Evaluation of Clinical Evolution of Breast Augmentation ...the ideal implant, aiming at reducing the capsular contracture index, one of the main late complications of this type of

Advances in Plastic & Reconstructive Surgery © All rights are reserved by Ivana Leme de Calaes. et al.

*Address for Correspondence: Dr. Ivana Leme de Calaes, Resident physician of Plastic Surgery, Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Brazil, E-Mail: [email protected]

Received: June 24, 2019; Date Accepted: July 8, 2019; Date Published: July 10, 2018.

Ivana Leme de Calaes Resident physician of Plastic Surgery, Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP)

AbstractIntroduction: Breast augmentation surgery is one of the most often performed within Plastic Surgery. Throughout history, several materials have been used, the use of silicone for implants having begun in the 1960s. Several studies have been conducted in search of the ideal implant, aiming at reducing the capsular contracture index, one of the main late complications of this type of surgery. In recent years, Brazilian researchers have developed implants coated with silicone foam and studies on rats have been demonstrating the superiority of this material.

Objectives: To evaluate whether silicone foam implants have a different evolution pattern when compared to conventional textured implants, mainly observing the possible decrease in the capsular contracture index and postoperative ptosis (breast sagging).

Material and Method: Fifty-eight female patients underwent surgery. They were divided into two groups (silicone foam-Lifesil®- and microtexturized silicone – Lifesil®). Evolution was analyzed in postoperative appointments, 30 days, 120 days, 360 days after surgery, and then annually, withup to 3 years of follow-up.

Results and Discussion: Silicone foam envelope implants were more difficult to introduce with the same incision size (p<0.001). When comparing groups, there were no statistically significant differences for breast tenderness, presence of stretchmarks, presence of rippling (visible implant folds), breast sagging (breast ptosis), capsular contracture and quality of scars. There was a higher rate of patients who were very satisfied with the result 360 days after surgery in the group that received silicone foam implants (p=0.036).

Conclusion: a) Due to their external roughness, implants with silicone foam envelope are more difficult to be introduced in the same incision when compared to implants with a smooth texture; b) There was no statistical difference for the variables: quality of scars, capsular contracture, presence of stretchmarks, breast ptosis, presence of rippling, and alterations of sensitivities between groups; c) The patients’ satisfaction 360 days after surgery was higher in the group that received silicone foam envelope implants with a higher percentage of patients who were very satisfied with the results of the surgery.

Level of evidence: III B.

Keywords: Textured Silicone Implants; Silicone Foam. Breast Implants; Capsular Contracture; Augmentation Mammoplasty.

useful characterization of serotonin receptor subtypes in the treatment of

Research Article ISSN: 2572-6684

Evaluation of Clinical Evolution of Breast Augmentation Using Implants with Silicone Foam Envelope and Implants with Textured Silicone Envelope

The constant search for a more pleasing phenotype has led to an increase in surgeries in this body segment. Currently, augmentation mammoplasty is the second most performed plastic surgery in Brazil (second only to liposuction), reaching 158,950 procedures in 2015 according to the Brazilian Society of Plastic Surgery [1] (the United States being the leader in relation to the number of patients who have undergone surgery [2]).

Throughout history, different materials have been used for breast augmentation, from paraffin injections to the current use of silicone implants. The first silicone gel breast implant was developed by Cronin and Gerow [3] in 1963, giving rise to a number of changes, mainly in relation to the surface, characterized primarily by its smooth texture. Although these innovations increased the degree of satisfaction compared to previous methods, they left to be desired regarding a common complication, namely, capsular contracture.

Histologically, the capsule has several layers composed of fibro-

Introduction The breasts are superficial organs with ectodermal origin,

classified as glands. They are susceptible to cyclical hormonal fluctuations and to the natural aging process, with flabbiness of the skin and replacement of the glandular tissue by fatty tissue. The breasts, thus, have an extremely important role in the female body’s aesthetics, acting in sensuality and in the improvement of women’s self-esteem.

