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贝拉凝胶乳房植入物：一项前瞻性队列研究的6年结果。

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

作者信息

Oh Joon Seok, Jeong Jae Hoon, Myung Yujin, Oh Jeongseok, Kang Shin Hyeok, Park Eonju, Kim Ara, Bang Sa Ik, Heo Chan Yeong

机构信息

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

Department of Plastic and Reconstructive Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Arch Plast Surg. 2020 May;47(3):235-241. doi: 10.5999/aps.2019.01858. Epub 2020 May 15.

DOI:10.5999/aps.2019.01858
PMID:32453932
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7264914/
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.

摘要

背景：这是在亚洲女性中使用一家亚洲公司生产的乳房植入物进行的首例临床研究。关于贝拉吉尔（BellaGel）乳房植入物安全性和有效性的四年数据已经公布，我们现在报告六年数据。 方法：本研究计划进行10年。它纳入了103例使用贝拉吉尔乳房植入物进行乳房重建或隆乳的患者。测量并分析植入物破裂和包膜挛缩的发生率，以评估乳房植入物的有效性。 结果：在患者术后6年的随访中，植入物破裂率和包膜挛缩率分别为1.15%和2.30%。重建病例中的植入物破裂率为3.77%，隆乳病例中为0%。重建病例中的包膜挛缩率为5.66%，隆乳病例中为0.83%。 结论：这项计划为期10年的研究的六年数据表明，贝拉吉尔粘性硅胶填充乳房植入物是一种可用于乳房重建和隆乳的有效且安全的医疗器械。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/16a7f4b6e196/aps-2019-01858f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/070b8f6bf425/aps-2019-01858f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/7c2494f88be2/aps-2019-01858f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/16a7f4b6e196/aps-2019-01858f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/070b8f6bf425/aps-2019-01858f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/7c2494f88be2/aps-2019-01858f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e3/7264914/16a7f4b6e196/aps-2019-01858f3.jpg

相似文献

[1]
BellaGel breast implant: 6-Year results of a prospective cohort study.

Arch Plast Surg. 2020-5

[2]
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J Plast Surg Hand Surg. 2019-8

[3]
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

[4]
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

[5]
Short-term Safety of a Silicone Gel-filled Breast Implant: A Manufacturer-sponsored, Retrospective Study.

Plast Reconstr Surg Glob Open. 2020-5-14

[6]
Management of Capsular Contracture in Cases of Silicone Gel Breast Implant Rupture with Use of Pulse Lavage and Open Capsulotomy.

Aesthetic Plast Surg. 2019-7-31

[7]
A 10-Year Prospective Study of Implant-Based Breast Augmentation and Reconstruction.

Eplasty. 2018-2-8

[8]
Clinical experience with a fourth-generation textured silicone gel breast implant: a review of 1012 Mentor MemoryGel breast implants.

Aesthet Surg J. 2008

[9]
Capsular contracture rate in a low-risk population after primary augmentation mammaplasty.

Aesthet Surg J. 2013-5

[10]
Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel.

Aesthet Surg J. 2015-5

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]
Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

Aesthetic Plast Surg. 2023-6

[3]
Analysis of the Molecular Signature of Breast Implant-Associated Anaplastic Large Cell Lymphoma in an Asian Patient.

Aesthet Surg J. 2021-4-12

本文引用的文献

[1]
BellaGel breast implant: 4-year results of a prospective cohort study.

J Plast Surg Hand Surg. 2019-8

[2]
Acellular Dermal Matrix-Assisted Direct-to-Implant Breast Reconstruction and Capsular Contracture: A 13-Year Experience.

Plast Reconstr Surg. 2016-8

[3]
Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel.

Plast Reconstr Surg. 2012-11

[4]
Style 410 highly cohesive silicone breast implant core study results at 3 years.

Plast Reconstr Surg. 2007-12

[5]
The Mentor Study on Contour Profile Gel Silicone MemoryGel Breast Implants.

Plast Reconstr Surg. 2007-12

[6]
The Mentor Core Study on Silicone MemoryGel Breast Implants.

Plast Reconstr Surg. 2007-12

[7]
Prospective analysis of the outcome of subpectoral breast augmentation: sensory changes, muscle function, and body image.

Plast Reconstr Surg. 2004-2

[8]
Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electron microscopic study.

Plast Reconstr Surg. 2001-12

[9]
The fate of breast implants: a critical analysis of complications and outcomes.

Plast Reconstr Surg. 1995-12

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