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Mechanical failure of inflatable penile prostheses: a 2025 snapshot and historical context

International Journal of Impotence Research (2025)Cite this article

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Inflatable penile prostheses (IPPs) are the preferred surgical option for men with erectile dysfunction that is unresponsive to medical therapy, offering superior cosmetic and functional outcomes [1]. However, device reliability remains a clinical concern even after 5 decades of usage [2]. For the first 5 months of 2025, the United States (US) Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) recorded 1324 reports of American IPPs removed for adverse events [3].

Boston Scientific (Marlborough, USA) accounted for 586 (44.3%) events, while 738 (55.7%) were linked to Coloplast (Minneapolis, USA) [3]. A PubMed search identified 581 articles that analyzed MAUDE data across a broad range of implants, including cochlear implants [4], devices for benign prostatic hyperplasia [5], guidewires [6], nitinol stents [7], barbed sutures [8], intercranial devices for epilepsy [9], breast implants [10], nasal epistaxis balloons [11], dermal fillers [12], and many more. To the best of our knowledge, however, this is the first study to examine MAUDE reports for IPPs. Given that approximately 2,000 IPPs are placed each month in the US, the monthly number of explant procedures appears disproportionately high relative to the implanted population [3]. A closer analysis of the data is warranted to detect preventable adverse events.

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Fig. 1: Mentor & Coloplast Pumps.
Fig. 2: Tubing Breakage.
Fig. 3: Separation of the Silicone Material.
Fig. 4: Tubing Breakage.

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Author information

Authors and Affiliations

  1. Institute for Urologic Excellence, Sarasota, FL, USA

    Steven K. Wilson

  2. University of Alabama, Birmingham, AL, USA

    John J. Mulcahy

  3. Mayo Clinic, Rochester, MN, USA

    Tobias Köhler

  4. Perito Urology, Coral Gables, FL, USA

    Paul Perito & Alfredo Suarez Sarmiento

  5. Istanbul Kent University, Istanbul, Turkey

    Ahmet Tevfik Albayrak

Authors
  1. Steven K. Wilson
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  2. John J. Mulcahy
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  3. Tobias Köhler
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  4. Paul Perito
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  5. Ahmet Tevfik Albayrak
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  6. Alfredo Suarez Sarmiento
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Contributions

SKW: Contributed substantially to the conception and design of the study, drafting significant portions of the manuscript, and providing critical revisions for intellectual content. JJM: Participated in the conceptual framework of the article and critically revised the manuscript for important intellectual content. TK: Assisted with data analysis, interpretation of findings, and contributed to manuscript revisions for clarity and accuracy. PP: Provided critical review and editing of the manuscript and contributed to the discussion of clinical implications. ATA: Performed a detailed literature review, drafted sections of the manuscript, and coordinated the final preparation and submission process. AS: Contributed to data collection, assisted with drafting specific sections of the manuscript, and reviewed the final version for scientific accuracy.

Corresponding author

Correspondence to Ahmet Tevfik Albayrak.

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Competing interests

SKW: Consultant, International Medical Devices, Rigicon, Uramix. JJM: Consultant, Boston Scientific, Coloplast. TK: None. PP: Consultant, Boston Scientific, Coloplast. ATA: None. AS: None.

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Wilson, S.K., Mulcahy, J.J., Köhler, T. et al. Mechanical failure of inflatable penile prostheses: a 2025 snapshot and historical context. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01154-y

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