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BellaGel breast implant: 6-Year results of a prospective cohort study

Archives of Plastic Surgery 2020년 47권 3호 p.235 ~ 241
오준석, 정재훈, 명유진, 오정석, Kang Shin-Hyeok, 박언주, 김아라, 방사익, 허찬영,
소속 상세정보
오준석 ( Oh Joon-Seok ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery
정재훈 ( Jeong Jae-Hoon ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery
명유진 ( Myung Yu-Jin ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery
오정석 ( Oh Jeong-Seok ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery
 ( Kang Shin-Hyeok ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery
박언주 ( Park Eon-Ju ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery
김아라 ( Kim A-Ra ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Plastic and Reconstructive Surgery
방사익 ( Bang Sa-Ik ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Plastic and Reconstructive Surgery
허찬영 ( Heo Chan-Yeong ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Plastic and Reconstructive Surgery

Abstract


Background: This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data.

Methods: This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant.

Results: At patients’ 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases.

Conclusions: The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.

키워드

Breast implant; Mammaplasty; Capsular contracture

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