Benefits and Risk Information

AMS 800™ URINARY CONTROL SYSTEM (AUS)

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

Your doctor is your best source for information on the risks and benefits of the AMS 800™ Urinary Control System. Talk to your doctor for a complete listing of risks, warnings and important safety information.

The AMS 800™ Urinary Control System is intended for use in the treatment of male stress urinary incontinence (intrinsic sphincter deficiency) following prostate surgery.

Men with diabetes, spinal cord injuries or skin infections may have an increased risk of infection. Some AMS 800 devices contain an antibiotic (InhibiZone™ Antibiotic Surface Treatment). The device may not be suited for patients who are allergic to the antibiotics contained within the device (rifampin, minocycline or other tetracyclines) or have systemic lupus.

Potential risks may include: device malfunction/failure leading to additional surgery, wearing away/loss of tissue (device/tissue erosion), inability to urinate (urinary retention), infection, and pain/soreness. MH-545611-AA

ADVANCE™ MALE SLING SYSTEM

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

Your doctor is your best source for information on the risks and benefits of the AdVance™ Male Sling System. Talk to your doctor for a complete listing of risks, warnings and important safety information.

The AdVance™ Male Sling System is intended for the treatment of male stress urinary incontinence (SUI). Potential risks may include inability to urinate (urinary retention), return to incontinence and pain. MH-547816-AA