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Short-term Safety of a Silicone Gel-filled Breast Implant: A Manufacturer-sponsored, Retrospective Study.

作者信息

Yoon Seanhyuck, Chang Jae-Hoon

机构信息

V Plastic Surgery Clinic, Daegu, Korea.

BS The Body Plastic Surgery Center, Busan, Korea.

出版信息

Plast Reconstr Surg Glob Open. 2020 May 14;8(5):e2807. doi: 10.1097/GOX.0000000000002807. eCollection 2020 May.


DOI:10.1097/GOX.0000000000002807
PMID:33154866
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7605890/
Abstract

UNLABELLED: Currently, 8 different brands of a silicone gel-filled breast implant are commercially available in Korea. But the superiority of short-term safety has not been established. METHODS: A total of 709 patients (1,418 breasts) received an implant-based augmentation mammaplasty. We compared a 1-year incidence of complications and complication-free survival among the breast implants. Moreover, we performed a subgroup analysis of the patient cohorts by excluding cases associated with a periareolar incision, revision or reoperation, and anatomic implants. RESULTS: In our series, 1-year incidences of complications were 0.55% (1/182), 3.14% (5/159), 5.19% (7/135), and 6.58% (10/152) in patients receiving the BellaGel/BellaGel SmoothFine, the Mentor CPG, the Matrix, and the Motiva Ergonomix, respectively. Moreover, the incidence of capsular contracture was 0.55%, 0.63%, 1.32%, and 3.70% in patients receiving the BellaGel/BellaGel SmoothFine, the Mentor CPG, the Motiva Ergonomix, and the Matrix, respectively. Furthermore, a complication-free survival was 24.82 ± 0.18, 22.23 ± 1.09, 22.15 ± 0.77, and 22.12 ± 1.07 months in patients receiving the BellaGel/BellaGel SmoothFine, the Motiva Ergonomix, the Mentor CPG, and the Matrix, respectively, except for the 2 other remaining products used for a smaller number of patients. However, a subgroup analysis showed no significant differences in a 1-year incidence of complication and complication-free survival among the BellaGel SmoothFine, the Motiva Ergonomix, and the Naturgel. CONCLUSION: It is impossible to draw a definite conclusion about the superiority of the short-term safety among the silicone gel-filled breast implants that are commercially available in Korea.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/3ea3a8518393/gox-8-e2807-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/97a96b60fda7/gox-8-e2807-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/45facad27c2c/gox-8-e2807-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/79f4a705672e/gox-8-e2807-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/8a5684425ce4/gox-8-e2807-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/3ea3a8518393/gox-8-e2807-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/97a96b60fda7/gox-8-e2807-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/45facad27c2c/gox-8-e2807-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/79f4a705672e/gox-8-e2807-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/8a5684425ce4/gox-8-e2807-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc38/7605890/3ea3a8518393/gox-8-e2807-g005.jpg

相似文献

[1]
Short-term Safety of a Silicone Gel-filled Breast Implant: A Manufacturer-sponsored, Retrospective Study.

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[2]
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[3]
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[5]
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[6]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Advances in Etiology and Prevention of Capsular Contracture After Breast Implantation.

Aesthetic Plast Surg. 2025-4

[2]
Feasibility of Imaging Modalities Combined with a Silicone Gel-Filled Breast Implant in Korean Women.

Gels. 2023-3-16

[3]
Complication Rates after Breast Surgery with the Motiva Smooth Silk Surface Silicone Gel Implants-A Systematic Review and Meta-Analysis.

J Clin Med. 2023-2-27

[4]
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.

PLoS One. 2023

[5]
Asiaticoside Combined With Carbon Ion Implantation to Improve the Biocompatibility of Silicone Rubber and to Reduce the Risk of Capsule Contracture.

Front Bioeng Biotechnol. 2022-5-12

[6]
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.

Aesthet Surg J Open Forum. 2021-11-9

[7]
Four-Year Interim Results of the Safety of Augmentation Mammaplasty Using the Motiva Ergonomix™ Round SilkSurface: A Multicenter, Retrospective Study.

Aesthetic Plast Surg. 2021-6

本文引用的文献

[1]
Short-term Safety of Augmentation Mammaplasty Using the BellaGel Implants in Korean Women.

Plast Reconstr Surg Glob Open. 2019-12-24

[2]
The "Game of Implants": A Perspective on the Crisis-Prone History of Breast Implants.

Aesthet Surg J. 2019-1-31

[3]
Effect of Keller Funnel on the Rate of Capsular Contracture in Periareolar Breast Augmentation.

Plast Reconstr Surg Glob Open. 2018-6-18

[4]
Long-Term Safety of Textured and Smooth Breast Implants.

Aesthet Surg J. 2017-12-13

[5]
Functional biocompatibility testing of silicone breast implants and a novel classification system based on surface roughness.

J Mech Behav Biomed Mater. 2017-6-27

[6]
Intraoperative Comparison of Anatomical versus Round Implants in Breast Augmentation: A Randomized Controlled Trial.

Plast Reconstr Surg. 2017-3

[7]
Prospective Analysis of Primary Breast Augmentation on Body Image Using the BREAST-Q: Results from a Nationwide Study.

Plast Reconstr Surg. 2016-6

[8]
Different types of implants for reconstructive breast surgery.

Cochrane Database Syst Rev. 2016-5-16

[9]
Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

Aesthet Surg J. 2016-4

[10]
Characterization of Breast Implant Surfaces, Shapes, and Biomechanics: A Comparison of High Cohesive Anatomically Shaped Textured Silicone, Breast Implants from Three Different Manufacturers.

Aesthetic Plast Surg. 2016-2

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