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8.
PRECAUTIONS
•
Temporary weight-loss treatments have been shown to
have poor long-term success rates in obese and
severely obese patients.
When filling the IGB, the use of sterile saline and
•
aseptic technique, similar to changing IV fluids (e.g. use
of clean gloves, sterile syringe, etc.), is recommended.
Though the cause of hyperinflation is unknown, it may
be
caused
contaminating
mitigation is to avoid contaminating the saline within the
balloon with micro-organisms that may lead to
spontaneous hyperinflation.
If difficulty with the IGB Placement Catheter Assembly
•
is noted during placement (e.g., resistance to IGB
filling), then the device should be removed and replaced
with a new IGB. To lessen, or prevent Placement
Catheter defects, the catheter must remain slack during
the filling process. If the Placement Catheter is under
tension during this process, the tip of the catheter may
dislodge from the IGB and prevent further IGB
deployment.
•
Placement of the IGB within the stomach has been
shown to produce a delay in gastric emptying. This can
create a variety of expected and predictable reactions
including a feeling of heaviness in the abdomen,
nausea
and
belching, esophagitis, heartburn, diarrhea and, at times,
abdominal, back or epigastric pain and cramping. Food
digestion may be slowed throughout the entire
placement duration due to the delay in gastric emptying.
Most patients acclimate to the presence of the device
within the first two (2) weeks. In order to prevent or
ameliorate the symptoms most frequently experienced
after placement, physicians should prescribe proton
pump inhibitors (PPIs) and antiemetics prophylactically
and consider prescribing temporarily antispasmodics or
anticholinergic medications for cramping due to
accommodation
medications for symptoms due to the delay in gastric
emptying. Patients should be advised to immediately
contact their physician for any unusually severe,
worsening,
or
medications can further delay gastric emptying and may
lead to stomach distention, perforation and possibly
death.
•
To prevent ulcers and control gastroesophageal reflux
symptoms, it is recommended that the patient start a
program of oral proton pump inhibitors (PPIs) for
approximately 3-5 days prior to IGB placement so a
maximal gastric acid suppression effect will be present
on the day of placement. It is recommended that the
PPI dose be given sublingually after IGB placement if
nausea and/or vomiting are present. A starting full dose
daily regimen of an oral PPI should be continued as
long as the IGB is in place. Other medications that are
started prophylactically should be continued after IGB
placement
until
Furthermore, subjects will be directed to avoid
medications
gastroduodenal mucosal damage.
by
fungal
or
bacterial
the
balloon.
One
recommended
vomiting,
gastroesophageal
of
the
IGB,
and/or
recurrent
symptoms
they
are
no
longer
known
to
cause
or
•
•
microbes
•
•
•
reflux,
•
prokinetic
9.
RISK ASSOCIATED WITH RE-USE
The IGB System is for single use only. Removal of the IGB
requires that it be punctured in situ to deflate, and any
subsequent reuse would result in the IGB deflating in the
as
these
stomach. This could lead to possible bowel obstruction and
may require surgery to remove. Should an IGB be removed
from the patient prior to being filled with saline, it still cannot
be reused on a new patient as any attempt to decontaminate
this device could cause damage resulting again in deflation
after implantation.
needed.
exacerbate
6
The IGB is a silicone elastomer balloon which may be
degraded by gastric acid. Physicians have reported the
concurrent use of medications, such as proton pump
inhibitors, may reduce acid formation or reduce acidity
which can prolong the integrity of the IGB (reduce the
risk of device deflation) and may help to reduce the risk
of gastric ulcers and subsequent perforation.
The physiological response of the patient to the
presence of the IGB may vary depending upon the
patient's general condition and the level and type of
activity. The types and frequency of administration of
drugs or diet supplements and the overall diet of the
patient may also affect the response.
The IGB has not been studied on individuals who have
a patulous pylorus, active H. pylori infection, and
subjects with either symptoms or a diagnosis of delayed
gastric emptying.
Patients
taking
anti-cholinergic
psychotropic medications should be informed that these
medications will delay gastric emptying and should be
used sparingly as they may put them at greater risk for
stomach distention and perforation. Patients should be
advised to immediately contact their physician for any
unusually severe, worsening or recurrent symptoms.
A patient who's deflated (i.e. collapsed) IGB has moved
into the intestines must be monitored closely for an
appropriate period of time (at least 2 weeks) to confirm
its uneventful passage through the intestine.
In preparation for removal, some patients may have
retained contents in the stomach. Some patients may
have clinically significant delay in gastric emptying and
refractory intolerance to the IGB, necessitating early
removal, and possibly leading to other adverse events.
These patients may be at higher risk of aspiration upon
removal and/or upon administration of anesthetic. The
anesthesia team should be alerted to the risk for
aspiration in these patients.
medications
or
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