Clinical Information - Females - AMS 800 Instrucciones De Uso

Room Manual to prepare the radiopaque solution with the
correct concentration.
How Supplied and Storage
Store device in a clean, dry, dark area at room temperature.
Contents supplied STERILE. Do not use if
WARNING:
sterile barrier is damaged. If damage is found, call your AMS
representative.
For single patient use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of the product and packaging in accordance
with hospital, administrative and/or local government policy.
Clinical Information – Females
The AMS 800 is indicated for the treatment of urinary
incontinence in females and in children. A literature review was
performed to evaluate the safety and efficacy of the AMS 800
in female patients. A total of seventeen documents, specifically
reporting clinical information for female patients only, were
analyzed. Clinical data, including patient demographics, etiology,
complications, and success criteria and rates are reported below.
Patients
Clinical efficacy has been reported for 938 female patients,
ages ranging from 9-85, implanted with the AMS 800
The mean reported follow-up on 785 AMS 800 patients
was 3.6 years . Various patient etiologies were reported,
1-17
including neuropathic bladder dysfunction
incontinence
1,4,6,7,8,9,12,15,16,17
congenital defects (exstrophy)
cystectomy , nonneurogenic bladder
1
deficiency , myelomeningocele
2,6
palsy . Prior surgery or radiotherapy were reported in 354
14
patients
2,3,5,6,8,10,12,15,16
Complications
The following adverse events have been associated with the
use of this product: bladder injury, bleeding, bothered by
device, contracture, cuff erosion, cutaneous erosion, deep
vein thrombosis, device damage – unrelated procedure, device
displacement, device fluid leak, device malfunction, dysuria,
early post-operative morbidity, edema, enterocutaneous fistula,
exposure to biohazardous material, extrusion, fibrosis, foreign
body/unretrieved device fragment, hematuria, herniation,
herniation of the device, incisional hernia, infection, infection/
erosion, labia hematoma, limited urethral coaptation, loose
cuff, nerve injury, overactive bladder, pelvic abscess, perforation,
phlebitis, pressure atrophy at cuff site, pulmonary embolus,
pump erosion, sphincter-related problem, superficial wound
dehiscence, upper urinary tract deterioration, urethral atrophy,
urethral injury, urethral stricture, urge de novo, urinary
retention, urinary urgency, vaginal injury, wound dehiscence,
wound seroma.
Table 1 summarizes the reported complications for 938 patients
receiving an AMS 800 implant. The most common reported
complication was bladder injury, which occurred in 5.8% of
patients (n=54). There may have been more than one reported
, pelvic/perineal trauma
, hysterectomy
1
2,13
, spinal injury
13,14
.
1-17
, stress
1,2,3, 4,13
,
1,4,12,13
, radiotherapy
1
, intrinsic sphincter
, and cerebral
13
.
,
1
5 5