The AMS 700™ Series Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). These devices are contraindicated in patients who have active urogenital infections or active skin infections in the region of surgery (or for the AMS 700 with InhibiZone™ have a known sensitivity or allergy to rifampin, minocycline, or other tetracyclines). Implantation will make latent natural or spontaneous erections, as well as other interventional treatment options, impossible. Men with diabetes, spinal cord injuries, or open sores may have an increased risk of infection. Failure to evaluate and treat device erosion may result in infection and loss of tissue. Implantation may result in penile shortening, curvature, or scarring.
Possible adverse events include, but are not limited to, urogenital pain (usually associated with healing), urogenital edema, urogenital ecchymosis, urogenital erythema, reservoir encapsulation, patient dissatisfaction, auto-inflation, mechanical malfunction, and impaired urination. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.