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.


What happens after obesity surgery?

after obesity surgery

Obesity surgery can change your life. In fact, that’s one of the main purposes of bariatric surgery — to give patients renewed energy, vigor and opportunity. But all of these things take an investment from the patient, as well. Once patients are given a fresh start with obesity surgery, they must make sure to take care of themselves in order to maintain it.

“Weight loss surgery is not just about losing weight,” Dr. Dirk says. “It is about engaging in the life changes needed to become a healthy person.”

So if you’re considering kick-starting your health with weight loss surgery, what do you need to do to ensure success? First and foremost, the patient must eat healthfully and exercise, Dr. Dirk says.

Dr. Dirk makes it easy to eat healthily. He provides a nutrition plan for all his patients to guide them after they leave the operating room. Patients eat five to eight small meals daily — mainly proteins and other nutrient-dense foods.

Because of the way obesity surgery works, patients’ bodies tell them when enough is enough, so small meals make the perfect portions. Patients enjoy eating all types of meat and healthy foods, and are even able to eat dessert — their body stops them once they have enjoyed all they need. Patients can even drink alcohol, although most report they become “cheap dates” when their tolerance goes down with their weight.

As for exercise, Dr. Dirk recommends an hour of aerobic exercise every day. When he follows up with patients after surgery, those who exercise are the first to see their medical conditions, like diabetes or blood pressure, improve.

The exercise program may seem daunting at first, but one of the great parts about obesity surgery is the renewed energy. It will help make the workouts easier and be a great reward for keeping up with your health post-surgery.

“My patients tell me that their fatigue disappears and that they look forward to getting out of bed in the morning,” Dr. Dirk says. “They say they can play with their children, go on walks, walk on the beach and in the park.”

The rewards far outweigh the work, but remember, there is work involved. Obesity surgery is not a cure-all, but it is a great way to reset your body and your life to make way for a better tomorrow.

“This surgery is about you, your health and your life,” Dr. Dirk says. “Once this surgery takes place, you are in charge of your future. Make it a great one!”