AMS Ambicor™

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Prior to use, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.

Indications for Use: The AMS Ambicor™ Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

Contraindications: Patients who have active urogenital infections or active skin infections in the region of surgery.

Warnings: Implantation of the device 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 associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile curvature, or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical.

Precautions: Migration of the device components can occur if the cylinders are improperly sized, if the pump or the reservoir is not positioned properly, or if the tubing lengths are incorrect.

Potential Adverse Events: May include device malfunction/failure leading to additional surgery, device migration potentially leading to exposure through the tissue, device/tissue erosion, infection, unintended-inflation of the device and pain/soreness. MH-545612-AB