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

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

Antonio de Aracoeli Lopes Ramalho  1 , Albaniza Alves Tavares  1 , Henrique Nunes da Silva  1 , Rômulo Feitosa Navarro  1 , Victhor Alexandre Vilarins Cardoso da Silva  2 , Stela Candioto Melchior  2 , Maria Glória Vicente  2 , Marcus Vinícius Lia Fook  1 , Suédina Maria de Lima Silva  1
Affiliations

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

Antonio de Aracoeli Lopes Ramalho et al. J Clin Med. .

Abstract

Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

Keywords: breast implants; breasts; health surveillance; medical device safety.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Co-occurrence and connectivity of terms found in titles, keywords, and abstracts of publications retrieved from the databases. Analysis was performed via VOSviewer 1.6.20 software (2023), with a minimum of 2 occurrences and a “total count” setting. Sources: BVS, PubMed, Embase and ClinicalTrials (2024).
Figure 2
Figure 2
(a) Annual evolution of adverse event (AE) and technical complaint (TC) reports related to breast implants (2007–2023); (b) temporal evolution of the proportion of reports made by regulatory bodies, healthcare facilities, and companies. Source: ANVISA. Notivisa. The data were updated on 10/09/2024 and are subject to review.
Figure 2
Figure 2
(a) Annual evolution of adverse event (AE) and technical complaint (TC) reports related to breast implants (2007–2023); (b) temporal evolution of the proportion of reports made by regulatory bodies, healthcare facilities, and companies. Source: ANVISA. Notivisa. The data were updated on 10/09/2024 and are subject to review.
Figure 3
Figure 3
Pareto chart of the occurrence of adverse events associated with breast implants—Brazil, 2007–2023. Source: ANVISA. Notivisa. The data were updated on 10 September 2024 and are subject to review.
Figure 4
Figure 4
Clinical algorithm for the evaluation and management of patients with breast implants, based on symptomatology and postmarketing technovigilance data. ACT: Action to be taken by the healthcare provider based on the clinical scenario.
See this image and copyright information in PMC

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