Bizarre FDA Device: Drain Stomach, Drop Pounds

Medical staff preparing endoscope near patient on hospital bed — Photo: Roman Zaiets / Shutterstock

A tube implanted straight into the stomach lets a patient drain part of a meal into the toilet minutes after eating, and the Food and Drug Administration approved that device for weight loss back in 2016.

Quick Take

The FDA approved AspireAssist on June 14, 2016, for adults with a body mass index between 35 and 55 who could not lose weight through diet and lifestyle changes alone.
A thin tube connects the stomach to a skin port, letting users empty a portion of a meal after eating instead of digesting all of it.
In the pivotal trial, treated patients lost far more excess weight than a lifestyle-only group over one year.
Critics have called the device “assisted bulimia,” a label the doctors who studied it firmly reject.

How the Device Works Inside the Body

The system, called AspireAssist, centers on a thin silicone tube known as the A-Tube. A surgeon threads it through the abdominal wall directly into the stomach, creating a small port flush with the skin. After a meal, the patient connects a handheld device to that port. Roughly 20 to 30 minutes later, they drain part of the food into the toilet and flush the tube with water, according to the device’s federally approved instructions for use.

What the FDA’s Own Trial Found

Before clearing the device, the FDA reviewed a randomized trial of 111 patients using AspireAssist against 60 patients who only received lifestyle counseling. At 52 weeks, the treated group lost an average of 31.5 percent of their excess body weight, compared with 9.8 percent in the counseling-only group. That gap is what convinced regulators the device deserved approval for adults who had already failed to lose weight through diet and exercise alone.

Cost has always been part of the conversation around this device. Industry reporting placed the price of implantation and follow-up care anywhere from about $7,000 to $15,000, depending on the clinic and region. The company behind the device, Aspire Bariatrics, later publicized four-year follow-up data describing the therapy as safe, effective, and durable for people who stuck with it long term.

A Decade of Debate Over “Assisted Bulimia”

The device drew sharp public pushback almost immediately after approval. Critics, including some bariatric surgeons, branded it “assisted bulimia” or a “bulimia machine,” arguing that a device built around removing food from the stomach mirrors the very behavior doctors treat as an eating disorder in other contexts. That framing spread quickly through news coverage in 2016 and has followed the device ever since.

Physicians who actually tested the device in clinical trials pushed back hard on that comparison. Dr. Shelby Sullivan of Washington University in St. Louis, who helped evaluate AspireAssist, said plainly that “there is no such thing as medical bulimia or assisted bulimia.” Her point was straightforward: a supervised, FDA-regulated procedure aimed at weight loss under a doctor’s care is not the same thing as a psychiatric disorder rooted in secrecy and self-harm.

Why the Comparison Falls Short

The stigma-driven label ignores what the device actually does and who it’s for. This is not a hidden, compulsive behavior; it’s a disclosed, monitored medical treatment chosen by adults who already tried diet and exercise and failed. Treating informed patients like they can’t be trusted to weigh their own risks with a doctor’s guidance is exactly the kind of paternalism that gets in the way of real solutions for a genuine health crisis.

AspireAssist is no longer sold in the United States. Aspire Bariatrics pulled the product from the market a few years after approval, citing financial pressure tied to the pandemic rather than any new safety finding. The FDA’s own consumer guidance now lists it among devices approved in the past that companies chose to stop marketing, not one the agency withdrew for failing patients.

What remains is a case study in how a device can clear rigorous federal review, post real weight-loss numbers in a controlled trial, and still get defined in the public mind by a shock label instead of the data behind it. The clinical record shows a tool with measurable results for a narrow group of patients. The “assisted bulimia” framing shows how fast a legitimate medical option can get buried under disgust once it sounds strange enough to go viral.