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Cosmetic: Original Articles

Subfascial versus Subglandular Breast Augmentation: A Randomized Prospective Evaluation Considering a 5-Year Follow-Up

Graf, Ruth M. M.D., Ph.D.; Junior, Ivan Maluf M.D.; de Paula, Dayane R. M.D.; Ono, Maria C. C. M.D., Ph.D.; Urban, Linei A. B. D. M.D.; Freitas, Renato S. M.D., Ph.D.

Author Information
Plastic and Reconstructive Surgery: October 2021 - Volume 148 - Issue 4 - p 760-770
doi: 10.1097/PRS.0000000000008384
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Abstract

Breast augmentation is one of the most popular cosmetic surgical procedures worldwide, and many methods have been developed to reach the best result. In this context, the selection of the pocket plane is one of the most critical factors in the dynamics established between the implants and soft tissues after surgery.1

Cronin and Gerow first introduced subglandular silicone implants in 1962.2 Subglandular placement has the advantage of more uncomplicated dissection.3 However, this plane can result in the visibility of the edge and palpability of the implant, particularly in thin patients.4,5

Subfascial breast augmentation was first performed in the 2000s.6,7 It places the implant above the pectoralis major muscle but below its fascia. The superficial fascia of the pectoralis major muscle, a well-defined structure in the upper thorax, lies over this muscle, is attached to the sternum and clavicle, and is continuous with the fascia of the shoulder, axilla, and thorax inferolaterally.8 The thickness of the pectoral fascia varies from 0.2 to 1.14 mm.9 This structure provides additional support to the implant and, in contrast to the subglandular approach, preserves the Cooper’s ligaments that attach the breast parenchyma to the chest wall.4 In the subfascial method, the upper displacement of the implant is avoided because the fascia and pectoral muscle force the implant to remain in its original position. This results in the projection of the upper pole of the implant, which provides a more natural look and, besides, avoids direct contact with the glandular or subcutaneous tissue.10

The subfascial approach is especially attractive for plastic surgeons who have been searching for alternative implant pockets.7 The pectoral fascia is a single layer that can be easily recognized and is sufficiently strong, which is evident during surgical manipulation.9,11,12 According to some authors, when the subglandular dissection is performed, the fibers connecting the deep layer of the superficial fascia and the superficial layer of the deep pectoral fascia are divided.9,12,13 In contrast, when the subfascial dissection is conducted, these fiber attachments are preserved and thus maintain better implant positioning.2,10,12–14 In addition, the superficial fascia of the pectoralis major muscle favors the creation of a support structure for the upper pole of the implant and avoid its upper displacement, resulting in a more natural upper pole.15,16 When comparing to other methods, subfascial provides extra soft-tissue coverage and avoids the limitations of the submuscular position without breast animation when the pectoral muscle is contracted.1,2,7,9–16 An option to improve the result in the subfascial approach is dissecting the subfascial pocket, detaching the fascia from the pectoralis major muscle and spreading some muscle fibers at the superior and medial pole of the breast. This maneuver gives an even more natural upper pole, without breast animation. [See Video (online), which demonstrates how to dissect the subfascial pocket, detaching the fascial from the pectoralis major muscle and spreading some muscle fibers at the superior and medial pole of the breast.]

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Fig. 1.
Fig. 1.:
(Above) magnetic resonance imaging showing a flipping of one breast implant on the right. (Below) The patient had the left implant in the subfascial plane and the right (which flipped) in the subglandular plane (front view).

Although there is no unanimity concerning which is the best surgical pocket, the decision is usually defined by the surgeon’s preference and experience and based on breast anatomy.17 Despite the reliability of the subglandular pocket, placing the silicone implant next to the glandular tissue may result in an unsatisfactory result regarding the visibility and palpability of the implant. This is particularly noticeable in thin patients with smaller breasts and inadequate soft-tissue coverage, where a sharp transition can be seen in the limits of the implant.13,14 In this context, we present a new prospective study to compare clinical and radiologic characteristics of subfascial and subglandular implants in primary breast augmentation during a 1-year and 5-year follow-up.

