SAN FRANCISCO (CBS SF) — The FDA has approved a calorie-cutting weight loss device that lets people drain food from their stomachs before they digest it.
The device is called AspireAssist and was approved in the European Union in late 2011.
The makers of AspireAssist compare it to common feeding tubes used in patients who cannot take food through their mouths, and say it is safer and less invasive than gastric bypasses and lap bands.
The system takes about 15 minutes to implant in a sedated patient, and consists of a thin tube inserted through the abdomen into the stomach. A small pump is used to wash water into the stomach and suck the undigested food out into an external bag.
As much as a third of a patient’s undigested food can be pumped out after each meal and flushed down the toilet. A chip-size button covers the opening when not in use.
Removal of the tube is a 10-minute procedure, usually performed under twilight anesthesia.
The manufacturers of AspireAssist say the device is intended for adults with a BMI between 35 and 55 who are unable to lose weight with diet and exercise alone.
In a U.S. clinical trial involving 171 patients, people lost three times more weight using AspireAssist than those who only received nutrition and lifestyle counseling, according to the Philadelphia-based manufacturer.
The most common side effect was abdominal discomfort, and skin irritation around the insertion area. Other side effects include nausea, vomiting, constipation and diarrhea. There is also some risk of leakage near the tube, infection and ulceration. Unintended puncture of the stomach or intestinal wall could result in death.
The FDA says some patients also experienced improvements in conditions associated with obesity, such as diabetes, hypertension and quality of life.
Despite the success rate, the device has stirred considerable controversy, drawing praise from some, criticism from others, and even laughs in a late-night comedy sketch.
British gastroenterologist Dr. Anthony Shonde told the Daily Mail, he considers AspireAssist “an excellent alternative to obesity surgery.”
But Tam Fri of the UK’s National Obesity Forum disagrees, saying the device is simply “vomit on demand.” He said it encourages people to “eat like pigs and not suffer the consequences.”
Last year, late night host Stephen Colbert showed footage from an AspireAssist video during a sketch about his own issues with weight loss and quipped, “Machine Assisted Abdominal Vomiting, what a time saver.”
Humor aside, in its press release, the FDA strongly cautions against use of AspireAssist by patients with eating disorders including bulimia, diagnosed binge eating, and night eating syndrome.” Also, it is not intended for women who are pregnant or breastfeeding.
AspireAssist should only be used under medical supervision. William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health said, “Patients need to be regularly monitored by their health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”