Exploration of Point-of-Care Ultrasonography for Silicone Breast Implant Rupture Detection and Classification.

Background and Objectives: The surge in breast-related surgeries in Korea underscores the critical need for an accurate early diagnosis of silicone breast implant-related issues. Complications such as BIA-ALCL and BIA-SCC add complexity to breast health concerns, necessitating vigilant monitoring. Despite advancements, discrepancies persist between ultrasonographic and pathologic classifications of silicone implant ruptures, highlighting a need for enhanced diagnostic tools. This study explores the reliability of ultrasonography in diagnosing silicone breast implant ruptures and determining the extent of silicone migration, specifically with a focus on guiding potential capsulectomy based on pathology. Materials and Methods: A comprehensive review of medical records encompassing 5557 breast implants across 2790 patients who underwent ultrasound-assisted examinations was conducted. Among the screened implants, 8.9% (249 cases) were diagnosed with silicone breast implant rupture through ultrasonography. Subsequently, 89 women underwent revisional surgery, involving capsulectomy. The pathological analysis of 111 periprosthetic capsules from these cases aimed to assess the extent of silicone migration, and the findings were juxtaposed with the existing ultrasonographic rupture classification. Results: The diagnostic agreement between preoperative sonography and postoperative findings reached 100% for silicone breast implant ruptures. All eighty prosthetic capsules exhibiting a snowstorm sign in ultrasonography demonstrated silicone migration to capsules upon pathologic findings. Conclusions: High-resolution ultrasonography emerged as a valuable and reliable imaging modality for diagnosing silicone breast implant ruptures, with a notable ability to ascertain the extent of free silicone migration to capsules. This diagnostic precision is pivotal in informing decisions about potential capsulectomy during revisional surgery. The study advocates for an update to the current binary ultrasonographic classification, suggesting a more nuanced categorization into three types (subcapsular, intracapsular, and extracapsular) based on pathology.

Use of High-Resolution Ultrasound in Characterizing a Breast Implant and Detecting a Rupture of the Device.

SUMMARY: With the emergence of state-of-the art implant technology and advanced surgical techniques, plastic surgeons face challenging problems, such as identification of a specific type of a device and diagnosis of postoperative complications, in managing patients undergoing implant-based augmentation mammaplasty. In this article, the authors introduce a novel method for characterizing a breast implant based on diverse factors (eg, filler properties, type of pocket, surface topography, shape type, and manufacturer of the device) and detecting the presence and scope of rupture using high-resolution ultrasound.

A Surgeon's Empirical Perspectives on Use of High-resolution Ultrasound in Preoperatively Detecting a Rupture in the Context of Breast Implant Crisis in Korea.

BACKGROUND: We previously proposed a novel method for detecting a rupture of a breast implant using high-resolution ultrasound (HRUS). We therefore conducted this retrospective, observational study to describe its feasibility in making a preoperative diagnosis of rupture of the device in patients receiving an implant-based augmentation mammaplasty. METHODS: We initially evaluated the medical records of the patients who had received primary or secondary augmentation mammaplasty using a breast implant at other hospitals for aesthetic or reconstructive purposes between August 31, 2017, and August 31, 2020. The patients underwent breast US using the Aplio i600 (Canon Medical System, Otawara, Tochigi, Japan) system with a 7-18 MHz linear transducer. Through a retrospective review of the patients' medical records, we analyzed their baseline and clinical characteristics. Then, we compared an agreement between preoperative diagnosis of rupture on HRUS and findings at reoperation. RESULTS: A total of 29 patients with rupture (55 breasts) were evaluated for the performance of ultrasound in making a diagnosis of rupture. This showed that they were unaware of rupture but they were diagnosed with it on ultrasound. Preoperatively, there were no cases of rupture in 110 left breasts (80.9%) and 107 right breasts (78.7%), which exactly matched to the number of breasts without rupture on HRUS. Moreover, preoperatively, there were 26 (19.1%) and 29 cases (21.3%) of rupture in the left and right breast, respectively, which exactly matched to the number of breasts with rupture on HRUS. CONCLUSIONS: In conclusion, patients who are suspected of having rupture of a breast implant should be stringently evaluated for presence of rupture and, if any, its scope using HRUS. Moreover, we propose that surgeons consider using HRUS in making a preoperative diagnosis of rupture of a breast implant. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Role of High Resolution Ultrasonography in Elucidating Features of the Breast Implants in Asymptomatic Patients After Implant-based Augmentation Mammaplasty.

BACKGROUND: We conducted this study to describe the feasibility of high-resolution ultrasound (HRUS) in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty. METHODS: The current study was conducted in a total of 612 patients (n =6 12) receiving an implant-based augmentation mammaplasty at other hospitals between August 31, 2017 and August 31, 2020. Of these, 136 patients (n = 136; 272 breasts) receiving reoperation were included in the current study. We compared between the patients' subjective awareness of a breast implant and its HRUS findings and an agreement between HRUS findings of a breast implant and its findings at reoperation. RESULTS: The proportion of the patients receiving a silicone gel-filled breast implant was increased from 65.44% (89/136) to 81.61% (111/136) on HRUS. Moreover, HRUS was effective in identifying a manufacturer of the device. CONCLUSIONS: In conclusion, our results indicate that HRUS is feasible in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty. But further prospective, large-scale studies are warranted to corroborate our results. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors. www.springer.com/00266 .

High-Resolution Ultrasound-Assisted Assessment of Preliminary Short-term Safety Outcomes of an Implant-Based Augmentation Mammaplasty Using a Bioengineered, Cell-Friendly, Smooth-Surface Device in Korean Females.