PATIENTS AND METHODS

This study consisted of a prospective, randomized, controlled, double-blinded clinical trial. It was carried out by the Plastic Surgery Unit at the Federal University of Paraná, Curitiba, Brazil, after approval by the Research Ethics Board of this institution, under the protocol number 53899.

The project lasted 5 years. The inclusion criteria were as follows: female patients who wished to undergo surgery for breast augmentation; normal weight or overweight (body mass index between 18 and 30 kg/m2); minimum age of 18 years; and anesthesiologist’s authorization for the procedure. The exclusion criteria were as follows: patients who had previously undergone any breast surgery; evidence of any abnormalities in the preoperative image scanning (ultrasound scan or mammography); congenital deformities in the thoracic wall. Patients with postoperative hematomas, infection, or prosthesis extrusion were also excluded.

Twenty patients who wished to undergo aesthetic breast augmentation were selected. Each patient was randomly sorted on the day of surgery, as follows: subglandular, left or right breast and subfascial, left or right breast. The patients were operated on three consecutive weekends to be in the same evolution period at the evaluation moment. They were guided on the proposed treatment and freely signed an informed consent form.

Implants

The implant size varied between 175 and 305 cc (Table 1), chosen according to the breast volume and width of the breast base, and also to the patients’ desire. These parameters were predetermined and decided before the surgery as a group. The implants were donated by Silimed (Curitiba, Brazil); all were round, textured, and with a high profile. In cases of asymmetry, the decision regarding implant size was made before the operation. The two surgeons performed the operations following the proposed plane. Only three patients received different implant sizes, with a small variation between them (30 cc in two patients and 40 cc in one patient) (Table 1).

Table 1. - Comparison of Breast Characteristics and Device Volumes
Plane No. Mean (cc) Mean (cc) Mean (cc) Mean (cc) Mean (cc) p*
Breast volume
 SF 10 220.0 215.0 130.0 310.0 53.1 0.871
 SG 12 223.3 220.0 130.0 300.0 42.3
Implant volume
 SF 20 264.3 260.0 225.0 305.0 29.3 0.722
 SG 20 260.3 275.0 175.0 305.0 40.3
SF, subfascial method; SG, subglandular method.
*t test for independent samples (p < 0.05).

For antisepsis, antibiotic prophylaxis intravenously with cephalosporin was performed in 1 hour before the procedure and continued for 1 week; pocket irrigation was conducted with Adams solution.18 Change and wash of gloves with a sterilized solution were conducted to prevent biofilm.

Procedures were carried out with patients under general anesthesia. At that moment, after the surgical marks, the subfascial or subglandular method was sorted to be performed in the right breast, followed by the selection of the procedure in the left breast. That is, a single patient could have an subglandular implant in one breast, and an subfascial implant in the other breast or could have both implants placed in the same plane (either subglandular or subfascial). The access was accomplished through the inframammary fold. Information on the kind of implant placement and the anatomical plane used was not divulged to patients, guest surgeons, and evaluators during the study to avoid biases.

Patient Evaluation

All patients were examined by five guest surgeons, nonresearch participants, in the first month and 1 and 5 years after surgery to evaluate any potential difference between the breasts. The analyzed criteria were breast shape, contour, consistency, and asymmetry.

The breast shape and contour were assessed to compare subglandular and subfascial planes. Breast consistency was evaluated to observe the degree of capsular contracture, according to Baker’s classification,19,20 to verify whether there was a higher contracture rate for either plane. Finally, breast asymmetries were checked to confirm if the implant insertion through different planes in the same patient was perceptible.

Analysis of Magnetic Resonance Imaging

Imaging analysis was held employing magnetic resonance imaging in the first and fifth years after surgery to observe the capsule aspect, capsule thickness, presence of seroma, and implant positioning. The imaging assessment was conducted at Advanced Diagnostic Imaging Center, Curitiba, Paraná, Brazil. Magnetic resonance imaging examination was performed using a Siemens Magneton Avanto 1.5-T magnetic resonance imaging Scanner (Avanto; Siemens, Munich, Germany), at the prone position, and with a dedicated 16-channel coil. The examination protocol included T2-weighted axial sequences with fat suppression, sagittal short tau inversion recovery with silicone saturation, sagittal short tau inversion recovery with water saturation followed by a dynamic T1-weighted three-dimensional axial, and sagittal sequence with fat saturation.

