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Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis
Steven K Wilson1, Lexiaochuan Wen2, Mariano Rossello3
1Department of Urology, Institute for Urologic Excellence, La Quinta, CA, USA.
BJU International
|January 12, 2023
Summary
Early results show the Rigicon Infla10 inflatable penile prosthesis (IPP) has good durability. Most patients experienced no device removal or revision, with outcomes comparable to other IPPs.
Area of Science:
- Urology
- Medical Devices
- Implantable Devices
Background:
- The Rigicon Infla10 is a new three-piece inflatable penile prosthesis (IPP).
- Assessing early outcomes and device durability is crucial for patient satisfaction and treatment success.
Purpose of the Study:
- To analyze patient information forms (PIFs) for the Rigicon Infla10 IPP.
- To summarize early outcomes, including device durability and reoperation rates.
Main Methods:
- Retrospective review of 319 PIFs for the Rigicon Infla10 IPP.
- Data collected from January 2019 to December 2021.
- Assessment of device durability, infection, mechanical failure, and medical reasons for reoperation.
Main Results:
- Mean follow-up was 21.2 months.
- 4.4% of devices required removal or revision.
- Mechanical failure occurred in 2.5%, component migration in 0.7%. No infections were observed.
- 95.6% of devices were free from explant or revision at 21 months.
Conclusions:
- Early results demonstrate satisfactory durability for the Rigicon Infla10 IPP.
- Reoperation rates are comparable to contemporary IPPs.
- The device shows initial promise for treating erectile dysfunction.