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Ivana Leme dC. Evaluation of Clinical Evolution of Breast Augmentation Using Implants with Silicone Foam Envelope and Implants with Textured Silicone Envelope. Adv Plast Reconstr Surg, 2019; 3(3): 252-258.

blasts, fibrocytes, myofibroblasts and histiocytes surrounded by acellular tissue, rich in collagen fibers. This layer, in circular arrangement, exerts traction on the implant and determines signs and symptoms ranging from discomfort or breast stiffening sensation to continuous and refractory pain, with possible loss of mobility and aesthetic deformity [4]. Capsular contracture may occur at any moment after surgery, but usually happens in the first months. This condition is better diagnosed clinically, as mentioned above, but imaging tests are usually requested for diagnostic confirmation [5].

Different factors may determine the formation and intensity of the peri-implant capsule: presence of bruises, subclinical infection, silicone extravasation, type of envelope/coating, site/plan of the prosthesis’ placement, and immune response. The coating of the implant was proven to be an important factor for major reduction in the formation of capsular contracture, leading most breast implant manufactures to replace the production of smooth coating with that of textured implants and, after further studies, some manufacturers have published advantages in using polyurethane-coated implants, because the reduction of the capsular contracture index was attributed to the three-dimensional structure obtained with this configuration, which causes the vector sum resulting from the contraction of capsular fibers to be smaller.

On the other hand, the use of silicone implants coated with polyurethane has been target of several criticisms due to the difficulty of removal in a possible surgical retreatment, as well as to questions about the toxicity caused by the metabolism of the material in the long term, and also to the uncertainties regarding possible damages to the organism caused by the intense inflammatory reaction produced. Thus, Wagenführ Jr [6] developed silicone implants with a silicone foam envelope, which would theoretically have the advantage of the foam’s structure being similar to that of polyurethane without, however, featuring the negative aspects such as degradation, inflammation and possible toxicity of catabolites such as 2-4 TDA (toluenediamine). In 2009, Balderrama [7] confirmed this expectation through experimental studies on rats; however, other clinical issues could not be confirmed with these studies, since they were performed on animals. Among these issues, the following can be mentioned: greater adhesion of this type of coating (silicone foam) to the breast tissues, resulting in a lower rate of breast ptosis in the late postoperative period, and less visualization of rippling (implant folds), especially in the upper pole of the breasts of slim patients, as Wagenführ supposed.

To clarify the clinical evolution of this new material for coating the implants (silicone foam), when compared to the textured silicone implants, this prospective study was elaborated, also evaluating possible differences in the patients' complaints, such as: incidence of capsular contracture, stretch marks (due to tissue distension resulting from the inclusion of the implants), scar quality, sensitivity changes and patient satisfaction rate after surgery.

Objectives

To evaluate the clinical evolution of silicone implants coated with silicone foam compared to that of textured silicone implants, manufactured by the same brand.

To compare possible complications and safety of the two types of implants in young women, with emphasis on the capsular contra-cture index capsular, maintenance of the implant’s position and breast shape 30, 120, 360 days after surgery, and then annually, through clinical examination and standardized photographic docume-ntation. To analyze the patient’s satisfaction in the different phases of the post-operative period, for each of the groups.

Material and Method After the study was approved by the Ethics Committee of

Unicamp, 60 healthy patients with a minimum age of 18 years old and complaints of hypomastia were selected from the Outpatient Plastic Surgery Clinic of Unicamp’s Clinical Hospital. Patients who had underwent previous inclusion of breast implants, patients with mastectomy sequelae, pregnant women or recent mothers, patients with mammary ptosis (who required mastopexy), and those with breast abnormalities or nodules with BI-RADS classification 4 or higher in the preoperative ultrasonography and/or mammography were excluded.

For inclusion in the research protocol, the patients had to sign the Informed Consent Form. Preoperative examinations were requested and the breasts were measured to determine the volume of the implants. The latterwere provided by the Lifesil Silicone Implant company, in two models: envelope with silicone foam surface (macrotexture) and envelope with textured surface (microtexture or smooth texture). The models were sent on the day of surgery for randomization only in the intraoperative period. The patients had no surgery expenditure.

Both models of implants are released for commercialization by ANVISA, a health regulatory agency in Brazil.

An incision (4 cm) in the inframammary sulcus and dissection in the subglandular plane were standardized; then, the coating of the implants (always bilateral) was randomly chosen. In this way, the patients were randomly assigned to two groups with 30 individuals each: Group A (silicone foam envelope) and Group B (textured silicone envelope).