Subsequently, all examinations were sent to a workstation (Carestream Health, Rochester, N.Y.), where two breast radiologists classified the examinations under the following criteria:

  • Location, described as subfascial or subglandular.
  • Presence of periprosthetic fluid (seroma), rated as absent, minimal, moderate, or high.
  • Number of folds around the implants, rated as absent, between one and three folds, between four and six folds, or over six folds.
  • The thickness of the reactive capsule around the implants, which was measured in millimeters considering the thickest portion of the capsule, observed in the T2-weighted axial sequence (magnified 600 percent).
  • Measurement of the implant base, measured in millimeters, by designing two lines between the patch and the farthest portion of the implant base, observed in the T2-weighted axial image sequence (magnified 600 percent).
  • Measurement of the implant projection, measured in millimeters, in the anteroposterior direction, with the central portion of the implant (between the shell and the areola) observed in the T2-weighted sagittal image sequence.

Statistical Tests

For the description of the quantitative variables, the mean, median, minimum, maximum, and standard deviation values were calculated. The qualitative variables were considered as frequencies and thus, were represented by percentages. The estimation of the proportions of the events of interest through the cluster approach was used to compare the two pocket planes (subfascial and subglandular) with the evaluations made by five professionals. Concerning the quantitative variables to compare the two groups, the t test was used to analyze independent samples. Fisher’s exact test was applied to compare the groups with the dichotomous variables. A difference between the two study groups was considered significant when p < 0.05.

RESULTS

The study included 20 patients, totaling 40 breasts. The mean age of patients was 23.50 years, ranging from 20 to 28 years. The patients were all nonsmokers and had no chronic diseases. Five patients got pregnant after breast augmentation. Preoperative breast and implant mean volumes were not significantly different between patients (Table 1).

Breast Consistency

The degree of contracture was clinically graded according to the Baker’s classification. The clinical evaluation of breast consistency in the 1-year and 5-year postoperative examinations according to the pocket plane (i.e., subglandular or subfascial) are shown in Tables 2 and 3, respectively. There were no significant differences between methods in the evaluation performed 1 year after surgery concerning the number evaluations of normal/slightly contracted capsules (Baker grade I and II) (Table 2). However, after 5 years, 100 percent of the evaluations for the subfascial group were classified as normal/slightly contracted capsules, whereas only 84.20 percent were for the subglandular group (p = 0.029) (Table 3).

Table 2. - Comparison between the Subfascial and Subglandular Methods at the 1-Year Follow-Up
Plane Frequency SE 95% CI p
% Baker grade I and II
 SF 100.00 0.325
 SG 99.10 0.90 97.1–101
% Hits of the insertion plane
 SF 58.30 5.40 47.0–69.6 0.793
 SG 56.10 6.60 42.2–69.9
% Good or excellent breast contour
 SF 91.50 2.00 87.3–95.7 0.850
 SG 90.90 2.40 85.9–96
% Good or excellent breast shape
 SF 94.30 2.70 88.6–100 0.499
 SG 91.80 2.50 86.6–97.0
% Symmetric or almost symmetric
 SF 86.90 3.00 80.7–93.1 0.955
 SG 87.20 3.00 80.8–93.5
SF, subfascial; SG, subglandular.

Table 3. - Comparison between the Subfascial and Subglandular Methods at the 5-Year Follow-Up
Plane Frequency SE 95% CI p
% Baker grade I and II
 SF 100.00 0.029
 SG 84.20 6.90 69.6–98.8
% Hits of the insertion plane
 SF 54.30 6.40 40.4–68.2 0.532
 SG 61.40 9.20 41.4–81.4
% Good or excellent breast contour
 SF 95.70 2.30 90.8–100 0.037
 SG 81.40 6.10 68.3–94.6
% Good or excellent breast shape
 SF 97.10 1.90 92.9–100 0.040
 SG 84.30 5.60 72.2–96.4
% Symmetric or almost symmetric
 SF 95.70 2.30 90.8–100 0.231
 SG 90.00 4.10 81.2–98.8
SF, subfascial; SG, subglandular.

