Since supplements are on the “quack watch” list, let’s start a medical equivalent. As to what we call it I am open for suggestions. MedQuack Watch? Let’s start the list off with a new obesity-treatment device just approved by the US Food and Drug Administration (FDA), AspireAssist.
There’s a new option for obese people who might be struggling to lose weight, but it may not be for the faint of heart. The US Food and Drug Administration (FDA) has approved the AspireAssist (Aspire Bariatrics) obesity-treatment device, which will allow patients to drain part of their stomach contents after each meal, preventing the absorption of approximately 30% of calories consumed.
The device consists of a tube that is endoscopically placed through an incision in the skin into the stomach and a disk-shaped port valve that is placed outside the body, flush with the abdominal skin. Approximately 20 to 30 minutes after eating, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents into the toilet. The process takes approximately 5 to 10 minutes.
The approval follows a review of data from a clinical trial of 111 patients treated with the device and lifestyle moderation and 60 control patients who received lifestyle therapy only. After 1 year, those who used the AspireAssist device lost an average of 12.1% of their total body weight, compared with 3.6% for those in the control group. Patients in both groups had small improvements in obesity-associated conditions including diabetes, hypertension, and quality of life. “These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling,” the FDA explained in the news release.
Patients must be monitored closely; the device automatically stops working after 115 cycles, or approximately 5 to 6 weeks of therapy, to ensure that the patient returns for medical follow-up and a replacement part for the device.
Side effects include occasional indigestion, nausea, vomiting, constipation, and diarrhea.
Aspire Bariatrics says on its website that bulimia “is a psychological illness characterized by excessive and uncontrolled binging episodes followed by purging.” The device is used under a doctor’s supervision and monitoring, and “does not cause bulimia.”
However, it has been likened to “surgically assisted bulimia.”
Risks associated with endoscopic surgical placement of the gastric tube include sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the abdominal lining, sores inside the stomach, pneumonia, unintended puncture of the stomach or intestinal wall, and death.
A number of risks related to the abdominal opening for the port valve may necessitate removal of the device. These include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site of the tube placement, leakage, bleeding and/or infection around the site where the tube is placed, and migration of the device into the stomach wall. Persistent fistula (an abnormal passageway between the stomach and the abdominal wall) may occur after the device is removed.
OMG. If I am considered a “quack”, then what category is this considered to be in? This is unbelievable. I am speechless!
AspireAssist Obesity Device Approved by FDA. Medscape. Jun 14, 2016.