FDA Approves A New Obesity-Fighting Medical Device

According to World Health Organization, obesity has more than doubled since 2015. In 2014, 13% of adults worldwide aged 18 or above were obese. In recent years obesity has reached alarming levels, with at least 2.8 million people dying annually around the globe. The situation has become so terrifying that the Food and Drug Authority has started approving medical devices that help prevent obesity from reaching pandemic levels. One of the devices approved by FDA in recent times was Reshape Dual Balloon System, a balloon based obesity treatment, which was approved back in 2015. The most recent obesity-fighting medical device to get approved by the FDA is AspireAssist. This decision was announced in a press statement yesterday.

A New Obesity-Fighting Medical Device

AspireAssist is marketed as a minimally-invasive and reversible procedure that can be done under twilight-sedation, a mild anesthetic technique.  It works rather unconventionally- the device uses an external pump that extracts about 30% of the stomach’s contents before they are absorbed from the intestine into the bloodstream, and dumps them into the toilet. To begin the process, a thin tube is placed in a person’s stomach with an endoscope via a small incision in the abdomen, which connects the stomach to a small button on the skin. After each meal, the device attempts to empty about 30% of the stomach’s contents via the tube by connecting a small, handheld device to the button.

The procedure is performed twenty minutes after the meal has been consumed and takes about 5 to 10 minutes to complete. The procedure is performed in a restroom, and the food is drained directly into the toilet. The process called aspiration only extracts about a third of the stomach’s contents and the body still gets its required calories. This therapy is most effective when used in conjunction with lifestyle counseling. The program enables one-on-one counseling with support programs that encourage healthier eating and an active lifestyle.

The FDA studied results from a clinical trial of 111 participants treated with AspireAssist and appropriate lifestyle therapy, and 60 control patients who received only the lifestyle therapy.  The FDA examined the results to test the effectiveness of AspireAssist compared to standard obesity treatments with regards to weight loss, quality of life, complications, adverse reactions and feasibility. The study included adults in the age group of 20 to 60 years old, with a body mass index (BMI) of 35, which is considered obese. Obesity is calculated using BMI, which is a measure of height to weight. People are considered overweight when their BMI hits 25, and obese when it hits 30. The inclusion criteria also featured the absence of an eating disorder, severe co-morbidity and the failure to achieve weight loss with lifestyle changes or other conservative approaches. The study did not include participants with recent myocardial infarction, ongoing cancer, chronic liver and or kidney disease or any sort of mental illness, including substance abuse and eating disorders that can exclude the patient from aspiration therapy.

After one year, patients using AspireAssist lost an average of 12.1% of their total body weight compared to only 3.6% of the control group patients. The result also showed additional benefits such as decreased hypertension, diabetes, and an overall improved lifestyle in both groups. These results could be attributed to the lifestyle counseling therapy. Dr. William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, who’s major focus as part of his job is to ensure the safety of medical devices, said in a statement, “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 health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”

Side-effects And Risks Of The Treatment

There were several side effects of the treatment as observed in the study. Side effects related to use of the AspireAssist included occasional indigestion, nausea, constipation, vomiting and diarrhea. There were certain risks associated with the unconventional treatment as well. The endoscopic tube placement procedure could lead to complications such as an allergic reaction, internal bleeding,  infection, inflammation of the stomach lining, skin rash, redness, sores, pneumonia, accidental puncture of the stomach or intestinal wall and even death.

Risks related to the abdominal opening for the port valve include abdominal discomfort or pain, irritation, hardening or inflammation of the stomach lining, bleeding or infection. The device removal process can also lead to surgical complications and or persistent fistula, an abnormal passageway between the stomach and the abdominal wall.

Patients who undergo the procedure have to frequently pay medical visits to their physicians who monitor device use and weight loss and provide lifestyle therapy counseling. Patients have to be constantly monitored by physicians to shorten the length of the tube as they lose weight. The device also has a safety feature that keeps track of the number of times the drain tube is connected to the port and automatically stops working after 115 cycles (approximately five to six weeks of therapy). The patients must then return for a medical visit to get a replacement part for the device in order to continue the therapy.

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Moreover, people who are bulimic or have a binge eating disorder or suffer from night eating syndrome or have uncontrolled hypotension or a history of mental or cardiovascular illnesses are at a higher risk of surgical complications. The most significant shortcoming of the device is that it can encourage healthy people to pick up unhealthy eating disorders such as bulimia, which is an eating disorder characterized by binge eating followed by purging or over-eating as a shortcut for weight loss.

Therefore, people looking to limit obesity using this technique should be mindful of the associated risks and look for healthier alternatives such as fruits and vegetables, which are a plentiful source of vitamins and minerals and are responsible for ensuring healthy bodily functions, improving homeostasis and helping fight many diseases such as blood pressure, cancer, scurvy and atherosclerosis.

The AspireAssist System is manufactured by Aspire Bariatrics, a medical company aimed at providing low risk treatments for weight loss in overweight patients, located in King of Prussia, Pennsylvania.

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