Safety and Efficacy Outcomes of ZSI 475 Penile Prosthesis

Blewniewski, Mariusz; Ostrowski, Ireneusz; Pottek, Tobias; Neugart, Frank; Ciechan, Janusz; Llorens, Christophe; Różański, Waldemar

doi:10.5301/uj.5000240

Cited by 13 publications

(10 citation statements)

References 13 publications

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“…Worldwide, over the last decades, 3p-IPPs have been produced and marketed by two brands: AMS and Coloplast [ 1 ]. In the recent years, Zephyr surgical implants have been proposed on the market, a new 3p-IPP, the ZSI 475, and some preliminary reports on these devices have been published [ [12] , [13] ].…”

Section: Discussionmentioning

confidence: 99%

Initial experience of a single center with the use of ZSI 475 penile prosthesis

Colombo

Gentile

Vagnoni

et al. 2021

Asian Journal of Urology

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Objective To evaluate surgical outcomes after implantation of the Zephyr ZSI 475 inflatable penile prosthesis (IPP) and patients' quality of life. Methods From December 2014 to September 2018, 15 patients underwent prosthesis implantation with ZSI 475. A retrospective review of clinical data was performed. Patients' quality of life after implantation was investigated with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. Results The median age of patients was 57 years and the average follow-up time was 22 months. Twelve patients received a standard implantation due to severe erectile dysfunction (ED); three patients also presented penile curvature and additional corporoplasty with grafting was necessary. Three procedures had to be interrupted due to defects of the insertion tools. In one case a manufacturing defect resulted in a pump leak. In one case, a severe postoperative complication occurred, which requested explanation of the device. During the follow-up, four patients experienced mechanical failure of the prosthesis. Results of QoLSPP questionnaire at 12 months were skewed toward the positive end of the scale in all domains. Conclusion In our initial experience, ZSI 475 suffered a high rate of mechanical failures; on the other hand, the company showed great commitment in order to improve the quality and reliability of the device. The lower cost of ZSI 475 may add to the chances of the product to become a cost-effective alternative to treat those patient who need a IPP.

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Section: Discussionmentioning

confidence: 99%

Initial experience of a single center with the use of ZSI 475 penile prosthesis

Colombo

Gentile

Vagnoni

et al. 2021

Asian Journal of Urology

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“…In one study, the mean time between neophallus construction and prosthesis placement was 3.5 years. 49 The first reported prosthesis placement in a neophallus was described in 1978. 50 In the 1990s, a modified single-cylinder 2-piece Mentor GFS, then later the Ambicor prosthesis was utilized in the neophallus, which provided excellent axial rigidity and avoided a separate reservoir.…”

Section: Safety In Transgender Patientsmentioning

confidence: 99%

Safety and Efficacy of Inflatable Penile Prostheses for the Treatment of Erectile Dysfunction: Evidence to Date

Wang¹,

Levine²

2022

MDER

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Erectile dysfunction (ED) is a common problem, and prevalence rates are expected to rise as life expectancy increases worldwide. In more severe cases of ED, penile prosthesis implantation has been an excellent option for patients. Over the past few decades, significant design improvements have been made to the penile prosthesis and modifications to surgical technique to improve clinical outcomes. The purpose of this review is to summarize the safety and efficacy of FDA-approved penile implants in the US market. Design modifications have greatly improved the safety and reliability of the implant. Development of improved surgical techniques has decreased intraoperative injuries and reservoir-related complications. With its high overall satisfaction rates and low risk of complications, the inflatable penile prosthesis remains an excellent option for patients with erectile dysfunction.

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“…Few literature is reporting on the use of erectile implants following penis reconstruction in trans men. Specifically, there are several complications associated with implant placement in the reconstructed penis, such as hematoma, infection, urinary fistulas and strictures, partial or total penis necrosis, as well as implant deformity [39][40][41][42].…”

Section: Erection Implantsmentioning

confidence: 99%

Gender Affirming Surgery: Assigned Female at Birth

Selvaggi

2022

Practical Clinical Andrology

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The acronym AFAB refers to those persons who have been ‘Assigned Female at Birth’. AFAB persons who, later in life, do not identify as female, are said to present a condition named ‘Gender Incongruence’ (GI). They might identify as men, or as non-binary. Persons presenting the condition of GI might experience a Gender Dysphoria (GD), which is defined as the discomfort due to the mismatch between their anatomical characteristics and the gender in which they are self-identifying. Thus, patients with GD are requesting surgical procedure (s) in order to align one’s body—mostly chest and genitals—to best match with one’s identity. The final aim is to reduce one’s dysphoria.The World Professional Association for Transgender Health currently publishes a series of guidelines, which are named as Standards of Care, for patients presenting GI.In this chapter, we provide an overview on surgical planning and technics, and possible outcomes for Chest-Contouring-Mastectomy (CMM) and genital surgery (metoidioplasty and phalloplasty). Nearly all trans men, and many non-binary AFAB individuals might seek for CCM; the surgery mostly consists in (partial) removal of the breast glandular tissue and, often, reduction of the Nipple-Areola-Complex. Some AFAB individuals with GI are also interested in penis reconstruction: metoidioplasty consists in the surgical enlargement of an hypertrophic clitoris, while phalloplasty consists in the construction of a penis with either larger, local, or distant flaps (including free flaps). Limitations and complications of the different surgical approaches are also presented.

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Safety and Efficacy Outcomes of ZSI 475 Penile Prosthesis

Cited by 13 publications

References 13 publications

Initial experience of a single center with the use of ZSI 475 penile prosthesis

Initial experience of a single center with the use of ZSI 475 penile prosthesis

Safety and Efficacy of Inflatable Penile Prostheses for the Treatment of Erectile Dysfunction: Evidence to Date

Gender Affirming Surgery: Assigned Female at Birth

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