37582-01E
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Blom-Singer® Indwelling Valved/Plug Insert
Voice Prosthesis Removal
Never attempt to remove the Indwelling voice prosthesis by
yourself or allow anyone other than a qualified, trained medical
professional to remove the voice prosthesis.
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.
