Less than a month ago the Food and Drug Administration (FDA) approved a medical device to help combat obesity.
Now the Academy for Eating Disorders (AED) accuses the agency of faulty judgment, saying the device should never have been approved because it enables purging, a practice associated with bulimia nervosa.
The device behind the controversy is called AspireAssist. A doctor places a thin tube in the patent's stomach. The tube is connected to a button the patent controls.
After a big meal, the patient uses a small device that pumps a third of the stomach contents into a toilet. The food is removed before it can be digested and contributes to body mass.
Bariatric surgery alternative
The FDA gave its blessing to AspireAssist as an alternative to bariatric surgery, in which metal bands are placed around the stomach to make it hold less. Apparently the regulators who flashed the green light could see little difference between the two methods, except that AspireAssist might be less invasive.
The Academy for Eating Disorders says there is a big difference, calling it “a mechanized form of bullimia nervosa.”
"Such a device may carry very serious physical and mental health consequences, including life-threatening situations, and should not be approved by the FDA,” said AED President Dr. Eva Trujillo.
She predicted the FDA action will proved to be “yet another in a long list of misguided, unsuccessful, and dangerous products for losing weight.”
“We need to stop subjecting people in larger bodies to unsafe procedures and insisting they are a problem to be fixed,” Trujillo said.
Calls for reversal
The group said the FDA should rescind its approval of AspireAssist, something that is rarely done.
Judging from the ConsumerAffairs readers who responded to our original story on the FDA approval in June, the public is siding with AED.
“I'm completely appalled by the idea of eating food and then pumping it directly into the toilet,” one reader posted. “I can only imagine what people who don't have access to adequate nutrition think of this. It's disgusting,” said one reader.