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回顾性多中心队列分析 621 例 BellaGel 硅凝胶乳房植入物,研究其理化性能和表面形貌。

Retrospective multicenter cohort analysis of 621 cases of BellaGel silicone breast implants with study of physicochemical properties and surface topography.

机构信息

Department of Plastic and Reconstructive Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Republic of Korea.

Department of Plastic and Reconstructive Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Republic of Korea.

出版信息

J Plast Reconstr Aesthet Surg. 2021 Mar;74(3):486-494. doi: 10.1016/j.bjps.2020.08.134. Epub 2020 Sep 20.


DOI:10.1016/j.bjps.2020.08.134
PMID:33093011
Abstract

This study aimed to assess the effectiveness and safety of BellaGel implants after implantation in Asian women and inform surgeons of another option for use in breast augmentation and reconstruction. This study was conducted in eight hospitals from November 27, 2015 to April 30, 2018. All patients underwent augmentation mammoplasty or implant-based breast reconstruction with BellaGel implants. Complication rates were compared between groups, and the cumulative hazard function was compared using the Kaplan-Meier survival analysis. Implants were grouped by surface type, and the cumulative hazard functions of total complication cases were compared. The biomechanical properties of the BellaGel implant and other company representative implants were tested using a mechanical testing machine, and surface topography was analyzed using a 3D laser scanning confocal microscope. There was a significant difference in the incidence of complications between the reconstruction (17.1%) and augmentation (4.7%) groups, but no significant difference in the complication rates of each group. There was no difference in the reoperation or revision rates between the groups. The log rank test showed a statistically significant difference in cumulative hazard function between the groups. Among the three types of implants (smooth, textured, and microtextured), the microtextured type had the lowest complication rate. The BellaGel microtexture implant had the highest maximal tensile load and displacement value. The BellaGel and Silksurface implants had the highest stored energy, although there was no significant difference. BellaGel implants can serve as a criterion for the selection of safe and effective implants among currently available implants.

摘要

本研究旨在评估 BellaGel 植入物在亚洲女性中的有效性和安全性,并为外科医生提供另一种用于隆胸和重建的选择。这项研究于 2015 年 11 月 27 日至 2018 年 4 月 30 日在八家医院进行。所有患者均接受了 BellaGel 植入物的隆胸或基于植入物的乳房重建。比较了两组之间的并发症发生率,并使用 Kaplan-Meier 生存分析比较了累积危险函数。根据表面类型对植入物进行分组,并比较总并发症病例的累积危险函数。使用机械试验机测试了 BellaGel 植入物和其他公司代表性植入物的生物力学性能,并使用 3D 激光扫描共聚焦显微镜分析了表面形貌。重建组(17.1%)和隆胸组(4.7%)的并发症发生率存在显著差异,但每组的并发症发生率无显著差异。两组之间的再次手术或修订率没有差异。对数秩检验显示组间累积危险函数存在统计学差异。在三种类型的植入物(光滑、纹理和微纹理)中,微纹理类型的并发症发生率最低。BellaGel 微纹理植入物具有最高的最大拉伸载荷和位移值。BellaGel 和 Silksurface 植入物具有最高的储能,尽管没有显著差异。BellaGel 植入物可作为目前可用植入物中选择安全有效植入物的标准。

相似文献

[1]
Retrospective multicenter cohort analysis of 621 cases of BellaGel silicone breast implants with study of physicochemical properties and surface topography.

J Plast Reconstr Aesthet Surg. 2021-3

[2]
A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea.

Medicina (Kaunas). 2021-12-16

[3]
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[4]
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[5]
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J Plast Surg Hand Surg. 2021-12

[6]
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J Plast Surg Hand Surg. 2019-8

[7]
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[8]
Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

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[9]
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

[10]
Silicone Implants with Smooth Surfaces Induce Thinner but Denser Fibrotic Capsules Compared to Those with Textured Surfaces in a Rodent Model.

PLoS One. 2015-7-7

引用本文的文献

[1]
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

[2]
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

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