What is it about?

This study analyzed data from patient information forms (PIFs) of 319 patients who were implanted with the Rigicon Infla10â three-piece inflatable penile prosthesis (IPP) between January 2019 and December 2021. The study aimed to summarize early outcomes of the device, including durability and rates of reoperation for infection, mechanical failure, or medical reasons. The mean follow-up was 21.2 months, and the mean patient age was 58.5 years. The vast majority of the devices (95.6%) were free from explant or revision 21 months after the original implant date. The study found that the most common reason for implantation was organic erectile dysfunction, and most surgeries were conducted through a penoscrotal incision. The study authors concluded that the early results demonstrate initial durability equivalent to that of other contemporary devices.

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Why is it important?

The research is important because it provides early outcomes and device durability for the newly introduced Rigicon Infla10 Inflatable Penile Prosthesis (IPP). The study used data from patient information forms (PIFs) submitted to the manufacturer, which is a recognized and widely accepted means to accomplish outcome data in infrequently performed surgeries like IPP implantation. This research helps manufacturers study and improve their devices and contributes to the medical community's understanding of the safety and efficacy of the Rigicon Infla10 IPP. Key Takeaways: 1. The study analyzed PIFs from 319 patients implanted with the Rigicon Infla10 IPP between January 2019 and December 2021. 2. The mean follow-up was 21.2 months, and the mean patient age was 58.5 years. 3. The most common reason for implantation was organic erectile dysfunction, but the researchers suggest removing this nonspecific destination from the PIF to encourage more accurate identification of causative factors. 4. 4.4% of devices required removal or revision, with complications including mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. 5. The vast majority of the early Rigicon Infla10 IPPs were included in this retrospective analysis of volunteered PIFs, showing initial durability from reoperation equivalent to that of other contemporary devices.

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This page is a summary of: Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis, BJU International, March 2023, Wiley,
DOI: 10.1111/bju.15960.
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