Insertion Plane

Tables 2 and 3 also show the rate of insertion plane of breast implants identified correctly by the evaluators in the 1- and 5-year postoperative examinations, respectively. In the 1-year postoperative examinations, there were 58.30 percent hits for the subfascial group and 56.10 percent for the subglandular group. In the 5-year postoperative examinations, there were 54.30 percent hits for the subfascial group and 61.40 percent for the subglandular group. The results were not significantly different between groups for both evaluations.

Breast Contour

In the 1-year postoperative examinations, 91.50 percent and 90.90 percent of the evaluations were good or excellent for the subfascial and subglandular groups, respectively, with no significant differences (Table 2). In contrast, in the 5-year postoperative examinations, the difference in breast contour became evident between groups: whereas 95.70 percent of the evaluations of the subfascial group were classified as good or excellent, only 81.40 percent were for the subglandular group (p = 0.037) (Table 3).

Breast Shape

Regarding breast shape, 94.30 percent and 91.80 percent of the evaluations for the subfascial and subglandular groups were classified as good or excellent, respectively, in the 1-year postoperative examinations, with no significant difference between groups (Table 2). However, at 5 years after surgery, the difference between groups was significant (p = 0.040), with 97.10 percent of the evaluations classified as good or excellent for the subfascial group, and only 84.30 percent for the subglandular group (Table 3).

Breast Symmetry

In the 1-year postoperative examinations, 86.90 percent and 87.20 percent of the evaluations of the subfascial and subglandular groups, respectively, were classified as symmetric or almost symmetric, a result without statistical significance (Table 2). In the 5-year postoperative examinations, 95.70 percent and 90.00 percent of the evaluations of the subfascial and subglandular groups, respectively, fell into these categories, also without significant difference (Table 3).

Base of Breast Implant

Table 4 shows the descriptive statistics of each variable per procedure regarding the results of the magnetic resonance imaging scans. Unfortunately, some patients could not undergo the magnetic resonance imaging because they were living in distant cities or were pregnant. The base of the breast implant was significantly wider in the subfascial when compared to the subglandular group, both 1 and 5 years after surgery (p < 0.001 and p = 0.008, respectively). In contrast, there were no significant differences between groups, in the two evaluations periods, concerning capsule thickness and implant projection.

Table 4. - Means, Medians, Minimum-Maximum Values, SD, and p Value of the Three Variables Analyzed in the Magnetic Resonance Imaging Scans for the Subfascial and Subglandular Groups 1 and 5 Years Postoperatively
Plane No. Mean (cm) Median (cm) Minimum (cm) Maximum (cm) SD p*
Capsule thickness
 1 yr
  SF 18 1.8 1.8 1.4 2.2 0.2 0.971
  SG 16 1.8 1.8 1.4 2.3 0.2
 5 yr
  SF 20 2.1 2 1.4 3.3 0.5 0.851
  SG 20 2.1 2.1 1.5 2.9 0.3
Base
 1 yr
  SF 18 95.8 95.3 84.0 104.6 6.4 <0.001
  SG 15 85.8 85.0 71.3 101.6 8.0
 5 yr
  SF 20 91.2 92 72.4 102.3 8.9 0.008
  SG 20 81.9 80.1 64.1 100.2 11.8
Projection
 1 yr
  SF 18 51.6 51.2 43.5 62.7 4.8 0.090
  SG 16 54.8 53.1 46.9 64.1 5.9
 5 yr
  SF 20 53 51 45.9 71.1 6.5 0.161
  SG 19 56.3 55.7 45.1 72.0 7.7
SF, subfascial; SG, subglandular.
*t test for independent samples (p < 0.05).

Regarding the comparisons between the implant bases used and the measurements of the base width on magnetic resonance imaging, there was no correlation between them, even when implants with different sizes were used in the same patient (Table 1). Coincidently, capsular contracture occurred in patients with the same size of implants. One patient had a flipping of one breast implant, which was diagnosed by magnetic resonance imaging. She had the left implant in the subfascial plane and the right (which flipped) in the subglandular plane (Fig. 1).

