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Accessories to maintain the device function (for
patient’s use)
•
Provox Brush / Provox Brush XL
is used by the patient to clean
the inside of the prosthesis.
•
Provox Flush
is an additional cleaning device that allows flushing
of the prosthesis.
•
Provox Vega Plug
is a First Aid tool for patient’s use that
temporarily blocks leakage through the prosthesis.
Other supplementary products that can be used with
Provox voice prostheses
•
Provox HME:
Heat- and Moisture Exchanger partially restores
lost nasal functions (heating, humidifying, breathing resistance).
•
Provox FreeHands HME:
A Heat and Moisture Exchanger
combined with an automatic tracheostoma valve, designed to
allow hands-free speech.
•
Provox LaryTube:
A silicone tracheal cannula intended to
support shrinking stomas while retaining other rehabilitation
devices of the Provox System.
•
Provox LaryButton:
A soft, self-retaining silicone tracheal
cannula intended to support shrinking stomas while retaining other
rehabilitation devices of the Provox System.
4. Adverse events/Trouble shooting
information
The following are possible risks associated with prosthetic voice
rehabilitation:
Prosthesis related
Leakage through the valve
– Leakage through the prosthesis may
occur in association with Candida overgrowth of the valve flap or
dislodgement of the radio opaque ring (valve seat). It may also occur
if the esophageal flange of the prosthesis is not fully developed in the
lumen of the esophagus or if the prosthesis is too short. Endoscopic
examination should be performed to determine whether any of
these phenomena has occurred. If the prosthesis is in the correct
position and of the right length, and if cleaning of the prosthesis
does not resolve leakage through the prosthesis, replacement of the
prosthesis is indicated.
Candida overgrowth
– Candida overgrowth of the prosthesis occurs
in almost all patients. Radiotherapy, salivary content and dietary habits
may influence how rapidly Candida can affect the silicone material.
Treatment with antifungal agents may be considered as a preventive
measure if Candida overgrowth causes leakage through the prosthesis
or other incompetence of the valve.
Compatibility with antifungal medicine
– An unknown variety
of chemical substances may immediately influence the material
properties of the device or may be absorbed by the material and
subsequently released at a later time. Therefore, the introduction of
antifungal medicines or drugs directly to or within close proximity
of the voice prosthesis should be carefully assessed.
Laboratory tests show only minor negative influence on the function
of the Provox Vega voice prosthesis and components when using the
following antifungal medications:
• Nystatin
• Fluconazole
• Mikonazol
Puncture related
Aspiration of the prosthesis
– Accidental aspiration of the voice
prosthesis or other components of the voice rehabilitation system
may occur. Immediate symptoms may include gagging, coughing,
choking or wheezing. As with any other foreign body, complications
from aspiration of a component may cause obstruction or infection.
Complications may include pneumonia, atelectasis, bronchitis,
lung abscess, bronchopulmonary fistula and asthma. If the patient
can breathe, coughing may remove the foreign body. Partial airway
obstruction or complete airway obstruction requires immediate
intervention for removal of the object.
Ingestion of the prosthesis
– Accidental ingestion of the voice
prosthesis, or other components of the voice rehabilitation system,
may occur. As with any other foreign body, the symptoms caused by
ingestion of the prosthesis or component of the voice rehabilitation
system depends largely on size, location, degree of obstruction (if
any) and the length of time it has been present. Ingested components
that have remained in the lower esophagus may be removed by
esophaguscopy or observed for a short period of time. The object
may pass spontaneously into the stomach; foreign bodies that pass
into the stomach usually pass through the intestinal tract. Surgical
removal of foreign bodies in the intestinal tract must be considered
when bowel obstruction occurs, bleeding is present, perforation occurs
or the object fails to pass through the intestinal tract.
Hemorrhage/Bleeding of the puncture
– Slight bleeding from
the edges of the TE-puncture may occur during replacement of the
prosthesis and generally resolves spontaneously. Patients on anti-
coagulant therapy, however, should be carefully evaluated for the risk
of hemorrhage prior to placement or replacement of the prosthesis.
Infection and/or edema of the TE-puncture
–Infection, granulation
formation and/or edema of the puncture (e.g during radio therapy)
