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10. The implanter should check that there is an adequate
amount of bulbospongiosus muscle to surround and support
a bulbous urethral cuff implant. Thinner spongiosum
typically occurs toward the distal end of the bulbous urethra,
and implantation of the cuff where the spongiosum is thin
increases the chance of erosion and other complications.
This warning is especially important for double cuff
implants, where the second cuff is placed distal to the first
implanted cuff.
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
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 bulbous urethra or bladder
neck.
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 surgi cal correction including
replacement of the device. The physician should advise
patients of these possi bili ties and warn them to avoid
trauma to these areas.
8. 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 (rifampicin) and minocycline can cause
additional stress on the hepatic and renal systems.
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