apollo endosurgery ORBERA Guia Del Usuario página 5

are also significantly higher when filled to a larger
volume than indicated (greater than 700cc).
• Bowel obstructions have been reported due to deflated
IGBs (i.e. collapsed) passing into the intestines and
have required surgical removal. The risk of intestinal
obstruction may be higher in patients who have a
dysmotility disorder or who have had prior abdominal or
gynecological surgery, radiation therapy, and/or active
inflammatory bowel disease, so this should be
considered in assessing the risk of the procedure.
Bowel obstructions can result in death.
Deflated devices should be removed promptly. Patients
•
should be advised that IGB deflation may lead to
serious adverse events including bowel obstruction and
need for emergency
immediately call their physician to receive instructions
on preparing for removal of the IGB.
• Patients reporting loss of satiety, increased hunger
and/or weight gain should be examined endoscopically,
as this is indicative of a IGB deflation.
If it is necessary to replace an IGB that has
•
spontaneously deflated
replacement IGB with the same volume of sterile saline
that was used during the placement of previous IGB (i.e.
initial fill volume). A greater initial fill volume in the
replacement IGB may result in severe nausea, vomiting
or ulcer formation.
Acute pancreatitis has been reported as a result of
•
injury to the pancreas by the IGB. Patients experiencing
any symptoms of acute pancreatitis should be
counseled to seek immediate care. Symptoms may
include nausea, vomiting, abdominal or back pain,
either steady or cyclic. If abdominal pain is steady,
pancreatitis may have developed.
Spontaneous hyperinflation of an indwelling IGB with
•
gas has been reported in patients with an indwelling
IGB. Symptoms of significant IGB over-inflation include
intense abdominal pain, swelling of the upper abdomen
(abdominal distension) with or without discomfort,
difficulty breathing, gastroesophageal reflux, nausea
and/or vomiting. Patients experiencing any of these
symptoms should be counseled to seek immediate care
and should be evaluated for hyperinflation, particularly
when persistent abdominal pain, abdominal distension,
and food intolerance
accommodative period of the IGB. Plain radiographic
films will often demonstrate hyperinflation with a large
air-fluid level within the IGB and an increase in IGB
volume compared to the original volume.
Hyperinflation of the IGB often warrants its early
•
removal to prevent serious complications such as
gastric outlet obstruction and contact ulceration.
Because hyperinflation increases the internal pressure
of the IGB (due to accumulated gas) and may increase
the fragility of the IGB wall, there is an increased risk of
rupture followed by the sudden forceful release of gas
and fluid contents
endoscopically manipulated. Therefore, it is suggested
that the patient's airway is protected with endotracheal
intubation prior to endoscopic removal in order to
prevent pulmonary aspiration of the balloon contents.
Additionally, in situations in which controlled balloon
surgery. Patients should
(i.e. collapsed), fill
occur beyond the initial
when it is punctured
aspiration is done, it is recommended that mid-stream
fluid aspirated from the balloon is sent for bacterial and
fungal cultures.
Pregnancy or breast-feeding contraindicates use of this
•
device. Should pregnancy be confirmed at any time
during the course of treatment, the device should be
removed as soon as it is safely possible.
Endoscopic removal of the IGB must be completed in
•
the presence of an empty stomach. Patients should be
on a liquid diet for 72 hours and NPO (i.e. nothing by
mouth) for a minimum of 12 hours prior to removal. If
food is found in the stomach upon endoscopic
examination, then measures (aspiration of stomach
contents,
procedure) must be taken to protect the airway. The
risk of aspiration of gastric contents into the patient's
lungs represents a serious risk which can result in
death. IGBs cause delayed gastric emptying which may
increase the time typically needed to ensure an empty
stomach prior to endoscopic procedures
• Patients should be advised to take the necessary
precautions to prevent pregnancy prior to placement
the
and throughout the duration of treatment. Patients
should be instructed to inform you as soon as possible
if pregnancy is confirmed during treatment, so that
removal of the device can be arranged.
Patients with an IGB that present with severe abdominal
•
pain that have a negative endoscopy and x-ray may
additionally require a CT scan to definitively rule out a
perforation.
• The IGB is composed of soft silicone elastomer and is
easily damaged by instruments or sharp objects. The
IGB must be handled only with gloved hands and with
the instruments recommended in this document.
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
or
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 vomiting, gastroesophageal reflux,
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endotracheal intubation,
by fungal or bacterial
the balloon. One
or delay of
microbes
recommended