Initial Safety Outcomes for Rigicon Infla10^® Inflatable Penile Prosthesis

Author(s): Steven K Wilson, Lexiaochuan Wen, Mariano Rossello, Pedro Maria, Rafael Carrion, Paul Perito, David Ralph, Gabriele Antonini, Alejandro Carvajal, Metin I Ozturk, Eric Chung

JOURNAL

BJU International

YEAR

2023

DOI

https://doi.org/10.1111/bju.15960

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Abstract Short Summary

This multicenter retrospective study evaluated early safety outcomes of the Rigicon Infla10® IPP in 319 patients. At 21 months, 95.6% of devices remained free from revision or removal. The device showed low rates of mechanical failure and no infections.

Abstract

Objective:

To assess the initial safety and durability outcomes of the Rigicon Infla10^® inflatable penile prosthesis based on retrospective review of PIFs from early implantations.

Key Findings:

Among 319 patients, the overall revision/removal rate was 4.4%. Mechanical failure occurred in 2.5%, component migration in 0.7%, and there were no infections reported. Kaplan-Meier analysis showed device survival rates of 95.6% at 12 months and 93.7% at 36 months.

Conclusion:

The Rigicon Infla10® demonstrated low rates of mechanical complications and no infections in this early analysis. Its safety profile is consistent with existing IPP devices on the market.

Clinical Relevance:

These findings support the Rigicon Infla10® as a safe and viable IPP option, with complication rates comparable to established competitors, especially valuable for urologists evaluating new prosthetic technologies.

Keywords

Infla10® inflatable penile prosthesis IPP erectile dysfunction mechanical failure reoperation penile implant safety Rigicon

This publication is available through the external link above. See the abstract for a summary of the research.

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