The clinical evaluations were performed by the author and/or supervisor of the study, 30 days, 120 days, 360 days after surgery, and then annually; resident physicians did not perform care or measure-ments of patients in this study. The patient’s complaints were recorded, measurements of the breasts (distance from fúrcula to nipple, from the are olato the inframammary sulcus, and others measures), checked for the presence of scars and stretch marks, rippling (visible edges of the implants), ptosis (sagging) of the breasts and evaluated the signs of capsular contracture (according to Baker’s classification). Standardized photographic documentation (front-on,

Figure 1: Breast implants coated with silicone foam.

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Ivana Leme dC. Evaluation of Clinical Evolution of Breast Augmentation Using Implants with Silicone Foam Envelope and Implants with Textured Silicone Envelope. Adv Plast Reconstr Surg, 2019; 3(3): 252-258.

semi-profile and profile portraits), captured by a Canon G7 camera, was obtained during the different evaluation periods. After each visit, the patients filled out a questionnaire in which they scored from 0 to 10 personal satisfaction on the following questions: stretch marks, scar, breast consistency, ptosis (sagging) of the breasts, sensitivity and general satisfaction with the result. There was a table to standardize the score: 0-2 (very dissatisfied), 3-4 (unsatisfied), 5-6 (indifferent), 7-8 (satisfied) and 9-10 (very satisfied).

The surgeries were performed between July 2014 and March 2017; in this period, two patients were excluded, one belonging to group A and the other to group B, for different reasons: pregnancy and loss of follow-up, respectively. Thus, the statistical analysis was held with n=58 patients.There was a long period between the surgeries, because the country went through a major political-financial crisis, generating budget deficits within the Hospital and the University, lack of beds for hospitalization, priority of the public health system in performing reconstructive surgery and limitation of the donations of these implants.

Statistical Analysis

Chi-square test, Fisher’s exact test and Mann-Whitney test were used, with statistical 95% confidence intervals (p<0.05).

Results The patient’s were divided according to the texture of the implants

received after randomization: Group A (silicone foam) and Group B (standard textured silicone). Analysis consists of 58 patients whose postoperative follow-up period was 1 year, 38 patients whose postope-rative follow-up period was 2 years, and 16 patients whose postope-rative follow-up period was 3 years.

The mean age for Group A was 22.86 years old (19-39 years) and 23.86 years old for Group B (19-50 years). There was no significant difference between groups (p=0.3063).

In the comparison of groups to the implants’ volume, there was statistical difference between the groups: Group A (silicone foam) had a higher mean than Group B (p-value<0.05 in the 3 comparisons).

Prosthesis’ volume Mean Median Standard deviation

N P-value

Right Group A 287.9 275 49.4 29

0.013 Group B 264.7 250 33.8 29

Left Group A 292.2 275 43.9 29

0.002 Group B 258.6 250 33.6 29

Medium Group A 290.1 275 45.9 29

0.005 Group B 261.6 250 32.9 29

Table 1: Implants’ Volume

Regarding the possible difficulty of introducing the implant, there is statistical difference between the groups, with p<0.05, the foam implants being more difficult to be introduced by the same incision size.

48.3% 51.7%

6.9%

93.1%

0%10%20%30%40%50%60%70%80%90%

100%

With difficulty Without difficulty

Comparison of groups for “Difficulty of implant placement”

Group A Group B

Right contracture Group A Group B Total P-value

N % N % N %

30 days of postoperative follow-up Absence 29 100% 29 100% 58 100% - × -

120 days of postoperative follow-up Absence 29 100% 29 100% 58 100% - × -

360 days of postoperative follow-up

Absence 29 100% 27 93.1% 56 96.6%

0.150 Baker 2 0 0.0% 2 6.9% 2 3.4%

2 years of postoperative follow-up

Absence 19 100% 17 89.5% 36 94.7%

0.146 Baker 2 0 0.0% 2 10.5% 2 5.3%

3 years of postoperative follow-up

Absence 8 100% 7 87.5% 15 93.8%

0.302 Baker 3

& 4 0 0.0% 1 12.5% 1 6.3%

P-value< 0.001

Scars were classified as optimal in the majority of patients with 1 year or more of postoperative follow-up; only one patient had keloid. The differences between the groups were not significant.

