A Case of Silicone Allergy Induced by a Subcutaneous Implantable Cardioverter Defibrillator

Q: What are the key findings of this study?

A 54-year-old man developed a rare silicone-induced allergic skin ulceration following S-ICD implantation, which progressed to device exposure and necessitated complete system removal.

Q: What is the clinical evidence from this study?

Study design: Case Report. Population: Silicone allergy induced by S-ICD (n=1). Intervention: Subcutaneous implantable cardioverter-defibrillator (S-ICD). Primary outcome: Silicone-related hypersensitivity reaction.

Q: What does this research mean for the field?

Subcutaneous implantable cardioverter-defibrillator implantation can induce silicone hypersensitivity presenting as delayed, noninfectious granulomatous wound complications requiring complete device removal. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Wataru Shinkai; Jun Kishihara; Megumi Toraiwa; Yuki Arakawa; Shuhei Kobayashi; Hironori Nakamura; Naruya Ishizue; Jun Oikawa; Hidehira Fukaya; J Ako

doi:10.1002/joa3.70417

July 12, 2026Journal of ArrhythmiaOpen Access

A Case of Silicone Allergy Induced by a Subcutaneous Implantable Cardioverter Defibrillator

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Key result

S-ICD implantation causes rare silicone-induced skin ulceration necessitating complete system removal.

n=1

Figures

Graphical abstract published by Journal of Arrhythmia — Graphical abstract · Published by Journal of Arrhythmia · CC BY-NC-ND

Why the study?

Allergic reactions associated with subcutaneous implantable cardioverter-defibrillators are extremely rare, and silicone-related cases are scarcely reported.

Key Points

To describe a rare case of silicone hypersensitivity that caused noninfectious wound deterioration and device exposure following subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation.
Clinical and diagnostic evaluation of a 54-year-old man presenting with a granulomatous incision site lesion 7 months after S-ICD implantation for idiopathic ventricular fibrillation.
Serial blood tests, wound and blood microbial cultures, longitudinal clinical monitoring, and post-explantation patch testing to identify potential contact allergens.
Initial evaluation showed an absence of systemic infection signs (WBC 6.1 × 10^9 /L, CRP 0.56 mg/dL, negative blood cultures, and no fever), despite scant MSSA growth (< 3 semi-quantitative).
Conservative therapy failed, leading to recurrent fistula formation and eventual generator exposure at 6 years (admission WBC 7.4 × 10^9 /L, CRP 0.14 mg/dL), requiring complete device extraction.
Patch testing confirmed a positive allergic reaction to silicone, corresponding to components anatomically localized near the lesions (suture sleeve and generator header).

Study Design

Type

Case Report (n=1)

Structured PICO

P

Population

A 54-year-old man who developed a granulomatous lesion and subsequent device exposure due to silicone hypersensitivity following S-ICD implantation.

E

Exposure

Subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation.

O

Outcome

Development of silicone-induced allergic skin ulceration and granulomatous lesion.safety

Silicone-related hypersensitivity, although extremely rare, should be considered when evaluating noninfectious wound complications after S-ICD implantation.

Limitations

Histopathological examination of the wound tissue was not performed
Advanced imaging modalities for excluding occult infection, such as FDG-PET/CT, were not performed
Histopathological examination of the wound tissue was not performed.
Advanced imaging modalities for excluding occult infection, such as FDG-PET/CT, were not performed.

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Implication

Silicone allergy merits consideration in noninfectious S-ICD wound issues; case report leaves open need for screening protocols.

Abstract

Background Allergic reactions associated with subcutaneous implantable cardioverter‐defibrillator (S‐ICD) are extremely rare, and silicone‐related cases are scarcely reported. Methods and Results A 54‐year‐old man with a transvenous implantable cardioverter‐defibrillator (TV‐ICD) for idiopathic ventricular fibrillation underwent removal of an infected TV‐ICD system, followed by S‐ICD implantation. Seven months later, a granulomatous lesion developed at the xiphoid incision site without signs of infection. Conservative management was initially selected; however, progressive wound deterioration and eventual device exposure necessitated complete system removal. Patch testing demonstrated a positive reaction to silicone, a device component corresponding to the lesion site. Conclusions This case highlights that silicone‐related hypersensitivity, although extremely rare, should be considered when evaluating noninfectious wound complications after S‐ICD implantation.

Discussion

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Cite This Study

Shinkai et al. (2026) conducted a case report in Silicone allergy induced by S-ICD (n=1). Subcutaneous implantable cardioverter-defibrillator (S-ICD) was evaluated on Silicone-related hypersensitivity reaction. A 54-year-old man developed a rare silicone-induced allergic skin ulceration following S-ICD implantation, which progressed to device exposure and necessitated complete system removal.

synapsesocial.com/papers/6a5600ff10535b590d162476 https://doi.org/10.1002/joa3.70417

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A Case of Silicone Allergy Induced by a Subcutaneous Implantable Cardioverter Defibrillator

Figures

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

A Case of Silicone Allergy Induced by a Subcutaneous Implantable Cardioverter Defibrillator

Figures

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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