Background: In this study, we describe our clinical experience with the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer (BellaGel<sup>®</sup> SmoothFine;...Background: In this study, we describe our clinical experience with the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer (BellaGel<sup>®</sup> SmoothFine;HansBiomed Co. Ltd., Seoul, Korea) in Asian women. Methods: We analyzed 223 women (mean age = 35.28 ± 9.45 years and mean follow-up period = 12.03 ± 2.48 months), comprising 118 bilateral cases and 109 unilateral ones, who received breast augmentation using the BellaGel<sup>®</sup> SmoothFine at our hospital between June 4, 2018 and February 28, 2019. For safety assessment, we analyzed frequencies of postoperative complications and overall survival of the BellaGel<sup>®</sup> SmoothFine. Results: Postoperatively, complications (12 cases, 5.38%) include asymmetry (3 cases, 1.35%), hematoma (2 cases, 0.90%), hypertrophic scars (2 cases, 0.90%), wound disruption (2 cases, 0.90%), rippling (1 case, 0.45%), capsular contracture (1 case, 0.45%), stretch deformities with skin excess (1 case, 0.45%). In addition, time-to-events were calculated as 10.94 ± 0.64 months (95% CI 9.69 - 12.19) and the survival rate reached 0.290 ± 0.168 (95% CI 0.094 - 0.901) at 12 months postoperatively. Conclusions: Here, we describe our clinical experience with the BellaGel<sup>®</sup> SmoothFine. Our results are of significance in that this is the first report about the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer for Asian women.展开更多
文摘Background: In this study, we describe our clinical experience with the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer (BellaGel<sup>®</sup> SmoothFine;HansBiomed Co. Ltd., Seoul, Korea) in Asian women. Methods: We analyzed 223 women (mean age = 35.28 ± 9.45 years and mean follow-up period = 12.03 ± 2.48 months), comprising 118 bilateral cases and 109 unilateral ones, who received breast augmentation using the BellaGel<sup>®</sup> SmoothFine at our hospital between June 4, 2018 and February 28, 2019. For safety assessment, we analyzed frequencies of postoperative complications and overall survival of the BellaGel<sup>®</sup> SmoothFine. Results: Postoperatively, complications (12 cases, 5.38%) include asymmetry (3 cases, 1.35%), hematoma (2 cases, 0.90%), hypertrophic scars (2 cases, 0.90%), wound disruption (2 cases, 0.90%), rippling (1 case, 0.45%), capsular contracture (1 case, 0.45%), stretch deformities with skin excess (1 case, 0.45%). In addition, time-to-events were calculated as 10.94 ± 0.64 months (95% CI 9.69 - 12.19) and the survival rate reached 0.290 ± 0.168 (95% CI 0.094 - 0.901) at 12 months postoperatively. Conclusions: Here, we describe our clinical experience with the BellaGel<sup>®</sup> SmoothFine. Our results are of significance in that this is the first report about the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer for Asian women.
