The AMS Ambicor™ Two-Piece 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. 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), patient dissatisfaction, mechanical malfunction, auto-inflation, penile curvature or sensation change, urogenital hematoma, urogenital edema, and infection. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.