Number of Folds

Differences in the number of folds in the implants between methods and postoperative examinations are shown in Table 5. For each method, it was tested whether the number of folds would be different between follow-up periods. These values were obtained for both subfascial (p = 0.003) and subglandular (p < 0.001) groups. Thus, the tests were compared. Both had values of p = 0.002 (Table 5). The subfascial method always obtained the best results for zero folds and the intervals of one to three folds and four to six folds, regardless of the examination period. There were no differences between the subfascial and subglandular planes for more than 6 folds, at both 1-year and 5-year follow-up.

Table 5. - Comparison of Subfascial and Subglandular Procedures Regarding the Classification of Results of the Number of Folds at 1 and 5-Year Follow-Up*
No. of Folds SF (%) SG (%)
1-yr follow-up
 0 14 (77.8) 9 (56.3)
 1–3 3 (16.7) 5 (31.3)
 4–6 1 (5.6) 2 (12.5)
 > 6 0 (0.0) 0 (0.0)
 Total 18 (100.0) 16 (100.0)
5-yr follow-up
 0 9 (45.0) 6 (30.0)
 1–3 7 (35.0) 8 (40.0)
 4–6 3 (15.0) 5 (25.0)
 >6 1 (5.0) 1 (5.0)
 Total 20 (100.0) 20 (100.0)
SF, subfascial; SG, subglandular.
*p = 0.002.

DISCUSSION

The subfascial breast augmentation method was first described in 20006 and, after that, many surgeons around the world have performed it.5–17 Its advantages are related to an extra tissue coverage, mainly in the upper and medial portions of the breast (in comparison with the subglandular method), and less painful recovery and absence of animation deformity (in comparison with the submuscular method).

In a prospective study comparing postoperative results of transaxillary breast augmentation in the subglandular, subfascial, and submuscular pockets, similar rates of satisfaction among the three methods were found,5 except for three patients, who had mild implant distortion during contracture of the pectoralis major muscle in the submuscular group. Another retrospective, nonrandomized, comparative study between subfascial and subglandular methods resulted in no statistical differences after a follow-up of 51 months, considering complication rates and patient’s satisfaction.4

In this randomized, double-blinded, prospective study, we performed breast surgery using subfascial and subglandular methods and compared them in 1- and 5-year postoperative examinations (Figs. 2 through 5). Considering breast consistency, no differences were observed between the groups according to the Baker classification at 1-year postoperatively; however, a significant difference was evidenced after 5 years, as the subglandular group showed only 84.20 percent of breasts classified into Baker grades I and II and the subfascial group had 100 percent (Table 3). This finding indicates that the capsular contracture was more frequent in the subglandular method in comparison to subfascial, evidencing the superiority of the subfascial method. Because many believe that capsular contracture is related to low-grade bacterial contamination from the native breast tissue (e.g., thus advocating for inframammary fold incisions, antibiotic irrigation, no-touch technique), we believe that subfascial placement, which separates the implant from the native breast tissue, could lead to less bacterial contamination and thus lower contracture rates.

Fig. 2.
Fig. 2.:
(Above, left) Case of a bilateral subfascial breast implant in the five-year postoperative (front view). (Above, right) Right oblique view. (Below, left) Left oblique view. (Below, right) Left profile view.
Fig. 3.
Fig. 3.:
(Above, left) Case of a bilateral subglandular breast implant in the five-year postoperative (front view). (Above, center) Right oblique view. (Above, right) Right profile view. (Below, left) Left oblique view. (Below, right) Left profile view.
Fig. 4.
Fig. 4.:
(Above, left) Case of a subfascial breast implant in the left breast and a subglandular breast implant in the right breast in the 5-year postoperative (front view). (Above, right) Left profile view. (Below, left) Right oblique view. (Below, right) Right profile view.
Fig. 5.
Fig. 5.:
(Above, left) Case of a bilateral subglandular breast implant with contracture in the five-year postoperative. (Above, center) Left oblique view. (Above, right) Left profile view. (Below, left) Right oblique view. (Below, left) Right profile view.

