FDA-Approved Weight Loss Medical Device

The AspireAssist obesity device was approved by the U.S. Food and Drug Administration (FDA) in June 2016 for the treatment of obesity based on favorable results of a small clinical study. The FDA specifically warns individuals with eating disorders not to use this device. Among the many contraindications listed on the FDA website are for individuals diagnosed with bulimia, binge eating disorder and night eating syndrome.2 The dilemma is that many people with these disorders are undiagnosed, so an inherent flaw exists in this warning. One can assume the considerable dangers of bulimia alone would be compounded with use of this device.

The FDA also stated overweight individuals need to be regularly monitored by healthcare providers, follow a lifestyle program to help develop healthier eating habits and reduce caloric intake. Moreover, they said the device is not intended to be used for short durations in those who are moderately overweight. It is meant as adjunctive therapy for clients aged 22 and older who are obese, with a body mass index of 35 to 55. It should not be considered unless an individual has failed to achieve and maintain weight loss through nonsurgical weight-loss methods.2

In Australia, AspireAssist is advertised only for gastro-draining purposes and not as a weight loss device. A statement provided to Australian news outlets by the Therapeutic Goods Administration (TGA) said, “A gastrostomy aspiration system stomach tube manufactured by Aspire Bariatrics is included in the Australian Register of Therapeutic Goods and therefore approved for supply in Australia. The specific clinical use of any medical device is a matter for the treating clinician. TGA does not regulate clinical practice. Patients using this device for gastric drainage are under the treatment of a health care professional.”1 TGA is part of the Australian Government Department of Health, which is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices and blood and blood products.3

Is AspireAssist a Bulimia Machine?

Australian news articles are not the first to convey concerns about this device. Shortly after the device was approved in the U.S., there were several articles comparing it to bulimia. A June 2016 Huffington Post article stated, “There’s been a lot of visceral reaction to the stomach-draining device that was just approved by the FDA.” A look at the AspireAssist website would make you believe getting this device implanted is a piece of cake, i.e. Real Results; Quick Recovery; Simple Procedure; Healthy, Normal Lifestyle; Reversible and Affordable are a few of the upbeat words the company uses on its home page to market this device.4,5 The reality is far from a leisurely walk in the park, according to the FDA.

Surgeons insert a tube in the upper part of the stomach with an endoscope, via a small incision in the abdomen. A disk-shaped port valve lies outside the body, flush against the skin of the abdomen. The valve is connected to the tube and remains in place. About 20 to 30 minutes after eating a meal, the individual attaches the device’s external connector and tubing to the port valve, opens it and drains the contents. Once open, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. As a safety precaution, after 30% of the stomach contents are drained, the device shuts off. Of course when a person with bulimia purges, they typically empty their stomach. In gastric bypass, a smaller stomach is created so people eat less.2,4

Considerable Health Risks

According to the FDA, the endoscopic surgical placement of the gastric tube is associated with the following risks:

  • Sore throat
  • Pain
  • Abdominal bloating
  • Indigestion
  • Bleeding
  • Infection
  • Nausea
  • Vomiting
  • Sedation-related breathing problems
  • Inflammation of the lining of the abdomen
  • Sores on the inside of the stomach
  • Pneumonia
  • Unintended puncture of the stomach or intestinal wall
  • Death2

Risks related to the abdominal opening for the port valve include:

  • Abdominal discomfort or pain
  • Irritation
  • Hardening or inflammation of the skin near the tube
  • Leakage
  • Bleeding and or infection near the tube
  • Device migration into the stomach wall2

After device removal, there may be a risk of a chronic fistula, an abnormal passageway between the stomach and the abdominal wall.2

Potential for Risky Use

The device has another safety feature that keeps track of the number of times the drain tube is connected to the port. It automatically stops working after 115 cycles (five to six weeks if the device is used correctly).2 That does not preclude its potential for abuse. Theoretically, a person could abuse this for a short duration, repetitively draining, eating, draining and eating. They could also fill the bottom 70% of their stomach with healthy, low-calorie foods and the top 30% with ice cream, cake and all sorts of other calorically dense goodies. Although aspiration is recommended 20-30 minutes after food consumption, it would be easy for a person to purge whatever food they ate last. As long as food is chewed thoroughly (so it fits through the 6 mm tube), it would end up in the toilet if aspirated immediately after eating. This certainly sounds like binging and purging, but with the assistance of a medical device.4 One has to wonder if such use would result in problems mimicking the side effects of bulimia.

  1. Device which allows users to drain food from their stomach has been compared to bulimia. News Australia website. http://www.news.com.au/lifestyle/fitness/weight-loss/device-which-allows-users-to-drain-food-from-their-stomach-has-been-compared-to-bulimia/news-story/52ba1392e5886bd5b474fc0806ecf37c Published May 16, 2017. Accessed May 18, 2017.
  2. FDA approves AspireAssist obesity device. U.S. Food and Drug Administration website. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm506625.htm Published June 14, 2016. Accessed May 18, 2017.
  3. TGA basics. Therapeutic Goods Administration. https://www.tga.gov.au/tga-basics Accessed May 18, 2017.
  4. AspireAssist: FDA-Approved ‘Bulimia Machine’ Product of A Quick-Fix Society. Huffington Post Canada website. http://www.huffingtonpost.ca/abby-langer/aspireassist-eating-disorders_b_10531988.html Published June 17, 2016. Accessed May 18, 2017.
  5. The AspireAssist®. Aspire Bariatrics website. http://www.aspirebariatrics.com/about-the-aspireassist/ Accessed May 18, 2017.

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