INTRODUCTION
The positive impact on patients’ quality of life undergoing the placement of breast
implants, especially in augmentation mastoplasty, is well known, knowing its risks
and limits1. Statistical data published by the International Association of Aesthetic Plastic
Surgery (ISAPS) indicate that 211,287 breast augmentation operations with silicone
implants were performed in Brazil in 2019. According to the 2018 census of the Brazilian
Society of Plastic Surgery (in portuguese Sociedade Brasileira de Cirurgia Plástica - SBCP), breast augmentation is the most performed cosmetic surgery in Brazil, corresponding
to 18.8% of all plastic surgeries2,3. Like Brazilian data, the American Society of Aesthetic Plastic Surgery (ASAPS) reported
280,692 breast implant surgeries in 20194. Currently, the estimated prevalence of women with silicone breast implants worldwide
is 50 million.5
There was not, there is not, and there will not be a silicone breast implant with
infinite durability unless the biological reaction of a foreign body is altered6. Some patients need to have their breasts reoperated due to capsular contracture,
rupture of the implant or the desire to change the implanted volume, and scientifically
the indication of these new surgeries is a consensus7. Silicone is not considered an inert material since several immunological effects
have been usually reported to the possible migration of the silicone gel through the
rupture of the elastomer or even with its membrane intact - the so-called bleed gel8.
Breast implant disease (BII) is a condition in which a wide variety of systemic symptoms
are self-reported by patients. The pathogenesis of this constellation of symptoms
and diagnostic criteria remains an object of study and, despite not yet being registered
in the International Code of Diseases, it is the subject of research by the U.S. regulatory
agency (FDA)9. In an increasing number of cases, patients have chosen to have their implants removed
in an effort to treat these symptoms10.
According to the American Society of Plastic Surgeons (ASPS) statistics, in the United
States of America, in recent years, there have been about 20,000 explants per year
related to breast reconstruction and around 30,000 explants related to aesthetic breast
surgery11. There is no doubt that the patient has the autonomy to define what will remain in
their body; however, there is a lack of evidence about the impact of implant removal
on patients’ symptoms for evidencebased medical advice to occur.
OBJECTIVE
This study aims to analyze the history of symptoms and verify the impressions of patients
who underwent breast explant surgery at three different times: before placing the
breast implants, while they had the implants and after the explant surgery.
METHODS
This research was designed as a multicenter longitudinal observational study using
a voluntary participation questionnaire. This research protocol was approved by the
National Council of Ethics in Research and is registered under the number 40784420.8.0000.5336.
Patients operated on by researchers working in five different hospitals were invited
to participate in the study through an e-mail sent in March 2021. This invitation
included the Informed Consent Form and the questionnaire with six sections for self-completion
of voluntary participation, which contained direct questions, multiple-choice questions,
and numerical scales of body satisfaction (zero corresponding to total dissatisfaction
and ten to total satisfaction)12 using Google Workspaces (Google Inc., California, USA).
Inclusion criteria were breast explant surgery performed with one of the research
physicians between January 2010 and September 2020 and age between 21 and 69 years
until the explant surgery. Exclusion criteria were vulnerable populations, surgery
to place a new breast implant after explant and users of illicit drugs.
The data obtained were exported to the IBM SPSS v. 20.0 (IBM, New York, USA) for statistical
analysis. Frequencies and percentages described categorical variables. The Kolmogorov
Smirnov test verified the symmetry of the variables. Quantitative variables with normal
distribution were described by the mean and standard deviation and those with non-normal
distribution by the median and the interquartile range. Symptoms were compared between
the times evaluated by the McNemar test. The body self-satisfaction scale was compared
between times using the Friedman test. To compare body self-satisfaction between patients
who underwent mastopexy or fat grafting together with the explant and those who only
underwent the explant, the Mann Whitney test was used. A significance level of 5%
was considered, represented by p<0.05.
