AMS 800 Instrucciones De Uso página 4

antibiotic therapy may result in removal of the prosthesis.
Infection followed by explantation of the device may result
in scarring which may make subsequent reimplantation more
difficult.
2. Erosion may be caused by infection, pressure on the tissue,
improper cuff sizing, improper balloon selection, tissue
damage, and component misplacement. The cuff may erode
around the urethra. The control pump may erode through
the labia or scrotum. The pressure-regulating balloon may
erode into the bladder. Acute urinary tract infection can
interfere with proper functioning of the device and may
lead to erosion of the urethra in the cuff area. Failure to
evaluate and promptly treat the erosion may result in a
substantial worsening of the condition leading to infection
and/or loss of tissue.
3. Poor bladder compliance or a small fibrotic bladder may
require some measure of intervention including, in some
cases, augmentation cystoplasty before implanting the
prosthesis.
4. 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.
5. Do not pass a catheter or any other instrument through the
urethra without first deflating the cuff and deactivating the
device to prevent potential damage to the urethra or the
AMS 800.
6. This device contains solid silicone elastomers. This device
does not contain silicone gel. The risks and benefits of
implanting this device in patients with documented
sensitivity to silicone should be carefully considered.
7. Surgical, physical, psychological, or mechanical
complications, if they occur, may necessitate revision or
removal of the prosthesis. Removal of the device without
timely reimplantation of a new device may complicate
subsequent reimplantation. The timing of reimplantation
should be determined by the treating physician based on
the patient's medical condition and history.
8. Product wear, component disconnection or other
mechanical problems may lead to surgical intervention.
Mechanical complications may include malfunctioning
of the components and leakage of fluid. Any mechanical
malfunction that does not permit the transfer of fluid from
the cuff to the balloon may result in outflow obstruction.
Mechanical events should be evaluated carefully by the
treating physician and the patient should consider risks and
benefits of treatment options, including revision surgery.
9. Previous patient history of adverse reaction(s) to radiopaque
solution precludes its use as a filling medium for the
prosthesis. Instead, saline should be used to fill the device.
10. Female patients with persistent incontinence should be
evaluated to rule out vesicovaginal fistula, which may have
resulted from an unrecognized iatrogenic injury.
11. If a hypersensitivity reaction develops to a device coated
with InhibiZone, the cuff and pump should be removed
and the patient treated appropriately.
Precautions
Patient Related
1. Patient selection requires thorough preoperative
consultation and evaluation by the physician.
2. Patients should be counseled in order to have a realistic
expectation of the physical, psychological, and functional
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