AMS 800 Instrucciones De Uso página 9

the reported reasons for revision and the percentage of each
reason for revision.
This trial did not include AMS 800 devices impregnated with
InhibiZone.
Table 3. PIF Sudy Revision Data
Reason for revision
Incontinence
Not specified
Infection
Fluid loss
Erosion
Other medical condition
Device out of specification/malfunction
Improper size of device
Other*
Urinary retention
Pain
* Other includes: hematoma, device migration/malposition,
patient dissatisfaction.
Clinical Information – Children
The AMS 800 is indicated for the treatment of urinary
incontinence in children of both sexes. The safety and efficacy
of the AMS 800 in children was evaluated by conducting a
literature review. Four documents, reporting clinical information
for patients under the age of 18, were analyzed and a summary
of the clinical evidence is reported here.
Clinical efficacy has been reported for 322 children who have
undergone implantation of the AMS 800. The mean age at the
time of implant ranged from 9.9 to 14 years, and mean follow-
up time reported was 5 to 15.4 years. Etiologies were similar
to those reported for female patients, with the addition of
sacral agenesis
18,19,21
sacralcoccygeal teratoma
bicarbonate into the umbilical artery
idiopathic , lipomeningocele
19
interstitial cystitis
ureter malfunction
Reported complications were similar to those reported for female
patients. Device revisions and bladder augmentation were the
most commonly reported reason for additional surgeries
Reported success rates were comparable to those reported for
female patients, with a reported range of 67% - 86%
This trial did not include AMS 800 devices impregnated with
InhibiZone.
Device Survival
Although it is not possible to predict exactly how long an
implanted prosthesis will function in a particular patient,
American Medical Systems, Inc. gathered data from two sources
on device removals and revisions to help gain insight into
product performance over time. Although these sources included
information gathered from male patients, it is expected that
similar data would result from analyzing data exclusively from
female patients and children. Figure 1 presents device survival
results from a prospective clinical study and a Bayesian analysis
that uses data from a prospective clinical study and a PIF Study
to estimate device survival at five years.
Prospective Clinical Study – A device survival curve was calculated
from data collected during a prospective clinical study (n=85)
with two-year follow-up. Using Kaplan-Meier analysis, the two-
year revision-free rate for the AMS 800 was 79.5% (95% CI
with 95% lower confidence bound 69.8%).
Bayesian Analysis – A Bayesian hierarchical model was used
to evaluate device safety in the prospective clinical study. The
Bayesian model estimated device survival using historical data
, lipoma , spinal cord abnormalities
18,21
or cyst , accidental injection of
18 21
, posterior urethral valves
21
, congenital absence of bladder neck
21
.
21
% revisions
19.8%
19.8%
13.2%
11.6%
10.7%
8.3%
5.8%
3.3%
3.3%
1.7%
1.7%
, urethral injury
18
18,20,21
,
18,20,21
,
20
,
21
, and
21
.
18,19,21
.
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