RESULTS
The invitation to participate in the study was sent to 283 patients, and 174 responses
were received. After removing incomplete questionnaires, the total was 156 patients
(55.1% of those sent). Table 1 shows the demographic characteristics of the participants who responded to the survey.
The mean age when the first implant was placed was 27 years and the median time, they
remained with the silicone was 10.5 years. 24.3% of the patients had at least one
implant replacement surgery.
Table 1 - Sample characteristics (n=156).
Characteristics |
Descriptive measures |
Gender, n (%) Female |
155 (99.4) |
Cisgender |
1 (0.6) |
Current age (years), mean±SD |
39.5±8.7 |
Age at first silicone placement (years), mean±SD
|
27.0±7.0 |
Age at explant (years), mean±SD |
38.2±8.7 |
White skin color, n (%) |
133 (85.8) |
Current Body Mass Index (cm|kg2), mean±SD
|
23.05±3.09 |
Table 1 - Sample characteristics (n=156).
Table 2 shows the relationship between silicone implants and patients’ symptoms. 91.7% of
patients had at least one symptom of BII while on silicone. All BII symptoms had a
statistically significant increase comparing the moments before implantation and while
with the implants. After explant, there was a significant decrease in all BII symptoms,
except for the relapsing fever. Only two symptoms did not return, with statistical
significance, the frequency before implantation, dry mouth (p=0.065) and irritable
bowel syndrome (p=0.096).
Table 2 - Frequency of symptoms before implantation, during implantation and after explant.
Symptoms |
Before implant |
During Implant |
After explant |
p Before During |
p During After |
p Before After |
Before After |
1 (0.6) |
100 (64.1) |
26 (16.7) |
<0.001 |
<0.001 |
<0.001 |
Arthritis |
- |
24 (15.4) |
7 (4.5) |
- |
|
- |
Arthralgia |
5 (3.2) |
69 (44.2) |
26 (16.7) |
<0.001 |
<0.001 |
<0.001 |
Chronic fatigue |
5 (3.2) |
95 (60.9) |
15 (9.6) |
<0.001 |
<0.001 |
0.031 |
Difficulty sleeping |
8 (5.1) |
94 (60.3) |
21 (13.5) |
<0.001 |
<0.001 |
0.004 |
Insufficient sleep |
9 (5.8) |
100 (64.1) |
26 (16.7) |
<0.001 |
<0.001 |
<0.001 |
Neurological manifestations associated with demyelination |
- |
11 (7.1) |
2 (1.3) |
- |
0.004 |
- |
Reasoning difficulties |
3 (1.9) |
89 (57.1) |
13 (8.3) |
<0.001 |
<0.001 |
0.013 |
Memory loss |
3 (1.9) |
90 (57.7) |
17 (10.9) |
<0.001 |
<0.001 |
0.003 |
Recurrent fever |
- |
7 (4.5) |
3 (1.9) |
- |
0.125 |
- |
Dry mouth |
2 (1.3) |
80 (51.3) |
9 (5.8) |
<0.001 |
<0.001 |
0.065 |
Irritable bowel syndrome |
8 (5.1) |
55 (35.3) |
16 (10.3) |
<0.001 |
<0.001 |
0.096 |
Loss of hair |
9 (5.8) |
106 (67.9) |
29 (18.6) |
<0.001 |
<0.001 |
<0.001 |
Sclerosis |
- |
1 (0.6) |
- |
- |
- |
- |
Table 2 - Frequency of symptoms before implantation, during implantation and after explant.
Figure 1 shows that, before placing the implant, 2.6% of the patients had at least three symptoms;
while they were with the implants, they became 84.0%, and after removal, 17.9% of
the patients remained with three or more symptoms; there was a significant difference
between before and during the use of implants (p<0.001), during and after (p<0.001)
and before and after (p<0.001). 84% of the patients had three or more symptoms of
BII, and 66.1% of them had an improvement in their symptoms after explant (Figure 1).
Figure 1 - Frequency of presence of 3 or more symptoms before, with the implant and after the
explant.
Figure 1 - (*#& different symbols represent statistical differences with p<0.001).
