Informed Consent Agreement

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ALLURION BALLOON SERVICES

NBC | INFORMED CONSENT AGREEMENT FOR ALLURION BALLOON SERVICES

This Informed Consent Agreement ("Agreement") outlines the terms and conditions of the Gastric Balloon Insertion Services ("Services") offered by the Nairobi Bariatric Center ("Clinic"). By signing this Agreement, you are consenting to participate in the Services, and you agree to abide by the responsibilities and terms outlined below:

Procedure Overview

As explained to me by the consulting doctor, I understand the anatomy of the Allurion Balloon procedure as follows:

  1. The process starts with an initial consultation with Dr.Shchukina, who will explain the process and make sure you feel safe and comfortable. They will discuss your weight-loss goals and health history to ensure that the Allurion Balloon is right for you.
  2. The procedure: Swallow a small capsule which contains the deflated gastric balloon. It is attached to a very thin catheter that the doctor will use to inflate the Balloon with water once placed in your stomach. X-rays are used to ensure the Balloon is in the right position and filled correctly before the catheter is gently removed.
  3. After approximately 16 weeks, the Balloon naturally deflates and passes through the digestive system*. NBC support team remain at hand to help you maintain your new relationship with food and keep the weight off.

Procedure Consent

I consent to have a the Allurion Balloon for the purpose of medical weight loss. I had an initial consultation with Nairobi Bariatric Center’s doctor, Dr. Shchukina, and we have agreed that my treatment will be the Allurion Balloon Procedure combined with Weight Loss Psychotherapy for sustainable results.

I will meet my attending doctor who will perform the procedure on the day of the procedure at the hospital. 

Benefits of the Allurion Balloon

It was brought to my attention that obesity is associated with early death and significant medical problems such as diabetes, obstructive sleep apnea, high cholesterol, infertility, cancer, gastro-esophageal reflux, arthritis, chronic headaches, gout, venous stasis disease, liver disease and heart failure, among other problems. This procedure aims to help you lose weight and improve the aforementioned obesity-related conditions.

Side Effects and Risks of the Gastric Balloon

I understand that there might be some common initial side effects associated with the procedure commonly experienced within the first few days after the procedure, such as:

  1. Nausea, vomiting, cramping, heartburn and constipation 
  2. Acidity
  3. Hypersalivation or dryness of the mouth

I understand that risks associated with the Allurion Balloon are very low but may include:

  1. In rare cases, the Allurion Balloon may require endoscopic or surgical intervention for removal.

Post Gastric Balloon Aftercare Expectations

I understand that it is required to undergo three (3) days of administration of IV fluids, and some IV medications to mitigate side effects. 

I was informed on how I will need to eat and drink for the balloon to settle well, smoothly and to get the best result in my weight loss journey.

In summary of Aftercare Expectations:

  1. Be present for the 3 days IV fluid support at the clinic
  2. Follow all post-procedure instructions closely
  3. Attend all follow-up appointments as scheduled
  4. Notify our team of any concerning symptoms

Alternative Options

Alternatives may include diet programs, exercise plans, weight loss medications, psychotherapy, and bariatric surgery. These options may be discussed to identify whether they may be appropriate for you.

Patient Responsibilities

In order to achieve your weight loss goals, it is important to be compliant and accept specific responsibilities, such as:

  1. I understand that if I do not follow through with all the terms of this document my physician may refuse to perform the procedure or may discharge me as a patient from the practice at any time.
  2. I will fully communicate to my physician any concerns and will also communicate to my physician or other applicable healthcare provider any suspected complications after Allurion Balloon insertion.
  3. I agree to keep my follow up appointments as recommended by my surgeon and/ or primary care physician.
  4. I agree to see my surgeon and family physician as directed.
  5. Any medical condition that exists or may develop, not in direct relationship to the gastric balloon insertion, must be treated by my primary care physician (and/or appropriate specialty physician), and I agree to coordinate my care with my surgeon. I understand that my surgeon may not be able to treat me or fill prescriptions for other medical conditions.
  6. I understand that successful long-term weight loss is dependent on following the principles and guidelines of the bariatric program.
  7. I understand that Nairobi Bariatric Center will not be held legally liable for noncompliance and complications that occur from it and I shall take full responsibility. 

Testimonial

Your journey can inspire many others considering weight loss procedures. Would you be open to sharing your story, photos, or even a video? You can choose to remain anonymous if you prefer. We'll always honor and present your experience with utmost respect. Your care and trust remain our priority.

Financial Responsibility

I acknowledge that the payment of the procedure is non-refundable. I acknowledge that the cost of the gastric balloon insertion is exclusive of the cost of removal, supplementary IV fluids that extend beyond the first 3 days, and potential ultrasound or any other supplementary procedures that may be recommended by the center. 

Agreement

By signing below, I acknowledge that I have fully read and understood this informed consent form. I had the opportunity to ask questions and have them answered. I voluntarily consent to this gastric balloon procedure as described herein.

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