
This bacterium, which has been linked to the development of other rheumatic diseases,
would cause chronic irritation in the capsule and serve as a trigger for symptoms1,12,13.
Although the surgeon’s impulse is to dissuade the patient and discourage implant removal,
we must remember that this right is hers, just as she had when she chose to have her
implant included. When a patient comes to their doctor to inquire about their implants,
it is an opportunity to address their concerns, provide scientific education and treat
if there is a problem.
It is important to offer real assistance to those who need guidance and care. One
of the main complaints of women diagnosed with BII is the lack of information at the
time of implantation. Many reported that they were not instructed on the procedure’s
risks, especially concerning the development of symptoms, BIA-ALCL and, mainly, that
implants are not lifelong11,14,15.
Trust is the foundation for a good doctor-patient relationship, and it is based on
the belief that the doctor is working for the best of the patient. The break occurs
when the patient realizes that her doctor has made a technical or judgment error.
Not listening to patients’ complaints, labeling them or assuming an unfriendly attitude
will drive them away from the plastic surgeon’s office, discredit the specialty and
increase litigation rates11,14.
It is important to remember that, despite being extensively studied from different
perspectives, the scientific community has never looked specifically at the direct
relationship between silicone implants and systemic symptoms. So far, there are no
prospective studies with good scientific evidence to confirm or refute this hypothesis.
Until then, we must be doctors above plastic surgeons and treat our patients with
all the attention and respect they deserve9.
Although we have few answers at the moment, the role of the plastic surgeon is to
try to differentiate patients who may actually be developing an autoimmune disease
due to the breast implant from those who were induced to be diagnosed with symptoms.
The lack of diagnostic methods reinforces the importance of careful anamnesis and
clinical examination and understanding the patient’s life context. Such differentiation
is extremely important in order to avoid unnecessary surgical interventions1,16.
Newby et al.1, when applying questionnaires to three different groups of women (with BII; undergoing
explants; without symptoms), found that 98% of the participants use support networks
on the Internet, such as Facebook and Instagram groups, and that 62 % reported that
the groups made them more alert to the diagnosis and fearful of the possibility of
developing symptoms. In addition, they showed that self-reported patients with BII
have higher rates of anxiety and depression than women undergoing explantation and
asymptomatic women, respectively. The same authors report that patients opt for the
explant on average 10 years after the primary surgery, despite reporting the onset
of symptoms within the first 2 years, which worsen over time1.
Explant
The option to remove implants has been growing dramatically in recent years, one of
the ten most performed surgeries in the United States last year. In the same way that
the diagnosis is commonly made through social network groups, the treatment is also
indicated by this means, so it is common for patients to arrive at the office requesting
the performance of the “explant with capsulectomy en bloc.” The terminology “en bloc”
is restricted to oncological pathologies, and, in the context of silicone implants,
it is indicated only in cases of anaplastic cell lymphomas (BIA-ALCL)15-17.
En bloc resection consists of resection of the implant, its capsule and adjacent tissues
(safety margin) without capsule violation. In the context of BII, there is no evidence
of capsule disease, and the incidence of capsular pathologies is extremely low (0.2%).
Total capsulectomy should be performed preferably (Figures 1 and 2), as long as it is technically feasible and safe. Special attention should be given
to implants in the retromuscular plane, always weighing the risk-benefit ratio, given
the possibility of chest wall perforation, pneumothorax and even death17.
Figure 1 - Bilateral total capsulectomy with intact capsules (popularly called en bloc).
Figure 1 - Bilateral total capsulectomy with intact capsules (popularly called en bloc).
Figure 2 - Silicone prosthesis explant.
Figure 2 - Silicone prosthesis explant.
The literature shows variable symptom improvement rates after explantation. Rohrich
et al.8 showed a progressive improvement in quality of life and body pain indices in patients
undergoing explantation in the first 6 months after surgery compared to the control
group. De Boer et al.18 showed a symptom improvement rate of 63% after observation of 14 months after explantation.
Magnusson et al.3, in turn, stratified patients into three distinct prognostic categories after explantation.
Patients without evidence of rheumatic or autoimmune disease (type A) have the best
prognosis, improving up to 80% of physical symptoms and 93% of psychological factors.
Women with evidence of rheumatic disease, without the autoimmune disease (type B),
tend to have a brief improvement in symptoms but experience a recurrence of symptoms
after 6 to 12 months (“Honeymoon period”). On the other hand, women who have a confirmed
diagnosis of autoimmune disease (type C) have the worst evolution, with no improvement
in symptoms or serological markers. Likewise, Lee et al.12 showed that some patients showed improvement in the most common symptoms after explantation
with capsulectomy, except for patients diagnosed with autoimmune disease.
On the other hand, Newby et al.1 demonstrated that women who underwent explant surgery had more severe physical symptoms
and worse mental health than the control group, although the symptoms were milder
than patients with BII and those with their implants. The authors conclude that these
results suggest that explantation may not be a cure for BII and that symptoms may
not resolve completely1.
After explantation, patients are generally satisfied with their aesthetic results
and have lower anxiety and stress levels after the procedure3,8.
CONCLUSION
The relationship between silicone breast implants and systemic diseases, including
autoimmune diseases, has been postulated, studied and discussed since the 1960s, but
the debate continues today. Prospective, randomized, well-designed studies are needed,
correlating different periods of patients, from the preoperative period of the implant
to the post-explant period.
Although we live in a world of lives, 5G and instant responses, good science continues
to move slower. The answers that everyone, doctors and patients, aspire to will take
a few years to arrive, as studies are developed specifically to look at symptoms and
their direct relationship to silicone implants.
Until then, we must be calm and considerate. There is no room for sensationalism,
fads, or panic in serious medicine. Our fundamental role is to welcome patients, listen
to their complaints, and explain what evidence is available at the moment and the
risks of the explant procedure. The decision is up to them.
The impulse must not be part of the decision-making process. The implant should not
be performed, nor should it be explanted by external pressure or by an anonymously
authored post on social networks. All information, risks, outcome expectations, and
possible benefits must be clarified preoperatively and a well-written consent form.
The omission of some information can be fatal in the doctor-patient relationship and
the loss of trust in the specialty. It is a surgical procedure and, as such, must
be respected, as it is not without risks.
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1. Federal University of Santa Catarina, Department of Plastic Surgery and Burns,
Florianópolis, SC, Brazil.
2. Erasto Gaertner Hospital, Curitiba, Paraná, Brazil.
Corresponding author: Ricardo Votto Júnior, Avenida Osvaldo Rodrigues Cabral 1570, sala 208, Florianópolis, SC, Brazil, Zip
Code 88015-710, E-mail: ricardo.votto@ufsc.br
Article received: April 14, 2021.
Article accepted: October 15, 2021.
Conflicts of interest: none.
