Tag Archives: intragastric balloon

FDA Approval of Semiglutide for Obesity & AGA Recommends Intragastric Balloons for Adults with Obesity

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June 4, 2021: FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014

“The U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity…The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater… The largest placebo-controlled trial enrolled adults without diabetes. Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo” 

T Muniraj et al. Gastroenterol 2021; 160-1799-1808. Full text: AGA Clinical Practice Guidelines on Intragastric Balloons in the Management of Obesity

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FDA Warning for Obesity Devices: Intragastric Balloons

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FDA Warning: Five Die While Using Obesity Devices (Intragastric Balloons)

An excerpt:

At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.

The FDA says it doesn’t know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.

Related blog post: In the News: Weight Loss Intragastric Balloons

In the News: Weight Loss Intragastric Balloons

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Two intragastric balloons have been approved for weight loss by the FDA.

FDA approval of ReShape  The FDA announced that 326 obese patients participated in a clinical trial where 187 who were randomly selected to receive the balloon lost an average of 14.3 pounds or 6.8 percent of their body weight when the device was removed at six months. The control group lost an average of 7.2 pounds or 3.3 percent of their body weight. Six months later, the patients who received the balloon had kept off 9.9 pounds of the original 14.3 pounds.

FDA approval Orbera intragastric balloon The pivotal study of ORBERA, known as IB-005, was a multicenter, prospective, randomized, non-blinded comparative study. Subjects from 15 U.S. investigational sites were enrolled between June 20, 2008 and October 10, 2010. The database for this PMA reflected data collected through October 28, 2011 and included 448 subjects…

From GI & Hep News: During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later….

At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001)… The majority of excess weight loss achieved at 6 months was also maintained at 12 months.