Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide.
Journal
International journal of impotence research
ISSN: 1476-5489
Titre abrégé: Int J Impot Res
Pays: England
ID NLM: 9007383
Informations de publication
Date de publication:
07 Sep 2023
07 Sep 2023
Historique:
received:
11
06
2023
accepted:
30
08
2023
revised:
24
08
2023
pubmed:
8
9
2023
medline:
8
9
2023
entrez:
7
9
2023
Statut:
aheadofprint
Résumé
Implantation of penile prosthesis is considered when conservative measures fail or are unacceptable to patients' wishing treatment for erectile dysfunction. In the United States (US), inflatable penile prostheses are more often used than malleable penile prostheses (MPP). Outside the US, the reverse is true because third-party reimbursement is not available, and MPP is considerably cheaper. Two American manufacturers make MPP; presently, a new manufacturer, Rigicon (Ronkonkoma NY), has recently begun to sell its MPP worldwide. Patient information forms submitted to the manufacturer between March 1, 2019, and December 8, 2022, were used to conduct an initial safety study for 605 first-time patients implanted with Rigicon10® by 46 physicians in 15 countries with a mean follow-up of 21.6 months. It has the same configuration of trimmable, paired silicone rods containing a twisted stainless-steel wire for bendability. However, it is available in six widths with hydrophilic coating compared to three widths offered by competitors. Revision or explantation was needed in 6 of 605 patients (0.99%) with half of those being removed for dissatisfaction (0.50%). Two (0.33%) suffered device infection and one (0.16%) required removal for erosion. Kaplan-Meier's statistical analysis showed three-year implant survival from revision = 99.2%. It demonstrated a comparable safety record with less than 1.00% of patients requiring reoperation.
Identifiants
pubmed: 37679463
doi: 10.1038/s41443-023-00761-x
pii: 10.1038/s41443-023-00761-x
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s).
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