Urinary Control System
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 800™ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
Contraindications: Patients whom the physician determines to be poor surgical candidates, urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract, have irresolvable detrusor hyperreflexia or bladder instability, or (for the AMS 800 prosthesis with InhibiZone™ Antibiotic Surface Treatment) have a known sensitivity or allergy to rifampin, minocycline or other tetracyclines, or patients with lupus erythematosus because minocycline has been reported to aggravate this condition.
Warnings: Patients with urinary tract infections, diabetes, spinal cord injuries, open sores or regional skin infections may have increased risk of infection associated with a prosthesis. Erosion may be caused by infection, pressure on the tissue, improper cuff sizing, improper balloon selection, tissue damage, and component misplacement. Patients with urge incontinence, overflow incontinence, detrusor hyperreflexia or bladder instability should have these conditions treated and controlled (or resolved) prior to implantation of the device. Surgical, physical, psychological, or mechanical complications, if they occur, may necessitate revision or removal of the prosthesis.
Potential Adverse Events: May include device malfunction/failure leading to additional surgery, device/tissue erosion through urethra/bladder/scrotum, urinary retention, infection, and pain/soreness. MH-545609-AA