Development of a penile prosthesis. the Hydroflex
Porter, C.H.
Urologic Clinics of North America 16(1): 149-164
1989
ISSN/ISBN: 0094-0143 PMID: 2916272 Document Number: 346047
The development and commercialization of a penile prosthesis is a long and involved process that is influenced by a large number of factors including the patient, surgeon, FDA, commercial viability, and competitive environment. The process is illustrated in this article by historically tracing some of the factors involved in the development of the American Medical Systems self-contained penile prosthesis, the Hydroflex. This device was introduced into unrestricted commercial distribution in May 1985.