Gastric Balloon Removal Consent Form

Gastric Balloon Consent Removal Form

DESCRIPTION

The Gastric Balloon is a temporary gastric balloon that promotes weight loss in overweight and obese individuals. The Allurion Balloon is a gastric balloon (also known as an intragastric balloon or IGB) that is enclosed in a Capsule and is swallowed by the patient to introduce the Balloon into the stomach. During swallowing, the proximal end of the Delivery Catheter remains outside of the patient’s mouth to permit filling. Once the Balloon position has been confirmed to be in the stomach via X-ray, the Balloon can be filled with the provided Filler Kit. After filling, the Delivery Catheter is removed from the Balloon by gently pulling back. The filled Gastric Balloon is designed to remain in the stomach for approximately 16 weeks. However, the duration of balloon residence may vary between individuals. During this time, the Balloon operates in the same ways as other IGBs to promote satiety and reduce food consumption The patient is supervised by a trained dietitian/ nutritionist that will ensure at least 4 follow-up visits during that period. At the end of the treatment period, the Balloon is designed to automatically open and drain. At this point, the empty Balloon is designed to transit the gastrointestinal tract and be excreted without further intervention. In some cases, the drained Balloon may exit the stomach via vomiting.

INDICATION
Any history of:
- Perforated appendicitis or any other perforated abdominal viscus
- Actual, or suspected, bowel obstruction small bowel surgery
- Intraperitoneal adhesion

Conditions that predispose to bowel obstruction:
Crohn’s disease
Severe GI motility disorder (example: severe, gastroparesis).

Conditions that predispose to gastric
perforation Any history of:
- Previous bariatric, gastric or esophageal surgery - Laparoscopic band ligation
- Anti-reflux surgery
GI bleeding or conditions that predispose to GI bleeding:
History of vascular lesions(Ex: esophageal gastric or duodenal varices, intestinal telangiectasia’s) Recent history of inflammatory conditions
(Ex: esophagitis, gastritis, gastric ulceration or duodenal ulceration) Benign or malignant GI tumors
Inability to discontinue use of NSAIDs (or other gastric irritants) during the device period Use of anticoagulants
Severe coagulopathy
Hepatic insufficiency or cirrhosis
Inability or unwillingness to take PPI

medication. Other conditions:
Serious or uncontrolled psychiatric illness
Diagnosed bulimia, binge eating, compulsive overeating, or similar eating-related psychological
disorder Alcoholism or drug addiction
Pancreatitis
Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery
disease Cancer
Known or suspected allergies to
polyurethane Pregnant or nursing
women
Inability or unwillingness to take prescribed antiemetic medications.

RISKS AND SIDE EFFECTS:
After balloon removal, certain side effects are normal and expected:
Common:
Nausea Vomiting Abdominal pain
Abdominal cramps Esophageal reflux
Throat pain due to endoscopy insertion
Uncommon:
Chest Pain Fatigue

Abdominal distention with or without discomfort, Gastritis, Gastric or duodenal ulcers, Mallory-Weiss tear, Mucosal laceration, Difficulty breathing, Dehydration, Halitosis, Infection, Allergic reaction, Adverse tissue reaction, Aspiration, aspiration pneumonia, Death. This list is non-exhaustive and other adverse events that are not listed here may arise.

I understand and agree that I am financially responsible for the payment I made for that any amount I paid for the sessions or procedures I booked it will only be valid up to 3 months from the date I made the payment. I understand that I need to utilize the sessions or procedures within 3 months period. I agree that my payment made is non-refundable or non-transferable post this period.

I declare that I have read and fully understood all points in this consent and that all of my questions were answered to my satisfaction and I take the full responsibility of my decision in this consent.