Figure 1 - Frequency of presence of 3 or more symptoms before, with the implant and after the
explant.
Figure 1 - (*#& different symbols represent statistical differences with p<0.001).
Table 3 shows that we did not find changes in the frequencies observed concerning cancer,
diabetes, epilepsy, deep vein thrombosis, pulmonary embolism, HIV, hepatitis, hypertension,
Chron’s disease, or nephropathies before implantation of silicone and after explant.
When analyzing autoimmune diseases, 9.7% of the patients had an autoimmune disease
before, 35.3% while they had the implants and 23.2% after the explant; there was a
significant difference between before and with silicone (p<0.001), with silicone and
after explant (p<0.001) and before and after implantation (p=0.001).
Table 3 - Frequency of diseases before implantation, during implantation and after explant.
Symptoms |
Before implant |
During Implant |
After explant |
p Before During |
p During After |
p Before After |
Diabetes |
- |
3 (1.9) |
1 (0.6) |
- |
0.500 |
- |
Epilepsy |
- |
- |
- |
- |
- |
- |
Cancer |
1 (0.6) |
2 (1.3)) |
1 (0.6) |
1.000 |
1.000 |
1.000 |
Hypothyroidism |
7 (4.5) |
31 (19.9) |
27 (17.3) |
<0.001 |
0.344 |
<0.001 |
Venous thrombosis |
- |
2 (1.3) |
- |
- |
- |
- |
Pulmonary embolism |
- |
- |
- |
- |
- |
- |
HIV |
- |
- |
- |
- |
- |
- |
Hepatitis |
1 (0.6) |
- |
- |
- |
- |
- |
High pressure |
- |
6 (3.8) |
2 (1.3) |
- |
0.125 |
- |
Chron’s Disease |
1 (0.6) |
5 (3.2) |
5 (3.2) |
0.219 |
1.000 |
0.125 |
Asthma |
10 (6.4) |
4 (2.6) |
3 (1.9) |
0.109 |
1.000 |
0.039 |
Kidney disease |
- |
1 (0.6) |
1 (0.6) |
- |
1.000 |
- |
Skin disease |
8(5.1) |
48 (30.8) |
13 (8.3) |
<0.001 |
<0.001 |
0.267 |
Table 3 - Frequency of diseases before implantation, during implantation and after explant.
Table 4 illustrates patients’ impressions of body appearance. Before silicone placement,
the median body self-satisfaction was 7; while they had the implants, the median became
9, and after the explant surgery, the median remained at 9. Patients’ satisfaction
with their body before placement was significantly lower than satisfaction while with
the implants (p<0.001) and after the explant (p<0.001); there was no difference in
the patients’ aesthetic satisfaction while they were on the silicone and after the
explant.
Table 4 - Patients’ impressions of body appearance.
Before putting |
While they were implanted |
After explant |
p |
Body self-satisfaction, 7 (5 to 8)a median (IQR)
|
9 (8 a 9)b |
9 (8 a 9)b |
<0.001 |
Table 4 - Patients’ impressions of body appearance.
The median of patients who underwent mastopexy concerning satisfaction with their
body was 9 (interquartile range from 8 to 10), and in those who did not, the median
was also 9 (interquartile range from 8 to 10), with no statistically significant difference.
(p=0.220). The median of patients who underwent fat grafting was 9 (interquartile
range from 8 to 10), and in those who did not, the median was also 9 (interquartile
range from 8 to 10), with no statistically significant difference between performing
only the explant or associating with mastopexy or fat grafting (p=0.186). Of the patients
evaluated, 1.3% would think about having silicone implants again, 6.4% would recommend
that a friend have silicone implants, and 97.4% would advise that a friend perform
the explant.
Of the patients evaluated, 83.3% reported regret having had the implant surgery, while
0.6% regretted having had the explant surgery. The physician’s advice who placed the
silicone helped in the decision to perform the explant in 32.9% of the patients, while
support groups on social networks helped in the decision of 87.2% and news in newspapers,
magazines or websites contributed to the decision of 46.5%.
