Med Lasers 2023; 12(4): 251-255  https://doi.org/10.25289/ML.23.037
Patient-reported outcomes of therapeutic ultrasound on capsular contracture after implant-based breast reconstruction: a preliminary study
Han Gyu Cha, Young Hun Kang, Seo Koo Lee, Eun Soo Park
Department of Plastic and Reconstructive Surgery, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea
Correspondence to: Eun Soo Park
E-mail: peunsoo@schmc.ac.kr
ORCID: https://orcid.org/0000-0003-2966-9122
Received: November 10, 2023; Accepted: December 7, 2023; Published online: December 12, 2023.
© Korean Society for Laser Medicine and Surgery. All rights reserved.

This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Capsular contracture after implant-based breast reconstruction (IBR) decreases a patient’s quality of life by causing pain, discomfort, and distortion of the breast. Surgical treatment is the mainstay of capsular contracture management despite the high recurrence rate. This paper reports the preliminary results of therapeutic ultrasound as an alternative treatment option.
Methods: Ten patients who underwent an immediate unilateral IBR after a skin- or nipple-sparing mastectomy that resulted in capsular contracture were included in this study. All patients underwent ultrasonic treatment twice a week for 40 minutes every session. The patient-reported outcome was measured using the modified Breast-QTM reconstruction module before and after the 8-week session.
Results: Among the five categories in the questionnaire, the average score of tightness/pulling and aching/throbbing feelings improved significantly after the ultrasound treatment without complications.
Conclusion: Therapeutic ultrasound was an effective non-surgical treatment in capsular contracture after IBR. Although it is less effective in the esthetical aspects, it helps improve the patient’s quality of life by reducing the subjective symptoms.
Keywords: Implant capsular contracture; Ultrasonics; Breast reconstruction
INTRODUCTION

Breast cancer has become the most common malignancy in women worldwide and thus, breast reconstruction after mastectomy also has become one of the essential process in treatment protocol [1]. More than 70% of breast reconstruction is done by implant-based technique either in one- or two-stage [2]. Although implant-based breast reconstruction (IBR) has advantages in its simplicity, short operative time, and lack of donor-site morbidity compared with autologous reconstruction, complications related with foreign body reaction are still unsolved.

Capsular contracture is the most common long-term complication in IBR and the rates have been reported to be up to 51% [3]. The exact mechanism has not been fully discovered and the result of prolonged inflammatory reaction is expected to result in fibrosis of contractile muscle and collagen deposition [4].

Capsular contracture not only disfigure the breast shape but also cause pain and stiffness that ultimately need alleviating procedure. Current mainstay of treatment includes capsulectomy, capsulotomy, implant change, and pocket change which are performed under general anesthesia. However, recurrence rate after the combination of such techniques remain as high as 54% [5]. Alternative treatment options include closed capsulotomy, injection of triamcinolone, and medications (leukotriene antagonist) [6-9].

Here, we report our preliminary result of ultrasonic treatment on capsular contracture after IBR and propose as a new non-surgical option.

METHODS
Ethics statement: This study was approved by the Institutional Review Board of Soonchunhyang University Bucheon Hospital (No. SCHBC 2023-11-006). Written informed consent was obtained from the patients.

The study included patients who underwent an immediate unilateral IBR after a skin- or nipple-sparing mastectomy from January 2022 to December 2022 and resulted in capsular contracture. A retrospective chart review was performed to evaluate patient demographics including age, body mass index, Baker’s classification, and surgical details including type of mastectomy and volume of implant (Table 1). Exclusion criteria was patient with history of revisional surgery, history of implant-related infection, and loss of follow-up.

Table 1 . Patient demographics

VariableValue (n = 10)
Age (yr)50.4 ± 6.6
Body mass index (kg/m2)23.8 ± 2.7
Type of mastectomy
Nipple-sparing6
Skin-sparing4
Volume of implant (cc)336 ± 105
Baker classification
I0
II6
III4
IV0

Values are presented as mean ± standard deviation or number only.



Treatment protocol

All patients underwent ultrasonic treatment (CAPSULITISTM, SU-Medical) twice a week with in supine position for 40 minutes every session. The device is connected to 6 transducers operating at 1 and 3 MHz, delivered pulsed ultrasound in a 1:1 sequential relay cycle at a power density of 2.0 Wcm2 during the pulse. The patient-reported outcome was measured by modified Breast-QTM reconstruction module before and after 8 week-session (Table 2) [10]. Satisfaction with physical well-being of chest was investigated through the questionnaire and average score of 5 categories including pain in breast, difficulty in lifting arm, difficulty in sleeping, tightness/pulling, and aching/throbbing feeling in breast were calculated before and after the procedure.

Table 2 . A modified questionnaire regarding physical well-being of chest extracted from Breast-QTM reconstruction module version 2.0

None of the timeSome of the timeAll of the time
1. Pain in breast123
2. Difficulty in lifting arm123
3. Difficulty in sleeping123
4. Tightness/pulling in breast123
5. Aching/throbbing in breast123


Statistical analysis

The Wilcoxon signed-rank test was used to compare patient-reported scores before and after the ultrasonic treatment. All statistical analyses were performed using IBM SPSS Statistics 20.0 for Windows (IBM Corp.) and A-value of p < 0.05 was considered statistically significant.

