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GFS Mark II inflatable penile prosthesis: four-year clinical study
1Potency, Inc., North Miami, Florida.
Urology
|February 1, 1994
Summary
The GFS Mark II inflatable penile prosthesis (IPP) demonstrated excellent mechanical performance with minimal issues. High patient and partner satisfaction rates were reported, highlighting its effectiveness.
Area of Science:
- Urology
- Medical Devices
- Prosthetics
Background:
- Erectile dysfunction affects a significant number of men, necessitating effective treatment options.
- Inflatable penile prostheses (IPPs) are a common surgical solution for severe erectile dysfunction.
- The GFS Mark II IPP is a specific model designed to improve upon existing IPP technology.
Purpose of the Study:
- To assess the mechanical reliability of the GFS Mark II inflatable penile prosthesis (IPP).
- To evaluate patient and partner satisfaction with the GFS Mark II IPP.
- To identify any potential complications or areas for improvement.
Main Methods:
- A cohort of 138 patients receiving GFS Mark II IPP implants between 1988 and 1991 were followed for 12-50 months.
- Prosthesis performance was evaluated through patient assessments.
- Patient and partner satisfaction was measured using questionnaires and interviews.
Main Results:
- A single mechanical issue was reported involving the prosthesis tubing.
- Two postoperative infections occurred among seven reported problems requiring explanation.
- Ninety-three percent of patients and 98% of partners reported satisfaction with the GFS Mark II IPP.
- The resipump feature allowed for office-based fluid volume adjustment in 13 patients.
Conclusions:
- The GFS Mark II connectorless IPP exhibits a low rate of mechanical complications over a four-year period.
- High patient and partner satisfaction underscores the efficacy of the GFS Mark II IPP.
- The integrated resipump offers a practical advantage for fluid volume management.

