Safety outcomes of the first Rigi10^™ malleable penile prostheses implanted worldwide

Author(s): Steven K. Wilson, Lexiaochuan Wen, Rafael Carrion, Francois Eid, Aaron Lentz, Bhavik Shah, Orhan Koca, Muhammed A. M. Hammad, Vijayant Govinda Gupta, Mohammad Hamdan

JOURNAL

IJIR: Your Sexual Medicine Journal

YEAR

2024

DOI

https://doi.org/10.1038/s41443-023-00761-x

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Abstract Short Summary

A global multi-center study analyzed the safety of Rigi10® MPP in 605 patients with ED. Results showed a <1% revision rate and no mechanical failures.

Abstract

Objective:

To assess the early safety and revision rates of the Rigi10^® malleable penile prosthesis following its worldwide launch.

Key Findings:

Among 605 first-time implantations, the revision rate was only 0.99%. There were no mechanical failures, with low rates of infection (0.33%) and erosion (0.16%). The 3-year implant survival was 99.2%.

Conclusion:

The Rigi10^® MPP demonstrated excellent early safety outcomes with a

<1% revision/removal rate and no mechanical failures after an average follow-up of 21.6 months.

Clinical Relevance:

This study confirms that the Rigi10^® MPP is a safe and reliable option for ED treatment, supporting its global adoption in diverse surgical settings.

Keywords

Rigi10 malleable penile prosthesis erectile dysfunction penile implant prosthetic urology revision rate patient safety Kaplan–Meier

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