The FDA’s New Gastric Balloon Warning: What Does It Mean?

Gastric Balloon Warning

While there are many different procedures and treatments for obesity, some can less safe and effective than others. For example, the U.S. Food and Drug Administration (FDA) recently issued a warning about fluid-filled gastric balloon treatments.

What are intragastric balloons?

Intragastric balloons are a relatively new weight loss procedure. A balloon or balloons are placed in an overweight or obese patient’s stomach in order to take up stomach space. The balloon limits how much a patient can eat and helps them feel fuller faster.

There are two types of intragastric balloons: fluid-filled balloons and air-filled balloons.

What does the FDA warning say?

In February 2017, the FDA issued a warning about the Orbera and ReShape fluid-filled intragastric balloon systems. Based on multiple incidents, the FDA reported two problems associated with fluid-filled intragastric balloons.

The first problem involves intragastric balloons over-inflating with air or with more fluid while in a patient’s stomach, requiring early removal of the balloon system.

The second problem is the development of acute pancreatitis, or inflammation of the pancreas. This problem also requires premature removal of the device.

What are Dr. Dirk’s thoughts?

According to Dr. Dirk, The FDA approves a medical device after a sample group of patients are observed for a period of time only to determine whether the device is safe.

FDA approval is based largely on the statistical probability of safety, not an absolute certainty. In other words, the FDA essentially makes an educated guess about safety of a treatment.

But despite the best efforts of regulators like the FDA, medical science takes time and many cases in order to discover what problems can crop up.

“The takeaway message here is is that the balloon is not a cure-all,” Dr. Dirk says. “Like any other medical device placed in the human body, it must be watched not only by the patient, but also by the doctors who placed the device in the patient.”

For more information about the intragastric balloon or other weight loss procedures offered by Dr. Dirk, schedule a consultation or call us to learn more 214-DRDIRK-1.