Evaluate Improvement of Erectile Dysfunction After Placement of the AMS IPP 2005 Inflatable Penile Prosthesis

Erectile dysfunction, the inability to attain or sustain a penile erection sufficient to
permit satisfactory sexual intercourse, affects an estimated ten to 30 million men in the
United States. Erectile dysfunction can be caused by many organic abnormalities, including
diabetes mellitus, hypertension, vascular disease, neurogenic disorders, and other chronic
diseases. Erectile dysfunction can be effectively treated with a variety of methods,
including the implantation of an inflatable penile prosthesis. A multi-center trial is to be
conducted to assess the AMS IPP 2002 Inflatable Penile Prosthesis including handling during
IPP implantation procedures and short-term follow-up experience of subjects. The study will
collect pre-operative information comparing the pump operation using scrotal models of the
current pump with the study pump, and baseline erectile function history. Surgical data will
be collected to assess device design and procedure enhancements. Patient and physician
assessment of study device function, ease of use, ease of training/learning, and adverse
events will be gathered post-operatively.

Inclusion Criteria:

- The subject has been diagnosed with erectile dysfunction and has made an informed
decision to be implanted with the AMS IPP 2005 Inflatable Penile Prosthesis Cylinder,
Pump, and Reservoir.

- The subject has not had a previous penile prosthesis, is willing and able to comply to
study protocol.

- No known sensitivity to rifampin, minocycline or other tetracyclines. Does not have
systemic lupus erythematosus.

Exclusion Criteria:

- Inadequate reading level for for reading and understanding the Informed Consent,
patient questionnaires, and other study materials.

- Has Urinary Tract Infection (UTI), urogenital infection, or active skin infection in
the region of surgery. Has a compromised immune system. Diagnosed with severe fibrosis
due to priapism

- Does not have the manual dexterity or mental ability to operate the pump.