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.
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