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Removal rate and mechanical failure in penile prosthesis implantation: A systematic review

International Journal of Impotence Research volume 38, pages 226–237 (2026) Cite this article

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Abstract

Erectile dysfunction affects around 40% of men and is increasingly prevalent with age and comorbid conditions like cardiovascular disease and depression. Inflatable penile prostheses could be considered one of the definitive treatments for this condition. This systematic review aims to compare the safety and durability of AMS 700® (Boston Scientific), Coloplast Titan® (Coloplast), Rigicon Infla 10® (Rigicon), and Zephyr ZSI 475® (Zephyr) inflatable penile prostheses, focusing on infection rates, removals, and mechanical failures. A systematic review following PRISMA guidelines was conducted. The search identified studies on penile prostheses safety and patient satisfaction. Inclusion criteria were studies on adult males undergoing three-component penile prosthesis implantation for erectile dysfunction reporting data on removal rates, causes, and mechanical failures. Studies on implantation of two-component or malleable penile prosthesis were excluded. After the screening, 30 studies published between 1994 and 2023 were included. The median follow-up duration ranged from 12 to 206 months. Removal rates ranged from 0% to 52.9%, generally below 10%, with infection rates typically under 5%. AMS 700® devices had removal rates from 0.3% to 52.9%, while Coloplast Titan® devices ranged from 0% to 6.2%. Rigicon Infla 10® showed a low mechanical failure rate of 2–3% over short follow-up periods. Zephyr ZSI 475® had high initial mechanical failure rates (25.7%). Mechanical failures varied widely, with AMS® reporting rates from 0 to 37.3%, Coloplast Titan® from 0 to 9.1% but with median shorter follow-up durations. Most inflatable penile prostheses demonstrate good long-term tolerance and durability. While AMS 700® and Coloplast Titan® prostheses are well-established, the low mechanical failure rates of the Rigicon Infla 10®, although promising, need to be confirmed by further studies with a longer follow-up. Preliminary Zephyr® data are inconclusive but highlight the need for further evaluations. Rigorous long-term follow-up and comparative studies are essential to confirm these findings and guide clinical decision-making.

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Acknowledgements

The authors report no involvement in the research by the sponsor that could have influenced the outcome of this work.

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  1. These authors contributed equally: Mattia Lo Re, Marta Pezzoli.

Authors and Affiliations

  1. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

    Mattia Lo Re, Marta Pezzoli, Andrea Cocci, Anna Cadenar & Andrea Minervini

  2. Unit of Oncologic Minimally Invasive Urology and Andrology, University of Florence, Careggi Hospital, 50100, Florence, Italy

    Mattia Lo Re, Marta Pezzoli, Andrea Cocci & Anna Cadenar

  3. Department of Urology, Hospital Universitario HM Sanchinarro, Instituto Investigación Sanitaria HM Hospitales and ROC Clinic, Madrid, Spain

    Esther Garcia Rojo & Javier Romero Otero

  4. MBC Hospital, Kigali, Rwanda

    Innocent Nzeyimana

  5. Department of Urology, Hospital Universitario HM Puerta del Sur, Instituto Investigación Sanitaria HM Hospitales and ROC Clinic, Madrid, Spain

    Manuel Alonso Isa

  6. Department of Urology, 12 de Octubre University Hospital, Madrid, Spain

    Borja Garcia Gomez

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Mattia Lo Re, Marta Pezzoli, and Borja Garcia Gomez have contributed substantially to the conception and the design of the manuscript. Mattia Lo Re, Marta Pezzoli, Esther Garcia Rojo, Andrea Cocci, and Anna Cadenar have participated to drafting the manuscript. Andrea Minervini, Javier Romero Otero and Borja Garcia Gomez revised it critically. All authors read and approved the final version of the manuscript.

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Correspondence to Borja Garcia Gomez.

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Lo Re, M., Pezzoli, M., Cocci, A. et al. Removal rate and mechanical failure in penile prosthesis implantation: A systematic review. Int J Impot Res 38, 226–237 (2026). https://doi.org/10.1038/s41443-025-01165-9

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