June 15, 2016 -- 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.
On Tuesday, the FDA approved a device called the AspireAssist. It doesn’t involve major surgery -- it works by removing some of what's in your stomach through a tube after you eat, getting rid of about a third of your calories.
Some critics say it’s a form of bulimia. But supporters of the device say it led to substantial weight loss in a trial of more than 100 people, and the FDA says it “helps provide effective control of calorie absorption, which is a key principle of weight management therapy.”
WebMD turned to the developer, the FDA, and three doctors to talk about the pros and cons.
Q: What is the AspireAssist, and how does it work?
The device consists of a surgically placed tube in the belly that removes some stomach contents after meals before the food is digested. "Patients drain about a third of what is in their stomach," says Katherine Crothall, PhD, president and CEO of Aspire Bariatrics, Inc., the developer of the device.
The tube is inserted through a small incision in the belly. Next, surgeons connect a disk-shaped valve to the tube. This valve lies outside your body, flush against the skin. The insertion is typically done while you're under ''twilight'' sedation rather than general anesthesia and takes about 15 minutes.
About 20 minutes after finishing a meal, you connect tubing to the valve using a handheld device about the size of a smartphone. You open the valve to empty your stomach contents into a toilet. The process takes about 5 or 10 minutes. The food still inside you is digested normally.
Some patients did decide not to join the trial, since their schedules didn't allow them to remove the food after meals, says Shelby Sullivan, MD, director of bariatric endoscopy at Washington University School of Medicine in St. Louis. She was involved in the research. Not many seemed to be ''grossed out'' by watching the food coming out, she says. Some patients have told her that the process inspired them to make healthier food choices, since they report that French fries and hamburgers look pretty bad coming out, while healthier foods don't.
You have to chew your food well so the pieces are small enough to drain out later, Sullivan says. That also encourages you to eat more slowly, and often to eat less, she says.
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.”
Q: How effective is AspireAssist?
The FDA approved the device based on results of a trial that compared 111 people treated with the device and counseling about nutrition and exercise with 60 people who got the counseling alone.
After a year, those on AspireAssist lost an average of 12.1% of their initial body weight, while the counseling-only group lost an average of 3.6%.
Q: Who is the device meant for, and it is intended for long-term or short-term use?
It's approved for people who are at least 22 years old and obese, with a body mass index (BMI) of 35 to 55, who have not lost weight or kept the pounds off with non-surgical treatments. People with eating disorders such as bulimia shouldn't be offered the device, the FDA says. It's not meant for short-term use in those who are moderately overweight, either.
People who use the device are supposed to get counseling about healthy eating and exercise so they'll make lifestyle changes as well.
The ideal candidate is ''someone not able to lose with diet and exercise alone and looking for long-term weight loss," Sullivan says. It can be used long-term so the weight stays off, Crothall says, and it has to be coupled with diet and exercise for good results.
You'd have to get checked by your doctor often, the FDA says. As you lose weight and your belly size decreases, the doctor has to shorten the tube so the valve remains against your skin. Also, the device stops working after about 5 or 6 weeks, so you have to return to your doctor to get a replacement part.
Q: How does AspireAssist compare with other treatments?
"It's less invasive and potentially has fewer risks than [weight loss] surgery, and may be more effective than medical therapy [drugs] alone," says Stacy Brethauer, MD, a staff bariatric surgeon at Cleveland Clinic. He's familiar with the device but has no ties to the company.
Surgery leads to the most weight loss though, he says. In general, meds result in a 5% weight loss after a year, Brethauer says, while surgery leads to a 30% to 35% loss.
Q: What are the side effects of AspireAssist?
After the tube placement, there can be pain at the site, Sullivan says, ''but it goes away typically within the first week." The FDA says the procedure to place the tube includes potential risks such as infections, stomach bloating, and unintentional puncture of the stomach or intestinal wall.
In the two U.S. studies of the device, two patients were hospitalized, one for pain at the site and the other for an infection, but both were released, Crothall says.
The device can be removed.
Q: How much does it cost, and is it covered by insurance?
The treatment, including the device placement, lifestyle counseling, monitoring, and follow-up, is expected to cost about $8,000 to $13,000 for the first year, Crothall says, with costs varying across the country. After that, expenses should be somewhat modest, she says, mainly for office visits. Most weight loss happens in the first year, she says.
In comparison, the average weight-loss surgery runs about $30,000 to $35,000, says John Morton, MD, immediate past president of the American Society for Metabolic and Bariatric Surgery. Insurance may cover the procedures for patients who meet the criteria.
Crothall says the company is in discussions with insurance companies to get coverage. She says the device will be available ''within days."
Q: What role is AspireAssist likely to have in weight-loss treatments?
"I think most likely it will have a role to play," Morton says, "but I am not sure how big a role."
One of his concerns is how much the device will inspire people to change their habits. "I am not sure this is something that is going to be built for the long term." He also worries about misuse by people wanting rapid weight loss.
It's too early to tell how big a role this will play, Brethauer agrees, due to the unique nature of the device.
Sullivan reports receiving travel honoraria from Aspire Bariatrics.