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GFS Mark II inflatable penile prosthesis: four-year clinical study

R L Fein1

  • 1Potency, Inc., North Miami, Florida.

Urology
|February 1, 1994
PubMed
Summary
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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.

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  • 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.