Important safety information

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 Artificial Urinary Sphincter. Talk to your doctor for a complete listing of risks, warnings, and important safety information.

The AMS 800 AUS is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

With all medical procedures, there are risks associated with the procedure and the use of the device. 

Patients with urinary tract infections, diabetes, spinal cord injuries, open sores, or skin infections in the region of the surgery have an increased risk of infection. The device is not suitable for patients with active urinary tract, genital or skin infections in the region of surgery. Some AMS 800 devices contain an antibiotic (InhibiZone™ Antibiotic Surface Treatment). AMS 800 with InhibiZone is not suitable for patients who are allergic to the antibiotics contained within the device (rifampin and minocycline HCl) or other tetracyclines, or for patients with systemic lupus, so devices that do not contain InhibiZone should be considered for these patients. 

The risks include but are not limited to: 

• Allergic reaction 
• Erosion (wearing away or a state of being worn away, as by friction or pressure resulting in a breakdown of tissue) 
• Limited urethral coaptation (limited closing of the urethra) which may be due to device leak, sizing, malfunction placement, or other causes 
• Device malfunction/failure leading to additional surgery 
• Malposition of parts (parts placed in an inappropriate position) 
• Device migration of a component (device moving to another part of the body) 
• Any problems with urination 

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.

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™ XP Male Sling System. Talk to your doctor for a complete listing of risks, warnings, and important safety information.

The AdVance™ XP 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, infection, erosion, device migration, pelvic organ dysfunction, bleeding, and pain. These devices are contraindicated for patients with urinary tract infections, blood coagulation disorders, a compromised immune system, or any other condition that would compromise healing, with renal insufficiency, and upper urinary tract relative obstruction. MH-557011-AB