DISCUSSION
An emerging reality that Plastic Surgery faces is the concern of patients that their
silicone implants are the cause of symptoms referred to by the term BII, or even that,
even without symptoms, they could develop diseases over time. Patients’ complaints
about BII should be taken seriously, and symptomatic patients may choose to have the
implant removed, informed that the explant will not necessarily be curative for any
systemic symptoms13. Our study showed that breast explant surgery has a significant reduction rate in
some BII symptoms.
Peters et al., in 1997, when studying 100 consecutive breast explant patients, observed
that the motivation for explant in 76% of cases was due to suspected health problems
related to silicone14. Our research showed similar results since the main reasons for explant were symptoms
of BII (26.9%), aesthetics (26.3%), diagnosis of an autoimmune disease (16.0%) and
Adjuvant-Induced Autoimmune Syndrome (ASIA) (16.0%).
A widely accepted theory proposes an adjuvant effect of silicone in developing autoimmune
diseases in genetically predisposed patients. However, the wide range of symptoms
in patients who develop these pathologies raises doubts about the relationship between
the silicone implant’s adjuvant effects with a specific autoimmune disease or a mixture
of these diseases15. The lack of consensus on this topic leaves an important gap in current knowledge;
however, the significant number of 16% of patients in our study opting for implant
removal after having the medical diagnosis of ASIA syndrome draws attention.
In the 1994 Baylor College cohort, 100 patients diagnosed with adjuvant breast disease
after silicone breast implants or silicone injections were studied16. This set of
symptoms described in 1994 is identical to those currently referred to as BII. In
this study, 96 patients underwent breast explant, and the mean age of patients at
the explant was 44 years. Graf et al., in 2019, studying 26 patients who wanted to
remove silicone implants, most of them because they wanted smaller breasts without
implants, observed a mean age of 59 years17. Our study found a younger population with a mean age of 38 years at explant.
Maijers et al., in 2013, studying 52 patients undergoing breast explant, observed
a significant reduction in BII symptoms in 69% of them18. These data agree with our
study, which found a 66.1% reduction in patients with three or more symptoms of BII.
de Boer et al., in 2017, demonstrated that the explant is useful for improving silicone-related
complaints in 75% of patients, whereas, in patients who developed autoimmune diseases,
improvement is only observed when the explant is combined with immunosuppressive therapy19.
Even so, we do not know all the triggers of autoimmune diseases, including regard
to each patient’s individual and unique issues, with the adjuvant being one of the
reasons for the development of the disease. Performing the explant would be an attempt
to remove the trigger that keeps the autoimmune disease in activity or that could
activate other autoimmune bases, generating new diseases. Several patients have, in
addition to breast implants, intrauterine devices, fillers, tattoos, and dental implants,
and all of these may be responsible for both the initial trigger and the maintenance
of the disease. There is no way to define which one was the precursor.
The 2017 Maastricht cohort study consisted of 100 patients diagnosed with ASIA syndrome
after placing silicone breast implants; 54 of these patients underwent explant surgery20.
Of these, 50% showed improvement in ASIA syndrome symptoms after explant. However,
improvement was observed only temporarily in seven patients, with recurrence of complaints
after a few weeks. Our study proved compatible, as we found a 66.1% improvement in
BII symptoms.
Wee et al., in 2017 and 2018, studied 752 patients who underwent breast explant and
observed that patients with breast implants with symptoms of BII had significant,
immediate, and sustained improvement in 11 common symptoms after surgery and that
this improvement was maintained beyond the immediate postoperative period21. This demonstrates that the data we obtained between the explant surgery and the
time of application of the questionnaire (median of 14 months) reflect a trend already
observed in other studies.
Miranda, in 2020, when studying 15 patients undergoing explant, described that the
most common symptoms such as myalgia, arthralgia, chronic fatigue, dry skin and hair
improved in more than 80% of patients and 100% of patients with symptoms of cognitive
impairment, fever and itching22. Our study observed improved arthralgia symptoms in 62%, chronic fatigue in 84%,
cognitive disorders in 85%, and fever in 57%.
