FDA Approves AspireAssist Obesity Device

FDA Approves AspireAssist

In a press release posted on June 14, 2016, the Food and Drug Administration (FDA) officially approved the use of an obesity treatment known as the AspireAssist device. To reduce the amount of calories consumed, a tube from the device is inserted into the patient’s stomach, and then the device is used to drain some food from the stomach after every meal. In combination with lifestyle therapy, the AspireAssist has been shown to be effective in helping users achieve long-term weight loss.

To use the device, a surgeon will first create an incision in the abdomen, and insert a tube into the patient’s stomach through the hole. Outside the skin, a valve lies against the patient’s skin. Around 20 to 30 minutes after a meal, the patient will attach the rest of the device to the valve, and use the device to drain the contents of their stomach into a toilet. It takes around 5 to 10 minutes to drain food, and the device drains approximately 30% of the calories consumed during the meal.

The obesity epidemic

Obesity is defined by the World Health Organization (WHO) as having a body mass index (BMI) of 30 or greater.1 Obesity rates are rising all over the world, and the US has one of the highest rates of obesity in the world. Current figures from the Centers for Disease Control and Prevention (CDC) show that approximately 34.9% of the adult population in the US is obese, while around 17% of children in the US are obese.2 There are many complex factors that contribute to current obesity rates. Obesity is often caused by an excessive caloric consumption and a lack of physical activity.5 However, genetic factors, certain medical conditions, environmental factors (i.e. having obese parents), lifestyle changes, and some mental health conditions can also lead to obesity.

Numerous health conditions are associated with obesity, and obesity has been shown to increase the risk of mortality, which makes obesity one of the leading causes of preventable deaths.3 Heart disease, hypertension, asthma, some types of cancer, type 2 diabetes, sleep apnea, osteoarthritis, strokes, infertility, gout, and liver disease are some of the conditions commonly associated with obesity.4 Obesity also has multiple effects on lifestyle, such as decreased mobility, social stigmatization, increased risk of migraines, increased back pain, and more.4

Treating obesity

Lifestyle changes – primarily reduced calorie consumption, increased intake of nutrient-rich foods combined with a reduction in consumption of foods high in sugars and fats, and physical exercise – are the most commonly recommended treatments for obesity. However, maintaining permanent weight loss through dieting and exercise is very difficult and requires an individual to follow strict dieting and exercise plans throughout their entire life.6 Most people are unable to permanently reduce their weight through lifestyle changes.6 Some medications designed to treat obesity may be effective at reducing weight by a small amount, but these often have negative side effects, and the patient may gain weight once the medication is discontinued.7

The most effective method of treating obesity is through weight loss surgery (bariatric surgery), and can reduce weight by 14-25%, reduce the risk of death, and reduce symptoms from obesity-related health conditions.8 However, weight loss surgery is very invasive, very costly, and complications such as depression, gastric dumping syndrome, bleeding, infections, metabolic bone diseases, and more are common.9 As a result, weight loss surgery is only intended to be considered in cases where the patient has a BMI of 40 or over, has been unsuccessful in other treatment methods such as dieting, and has obesity-related health conditions.

Treating obesity with the AspireAssist

Similar to weight loss surgery, the AspireAssist device is only intended for use in specific, severe conditions. It is intended to treat those who are over the age of 22, have a BMI of 35 or greater, and who have not been able to permanently reduce their weight through lifestyle changes, medication, or other therapy programs. The AspireAssist is not suitable for short-term weight loss in overweight people with a BMI under 35, or those with eating disorders, uncontrolled hypertension, inflammatory bowel disease, stomach ulcers, pregnancy, or lactation. As well, patients with a history of serious cardiovascular/pulmonary disease, chronic abdominal pain, or experiencing complications after surgery should not use the device.

A 2015 study showed that using the AspireAssist device along with traditional weight loss programs resulted in a 12.1% reduction in weight, compared to lifestyle therapies, which only resulted in a weight loss of 3.6%.10 Additionally, the patients’ quality of life was improved through alleviation of some of the symptoms of obesity-related conditions.

However, using the AspireAssist may also lead to side effects such as nausea, vomiting, indigestion, constipation, diarrhea, inflammation of the skin around where the device is placed, sores in the stomach, abdominal inflammation, bloating, and leakage. Nausea, indigestion, pain, bleeding, and infection may also occur from the surgery required to place the device. The treatment also comes with risk of complications that may require removal of the tube. After treatment has ended, there is a possibility that a passageway between the stomach and the abdominal wall may develop.

Due to the risks and the nature of the treatment, using the AspireAssist requires frequent consultations with a health care provider. According to William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, “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.” To ensure patients are using the device at appropriate intervals and are regularly visiting their doctor, the device is designed to shut off after 5-6 weeks of use; only a doctor can provide the patient with a replacement part. 

References

  1. “Obesity and Overweight Fact Sheet”. WHO. June 2016. Retrieved4 July 2016.
  2. Cynthia L. Ogden, Margaret D. Carroll, Brian K. Kit, Katherine M. Flegal. “Prevalence of Childhood and Adult Obesity in the United States, 2011-2012”. 2014; 311(8): 806-814.
  3. Barness LA, Opitz JM, Gilbert-Barness E (December 2007). “Obesity: genetic, molecular, and environmental aspects”. American Journal of Medical Genetics143A (24): 3016–34.
  4. Haslam DW, James WP (2005). “Obesity”.Lancet (Review) 366 (9492): 1197–209.
  5. Lau DC, Douketis JD, Morrison KM, Hramiak IM, Sharma AM, Ur E (April 2007).“2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children summary”CMAJ (Practice Guideline, Review) 176 (8): S1–13.
  6. Tate DF, Jeffery RW, Sherwood NE, Wing RR; Jeffery; Sherwood; Wing (1 April 2007).“Long-term weight losses associated with prescription of higher physical activity goals. Are higher levels of physical activity protective against weight regain?” J. Clin. Nutr. 85 (4): 954–9.
  7. Rucker D, Padwal R, Li SK, Curioni C, Lau DC (2007).“Long term pharmacotherapy for obesity and overweight: updated meta-analysis”.BMJ (Meta-analysis) 335 (7631): 1194–99.
  8. Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lönroth H, Näslund I, Olbers T, Stenlöf K, Torgerson J, Agren G, Carlsson LM (August 2007). “Effects of bariatric surgery on mortality in Swedish obese subjects”. Engl. J. Med. (Research Support) 357 (8): 741–52.
  9. Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA (2014). “The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012”.JAMA Surgery (Meta-analysis, Review) 149 (3): 275–87.
  10. Kumar, N (25 July 2015). “Endoscopic therapy for weight loss: Gastroplasty, duodenal sleeves, intragastric balloons, and aspiration”. World Journal of Gastrointestinal Endoscopy7 (9): 847–59.

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