In relation to capsular contracture, incidences were divided according to location:

Table 3: “Right Contracture”

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Ivana Leme dC. Evaluation of Clinical Evolution of Breast Augmentation Using Implants with Silicone Foam Envelope and Implants with Textured Silicone Envelope. Adv Plast Reconstr Surg, 2019; 3(3): 252-258.

Finally, one of the most prevalent complaints in the post opera-tive examinations: change in sensitivity. The patients were questioned about the maintenance of sensitivity, hipoesthesia or hyperesthesia in the breasts, nipple and scars. No statistical difference was found between groups (p>0.05).

Left contracture Group A Group B Total P-value

N % N % N %

Absence 29 100% 29 100% 58 100% - × -

Absence 29 100% 28 96.6% 57 98.3%

0.313 Baker 2 0 0.0% 1 3.4% 1 1.7%

Absence 29 100% 28 96.6% 57 98.3%

0.313 Baker 2 0 0.0% 1 3.4% 1 1.7%

Absence 19 100% 18 94.7% 37 97.4%

0.311 Baker 2 0 0.0% 1 5.3% 1 2.6%

Absence 8 100% 7 87.5% 15 93.8%

0.302 Baker 3

& 4 0 0.0% 1 12.5% 1 6.3%

30 days of postoperative follow-up

120 days of postoperative follow-up

360 days of postoperative follow-up

2 years of postoperative follow-up

3 years of postoperative follow-up

Table 4: “Left Contracture”

Only two patients had capsular contracture over the study period, both of which had textured implants. Of these, one had bilateral contracture, with progressive worsening of the contracture’s classifi-cation (Baker 4 in the postoperative 3-year follow-up). Surgical retreatment was indicated for this patient. The other patient with contracture completed 2 years of follow-up and is asymptomatic. Despite being present only in group B, capsular contracture had no statistically significant difference between groups.

The presence of new striae was evaluated in the different periods. There was no statistical difference (p>0.05).

Satisfaction rate (very dissatisfied, dissatisfied, indifferent, satisfied and very satisfied) was also analyzed; there were no very dissatisfied patients. The 360-days postoperative follow-up showed a higher incidence of patients who were very satisfied with the result in group A (silicone foam), when compared to group B, with statistical signifi-cance (p-value=0.036).

Considering the possibility of greater integration of macrote-xturized implants into the breast tissue, with consequent decrease in breast sagging during the postoperative period, this data was evaluated with measures from the sternal furcula up to the nipples and also according to the clinical observation of breast ptosis (Regnault classification): no significant difference in ptosis over time for both groups.

The patients had normal body mass index (BMI); thus, a possible postoperative observation would be the presence of rippling in very thin patients. However, this finding was not significant when comparing the groups at different postoperative follow-up periods.

PO30 PO120 PO360 PO2y PO3y

Evolution of the distribution of “Sensitivity” in Group A

Normal Increased Decreased

0%10%20%30%40%50%60%70%80%90%100%

0%

10%

20%

30%

40%

50%60%70%80%

90%

PO30 PO120 PO360 PO2y PO3y

Normal Increased Decreased

Evolution of the distribution of “Sensitivity” in Group B

There is practically no statistical difference between groups A and B for all variables. The only exception occurred for satisfaction rate, for the postoperative 360-day follow-up, where descriptively we have 86.2% very satisfied patients in Group A compared to 62.1% in Group B (p-value=0.036).

Discussion

The characteristics of an ideal implant were defined by Scales [8] in 1953. The Silastic® prosthesis was produced with the purpose of solving the problem of silicone leakage through the implant’s wall and of detachment of silicone molecules. Its membrane was supposed to be impermeable between the silicone layers. The studies by Cronin and Gerow [3] were the ones responsible for the development and dissemination of the use of silicone gel breast implant.

According to Lodovici [9], the medical grade silicone used for manufacturing the implants meets Scales’ requirements and, therefore,

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is the inclusion material that is most often used in augmentation mammoplasty. Currently, the implants have, in their interior, silicone with a higher degree of cohesiveness, granting greater safety to the patient in case of possible rupture of the implant; however, the coating of these implants is still under study, since capsular contracture is one of the main late complications of this type of surgery [10].

Smooth breast implants fell into disuse for many years because capsular contracture occurred five times more in these patients when compared to textured implants [11-13]. Alternatively, polyurethane-coated implants have been used since the 1970s, but with some studies showing possible negative effects of this type of coating [14-15].