RESULTS

A total of 10 patients were included in the study. There was no change in Baker’s classification after the treatment in all patients. Average score of patient-reported outcomes on pain in breast, difficulty in lifting arm, difficulty in sleeping, tightness/pulling, and aching/throbbing feeling in breast were 1.6, 1.3, 1.1, 1.9, and 1.9 before the procedure and 1.4, 1.2, 1.0, 1.4, and 1.4 after the procedure (Table 3). Tightness/pulling and aching/throbbing feeling in breast were significantly decreased after the treatment (Fig. 1). There were no other complications including burn injury, bruising, fat necrosis, or bleeding during the treatment.

Table 3 . Average of questionnaire score before and after ultrasonic treatment

BeforeAfterp-value
1. Pain in breast1.61.40.16
2. Difficulty in lifting arm1.31.20.32
3. Difficulty in sleeping1.11.00.32
4. Tightness/pulling in breast1.91.40.03
5. Aching/throbbing in breast1.91.40.033


Figure 1. Comparisons of patient-reported scores before and after the ultrasonic treatment. Tightness/pulling and aching/throbbing feeling in breast were significantly improved from 1.9 and 1.9 to 1.4 and 1.4, respectively (*p < 0.05).
DISCUSSION

Capsular contracture is an aesthetical, economical, and psychological burden in breast cancer patient who underwent IBR. The exact pathogenesis of capsular contracture remains unknown, but multiple factors have been proven to generate its formation. Surgically, implant surface texture, anatomic placement, bacterial contamination, and hematoma are causative factors that trigger foreign body response and inflammation around the prosthesis. Eventually, prolonged inflammation results in fibrosis with the participation of fibroblasts, T-cells, macrophages, and myofibroblasts [11]. Clinical presentation of capsular contracture includes pain, stiffness, and harden breast combined with distortion and asymmetry.

Although surgical management including capsulectomy and capsulotomy have been performed to eliminate this distressful long-term complication, no definite treatment has been established. As an alternative, various non-invasive and non-surgical treatment options have been proposed. Closed capsulotomy was attempted in 1970s and 1980s but became scarce due to complications such as contracture recurrence, implant rupture, and capsulotomy failure [6,12]. Intracapsular triamcinolone injection was proposed with its anti-inflammatory effect and but has been failed to demonstrate objective evidence. Recently many studies have been reported regarding leukotriene antagonists zafirlukast and montelukast. These leukotriene antagonists play an important role in inhibiting cysteinyl leukotrienes that are associated with inflammatory process and suppressing myofibroblasts [8]. Although they have shown inhibitory effects on capsular contracture formation, prolonged medication may induce side effects such as headache, nausea, abdominal pain, and rarely liver failure [13].

Application of therapeutic ultrasound in capsular contracture was first described in 1984 [14]. However, since then only few studies have been published including studies by Planas et al. [15,16] have shown 82.6% improvement at a year follow-up based only on Baker’s classification. Compared with their studies, we have focused on the result based not only on morphological change but also the symptoms including pain, tightness, pulling, and motion discomfort that most of patients complain about. In results, the most improved symptoms were tightness/pulling and aching/throbbing feeling in breast. Although there was no change in degree of capsular contracture according to Baker’s classification, the subjective symptoms that directly are related to patients’ quality of life has decreased significantly.

Therapeutic ultrasound is widely used at intensities of 0.2-100 W/cm2 and have been proven to improve bone and soft tissue healing [17,18]. Similar to previous studies, power density of 2 W/cm2 in our study was adequate to improve capsular contracture without over-heating effect and burn injury. In addition, the frequency of 1 to 3 MHz was adopted to provide enough depth field to the capsule below breast skin, artificial dermal matrix, and pectoralis muscle. The anticipant effect of therapeutic ultrasound on capsular contracture is based on a rat model study that has demonstrated the augmentation in the thickness, cellularity, and vascularization of the capsule [19]. Further studies including tissue biopsy will be needed to provide histologic evidence on the effect of therapeutic ultrasound on breast capsular contracture. In addition, since this preliminary study has small sample size and nonparametric test was used for statistical analysis, additional report with larger sample size would be needed to reinforce our data. Lastly, application of therapeutic ultrasound for prophylaxis of breast capsular contracture would be the final aim of our study.

In conclusion, therapeutic ultrasound is an effective non-surgical treatment in capsular contracture after IBR. Although it is less effective in aesthetical aspect, it helps to improve patients’ quality of life by reducing subjective symptoms in contracted breast.

ACKNOWLEDGMENTS

None.

AUTHOR CONTRIBUTIONS

Conceptualization: HGC, ESP. Data curation: YHK. Formal analysis: HGC, ESP. Funding acquisition: ESP. Investigation: SKL, YHK. Methodology: HGC. Project administration: HGC. Validation: HGC. Visualization: YHK. Writing–original draft: HGC. Writing–review & editing: all authors.

CONFLICT OF INTEREST

Eun Soo Park is an editorial board member of the journal, but was not involved in the review process of this manuscript. Otherwise, there is no conflict of interest to declare.

FUNDING

This work was supported by the Soonchunhyang University Research Fund.

DATA AVAILABILITY

Contact the corresponding author for data availability.

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