Critics of the device are calling for the FDA to reverse its approval, arguing that AspireAssist simulates and promotes eating disorders like bulimia and binge eating, according to Reuters.
“Such a device may carry very serious physical and mental health consequences, including life-threatening situations, and should not be approved by the FDA,” wrote Eva Trujillo, MD, president of the Academy of Eating Disorders, in a draft letter that will be sent to the FDA next week.
The FDA approved AspireAssist based on data from a 12-month clinical trial provided by the King of Prussia, Penn.-based manufacturer that assured the safety and efficacy of the product, according to an agency spokeswoman.
AspireAssist advocates believe the device offers a less invasive, more cost-effective approach to weight loss than bariatric surgeries.
“There is absolutely no medical evidence to suggest the use of this device could lead to an eating disorder, ” said Shelby Sullivan, MD, director of bariatric endoscopy at Washington University School of Medicine in St. Louis. “This isn’t the cold or the flu. Obesity is a chronic disease that needs chronic treatment.”
The Academy of Eating Disorders will continue its fight to take the device off the market and said the FDA has agreed to meet with the group in the near future.
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