AMS 800 Instrucciones De Uso página 5

outcome of the implantation of an AMS 800. Although
the prosthesis is designed to restore urinary control, some
patients continue to have a degree of incontinence after this
procedure.
3. Patients may experience pain when the device is activated
in the postoperative period and during the period of initial
use. Cases of chronic pain associated with device have been
reported. Pain with a severity or duration beyond what
is expected may require medical or surgical intervention.
Patients should be counseled on expected postoperative
pain including severity and duration.
4. Tissue fibrosis, previous surgery, or previous radiation
therapy in the area of the implant may preclude
implantation of a cuff at the urethra.
5. Any progressively degenerative disease, e.g. multiple
sclerosis, may limit the future usefulness of the implanted
prosthesis as a treatment for the patient's urinary
incontinence.
6. Adequate manual dexterity, strength, motivation, and
mental acuity are required for proper use of the device.
7. Trauma or injury to the pelvic, perineal or abdominal areas,
such as impact injuries associated with sports, can result
in damage to the implanted device and/or surrounding
tissues. This damage may result in the malfunction of the
device and may necessitate surgical correction including
replacement of the device. The physician should advise
patients of these possibilities and warn them to avoid
trauma to these areas.
8. Female patients of child-bearing age must be forewarned
that pregnancy is acceptable, but cesarean section may be
indicated to minimize the risk of damage to the bladder
neck and its surrounding cuff. For those patients who
become pregnant, deactivation of the device during the
third trimester is recommended to reduce the risk of
erosion. Those patients contemplating pregnancy should
consider delaying implantation.
9. Children receiving device should be evaluated at regular
intervals. Lifelong radiological and urodynamic surveillance
of the urinary tract is crucial. Before implantation, the
patient and their family should be informed of the
complication rate and the need for long-term follow-up.
10. Consideration should be given to the diameter of the
implanted occlusive cuff relative to catheters or other trans-
urethral devices. When fully deflated, the inside diameter
of the smallest occlusive cuff (3.5cm) generally exceeds
28F. Additional clearance is required to accommodate the
patient's urethral tissue between the trans-urethral device
and the occlusive cuff. Urethral tissue thickness is patient
specific and requires a physician's assessment to determine
its impact on sizing.
InhibiZone™ Related
1. Use of products with InhibiZone should be carefully
considered in patients with hepatic or renal disease, as use
of rifampin and minocycline HCl can cause additional
stress on the hepatic and renal systems.
2. Patients who receive a device with InhibiZone and are also
taking methoxyflourane should be carefully monitored for
signs of renal toxicity.
3. Patients who receive a device with InhibiZone and are
also taking warfarin should have their prothrombin time
monitored because tetracyclines have been reported to slow
3 3