BACKGROUND: The Motiva Ergonomix Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is one of the representative brands of the fifth generation of a silicone gel-filled breast implant with a microtextured surface. OBJECTIVES: In this study, the authors describe preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface in Korean females. METHODS: The authors performed a retrospective analysis of medical records in a total of 69 females (n = 69) receiving an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface between September 26, 2017, and December 31, 2020. The authors analyzed incidences of postoperative complications. RESULTS: A total of 6 cases (8.7%) of postoperative complications occurred; these include 2 cases (2.9%) of early seroma, 1 case (1.4%) of capsular contracture, 2 cases (2.9%) of alterations in the shape, and 1 case (1.4%) of foreign body sensation. Time-to-events were estimated at 266.81 ± 273.17 days. CONCLUSIONS: The authors describe our preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface in Korean females. But this deserves further large-scale studies with long periods of follow-up.

The Value of Capsule Thickness on Breast Ultrasound as an Indicator of the Severity of Capsular Contracture and Its Correlation with the Baker Classification.

BACKGROUND: We conducted this study to explore the value of the capsule thickness as an indicator of the severity of capsular contracture (CC) alternatively to the Baker classification system in patients who were treated with an implant-based augmentation mammaplasty. METHODS: A total of 117 eligible patients (202 breasts) were included in the current study. We measured the capsule thickness using ultrasound and histologic examination in association with the Baker grades I, II, III and IV. Then, we analysed agreement of the capsule thickness between the two methods using an intra-correlation coefficient (ICC 2,1) with 95% confidence intervals (CIs). The CC of Baker grades II, III and IV (105 breasts), for which the capsule thickness could be measured using US, served as Model 1. Moreover, Model 1 including the CC of Baker grades I (97 breasts) served as Model 2. RESULTS: The capsule thickness was measured as 0.58 ± 0.11 (0.4-0.8) mm, 1.07 ± 0.16 (0.8-1.31) mm and 1.89 ± 0.55 (1-4.1) mm on ultrasound in association with Baker grades II, III and IV, respectively. In addition, it was also measured as 0.28 ± 0.07 (0.09-0.41) mm, 0.58 ± 0.08 (0.42-0.75) mm, 1.06 ± 0.14 (0.79-1.34) mm and 2.13 ± 1.14 (1.38-6.98) mm on histologic examination in association with Baker grades I, II, III and IV, respectively. In Model 1 and 2, the ICC was calculated as 0.942 (95%CI 0.914-0.961) and 0.955 (95%CI 0.940-0.966), respectively. The cut-off values between the Baker grades I-II, II-III and III-IV were calculated as 0. mm, 0.8 mm and 1.2 mm, respectively. CONCLUSIONS: In conclusion, the capsule thickness might be used as an indicator of the severity of CC alternatively to the Baker classification system. But further studies are warranted to establish our results. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Short-term treatment outcomes and safety of two representative brands of the fifth-generation silicone gel-filled breast implants in Korea.

It is allegedly reported that the BellaGel® SmoothFine (HansBiomed Co. Ltd., Seoul, Korea) and Motiva ErgonomixTM (Establishment Labs Holdings Inc., Alajuela, Costa Rica) are representative brands of a microtextured breast implant in Korea. We compared short-term safety outcomes between them. We evaluated the patients who received breast augmentation using the BellaGel® SmoothFine (n = 264) or the Motiva Ergonomix™ (n = 76) for aesthetic purposes and those with available medical records. They were followed up during a mean period of 122.11 ± 95.37 (4-477) and 126.80 ± 116.29 (13-534) days in the corresponding order. Early seroma occurred at an incidence of 1.89 and 5.26% following breast augmentation using the BellaGel® SmoothFine and the Motiva ErgonomixTM, respectively. This difference reached statistical significance (p < 0.05). Of note, CC occurred at an incidence of 2.27 and 0.00% in the corresponding order. Cumulative incidences of postoperative complications depending on the type of breast implants showed no significant difference; statistical significance was analyzed using the log-rank test (χ2 = 1.71, df = 1, p = 0.19). Cumulative survival of the breast implant is shown in Table 3; the Motiva Ergonomix™ showed a longer survival as compared with the BellaGel® SmoothFine (130.13 ± 13.70 vs. 120.45 ± 5.76 days). In conclusion, we describe short-term treatment outcomes and safety of an implant-based breast augmentation using two representative brands of the fifth-generation silicone gel-filled breast implants in Korean women.

Short-term Safety of Augmentation Mammaplasty Using the BellaGel Implants in Korean Women.

Asian women are stereotypically characterized by a slim body, smaller breasts and areolae, and larger nipples when compared with White women. They would therefore be vulnerable to displacement of a breast implant if they receive larger implants. They are also prone to hypertrophic and prolonged hyperemic scars. Surgeons should therefore be aware of Asian women's breast anatomy, healing tendency, and preferences. We conducted this multicenter, retrospective study to assess the short-term safety of the BellaGel implants in Korean women. METHODS: We evaluated a total of 637 women (n = 637; 1,274 breasts) for incidences of postoperative complications and the cumulative Kaplan-Meier complication-free survival. RESULTS: Overall, there were 12 cases (1.9%) of postoperative complications; these include 6 cases (0.9%) of hematoma, 2 cases (0.3%) of infection, and 4 cases (0.6%) of seroma. Moreover, there was no significant difference in the cumulative complication-free survival at 120 weeks between the 4 types of the BellaGel implants (χ2 = 2.289, P = 0.513). CONCLUSION: In conclusion, we describe the short-term safety of augmentation mammaplasty using the BellaGel implants in Korean women. But further prospective, large-scale, multicenter studies with a long period of follow-up are warranted to establish our results.