Miseré & van der Hulst, in 2020, when studying 197 patients undergoing breast explant,
described that patients with symptoms of BII23 performed one in nine explants. About 60% of these patients experienced an improvement
in their complaints after implant removal. In our study, 84% of patients had three
or more symptoms of BII and had an improvement rate of 66.1% after explant.
One of the biggest fears when recommending explant surgery is the possibility of patient
regret. The regret would be both for the aesthetic issue of not being well accepted
with small breasts and for retractions and adhesions that could arise after the explant
accompanied by the absence of improvement in BII symptoms. There is a great discussion
about the aesthetic result of breast explant surgeries; many surgeons believe that
the body appearance after the intervention is frustrating and disharmonious.
In the opinion of the patients in our study, this did not occur. The regret of having
had the explant surgery was only 0.6%. We could observe, with statistical significance,
that the patients considered themselves more beautiful after implant placement and
that this perception of body satisfaction remained after their removal. We found no
difference in body selfassessment when comparing the patients while they had the implants
and after the explant surgery. Visual scales of body satisfaction are widely used
to evaluate results in Plastic Surgery12.
These data obtained in our research are of vital importance for us to understand that,
not always, the aesthetic ideal of the surgeon is identical to that of the patient
and that we must open our minds to understand the particularities of women who seek
breast explants. Likewise, there was no statistically significant difference in satisfaction
when we compared surgery with explant alone, explant with mastopexy, or explant associated
with fat grafting. We believe that this finding demonstrates that the indications
for associated surgeries were correctly performed; future research should focus on
the indications for surgeries associated with breast explant.
Our data showed a regret rate of having had the implant surgery of 83.3%. These data
must be carefully interpreted, as they conflict with the literature, which usually
reports high satisfaction with the result obtained after the breast augmentation procedure
with silicone implants24,25.
Support groups on social networks helped in the decision to perform the explant in
87.2% of the patients participating in our research, while news in newspapers, magazines
or websites contributed to the decision of 46.5%. Literature shows us that about 98%
of women diagnosed with BII use online support networks (Facebook and Instagram groups),
and 62% of them report that participation in groups made them more alert about the
diagnosis and fearful of the development of symptoms. symptoms5.
Considering the concerns of women with silicone implants and long-term research studying
nearly 100,000 individuals with breast implants that demonstrated higher rates of
autoimmune disease in people with breast implants, we must empathize with the concerns
of our patients and recognize the potential reality of BII symptoms26,27.
We observed that the physician’s advice who placed the silicone helped in the decision
to perform the explant in only 32.9% of the patients. It is important that our response
offers real assistance to those who need guidance and care. While our first impulse
may sometimes be to discourage a patient from having the implant removed, we must
remember that women are as empowered to have their implants removed as they were to
have the silicone implanted in their bodies.
Like any plastic surgery, implant removal must be approached based on the best and
latest scientific evidence and with a thorough understanding of the risks and benefits.
We believe that a patient with any type of complaint related to her implants should
first return to the surgeon who performed the implant, hoping that he or she is prepared
to examine and help each patient reach a decision appropriate to their individual
needs and beliefs28.
Often, the physician who diagnoses BII is not the plastic surgeon, as the patient
does not correlate the symptoms with the implants and starts looking for other physicians
such as rheumatologists and neurologists29. Even considering that you look for your surgeon, we know that it is a subject that
is not widely disseminated with diagnostic scores, making the patient feel helpless,
as professionals unaware of the disease can discredit the complaints and claim that
the causes would be psychosomatic30. Therefore, it is essential to listen to the patient’s concerns and take the time
to explain the potential risks and benefits of the various options. In the end, if
the surgeon prefers not to perform the explant and the patient still wants this surgery,
referral to a colleague with experience in this surgery may be the best alternative.28
In the research model we used, response rates were calculated by dividing the number
of usable responses by the total eligible number in the chosen sample31. Charles-de-Sá et al., in 2019, considered a response rate of around 10% as adequate,
stating that this value would be well above the average response rate of an SBCP questionnaire32. Our study obtained a rate of valid responses of 55.1%, allowing us to state that
the results obtained significantly reflect the reality of the selected sample.
