Capsular Contracture Rate in Augmentation Mammoplasty With Motiva Breast Implant Insertion: A Single-Center Experience in Korea.

BACKGROUND: Capsular contracture is the most common complication following breast implant surgery, and the implant shell characteristics are important in preventing this complication. OBJECTIVES: The aim of this study was to evaluate the capsular contracture rate for SmoothSilk Motiva implants (Establishment Labs Holdings Inc., New York, NY) in females who underwent primary and revisional breast augmentation over a 3-year period. METHODS: A total of 1324 cases that took place from 2017 to 2020 were retrospectively analyzed, with 1027 being primary surgeries and 297 being revisional surgeries. RESULTS: In the 1324 cases of augmentation mammoplasty with SmoothSilk Motiva implants, the overall capsular contracture rate was 1.8% (n = 24). The capsular contracture rate in the 1027 primary surgery cases was 1.07% (n = 11), and the capsular contracture rate in the 297 revisional surgery cases was significantly different at 4.39% (n = 13, P = .0001). More specifically, the capsular contracture rate in 182 revisional surgery for cases without capsular contracture was 1.12% (n = 2), and it showed no statistically significant difference from the rate in primary surgery cases (P = .965). However, the rate in 115 revisional surgery for cases with capsular contracture was 9.57% (n = 11), and it showed a statistically significant difference from the rate in primary surgery cases (P = .000) and the rate in revisional surgery for cases without capsular contracture (P = .001). CONCLUSIONS: Augmentation mammoplasty with SmoothSilk Motiva implants demonstrated a lower rate of capsular contracture than traditional smooth or textured implants. Revisional surgery for cases without capsular contracture showed a similar rate of capsular contracture to primary surgery cases, but the rates were higher in revisional surgery for cases with capsular contracture.

A non-manufacturer-sponsored, retrospective study to assess 2-year safety outcomes of the BellaGel® SmoothFine as compared with its competitors in the context of the first Korean case of a medical device fraud.

BACKGROUND: We conducted this study to assess preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud. METHODS: Our clinical series of the patients (n = 579; 1,158 breasts) received augmentation using the BellaGel® SmoothFine, Naturgel™, Motiva Ergonomix™, Eurosilicone Round Collection™, Natrelle® INSPIRA™, Natrelle® 410, Mentor® MemoryGel Xtra or Microthane®. The patients were evaluated for incidences of postoperative complications and Kaplan-Meier survival and hazards. RESULTS: Overall, there were a total of 101 cases (17.4%) of postoperative complications; these include 31 cases (5.4%) of shape deformity, 21 cases (3.6%) of CC, 18 cases (3.1%) of early seroma, 8 cases (1.4%) of infection, 5 cases (0.9%) of early hematoma, 1 case (0.2%) of delayed hematoma, 1 case (0.2%) of rupture and 1 case (0.2%) of ripping. Moreover, there were also 15 cases (2.6%) of other complications. There were significant differences in incidences of postoperative complications between the breast implants from different manufacturers (P = 0.034). The Natrelle® 410 showed the longest survival (333.3±268.2 [141.5-525.1] days). A subgroup analysis showed that there were no significant differences in incidences of postoperative complications between the breast implants (P = 0.831). Moreover, the Natrelle® INSPIRA™ showed the longest survival (223.7±107.1 [-42.3-489.6] days). CONCLUSIONS: Here, we describe preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud.

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.

LigaSure for the Creation of Bloodless Breast Pockets in Patients Undergoing Transaxillary Breast Augmentation.

The energy-based LigaSure device is widely utilized to facilitate dissection and hemostasis during various open and endoscopic procedures. Previous studies have demonstrated that this device can reduce intraoperative blood loss in various surgical settings. The present study aimed to report our experience with LigaSure and the advantages of using this device during transaxillary submuscular pocket dissection over those of a monopolar electrocautery dissector in patients undergoing breast augmentation. METHODS: A total of 156 patients who underwent transaxillary breast augmentation between November 2019 and May 2020 were retrospectively reviewed. Submuscular pocket dissection using LigaSure was performed in 92 patients and a conventional technique using a monopolar electrocautery dissector was performed in the remaining 64 patients. A bloodless breast pocket was defined as a clear operating field with little or no blood staining at any stage of the procedure. All endoscopic procedures were recorded to determine whether bloodless pockets had been established. The amount of postoperative drainage at 1 day after surgery was also assessed to compare between the LigaSure and conventional groups. RESULTS: Bloodless breast pockets were successfully established in 83 patients (90.2%) in the LigaSure group and in 38 patients (59.4%) in the conventional group (P < 0.001). Postoperative drainage amount at 1 day following surgery was significantly lower in the LigaSure group than in the conventional group (P < 0.001). CONCLUSION: Our findings indicate that the LigaSure system is a safe and effective alternative in breast augmentation requiring transaxillary submuscular dissection.

Diagnostic Utility of ABBI(R) (Advanced Breast Biopsy Instrumentation) for Nonpalpable Breast Lesions in Korea.

Introduction of mammography along with particular attention for the diagnosis and treatment of nonpalpable breast lesions has led to the development of nonresectional biopsies such as mammography-guided core needle biopsy, ultrasound-guided fine needle aspiration cytology, and localization and excisional biopsy. The Advanced Breast Biopsy Instrumentation (ABBI(R)) system, a recently developed device, has made it possible to remove a lesion completely under local anesthesia, thus providing a more reliable and rapid evaluation on an outpatient basis. We studied 159 patients with nonpalpable breast lesions from December 1996 to August 1998. Fifty-nine patients received core needle biopsies and 100 patients received excision with the ABBI system. The ABBI system patients had postexcisional mammography and specimen radiographs to confirm complete excision of the lesions. Pathologists examined permanent section specimens. In cases of malignancy, total mastectomy or reexcision was performed to secure a tumor-free margin. We collected malignant lesions in 23 of 159 patients, of whom 17 had ductal carcinoma in situ (DCIS). Postoperative histopathologic reports showed DCIS in 11 and infiltrating ductal carcinoma (IDC) in 2 among the 13 malignancies proven by stereotactic core biopsy. Among 10 malignancies proven by the ABBI system, there were 6 DCIS, 1 lobular carcinoma in situ (LCIS), and 3 IDC. In seven patients in whom mammography suggested malignancy but core biopsy showed benign lesion, localization and excisional biopsy confirmed DCIS in four of seven patients. The ABBI system is a more reliable and rapid method of evaluating breast lesions compared with stereotactic core biopsy. It is usually done under local anesthesia, minimizing the deformity of the breast. Therefore the ABBI system can be used as a preferred technique over conventional localization and excisional biopsy.