Indications For Use - AMS 800 Instrucciones De Uso

AMS 800™
Urinary Control System
For Female and Pediatric Patients
Instructions For Use
NOTE: For implant procedure information, consult the AMS 800 Urinary
Control System Operating Room Manual.
Brief Device Description
The AMS 800 Urinary Control System is an implantable,
fluid filled, solid silicone elastomer device used to treat urinary
incontinence. It is designed to restore the natural process of
urinary control. The device simulates normal sphincter function
by opening and closing the urethra at the control of the patient.
The AMS 800 consists of three interconnected components: a
cuff, a pump, and a pressure-regulating balloon (PRB). The three
components are connected with kink-resistant tubing. The
AMS 800 can be implanted at the bladder neck.
The AMS 800 Urinary Control System Cuff and Pump are
available with InhibiZone™, an antibiotic coating of rifampin
(rifampicin) and minocycline hydrochloride (minocycline HCl).*
For more information please refer to the Antibiotic Information
section.

Indications for Use

The AMS 800 is used to treat urinary incontinence due to
reduced urethral/bladder outlet resistance (intrinsic sphincter
deficiency) in males, females and children. The information
presented in this document focuses on implantation of the
AMS 800 in females and children. For information relating
to the implantation of the device in males, see the AMS 800
Urinary Control System Instructions for Use.
Contraindications
1. This device is contraindicated in patients whom the physician
determines to be poor candidates for surgical procedures and/
or anesthesia due to physical or mental conditions.
2. This device is contraindicated in patients with urinary
incontinence due to or complicated by an irreversibly
obstructed lower urinary tract.
3. This device is contraindicated in patients with irresolvable
detrusor hyperreflexia or bladder instability.
4. The implantation of the InhibiZone version of this device is
contraindicated in patients with known allergy or sensitivity
to rifampin or to minocycline HCl or other tetracyclines.
5. The implantation of products with InhibiZone is
contraindicated in patients with systemic lupus
erythematosus because minocycline HCl has been reported
to aggravate this condition.
Warnings
1. 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 associated with a
prosthesis. Appropriate measures should be taken to reduce
the likelihood of infection. Infection that fails to respond to
*
InhibiZone™ Antibiotic Surface treatment is not available in all markets.
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