FDA Approves Two Types of Gastric Balloons

October 25, 2015

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It has been a fantastic month for obesity sufferers across the country. The FDA (Food and Drug Administration) has approved two revolutionary new types of gastric balloon procedures. While one of these has been successfully used in various other countries for 17 years, with nearly a quarter of a million success stories, it has not been approved here yet. Now, however, this has all changed and people will be able to use this to their advantage. Physicians have stated that this move is truly ‘filling a gap’ in need for people suffering from obesity. This is because both devices are far more effective than losing weight through diet and exercise alone, while being much cheaper and safer than bariatric surgery.

The Good Stuff

The two FDA gastric balloon approvals are for:

  1. The Orbera gastric balloon.
  2. The ReShape Integrated Dual Balloon System.

Approving these two devices truly is a critical step in the right direction. Both have been put through various clinical trials in which patients who did have the device inserted were compared to patients who unknowingly had a placebo operation. It was found that weight loss over a six month period was higher in the groups that carried the balloons, and weight loss was more sustainable as well. This was particularly true for the ReShape study, where it was found that participants were able to sustain at least 66% of the weight they had lost. Most importantly, the balloons also increased the overall health and well-being of the individual patients, leading to lower blood pressure, lower cholesterol and some markers for diabetes.

The Bad Stuff

There are some limitations to both the Orbera and the ReShape balloons as well, however. These limitations included:

  • That 1% to 2% of people experience esophageal perforation, esophageal tearing and aspiration pneumonia upon removal of the balloon (both the Orbera and the ReShape).
  • That 35% of those who had the ReShape put in the place developed stomach ulcers while the balloon was in place.
  • That all patients will require at least some sedation to have the balloon put into place and removed again.

However, the reality is that there is no medical procedure that does not carry at least some risk. Compared to bariatric surgery, both the Orbera and the ReShape are far less risky. Additionally, all types of bariatric surgery will require at least local anesthetic, with most requiring general anesthetic. Statistics on death after bariatric surgery are also quite shocking.

Neither Orbera nor ReShape is claiming that their device is without risk. This is one of the reasons why they have been able to receive the FDA approval. This means that a patient is able to make up their own mind on whether or not they agree to have the procedure performed. Additionally, the FDA has only approved it for certain candidates, meaning that not anybody could have the balloon inserted. Some categories of people, such as pregnant women or those who have already had some type of gastric surgery, will not be able to have either balloon fitted.

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