Contraindications - Apollo ORBERA Intragastric Balloon System Bedienungsanleitung

Bowel obstructions have been reported due to deflated
balloons passing into the intestines and have required
surgical removal. Some obstructions have reportedly
been associated with patients who have diabetes or
who have had prior abdominal surgery, so this should be
considered in assessing the risk of the procedure. Bowel
obstructions can result in surgical treatment or death.
The risk of intestinal obstruction may be higher in patients
who have had prior abdominal or gynecological surgery.
The risk of intestinal obstruction may be higher in
patients who have a dysmotility disorder or diabetes.
Pregnancy or breast-feeding contraindicates use of this
device. Should pregnancy be confirmed at any time
during the course of treatment, it is recommended that
the device be removed.
Patients should be advised to take the necessary
precautions to prevent pregnancy prior to placement
and throughout the duration of treatment, and be
instructed to inform you as soon as possible if pregnancy
is confirmed during treatment, so that removal of the
device can be arranged.
Proper positioning of the Placement Catheter Assembly
and the ORBERA® System balloon within the stomach
is necessary to allow proper inflation. Lodging of the
balloon in the esophageal opening during inflation may
cause injury and/or device rupture.
The physiological response of the patient to the
presence of the ORBERA® System balloon 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.
Each patient must be monitored closely during the
entire term of treatment in order to detect the
development of possible complications. Each patient
should be instructed regarding symptoms of deflation,
gastrointestinal obstruction, acute pancreatitis,
spontaneous inflation, ulceration, gastric and
esophageal perforation, and other complications
which might occur, and should be advised to contact
his/her physician immediately upon the onset of such
symptoms.
Patients reporting loss of satiety, increased hunger and/or
weight gain should be examined endoscopically, as this is
indicative of a balloon deflation.
Patients with an intragastric balloon 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.
If it is necessary to replace a balloon which has
spontaneously deflated, the recommended initial fill
volume of the replacement balloon is the same as for the
first balloon or the most recent volume of the removed
balloon. A greater initial fill volume in the replacement
balloon may result in severe nausea, vomiting or ulcer
formation.
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 balloon, 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.
The ORBERA® System balloon is composed of soft silicone
elastomer and is easily damaged by instruments or sharp
objects. The balloon must be handled only with gloved
hands and with the instruments recommended in this
document.
RISK ASSOCIATED WITH RE-USE
The ORBERA® System balloon is for single use
only. Removal of the balloon requires that it is punctured
in situ to deflate, and any subsequent reuse would result
in the balloon deflating in the stomach. This could lead
to possible bowel obstruction and may require surgery
to remove. Should the balloon be removed prior to
implantation, it still cannot be reused as any attempt to
decontaminate this device could cause damage resulting
again in deflation after implantation.

CONTRAINDICATIONS

Contraindications for use of the ORBERA® System include:
• The presence of more than one ORBERA® System
Balloon at the same time.
• Prior gastrointestinal surgery.
• Any inflammatory disease of the gastrointestinal
tract including esophagitis, gastric ulceration,
duodenal ulceration, cancer or specific inflammation
such as Crohn's disease.
• Potential upper gastrointestinal bleeding conditions
such as esophageal or gastric varices, congenital or
acquired intestinal telangiectasis, or other congenital
anomalies of the gastrointestinal tract such as atresias
or stenoses.
• A large hiatal hernia or > 5cm hernia.
• A structural abnormality in the esophagus or pharynx
such as a stricture or diverticulum.
• Any other medical condition which would not permit
elective endoscopy.
• Major prior or present psychological disorder.
• Alcoholism or drug addiction.
• Patients unwilling to participate in an established
medically-supervised diet and behavior
modification program, with routine medical follow-
up.
• Patients receiving aspirin, anti-inflammatory agents,
anticoagulants or other gastric irritants, not under
medical supervision.
• Patients who are known to be pregnant or
breast-feeding.
COMPLICATIONS
Possible complications of the use of the ORBERA® System
include:
• Intestinal obstruction by the balloon. An
insufficiently inflated balloon or a leaking balloon
that has lost sufficient volume may be able to pass
from the stomach into the small bowel. It may pass
all the way through into the colon and be passed
with stool. However, if there should be a narrow area
in the bowel, as might occur after prior surgery on
the bowel or adhesion formation, the balloon may
not pass and then may cause a bowel obstruction.
If this occurs, percutaneous drainage, surgery or
endoscopic removal could be required.
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