Intragastric Balloon: FDA Concerns Raised after Patient Deaths

According to the CDC, 39.8% of American adults are obese. Given the risks associated with obesity, it’s no wonder that the healthcare industry has explored many solutions. One of these newer methods, known as the intragastric balloon, has helped many people shed pounds. But concern has been growing as some patients have experienced serious harm – or even death – after having the balloon placed.

Let’s look at how the procedure works, and what’s happening.

What is Intragastric Balloon Surgery, and How Does it Help People Lose Weight?

The intragastric balloon is inserted into a patient’s stomach endoscopically, through the esophagus. The outpatient procedure is much less invasive than other bariatric surgeries. Once inserted, the surgeon fills the balloon with a saline solution.

The inflated balloon fills a good part of the patient’s stomach, giving them less room for food. It’s a temporary device, designed to be worn for only about 6 months. After that, the surgeon will deflate and remove the balloon.

Simply put, the balloon is not a long-term fix; it’s a way to help someone jumpstart their weight loss. Other times, it may be used to prepare a patient for gastric bypass surgery.

Doctors want to see their patients develop lifestyle changes before getting the balloon. As with any weight loss method, there is always the possibility the weight will return. Patients with the intragastric balloon should expect to lose about 5-10% of their body weight. To complete their weight loss, patients should continue to make healthy lifestyle choices.

What are the Concerns about Intragastric Balloon Surgery?

While the benefits of the balloon sound promising, it’s not without significant risks. In fact, the FDA has now linked 12 deaths to intragastric balloon devices since 2016.

Some of the concerns have been with botched surgeries – for instance, the surgeon perforates the esophagus. Other times, it’s been with the balloon itself. The balloon may become hyperinflated, or cause stomach perforations, intestinal blockages, or acute pancreatitis. In some of the cases, it’s unknown exactly why the device caused the death.

Most commonly, the deaths happened within a few days of surgery. As a result, the FDA has pushed new labeling that warn doctors and patients of the risks. The FDA has been monitoring the manufacturers of the devices to identify any potential complications.

If I’m Considering this Surgery, What Should I Know?

Always talk with your doctor about all your options for weight management prior to considering a medical device.

There are times when the intragastric balloon is not going to be a good option. For instance, if you have already had laparoscopic surgery, suffer from an eating disorder, or can’t commit to making lifestyle changes.

Take the time to associate yourself with the risks of this, or any other weight loss procedure. Make sure to understand which side effects are normal, and when to be concerned. As always, remember you are your best advocate. Research the surgeon and device manufacturer you’re considering. Don’t hesitate to get a second, or even third, opinion.

What Should I Do if I’ve Suffered from a Botched Intragastric Balloon Surgery?

Even if you’ve done your homework, sometimes bad things still happen. A botched surgery can take a very big toll on your emotional and physical health. You might also struggle with paying growing medicals and making up for lost wages.

Going after a medical device manufacturer can be difficult, time-intensive, and expensive. For these reasons, we recommend you reach out to a personal injury attorney who has experience with handling medical malpractice lawsuits.

At Ladenburg Law, we’d be happy to schedule a no-fee consultation. Please call us.

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