ReShape Now Approved by Food and Drug Administration

The FDA (U.S. Food and Drug Administration) has recently approved a new and revolutionary tool for those fighting obesity. This tool is essentially a pair of balloons filled with saline, connected together. These balloons are implanted into the stomach temporarily, which triggers patients to feel fuller, thereby starting their weight loss journey.

The ReShape

The device is called the ReShape Dual Balloon by ReShape Medical. It is inserted into the stomach through an endoscope, which means through a tube that is placed in the mouth. The ReShape gastric balloon can be inserted in as little as half an hour under local anesthetic and is performed on an outpatient basis.

According to the FDA, the ReShape helps to make people feel fuller without changing the actual anatomy of the stomach. The device, which is intragastric, can stay in place for six months. It should be offered as part of a medically supervised exercise program and diet. Specifically, it is made for people who have a BMI of between 30 and 40 kg per square meter and who also have at least one obesity related condition. They must also have failed at attempts to lose weight through just diet and exercise.

People who have obesity often find that, in order to lose significant amount of weight and to maintain that loss, a combination of different solutions has to be offered. This helps to improve their overall lifestyle habits as well. Thanks to the ReShape, doctors and patients are able to enjoy a solution that does not require invasive surgery. It can quickly be implanted, it is not a permanent device and it is very easy to remove it.

In countries like Italy, Canada, Brazil and France, intragastric balloons filled with saline have already been used for many years. The European Union has been using the ReShape since December 2011. The FDA has completed a clinical trial with 326 participants aged between 22 and 60, who all had at least one medical condition related to obesity. Out of these, 187 received the ReShape and they had lost an average of 14.3 pounds after six months. Six months later, an average of 9.9 pounds was still lost. A control group underwent a fake endoscopic procedure and they lost just 7.2 pounds after six month.

Adverse Effects

There are a number of potential problems with this device, however. Rare, but existing, side effects include heart attacks, severe allergic reactions, infections, esophageal tears and breathing difficulties. More commonly, people experiencing vomiting and nausea, gastric ulcers, abdominal pain and indigestion.

As such, the FDA has released a caution for clinicians who are thinking of using the device. It is deemed not suitable for patients who:

  • Have already gone through some sort of bariatric or gastrointestinal surgery.
  • Have a diagnosis of bowel or inflammatory intestinal disease, symptoms of delayed gastric emptying, large hiatal hernia or an active H. Pylori infection.
  • Use aspirin every day.
  • Are pregnant.

The move has been welcomed by physicians.

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