Planning for major weight loss may soon become an easier pill − or balloon − to swallow.
As manufacturers ramp up for a GLP-1 legal battle and every food brand seems to be releasing new protein-packed products, medical device company Allurion Technologies has secured FDA approval for a new, non-invasive version of a known weight loss procedure.
The Allurion Gastric Balloon System, announced as an FDA-approved “state-of-the-art innovation” by the company on Feb. 23, works like existing gastric balloons and bariatric surgeries. Traditionally, placement of an intragastric balloon involves inserting a saline-filled silicone balloon into the stomach endoscopically, or down the throat using a thin tube, while the patient is under sedation. Once it’s in the stomach, it’s filled with saline, effectively reducing stomach size and limiting how much a patient can eat, according to the Mayo Clinic.
“Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” said Allurion founder and CEO Dr. Shantanu Gaur, in a statement. “Our goal is to deliver patients a metabolically healthy weight loss by helping them lose weight, keep it off, and maintain muscle. The Allurion Smart Capsule offers a safe and effective alternative to GLP-1s and bariatric surgery.”
A gastric balloon is already considered less invasive than other bariatric procedures, such as the gastric sleeve, banding or bypass surgeries, which create a smaller stomach through removing or manipulating parts of the organ.
The Allurion system, however, entails no sedation, surgery or endoscopy. Rather, patients need only swallow a balloon at their doctor’s office.
How does the Allurion gastric balloon work?
It works like this, according to Allurion: The patient swallows a deflated balloon attached to a catheter or thin tube. After an X-ray confirms it is correctly placed, the medical provider uses the catheter to fill the balloon with saline. The balloon is again checked for placement, the catheter is removed and the patient has a smaller stomach. It stays in place for about four months, at which point the balloon self-deflates and can be passed naturally. It can then be replaced and the process repeated.
Nausea, vomiting and abdominal pain are the most common side effects immediately after implantation, said the company. However, the vast majority of patients tolerate it well, it added.
The balloon system is intended for use in adults with obesity who are between 22 and 65 years old and have a body mass index (BMI) of 30 to 40. Trials showed that participants lost up to 14% of their body weight from one installation and that 96% sustained their weight loss one year after passing the balloon, according to Allurion, which noted that the participants paired the procedure with a “behavior change program.”
New swallowable weight loss balloon is a tool, not a ‘cure’
This “behavior change” component is likely to do much of the heavy lifting in getting and keeping weight down for patients using the system, Dr. Vance L. Albaugh, spokesperson for The Obesity Society, told USA TODAY.
“Obesity is a chronic, relapsing disease, and biology strongly pushes the body back toward its prior weight,” he said. “With reversible treatments, weight regain is common.”
Losing 14% of your body weight in four months is possible and can be meaningful to your health, Albaugh said, but it’s “usually not durable if the balloon is the only intervention.”
The time-limited nature of the treatment and its lack of long-term data pose potential challenges for patients considering Allurion over traditional bariatric surgery or GLP-1 medications, which offer 15-20% and more than 50% (up to 70%-80% in some cases) body weight loss, respectively.
Gastric balloons are not often opted for in the world of bariatric procedures, Albaugh told USA TODAY, accounting for only 1-1.5% of procedures today.
They are not effective as a “long-term stand-alone strategy,” Albaugh explained. “Balloons are temporary, and maintaining results typically requires an ongoing plan − behavioral support, medication, surgery or some combination. This ongoing need for procedures is accompanied by ongoing costs and potential complications that can add up.”
Patients typically pay between $3,000 to $4,000 for the Allurion program, the company told TODAY.com. And while the idea of lowering barriers for patients by removing endoscopy and anesthesia from the equation sounds appealing, Albaugh cautioned that it is a short-term tool for a long-term condition.
“FDA approval means it met standards for safety and effectiveness − not that it’s right for everyone or that it’s a ‘cure.’ People should look for realistic expectations and a long-term plan,” he said. “Patients need proper screening, monitoring and follow-up − this shouldn’t be treated like a consumer product … start with a medical assessment, not marketing” to find a treatment plan right for you.
This article originally appeared on USA TODAY: FDA approves weight loss balloon that you swallow
