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囊袋挛缩的风险因素分析:一项使用圆形、光滑和纹理假体进行乳房增大的 10 年 Sientra 研究。

Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation.

机构信息

Louisville and Lexington, KY; Marina Del Ray, CA; Charlotte, NC; Santa Monica, CA; and Santa Barbara, CA.

From the Division of Plastic Surgery, University of Louisville, and Division of Plastic Surgery, University of Kentucky; Division of Plastic Surgery, University of Southern California School of Medicine, University of Southern California; Department of Plastic Surgery, Presbyterian Hospitals; private practice; Clinical Operations and Medical Affairs, Sientra, Inc.; and MB Statistical Consulting.

出版信息

Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):20S-28S. doi: 10.1097/PRS.0000000000004351.


DOI:10.1097/PRS.0000000000004351
PMID:29595715
Abstract

BACKGROUND: Despite the increased understanding of surgical best practices, capsular contracture remains the most commonly reported complication and reason for reoperation following breast implant surgery. This study provides a long-term update to a previous investigation of potential contributing risk factors for capsular contracture in primary augmentation patients. METHODS: The data used for this analysis include 5,122 implants in 2,565 primary augmentation patients implanted by 34 surgeons based on long-term results from Sientra's clinical study. Potential risk factors, including patient and implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models. RESULTS: A total of 333 capsular contracture events in 224 patients were reported. The overall Kaplan-Meier rate for capsular contracture was 10.8% by device through 10 years. Results from the multivariate analysis found 8 factors to be independently associated with capsular contracture (implant placement, implant surface, incision site, hematoma or seroma development, device size, surgical bra, steroid, and antibiotic pocket irrigation; all P values < 0.05). Results from correlation analysis found 2 of the 8 factors to be more strongly associated with early onset capsular contracture events, compared with those occurring after 2 and 5 years of implantation (implant surface and steroid pocket irrigation). CONCLUSION: The results of this large-scale, multivariate analysis identified several significant risk factors for capsular contracture, including device features (smooth surface, smaller size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.

摘要

背景:尽管人们对手术最佳实践的理解有所增加,但包膜挛缩仍然是乳房植入手术后最常见的报告并发症和再次手术的原因。本研究对之前关于原发性隆胸患者包膜挛缩潜在致病因素的调查进行了长期更新。

方法:本分析使用的数据来自 Sientra 临床研究的长期结果,包括 34 名外科医生为 2565 名原发性隆胸患者植入的 5122 个植入物。使用频率和多变量模型分析了潜在的风险因素,包括患者和植入物特征、手术特征、口袋冲洗和术后特征。

结果:报告了 224 名患者中的 333 例包膜挛缩事件。通过设备,10 年内包膜挛缩的总体 Kaplan-Meier 发生率为 10.8%。多变量分析的结果发现 8 个因素与包膜挛缩独立相关(植入物位置、植入物表面、切口部位、血肿或血清肿形成、器械尺寸、手术胸罩、类固醇和抗生素口袋冲洗;所有 P 值均<0.05)。相关性分析的结果发现,与植入 2 年和 5 年后发生的包膜挛缩事件相比,8 个因素中有 2 个与早期包膜挛缩事件的发生更密切相关(植入物表面和类固醇口袋冲洗)。

结论:这项大规模多变量分析的结果确定了几个包膜挛缩的显著风险因素,包括器械特征(光滑表面、较小尺寸)、手术因素(乳晕周围切口、胸肌下放置、抗生素冲洗)、血肿/血清肿的发展以及手术胸罩的使用。

相似文献

[1]
Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation.

Plast Reconstr Surg. 2018-4

[2]
Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation.

Plast Reconstr Surg. 2013-11

[3]
Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

Plast Reconstr Surg. 2018-4

[4]
Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants.

Plast Reconstr Surg. 2017-1

[5]
Eight-Year Safety Data for Round and Anatomical Silicone Gel Breast Implants.

Aesthet Surg J. 2018-2-17

[6]
Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type.

J Plast Reconstr Aesthet Surg. 2013-5-9

[7]
Does Implant Surface Texture Affect the Risk of Capsular Contracture in Subglandular Breast Augmentation and Breast Augmentation-Mastopexy?

Aesthet Surg J. 2020-4-14

[8]
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

[9]
Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the U.S. Postapproval Study.

Plast Reconstr Surg. 2024-7-1

[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]
Breast Cancer Hormone Therapy Modulates Breast Implant Capsular Contracture.

Plast Reconstr Surg Glob Open. 2025-8-5

[2]
Capsular contractures following implant-based breast reconstruction in women undergoing risk-reducing mastectomy: national register-based study.

BJS Open. 2025-7-1

[3]
Implant surface selection in primary cosmetic breast augmentation: A national cross-sectional study of UK plastic surgeons.

JPRAS Open. 2025-6-17

[4]
Ensuring Equal Implantation Conditions on Both Sides During Breast Augmentation: Effective Decontamination of Implantation Funnels.

Aesthetic Plast Surg. 2025-6-2

[5]
A Rebuttal of a Meta-analysis Supporting Breast Implant Pocket Antimicrobial Irrigation.

Ann Plast Surg. 2025-7-1

[6]
A Comparison Between Two-Dimensional and Three-Dimensional Endoscopic Imaging for Breast Augmentation.

Cureus. 2025-1-23

[7]
Capsular Contracture After Breast Augmentation: A Systematic Review and Meta-Analysis.

Aesthet Surg J Open Forum. 2025-1-15

[8]
Concentration of Povidone-Iodine Pocket Irrigation in Implant-Based Breast Surgery: A Scoping Review.

Aesthetic Plast Surg. 2025-1-23

[9]
Recent Advancements of Nanomedicine in Breast Cancer Surgery.

Int J Nanomedicine. 2024-12-31

[10]
Complications and patient-reported outcomes after radiotherapy in breast cancer patients undergoing implant-based breast reconstruction: a retrospective study from a large Chinese breast disease center.

World J Surg Oncol. 2024-12-21

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