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上市后乳房植入物的安全性和性能:基于技术监测数据的综合综述

Safety and Performance of Postmarketing Breast Implants: An Integrated Review with Technovigilance Data.

作者信息

Ramalho Antonio de Aracoeli Lopes, Tavares Albaniza Alves, da Silva Henrique Nunes, Navarro Rômulo Feitosa, da Silva Victhor Alexandre Vilarins Cardoso, Melchior Stela Candioto, Vicente Maria Glória, Fook Marcus Vinícius Lia, Silva Suédina Maria de Lima

机构信息

Graduate Program in Materials Science and Engineering, Northeast Biomaterials Evaluation and Development Laboratory (CERTBIO), Academic Unit of Materials Engineering, Federal University of Campina Grande, Campina Grande 58429-900, PB, Brazil.

National Health Surveillance Agency, General Management of Monitoring of Products Subject to Health Surveillance, Technovigilance Management, Brasília 71205-050, DF, Brazil.

出版信息

J Clin Med. 2025 Jun 12;14(12):4164. doi: 10.3390/jcm14124164.


DOI:10.3390/jcm14124164
PMID:40565910
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12194552/
Abstract

: Breast implants are widely used in reconstructive surgeries, as well as in cosmetic procedures, to enhance or restore breast shape and volume. With advances in techniques and materials, these devices have become safer and more effective over the years. Nevertheless, complications such as capsular contracture, rupture, infections, or other types of malignancies (BIA-SCC). This study evaluated the postmarketing safety and performance of implants via technovigilance data and a review of scientific studies. : The research analyzed publications from the BVS, PubMed, Embase, and ClinicalTrials databases from between 2007 and 2023 (15 years), in addition to reports registered in the Notivisa system during the same period. : A total of 113 studies were identified, 15 of which were selected for the final analysis, which revealed that capsular contracture, seroma, infection, and rupture were the most common complications. In the Notivisa system, 786 reports were found, including 397 technical complaints and 389 adverse events, with pain, infections, and lymphoma among the most frequently reported issues. : These findings highlight the importance of continuous surveillance to identify risks and promote improvements in the quality and safety of breast implants, ensuring patient well-being. As a practical contribution, a clinical decision-making algorithm was proposed to support healthcare professionals in the early identification and management of implant-related complications.

摘要

乳房植入物广泛应用于重建手术以及美容手术中,以改善或恢复乳房的形状和体积。随着技术和材料的进步,这些装置多年来已变得更安全、更有效。然而,仍会出现诸如包膜挛缩、破裂、感染或其他类型的恶性肿瘤(乳腺植入物相关间变性大细胞淋巴瘤)等并发症。本研究通过技术监测数据和对科学研究的回顾,评估了植入物上市后的安全性和性能。:该研究分析了2007年至2023年(15年)期间来自BVS、PubMed、Embase和临床试验数据库的出版物,以及同期在Notivisa系统中登记的报告。:共识别出113项研究,其中15项被选入最终分析,结果显示包膜挛缩、血清肿、感染和破裂是最常见的并发症。在Notivisa系统中,发现了786份报告,包括397份技术投诉和389份不良事件,疼痛、感染和淋巴瘤是报告最频繁出现的问题。:这些发现凸显了持续监测对于识别风险以及促进乳房植入物质量和安全性提升、确保患者福祉的重要性。作为一项实际贡献,提出了一种临床决策算法,以支持医疗保健专业人员早期识别和管理与植入物相关的并发症。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/a2f61c57d210/jcm-14-04164-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/966bef0a3f7c/jcm-14-04164-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/1ae3944c27bb/jcm-14-04164-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/68233c1a0619/jcm-14-04164-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/a2f61c57d210/jcm-14-04164-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/966bef0a3f7c/jcm-14-04164-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/1ae3944c27bb/jcm-14-04164-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/68233c1a0619/jcm-14-04164-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3830/12194552/a2f61c57d210/jcm-14-04164-g004.jpg

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本文引用的文献

[1]
Reconstructive breast implant-related infections: Prevention, diagnosis, treatment, and pearls of wisdom.

J Infect. 2024-8

[2]
Management of complications following implant-based breast reconstruction: a narrative review.

Ann Transl Med. 2023-12-20

[3]
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

[4]
Nagor Impleo Round Silicone Gel Breast Implants: Early Outcome Analysis after 340 Primary Breast Augmentations.

J Clin Med. 2023-5-27

[5]
Separating Myth from Reality in Breast Implants: An Overview of 30 Years of Experience.

Plast Reconstr Surg. 2023-11-1

[6]
Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants.

Aesthetic Plast Surg. 2023-4

[7]
Antibacterial Designs for Implantable Medical Devices: Evolutions and Challenges.

J Funct Biomater. 2022-6-21

[8]
Breast Implant-Associated Immunological Disorders.

J Immunol Res. 2022

[9]
History of breast implants: Back to the future.

JPRAS Open. 2022-3-11

[10]
Aesthetic breast surgery: putting in context-a narrative review.

Gland Surg. 2021-9

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