AMS 800 Instrucciones De Uso página 11

Table 4. In Vitro Zone of Inhibition for
Device Samples* with InhibiZone Treatment
Organism
Staphylococcus
epidermidis
Staphylococcus aureus
Escherichia coli**
Enterococcus faecalis**
Candida albicans**
Proteus mirabilis**
* obtained using standardized kink-resistant tubing test samples containing
approximately 12µg minocycline HCl and 26 µg rifampin
** the isolates tested were not susceptible to rifampin and/or minocycline HCl
control disks
An animal infection study was conducted using 11 rabbits. Five
rabbits were implanted subcutaneously with 6 test samples each
and five rabbits were implanted subcutaneously with 6 control
samples each. One rabbit received three test samples and three
control samples. The test samples were portions of an InhibiZone
treated AMS 700 pump and the control samples were portions
of a standard AMS 700 pump without InhibiZone. The AMS
700 Pumps used in the 700 Series of Inflatable Penile Prostheses
is similar to AMS 800 Pumps used in the 800 Series of Artifical
Urinary Sphincters in regards to material composition, adhesive,
and InhibiZone application process. All samples were soaked in a
10 -10 CFU solution of staphylococcus aureus, Sheretz strain for
3 4
8 hours. Samples were then allowed to dry for 30 minutes prior
to surgical placement in the rabbit. After 2 days, all samples were
removed and observed for growth on the samples. The number
of coated samples that were infected was statistically significantly
lower than the number of control samples that were infected.
Silicone Information
This device is composed of a number of materials, including
solid silicone elastomers and a fluorosilicone lubricant. Silicone
gel is not a component in the materials of this device.
Solid silicone elastomers have been commonly used in a variety
of biomedical devices for over 40 years. Silicone fluids have an
extensive history of use in medical devices.
Scientific literature has included reports of adverse events and
other observations in patients with implantable silicone devices.
As reported, these events/observations indicate "allergic-like"
symptoms and in other cases a symptom complex associated
with immunological disorders. No causal relationship has been
established between these events and silicone elastomer or
fluorosilicone lubricant.
There are reports of malignant tumor formation in laboratory
animals only associated with implants of relatively large size.
Many different materials are associated with this effect in
animals, silicone elastomers among them. No such effect has
been described in humans.
Extensive testing has been conducted on all materials that
comprise the AMS 800. This testing has indicated no
toxicological response attributable to the materials. However,
some of the materials caused minor irritation when implanted in
animals.
Silicone elastomer particulate shedding and particulate
migrations to regional lymph nodes have been reported in
the literature on penile implants. There are no known clinical
sequelae to this phenomenon.
Mean (mm) S.D. (mm)
22.6 2.9
17.5 5.0
6.5 2.6
4.8 6.7
0.1 0.4
0.6 1.0
Number of
Isolates
21
25
24
21
21
17
9 9