AMS 800 Instrucciones De Uso página 8

complication for each patient.
This trial did not include AMS 800 devices impregnated with
InhibiZone.
Table 1. Complications in Patients Studied
Complication
Bladder injury
Vaginal injury
Cuff Erosion
Infection/erosion
Device Fluid leak
Incisional hernia
Urinary retention
Urethral injury
Urinary urgency
Labia hematoma
Infection
Pelvic abscess
Early post-operative morbidity
Pressure atrophy at cuff site
Cutaneous erosion
Bothered by device
Pulmonary embolus
Enterocutaneous fistula
Phlebitis
Upper urinary tract deterioration
Superficial wound dehiscence
Device malfunction
Device displacement
Device damage – unrelated
procedure
Wound seroma
Pump erosion
Sphincter-related problem
Loose cuff
Success Rates
Patient success rates were reported and analyzed. For those
defining clinical success
categorized into the following criteria:
• Fully and socially continent = 0-1 pad use per day
• Occasional incontinence = Consistent use of 1-2 pads
per day
• Fair/improved continence = Use of 3 pads per day
• Not improved = more than 3 pads per day
Success rates are summarized in Table 2.
Fully and socially continent
Occasional incontinence
Fair/improved
Not improved
Patient Information Form (PIF) Study
A retrospective analysis was performed for female patients
implanted (n=637) with the AMS 800 during the five-year
period 2000- 2005. The study examined Patient Information
Form (PIF) data sent to the manufacturer by the implanting
physician for original implants and revision surgeries. A revision
is a surgical intervention related to the function, placement, or
site reaction to the implanted device. PIF data is required to be
on file by the manufacturer in order to be eligible for product
replacement. Of the 637 female patients implanted during the
period studied, 76 patients had undergone a total of 88 revision
surgeries (1.16 revisions per patient). There were a total of 121
reported reasons for revisions. Note that more than one reason
may be listed for the same revision. The data in Table 3 presents
6
Percentage
5.8%
4.2%
3.4%
3.3%
2.8%
1.5%
1.3%
1.2%
1.1%
1.0%
0.6%
0.4%
0.4%
0.3%
0.3%
0.3%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
2,4,5,6,7,12,13,16,17
Table 2. Success Rates
Success Criteria
Reference
2,8,11,17
2,4,8,11,13
3,6,7,10,13,17
1
2,3,9,12,13,15,16,17
2
2,16
2,4,11
2,6
2,14
1,4,8,10,17
16
1
17
4
2
1
1
2
13
16
1,2,13,16,17
3
6
9
13
10
15,16
, rates of success were
% patients
86.9%
4.4%
4.3%
7.1