These effects were already being questioned since 1991 by the Food and Drug Administration (FDA [16]), which interrogated manufacturers regarding the implants’ quality, since complications such as ruptures, contractures, breast cancer risk and others were very common. They also raised suspicion regarding 2, 4-toluenediamine (TDA), which results from the degradation of polyurethane. The implants were withdrawn from the U.S. market in the following year. The good news came in 1995, when FDA allowed the use of TDA, judging the risk of cancer to be minimal. In 2000, saline implants were allowed for commercialization. Today, FDA grants an approval letter for silicone gel implants.

Studies by Wagenführ Jr [6] and Balderrama [7], presented the silicone foam as a new type of envelope/coating for breast implants. These studies, performed on rats, showed the biocompatibility of this new material, with lower inflammatory response to foreign bodies and without the biodegradable components present in polyurethane. They also show a lower index of capsular contracture and greater integration of the implants into the adjacent tissues, which may lead to a lower rate of complications associated with augmentation mammoplasties. And it was in search of these possible findings that the present clinical study began.

The qualitative variables along the different postoperative periods are described by FDA as possible findings and complications after augmentation mammoplasty; were evaluated the inframammary scars, which had very satisfactory aesthetic quality, especially when well positioned on the sulcus. Keloid was found in only one patient and has no significant relevance; the treatment was performed with serial infiltrations of triamcinolone (20 mg/ml). The debridement of the borders, sometimes necessary due to the friction caused by the introduction of the implants, especially those coated with foam (and also by the implants of greater volume) could lead to a greater tension in the suture, being able to cause larger scars. This fact is of relevance in the Brazilian population, which has the habit of wearing intimate and bath items of small sizes; but such differences were not observed with significance in the present study.

The presence of capsular contracture also showed no statistical difference. This is one of the major issues assessed throughout the study; and because it is one of the late complications, perhaps a longer follow-up period may show different results. One of these patients, with bilateral hardening, completed 3 years of follow-up, reporting worsening of breast consistency, with visible (although still small) deformity and sporadic pain, being classified as Baker 4; she has been scheduled for surgical retreatment.

In relation to breast sagging (ptosis) over time, the absence of differences between the groups can also be explained by the short follow-up period for this variable, considering that most patients are young, have no flabby skin and are not pregnant. The volume of the

implants presented a significant difference when measured volume in ml (with larger volumes of silicone foam implants), but it is known from the median that the difference was only one size above the manufacturer's grid, which for surgeons plastics, imply few clinical differences. Thus, the larger volume was not responsible for greater ptosis or presence of a greater amount of stretch marks in group A (without significant difference for these two variables, when comparing the groups).

Sensitivity changes were evaluated in the different postoperative periods: the manipulation of the region (skin incision associated with subglandular detachment) and the generated edema explain hypoe-sthesia, which is usually transient. There was also no significant difference between groups. Because the study was conducted within a Brazilian public hospital, with a budget deficit, there were no more objective methods / exams available for evaluating changes in sensiti-vity, and the findings were based only on patients' complaints.

Regarding the stretch marks, a correlation between the patients’ complaints, the physical examination and the comparison between the photos of the different postoperative periods was held because the gradual improvement of the appearance of the stretch marks throughout the study was noticed, making it difficult to confirm whether they were stretch marks caused before or after the surgery. When present, the stretch marks showed to be more prevalent bilaterally, hydration with oils and nocturnal use of retinoids having been prescribed, leading to a significant improvement of appearance. The comparison of this item received special attention due to the use of slightly larger volume implants in group A (silicone foam) and not the type of coating, since there would be little influence in the presence of stretch marks; thus, larger volumes could cause greater stretching of the skin, favoring stretch marks. However, there was also no statistical difference between groups.

When evaluating the patients’ degree of satisfaction, there was a higher rate of very satisfied patients in group A (silicone foam), statistically significant for the 1-year follow-up period (p=0.036). In previous periods, the patient who was not satisfied belonged to group B and desired larger implants (mainly after the edema’s regression), her satisfaction level in relation to the result having been classified as “indifferent”. The dissatisfied ones were the two patients who needed surgical retreatment (one for enlargement of the mammary store and improvement of the implants’ positioning and another for fixation of the inframammary sulcus, since the implants had “slipped” towards the abdomen, mainly the left one). So, after one year of surgery, patients who received implants coated with silicone foam showed a higher satisfaction rate than the control group (p<0.05).

