6
Aspiration of the prosthesis – Accidental aspiration of the voice prosthesis or other components
of the voice rehabilitation system may occur. As with any other foreign body, complications from
aspiration of a component may cause obstruction or infection. Immediate symptoms may include
coughing, wheezing or other abnormal breathing sounds, dyspnea, and respiratory arrest, partial or
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. If aspiration
and during endoscopy, the device may appear as a oval shape with an opening in the middle with an
light source on the clear silicone rubber may be seen. Also, in prostheses that have been in situ for
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 a 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 esophagoscopy 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 from 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.
to observe the stools for the ingested device. If the device does not pass spontaneously, or if there
are signs of obstruction (fever, vomiting, abdominal pain) a gastroenterologist should be consulted.
The silicone housing of the Vega voice prosthesis can be located and retrieved endoscopically. The
device may be retrieved by using a non toothed grasping forceps. During endoscopy, the device may
be visible on the device.
Infection and/or edema of the TE-puncture – Infection, granulation formation and/or edema of the
puncture may increase the length of the puncture tract. This may cause the prosthesis to be drawn
mucosa may also cause the prosthesis to protrude from the puncture. Temporary replacement of the
prosthesis by a prosthesis with a longer shaft is then advisable. If standard medical treatment does
not resolve the infection, the prosthesis should be removed. In some cases stenting the puncture with
new prosthesis may be required.
Granulation around the puncture
granulation may be considered.
Granulation/Hypertrophic scarring around the puncture – Bulging of the tracheal mucosa over
by using a laser. Alternatively, a prosthesis with a longer shaft can be used.
Protrusion/extrusion of the prosthesis – Protrusion of the prosthesis and subsequent spontaneous
required to avoid dislodgement into the trachea. The puncture may close spontaneously secondary
Tissue damage – If the prosthesis is too short, too long, or is pushed frequently against the esophageal
and/or esophageal tissues may occur. Inspect the conditions regularly to avoid severe damage.
Leakage through the valve – Leakage through the prosthesis may occur because:
rehabilitation and an indication to replace the voice prosthesis.
Leakage around the prosthesis – Transient leakage around the prosthesis may occur and may resolve
spontaneously. The most common reason is that the prosthesis is too long, which is solved by inserting
a shorter prosthesis. If the problem is not solved by inserting the correct length prosthesis, other
(e.g., collagen) or temporary removal of the voice prosthesis, should be considered. If the leakage
around the voice prosthesis is intractable, more conservative measures, such as surgical closure of
the puncture may be necessary.
2. Instructions for use
Please see accompanying Illustration manual for illustrations referenced in this Instructions
for Use.
section headings below.
Caution: The videos do not replace nor do they set forth the complete contents of the Instructions
for Use and /or Prescriber Information, and are not a substitute for reviewing the entire contents of
the Instructions for Use. The videos are only intended to further enhance the understanding of the
procedure after review of the Instructions for Use.
2.1 Preparation
Prior to the puncture always determine what size and diameter of voice prosthesis to use. The appropriate
size and diameter depends on the anatomy of the patient, local medical practice and preference of
the surgeon.