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<p>Silicone-coated prosthetic devices, a category of medical implants with a history spanning decades, have significantly impacted medical technology by enhancing patients’ quality of life and functional outcomes across various conditions. Since the use of these devices has been steadily rising and concerning complications have been reported, it is necessary to understand the epidemiologic characteristics, etiologies, and risk factors associated with their adverse outcomes. This study aims to provide a comprehensive overview of the survival rates and adverse effects of silicone-coated prosthetic devices. PubMed, Embase, and Scopus were systematically explored using a combination of keywords and Medical Subject Heading terms, including “silicone-coated prosthetic device”, “survival rate”, “adverse event”, “epidemiology”, “etiology”, and “risk factor”. Studies focusing on other aspects of silicone-coated prostheses or non-silicone-coated devices were excluded. Capsular contracture, infection, implant rupture, and allergic reactions are the most prevalent complications reported by the available literature. The acute inflammatory reaction against silicone-coated devices is initiated by neutrophils and monocytes activation resulting in the activation of pro-inflammatory macrophage M1 as a prominent mediator. This response is characterized by decreased interleukin (IL)-10 levels and elevated levels of IL-12, IL-23, IL-6, IL-1β, IL-17, tumor necrosis factor-α (TNF- α), and reactive nitrogen and oxygen species which leads to an increased activity of T-helper 1 and 17. IL-6, IL-8, TNF-α, and transforming growth factor-β are among the main factors involved in the chronic inflammatory response that could result in capsule contracture. Additionally, factors such as age, chronic diseases, surgical methods, and post-surgical care are identified as significant contributors to the viability of silicone-coated implants. Ongoing investigations continue to delve into the complicated aspects of the immune response to silicone-coated devices. The ultimate goal is to fully comprehend these complexities and devise strategies that minimize inflammation, ultimately enhancing the biocompatibility of these devices. </p><p>Level of Evidence: not gradable.</p>

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Survival rates and adverse events of silicone-coated prosthetic devices: a narrative review on epidemiology and risk factors

  • 期刊论文

  • 发表日期：

    2026年5月21日

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  • Pourya Shokri,
  • Mahdi Falah Tafti,
  • Ali Ebrahimi,
  • Niki Talebian,
  • Mobin Fathy,
  • Seyed Aria Nejadghaderi,
  • Reza Vafaee

摘要

Silicone-coated prosthetic devices, a category of medical implants with a history spanning decades, have significantly impacted medical technology by enhancing patients’ quality of life and functional outcomes across various conditions. Since the use of these devices has been steadily rising and concerning complications have been reported, it is necessary to understand the epidemiologic characteristics, etiologies, and risk factors associated with their adverse outcomes. This study aims to provide a comprehensive overview of the survival rates and adverse effects of silicone-coated prosthetic devices. PubMed, Embase, and Scopus were systematically explored using a combination of keywords and Medical Subject Heading terms, including “silicone-coated prosthetic device”, “survival rate”, “adverse event”, “epidemiology”, “etiology”, and “risk factor”. Studies focusing on other aspects of silicone-coated prostheses or non-silicone-coated devices were excluded. Capsular contracture, infection, implant rupture, and allergic reactions are the most prevalent complications reported by the available literature. The acute inflammatory reaction against silicone-coated devices is initiated by neutrophils and monocytes activation resulting in the activation of pro-inflammatory macrophage M1 as a prominent mediator. This response is characterized by decreased interleukin (IL)-10 levels and elevated levels of IL-12, IL-23, IL-6, IL-1β, IL-17, tumor necrosis factor-α (TNF- α), and reactive nitrogen and oxygen species which leads to an increased activity of T-helper 1 and 17. IL-6, IL-8, TNF-α, and transforming growth factor-β are among the main factors involved in the chronic inflammatory response that could result in capsule contracture. Additionally, factors such as age, chronic diseases, surgical methods, and post-surgical care are identified as significant contributors to the viability of silicone-coated implants. Ongoing investigations continue to delve into the complicated aspects of the immune response to silicone-coated devices. The ultimate goal is to fully comprehend these complexities and devise strategies that minimize inflammation, ultimately enhancing the biocompatibility of these devices.

Level of Evidence: not gradable.