No infection in the surgical wound or seroma, breast hematoma or rupture of implants was noted in the patients studied. Our postoperative findings are consistent with the literature on augmentation mammoplasty [17-21]. No relevant clinical studies or reviews of the literature on silicone foam envelope implants have been found so far. The number of complications shown by the patients in this study was lower than the average described in the literature [11, 17-21].

There are still no published papers in the world literature with patients using these silicone foam implants, which generated a deficit in the comparative analysis of this study; thus, the clinical evolution of these patients should be observed year after year, to ensure safety in the use of this new material.

Recent scientific reports have suggested a possible association

Adv Plast Reconstr Surg, 2019 Page 256 of 258

between anaplastic large cell lymphoma (ALCL) and breast implants, mainly macro textured ones also found in the literature as BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma). The first reports to the FDA were in 2011, but only in 2016 the World Health Organization recognized such T-cell lymphoma (non-Hodking) associated with textured breast implants. By September 2018, the FDA had received a total of 660 patient reports with BIA-ALCL associated with the implants, including the death of nine patients. However, some cases were reported in duplicity, thus leaving 457 cases reported. The current literature has reported several estimates that the BIA-ALCL can develop in 1 of 2,832 to 30,000 women with textured breast implants. The exact number of cases remains difficult to determine due to significant limitations in the worldwide reporting and lack of accurate data on the use of breast implants [22-27].

ALCL is usually found close to the implant itself and/or contained within the fibrous capsule. Symptoms such as pain, nodules, swelling or asymmetry that have developed after the initial surgical sites have completely healed are the main findings. After correct diagnosis, ALCL is usually treated with surgery to remove the implant and adjacent scar tissue; chemotherapy and / or radiation therapy are indicated. Therefore, it is known that women with breast implants may be at an increased risk of developing ALCL, although the current literature indicates that the risk is extremely low, with no need for a change in routine medical care and follow-up of the patients, being a symptomatic. Considering that this study began in 2014, there was no initial intention to investigate the BIA-ALCL, since there were not an expressive number of reported cases; Thus, in the future, we may have contributions from this work to a possible association (or not) of this lymphoma with silicone foam coated implants (since most of the reported cases are related to macro texturized implants, although no case reported with Lifesil implants).

In the case of the silicone foam implant, its coating is made up of 100% dimethylsiloxane elastomer, which has an adhesion inside the mamma, leaving no friction and possible seroma formation, generating a low ALCL risk (unlike other macrotextures). Thus, the silicone implant adherence is definitive, there is a bond between the implant and the capsule and, as the capsule is closely connected with the adjacent breast tissues, this implant will always adhere adjoining.

Conclusions

1. There was no statistically significant difference for thefollowing findings: quality of the scars, capsular contracture,presence of stretch marks, breast ptosis, presence of ripplingand alterations of sensitivities between the groups;

2. Absence of significant seroma, hematoma, peri-implantinfection and rupture of the implants was observed in allpatients in thestudy.

3. The patients’ satisfaction in the postoperative 360-day follow-upwas higher in the group that received silicone foam coatedimplants, with a higher percentage of very satisfied patients(p=0.036);

4. Implants with silicone foam envelope, because of their externalroughness, are more difficult to insert through a single incisionwhen compared to fine texture implants (p<0.001);

5. Silicone foam envelope implants proved to be as reliable astextured silicone envelope implants, making them a safe optionfor augmentation mammoplasty;

Compliance with Ethical StandardsConflict of Interest statement

The authors declare that they have no conflicts of interest to disclose, although the breast implants were donated by the LIFESIL Company.

Statement of human and animal rights, or ethical approval Study approved in the Committee of Ethics and Research (CEP)

of The State University of Campinas (UNICAMP) – CAAE 30209114.6.0000.5404

Informed Consent Registration of the document in the CEP- UNICAMP number

632767.

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Ivana Leme dC. Evaluation of Clinical Evolution of Breast Augmentation Using Implants with Silicone Foam Envelope and Implants with Textured Silicone Envelope. Adv Plast Reconstr Surg, 2019; 3(3): 252-258.

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