AMS 800™ Artificial Urinary Sphincter
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 800ᵀᴹ Artificial Urinary Sphincter. Talk to your doctor for a complete listing of risks, warnings, and important safety information.
The AMS 800ᵀᴹ Artificial Urinary Sphincter 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 (InhibiZoneᵀᴹ 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-AB
AdVance™ XP 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™ 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