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Orbera Intragastric Balloon
Intragastric balloon

While the Orbera Intragastric balloon has received positive reviews, a growing number of patients are reporting adverse events related to the device. Weight Loss have indicated that the device is associated with increased risk of acute pancreatitis. The FDA is reviewing the results of these studies to make recommendations to health care providers. The FDA also recommends health care providers discuss the risks and complications associated with using the device. Health care providers should discuss these risks with patients and follow product labels carefully. Physicians should also educate patients on the signs and symptoms of potentially life-threatening complications such as acute pancreatitis.

The Orbera Intragastric balloon is a temporary device placed through the esophagus and directly into the stomach. The device is worn for six months and helps the patient reduce the amount of food they eat. It works by retraining the brain to recognize when the stomach is full, thus reducing appetite.
Post-approval study findings

After receiving FDA approval in August 2015, ORBERA maker Apollo Endosurgery, Inc. has started a post-approval study for the balloon, which is intended to help obese adults lose weight and maintain their new weight. The study will continue for up to 12 months.

In the U.S., the FDA has received eight reports of deaths from Orbera. Since the product was approved, the FDA has worked with intragastric balloon manufacturers to track reported adverse events and implement mitigation strategies to minimize the risks. After the FDA approved Orbera, the company updated the product's labeling to provide more detailed information about its risks.

In the United States, the FDA has received more than 100 reports of balloon over-inflation. As a result, it has decided to require post-approval studies for this device. In addition, the agency is continuing to work with Apollo Endosurgery to study the causes of balloon over-inflation, as well as potential mitigation strategies.
Patient eligibility

Patient eligibility for Orbera depends on a number of factors. For example, patients with a BMI of 30 or below are considered good candidates. Those with a BMI above 40 have a much lower chance of qualifying. Additionally, the patient must be willing to follow a medically supervised program.

ORBERA is not suitable for patients with severe liver disease, or who are taking daily doses of anti-inflammatory drugs or prescription aspirin. In addition, patients who are pregnant or breastfeeding should not use ORBERA. Weight Loss should discuss the risks of the procedure with their doctor. Patients must be free of stomach problems, bowel obstruction, or other conditions.

Some patients may experience severe abdominal discomfort and even nausea after the procedure. This can occur as a result of the balloon being placed in the bowel. If stomach pain persists, it may be a sign of a more serious underlying problem. Severe pain in the abdomen should be investigated immediately by a doctor.
Cost

ORBERA is an FDA approved, weight-loss procedure that uses a balloon to help patients lose significant amounts of weight. The procedure can significantly improve a patient's appearance and health, and has long-lasting results. The cost of the procedure varies between $6000 and $9000, and depends on the type of procedure performed. Because the procedure is non-surgical, patients are typically expected to pay cash for it. However, Weight Loss offers attractive financing options up to 100% of the total cost.

The cost of Orbera may vary from country to country. Some countries offer lower cost options than others, and some insurance companies don't cover the procedure altogether. It is important to understand the costs associated with the procedure before choosing a provider. In most cases, the fee includes the cost of the balloon insertion, any necessary investigations, the surgeon's fee, aesthetic services, and follow-up appointments.
Results

While most patients have no known side effects, there are some cases of discomfort and adverse effects with the ORBERA balloon. Patients may experience gastric perforation and other complications. Patients should be aware of these risks before the procedure. The company also provides support for patients and offers a suite of tools for adjusting the treatment.

The company's intragastric balloon is a silicone elastic balloon filled with saline. The device is inserted through the esophagus through an endoscopic device. The endoscope helps ensure the accuracy of intragastric balloon placement. The intragastric balloon is then filled with a methylene-mixed saline solution. Methylene blue is a dye used in this procedure that turns the urine green.
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