23300088_Testicular Prosthesis IFU_0409 - AMS Labeling ...

Precautions
• Migration of the prosthesis may occur if the prosthesis is not
sutured in place.
• Use of an oversized prosthesis for the existing scrotal pocket
may result in necrosis and subsequent extrusion.
• The implantation of this prosthesis should only be considered in
patients whom the physician determines are adequate surgical
candidates.
• A thorough preoperative consulta tion should include a
discussion between patient and physician of all available
treatment options and their risks and benefits.
Warnings
This prosthesis contains a silicone elastomer. The risks and
benefits of implanting this prosthesis in patients with documented
sensitivity to silicone should be carefully considered.
Silicone Information
This prosthesis is composed of a silicone elastomer. Silicone gel is
not a component in the materials of this prosthesis.
Silicone elastomers have been commonly used in a variety of
biomedical devices for over 40 years and are used as a
biocompatibility reference against which new materials are tested.
Silicone elastomers 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.
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