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The AMS 800™ Urinary Control System (or 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. Device-tissue erosion may occur. Proper patient evaluation, selection, and counseling of realistic expectations should occur. Possible adverse events include, but are not limited to, compromised device function, pain/discomfort, delayed wound healing, migration, and recurrent incontinence.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.