The FDA Approves Controversial New Weight Loss Device

June 22nd 2016

Alex Mierjeski

It's estimated that a whopping one-third of adults suffer from obesity in the United States, and there are many approaches to solving this health crisis.

But not every new weight loss option is universally accepted, as evidenced in the response to a controversial new U.S. Food and Drug Administration-approved weight loss device.

Earlier this month, the FDA cleared the AspireAssist, a pump that drains undigested food directly from a person's stomach into the toilet (or wherever, #yolo). "It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy," according to the FDA, which specifically also said that it's not for those with a history of eating disorders.

The device, according to the FDA, helped patients lose an average of 12 percent of their body weight over a one-year period.

Manufacturer Aspire Bariatrics says that the tool provides a valuable resource for those who have had little success with other weight loss methods.

But critics have likened the tool to "assisted bulimia" or "mechanized bulimia" and do not see it as a healthy mode of weight loss. 

"This is the first time I look at a device that was approved by the FDA and I am absolutely, utterly, and totally appalled," Joseph Gutman, an endocrinologist and diabetologist, told The Verge. Gutman, who has spent more than 30 years treating patients with obesity, is undertaking an effort to rally 4,000 doctors to sue the FDA in a bid to remove the AspireAssist from the market, according to the site. And Gutman — who called the device a "bad joke" — is not the only skeptic to speak out. 

Other medical experts who spoke to The Verge worry about the lessons patients might learn about the quantity and quality of food they're able to ingest without consequence. They're also concerned about the credibility of the FDA clinical trial, which only ran for a year.

There is also risk involved with this device, the FDA explains:

"Risks related to the abdominal opening for the port valve include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall. All have the potential to necessitate removal of the device. After device removal, there may be a risk of persistent fistula, an abnormal passageway between the stomach and the abdominal wall."

Kathy Corthall, president and CEO of Aspire Bariatrics, says that the device bears no comparison to bulimia because patients have to thoroughly, slowly chew their food if they want to properly aspirate it after eating. In other words, they can't binge eat and successfully drain their stomachs. She added that the AspireAssist doesn't wreck a person's esophagus, either.

"This device actually helps patients develop far better eating habits, much greater awareness, they're eating slower, [and] they snack less," Corthall told ATTN:.

The Verge spoke to one patient who has been using AspireAssist since 2013, and who spoke highly of the device, saying that the device did make him chew thoroughly and upped his intake like fruit and steamed vegetables.

But critics contend that the device fits into a broader societal approach that doesn't necessarily seem to help solve the greater issue of obesity.

Writing for The Huffington Post, dietitian and nutritionist Abby Langer observed:

"[I]t's totally congruent with society's 'quick fix' mentality that demands a fast and easy solution to all of our problems."

"Weight loss," she added, "isn't fast and easy in cases like these."