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may be required more frequently. Some patients can be treated
successfully for yeast with oral medication or mouth rinses.
Device Removal
The voice prosthesis may be used until it ceases to function
correctly, that is, until it leaks or is not providing adequate
voice for speech. Many clinicians recommend routine follow-up
evaluations not longer than 6 months.
Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician or a licensed speech pathologist.
COMPLICATIONS
Although rare, the following complications have been identified
to occur with silicone prostheses of the Blom-Singer type. They
include:
•
stoma contamination or bacterial infection, which may require
removal of the prosthesis and/or appropriate antibiotics;
•
accidental inhalation of the voice prosthesis into the airway,
which may require removal by a physician;
•
inhalation of liquids through the prosthesis into the airway,
which may cause the patient to cough;
•
occasional movement out of position by the voice prosthesis,
requiring replacement after enlargement of the TE puncture
and additional supervision of the stoma care regimen;
•
puncture enlargement resulting in leakage of fluids around
the prosthesis;
•
inflammatory reaction around the puncture site and formation
of scar tissue;
•
dislodgment of the voice prosthesis and subsequent closure
of the TE puncture;
•
chronic and persistent leakage around the voice prosthesis,
requiring surgical revision or closure of the puncture;
•
difficulty speaking or swallowing;
•
tearing or other damage to the voice prosthesis from improper use;
•
yeast deposits causing leakage through the prosthesis or
inability of the valve to function properly;
•
accidental swallowing of the prosthesis into the esophagus
and/or gastrointestinal (GI) tract.
Blom-Singer ® Patient-changeable Voice Prostheses
37531-01F | 9
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