New Weight Loss Device May Become the Biggest Trend of 2017
The Center for Disease Control (CDC) estimates that one-third (36.5%) of US adults are obese. These statistics have continued to trend up in recent years. Obesity has been labeled a chronic disease by the American Medical Society and despite more prevalent nutrition education, community programs, hospital-supervised weight loss programs and surgical options; nothing seems to stop the trend. Researchers and entrepreneurs have high interest in discovering or creating the billion-dollar product or idea that can transform the health epidemic of obesity. Most recently a new device patented as the AspireAssist is the latest to make its way to healthcare consumers.
In June 2016, the FDA approved a new weight loss device. The device is made up of a pump attached to a hose that is surgically implanted into a patient’s stomach. This device functions by draining a portion of the stomach’s food content through the hose approximately 20-30 minutes after a meal. Approximately 30 percent of the calories consumed at the meal are then discarded.
Patients must meet these three criteria to be eligible for the device:
- At least 22 years of age
- Obese with a BMI of 35-55
- Not been able to lose weight through other approaches, excluding surgery
Facts and Frequently Asked Questions
- What is the Procedure Like?
Surgeons place the device by inserting a tube into the stomach with an endoscope via an abdominal incision. A port valve is then placed flush with the abdominal skin and connected to the tube. This port valve stays in place permanently for easy access.
- Is it Messy?
Once the stomach valve is opened it takes approximately 5-10 minutes to drain the food matter out. Makers of this device recommend emptying the food matter into the toilet. It is important to consider that once food begins to digest in the stomach it is intermingled with stomach acids and may smell a bit like vomit.
- Can You Have This Device Removed?
According to the manufacturers of the AspireAssist, patients can have their device removed once they reach their weight loss goals (or if they are unhappy with it for other reasons). It is recommended that patient’s stop using the device to evacuate food for at least three months to determine if they can maintain their weight loss without it.
- What Have The Results Been Like?
The FDA looked at a clinical trial of 111 patients who used this device and compared them to 60 control patients. After one year, the patients using the device lost 12.1% of their total body weight; compared to a 3.6% loss by the control group. The study also correlated the weight loss with small improvements in diseases such as hypertension, obesity, diabetes, and overall quality of life.
- Is it Safe?
Physicians, Registered Dietitians, and healthcare professionals are listing many red flags regarding this device. Firstly, it is hard to not draw comparisons to bulimia. Bulimia is defined as the cycle of binging and then compensatory behavior such as self-induced vomiting. Secondly, there are concerns that this device could alter patient's relationships with food psychologically. Alterations such as:
- Increased intake at a meal with the knowledge they are evacuating 30% of it later
- Decrease the likelihood of selecting healthy foods at mealtime
- Frequent evacuations (more than the 3X recommend daily by the manufacturer)
Thirdly, Nutritionists are concerned about the nutrition implications of flushing out approximately 30% of the food you eat. Food is not just composed of calories (carbohydrates, protein, fat). What if the contents the patient is flushing out are some of the only sources of key nutrients (vitamins, minerals, phytonutrients) they would consume that day, opening the door to deficiencies?
According to Doctor William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, “Patient’s 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”.
- What Does This Device Cost?
According to consumers it averages $8,000-$13,000 dependent on the physician placing it. Additionally, insurance companies do not cover this procedure yet.
Would You Ever Consider Getting This Device Placed?
This Video Shows How the Procedure Works
While obesity continues to be a growing problem, the physical, psychological, and financial concerns with this device may be enough to keep many consumers away. It has also not been on the market long enough to see many of the long-term results patient’s will have. Still, despite all the concerns with this product, this may be just what some patients are looking for.
Forssell H, Norén E., Endoscopy. 2015 Jan;47(1):68-71. doi: 10.1055/s-0034-1378097
Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S., Gastroenterology. 2013 Dec;145(6):1245-52
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