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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.
Silicone elastomers have been commonly
used in a variety of biomedical devices
for over 40 years and are used as a
biocompatability reference against which
new materials are tested. 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 casual
relationship has been established between
these events and silicone elastomer or
fluorosilicone lubricant.
There are reports of malignant tumor
formation in laboratory animals only,
not humans, 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 prostheses
in the AMS Ambicor. 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.
Magnetic Resonance
Imaging (MRI)
Important Safety
MR
Information
Non-clinical testing has demonstrated the
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