AMS 800™

The AMS 800™ Artificial Urinary Sphincter is intended to treat urinary incontinence  due to reduced outlet resistance (Intrinsic Sphincter Deficiency) following prostate surgery. The device is contraindicated in patients who are determined to be poor surgical candidates, have an irreversibly blocked lower urinary tract, have irresolvable detrusor hyperreflexia or bladder instability (or for the AMS 800 with InhibiZone™ have a known sensitivity or allergy to rifampin, minocycline, or other tetracyclines).

Patients with urinary tract infections, diabetes, spinal cord injuries, open sores, or regional skin infections may have increased infection risk. Possible adverse events include, but are not limited to, 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.

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