356 patients. The study followed patients for up to ten years
(mean: 4.1 years; range: 0.03-10.3 years). The revision data
presented in Table 2 and Table 3 below are based on a total of
317 revisions reported on 164 patients that required one or more
revisions during the ten-year period of the study.
The data in Table 2 presents the percentage of patients revised
during the specified follow-up period, the average number of
revisions conducted on patients requiring a revision and the
number of revisions expected per 100 patients for these studies
in comparison with the data of the prospective clinical study.
Table 2: Comparison of Revision Data from
Three Different Clinical Studies
Table 2: Comparison of Revision Data from
Three Different Clinical Studies
Prospective Study
PIF Study
Retrospective Study
(85 pts. over
(12,713 pts.
(356 pts. over
24 months) over 5 years) 9 years)
% pts. revised
16.5%
15.8%
46.1%
(14/85) (2014/12713) (164/356)
avg.. # of revisions per
1.07
1.05
1.93
pts. revised
(15/14)
(2116/2014)
(317/164)
# of revisions per 100 pts.
18
17
89
(15/85) (2116/12713) (317/356)
Table 3 shows revision data stratified by each reported reason
for revision from three different studies of male patients
implanted with the AMS 800. Under the PIF Study and
Retrospective Study multiple reasons were sometimes provided
for a single revision. Therefore, in order to stratify this revision
data by reason, all occurrences were included and presented as
“% reason.” The total number of reasons therefore exceeds the
total number of revisions reported for these studies.
Table 3: Reasons for Revision in Three Different Studies
Prospective Study
PIF Study
Retrospective Study
Revision Reasona (n=85) (n=12713)
(n=356)
revisions reasons
b
reasons
%
#
%
#
%
#
Infection
2.4% (2)
2.3% (297)
8.1% (29)
Infection/erosion
1.2% (1)
---- ----
---- ----
Erosion
2.4% (2)
3.6% (451)
22.5% (80)
Recurring
Incontinence
2.4%
(2)
5.7%
(724)
42.4%
(151)
Fluid Loss
----
----
2.3%
(298)
9.3%
(33)
Fluid Transfer
Impaired
----
----
0.3%
(38)
----
----
Pressure too low
----
----
1.1%
(140)
----
----
Mechanical
Malfunction
3.5% (3)
0.7% (89)
13.8% (49)
Migration/
Malposition
3.5% (3)
0.4% (46)
4.8% (17)
Iatrogenic
Complications
---- ----
0.4% (51)
0.6% (2)
Reimplantation/
Replacement
---- ----
---- ----
3.1% (11)
Pain
1.2% (1)
0.2% (22)
1.4% (5)
Patient
Dissatisfaction
1.2% (1)
0.2% (27)
1.7% (6)
Other
c
---- ----
2.4% (305)
---- ----
Not indicated
----
----
1.9%
(242)
----
----
a Note that some adverse events in the table such as fluid loss, pressure too low, fluid
transfer impaired and malposition could fall into the category of mechanical malfunction
or iatrogenic error. Since information is not available to place them in either category,
they are listed separately.
b Numbers of reasons can vary for the same percentage due to rounding.
c Other includes: double cuff, pressure too high, unable to activate, unable to deactivate,
atrophy, difficult to operate, urinary retention, air in the system, hematoma.
8