The results of 5-year postoperative considering the aesthetics of the breast contour were statistically different, with good and excellent evaluations in 95.70 percent of the subfascial group and 81.40 percent of the subglandular group (Table 3). Regarding breast shape, the statistical difference was also evident, with good and excellent evaluations in 97.10 percent of the subfascial group and 84.30 percent of the subglandular group (Table 3). These findings can be explained by the presence of the extra coverage by the superficial fascia in the subfascial method and also by the higher capsular contracture rate of the subglandular method, which influences the breast contour and shape. However, the score frequencies of hits/errors were not significantly different between the subfascial and subglandular groups in terms of clinical examination (visual assessment/breast palpation) when considering clinical differences regarding the type of pocket, although some evaluators detected a difference between the groups (Table 4).

To avoid biases, two breast radiologists were selected for radiologic evaluation using magnetic resonance imaging. The characteristics of the implant pocket and the identification of the fascia as an anatomical structure were analyzed in the magnetic resonance imaging scans, with the correct anatomical plane identified in 90 percent of the examinations in the subfascial group and 100 percent in the subglandular group at the 1-year follow-up (p < 0.001). At the 5-year, follow-up, the values of correct identification were 90 percent for the subfascial group and 94.7 percent for the subglandular group. However, a significant difference was evidenced after 5 years, as the subglandular group showed only 84.20 percent of breasts classified into Baker grade I and II and the subfascial group had 100 percent (Table 3). It means that in the subglandular group, 15.80 percent presented Baker grade III and IV and in subfascial group no patient presents Baker grade III and IV. This finding indicates that the capsular contracture was more frequent in the subglandular method in comparison to the subfascial method, evidencing the superiority of the subfascial method. For this purpose, the identification of the subfascial pocket was possible because of the clarity of the contour of the fascia in the upper breast pole.

Presence of capsule thickness, number of implant folds, base, and projection of the breast implant were defined as the analyzed characteristics. The implant base was significantly smaller in the subglandular pocket at the 5-year follow-up, but there were no significant differences in the projection of the breast implant in this same period, indicating that the pocket volume was smaller and capsular contracture was higher in the subglandular group than in the subfascial group (Table 3). It is worth mentioning that the base was already statistically smaller at the 1-year follow-up (Table 2). These findings represent the evolution of the capsular contracture process in the subglandular group, related to the aspect of a smaller breast base, although with no difference in the breast projection.

Comparison of the number of folds in the implants revealed significant differences between groups (p = 0.002), with more folds in the subglandular group, evidencing the presence of capsular contracture at long-term follow-up, as we performed in this study. At the 5-year follow-up, we indicated reoperation for one patient who had flipped implant and capsular contracture; when the new surgery takes place, the capsules will be removed.

A recently published study showed no significant differences between the subglandular and subfascial methods when performing a 1-year follow-up of the same 20 patients of our study, and suggested that the breast augmentation method could be selected according to the surgeon’s experience.17 The present study showed the importance of performing extended follow-up, because we found statistical differences regarding breast shape and contour, capsular contracture, implant base, and the number of folds between methods only after the 5-year follow-up. Although the 20 patients included in this study could be considered a small sample, we believe that the 40 breasts studied were an adequate number to support our findings. Moreover, regarding the possibility of the introducing a bias in this study because two surgeons performed the operations, it is important to highlight that they used the same methods to prevent biofilm and infection and all procedures of Adam’s list18; thus, we believe we were able to avoid such bias.

CONCLUSIONS

This prospective study sheds new light on the differences of two popular methods of breast implant, the subglandular and subfascial approaches. It shows the statistical differences regarding breast shape and contour, capsular contracture, implant base, and the number of folds between methods, thus providing a basis to support that the subfascial approach is superior to the subglandular approach. These significant differences were mostly found only in the 5-year postoperative examinations, showing the need to perform studies in extended follow-up to reach reliable results.

PATIENT CONSENT

Patients provided written consent for the use of their images.

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