The device is intended for individuals with a body mass index over 35 – a BMI over 30 is considered obese.
The device is intended for short-term use and is not advised for individuals with eating disorders.
The device only takes about five to 10 minutes to implant and removes roughly 30 percent of calories consumed in a meal.
The FDA approval is based on clinical trials involving 111 patients who used the device, along with a control group of 60 people who only changed lifestyle habits. After one year, the AspireAssist group lost on average 12 percent of their total body weight, whereas the control group lost only four percent.
Dr. William Maisel of the FDA said, “The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy. Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”
Side effects of AspireAssist include indigestion, nausea, vomiting, constipation, and diarrhea. There are some risks associated with the placement of the device including pain, bleeding, infection, inflammation, and accidental puncture of the stomach or intestines.
Also, read Bel Marra Health’s article: Female obesity rate in U.S. on the rise: CDC.
Sources:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506625.htm