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Warnings
1. Implantation of the device will
make latent natural or spontaneous
erections as well as other
interventional treatment options,
impossible.
2.
Men with diabetes, spinal cord injuries,
or open sores may have an increased
risk of infection associated with a
prosthesis.
3.
Failure to evaluate and promptly treat
erosion may result in a substantial
worsening of the condition leading to
infection and loss of tissue.
4.
Implantation of a penile prosthesis
may result in penile shortening,
curvature or scarring.
5.
This device contains solid silicone
elastomer. The risks and benefits of
implanting this device in patients with
documented sensitivity to silicone
should be carefully considered.
6.
Pre-existing abdominal or penile
scarring or contracture may
make surgical implantation more
complicated or impractical.
Precautions
Surgery Related
1.
Spontaneous unintended inflation or
deflation of the cylinders may occur
and may result in unintended partial
or full erections.
2.
Migration of the device components
can occur if the cylinders are
improperly sized, or if the pump is not
positioned properly.
3.
Removal of an implanted prosthesis
without timely reimplantation of
a new prosthesis may complicate
subsequent reimplantation or may
make it impossible.
4.
Improper measurement technique,
positioning or sizing may reduce
cylinder life.
5.
Unsuccessful outcomes have been
reported due to improper surgical
technique, anatomical misplacement
of components, improper sizing of
components, or tubing kinks.
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