The internal validity of our data is very consistent; however, the external validity
of our findings is not appropriate for the population with silicone breast implants
since the main limitation of our study lies in the selection of the sample composed
of 91, 7% of patients who had at least one symptom of BII while having breast implants.
Therefore, generalization of our results to the general population is discouraged.
Our data are strictly related to patients who spontaneously wished to undergo an explant;
our research was not designed to assess the prevalence or incidence of symptoms of
BII or ASIA syndrome. This relationship should be studied in the future through epidemiological
research with designs different from ours, ideally, population-based cohorts involving
people with breast implants and people who have never had silicone implants.
Our patients showed a statistically significant change in BII symptoms. However, not
all patients improved. Therefore, when talking to our patients, we must clarify that
there is no guarantee that symptoms will improve with implant removal. On the other
hand, several studies have shown improvement in symptoms in some patients without
laboratory evidence of autoimmune disease10.
We do not have this very precise improvement parameter because there are patients
who undergo explants without a precise pre-surgical clinical evaluation. At this point,
some diagnoses are not performed, and, in the postoperative period of the explant,
the symptoms of this undiagnosed or untreated disease will manifest. There is also
the bias that it may have triggered another autoimmune disease when the prosthesis
acted as a trigger.
Most autoimmune diseases cannot be cured after the trigger is fired and may alternate
moments of improvement with worsening of clinical manifestations since remission does
not depend only on the explant. Hypovitaminosis, decompensated chronic diseases, and
emotional issues such as the pandemic moment can also somehow interfere with this
evaluation. The diagnostic criteria for BII are vague and nonspecific; as a result,
the phenomenon is difficult to identify and treat33.
We need to emphasize that medical science is always evolving and that many diseases
and conditions remain poorly understood despite years of research. Staying up to date
on breast implants means knowing about the interests and requests of patients and
information brought by the media and studying the published literature and the reasons
for the scarcity of evidence of the highest degree29.
We have not stopped looking for solutions to the many legitimate questions being raised,
nor will we stop until the answers are found. Now, however, we need to help our patients
understand their current options and the potential risks and benefits of each course
of action, including the possibility of doing nothing28. We must rely on the best available scientific evidence to determine the most appropriate
counseling for our patients considering physical symptoms and the impact of uncertainty.
We cannot fail to value the motivations of our patients; we must seek to decipher
the enigma of BII and ensure that our patients know that we will never stop seeking
the best possible scientific evidence and excellence in medical care.
CONCLUSION
Some patients undergoing breast implant surgery have symptoms described as BII after
having silicone implants, and most of these symptoms disappear with the removal of
breast implants. Body self-satisfaction increases with the placement of breast implants
and remains high after their removal. Patients who undergo explant surgery are often
regretful of having had silicone implants, very satisfied with the decision to have
them removed, and equally satisfied with the outcome of the breast explant surgery.
Support groups in social networks were important in the decisionmaking of these patients.
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1. Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil
2. Sistema de Saúde Mãe de Deus, Porto Alegre, RS, Brazil
3. Hospital Erasto Gaertner, Serviço de Cirurgia Plástica e Microcirurgia, Curitiba,
PR, Brazil
4. Hospital Vale Paraibano de Cirurgias, Taubaté, SP, Brazil
5. Universidade Federal de Santa Catarina, Hospital Universitário, Florianópolis,
SC, Brazil
Corresponding author: Denis Souto Valente, R. Antônio Carlos Berta 475 - 702, Porto Alegre, RS, Brazil, Zip Code: 91340-020,
E-mail: denisvalentedr@gmail.com
Article received: May 11, 2021.
Article accepted: July 14, 2021.
Conflicts of interest: none.