Adverse Events - apollo endosurgery ORBERA Guia Del Usuario

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 of
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 recurrent
medications can further delay gastric emptying and may
lead to stomach distention, perforation and possibly
death.
To prevent ulcers and control gastroesophageal reflux
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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 they
Furthermore, subjects will be directed to avoid
medications known
gastroduodenal mucosal damage.
The IGB is a silicone elastomer balloon which may be
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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
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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
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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.
the IGB, and/or prokinetic
symptoms as
are no longer needed.
to cause or exacerbate
medications
In preparation for removal, some patients may have
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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.
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
stomach. This could lead to possible bowel obstruction and
these
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.
10.

ADVERSE EVENTS

It is important to discuss all possible adverse events with
your patient. Adverse events that may result from the use of
this product include the risks associated with the
medications and methods utilized in the endoscopic
procedure, the risks associated with any endoscopic
procedure, the risks associated with the IGB specifically,
and the risks associated with the patient's degree of
intolerance to a foreign object placed in the stomach.
NOTE: Any serious incident that has occurred in relation to
the device should be reported to Apollo Endosurgery (see
contact information at the end of this document) and any
appropriate government entity.
10.1 Possible Adverse Events
Possible adverse events associated with the use of the IGB
include:
• Death due to complications related to aspiration,
intestinal obstruction, gastric perforation, or esophageal
perforation, is possible.
Intestinal obstruction by the IGB. An insufficiently filled
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IGB or a leaking IGB that has lost sufficient volume may
be able to pass from the stomach into the small bowel.
It may pass all the way into the colon and be passed
with stool. However, if there is a narrow area in the
bowel or adhesion formation, which may occur after
previous surgery on the bowel, the IGB may not pass
and could cause a bowel obstruction. If this occurs,
surgery or endoscopic removal could be required.
• Esophageal obstruction. When the IGB is being filled in
or
the stomach, the IGB could be inadvertently pulled back
into the esophagus. If this occurs, surgery or
endoscopic removal could be required.
• Gastric outlet obstruction. A partially filled IGB (i.e.,
<400cc), or a leaking IGB could lead to gastric outlet
obstruction, requiring IGB removal. It is also possible for
a fully filled (400-700cc) IGB to impair the gastric outlet,
which can produce a mechanical impediment to gastric
emptying. Gastric outlet obstruction may require early
removal.
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