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

Journal of clinical medicine 2025 Vol.14(12)

Ramalho AAL, Tavares AA, da Silva HN, Navarro RF, da Silva VAVC, Melchior SC, Vicente MG, Fook MVL, Silva SML

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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.

추출된 의학 개체 (NER)

유형영어 표현한국어 / 풀이UMLS CUI출처등장
해부 breast 유방 dict 4
합병증 capsular contracture 피막구축 dict 2
합병증 implant-related scispacy 1
합병증 seroma 장액종 dict 1
합병증 infection 감염 dict 1
약물 Embase scispacy 1
질환 rupture C3203359
Rupture
scispacy 1
질환 infections C0851162
Infections of musculoskeletal system
scispacy 1
질환 malignancies C0006826
Malignant Neoplasms
scispacy 1
질환 pain C0030193
Pain
scispacy 1
질환 lymphoma C0024299
Lymphoma
scispacy 1
질환 Breast Implants scispacy 1
질환 BIA-SCC scispacy 1
기타 capsular scispacy 1
기타 ClinicalTrials scispacy 1
기타 patient scispacy 1

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