Critics urge FDA rethink on stomach-draining weight loss device

Record ID: 93308

  • Title: Critics urge FDA rethink on stomach-draining weight loss device
  • Date: 27th July 2016
  • Summary: BOSTON, MASSACHUSETTS, UNITED STATES (RECENT) (REUTERS) (SOUNDBITE) (English) DR. CHRISTOPHER THOMPSON, DIRECTOR OF THERAPEUTIC ENDOSCOPY AT BRIGHAM WOMAN'S HOSPITAL & AN ASSOCIATE PROFESSOR OF MEDICINE AT HARVARD MEDICAL SCHOOL, SAYING: "You leave a large number of patients with no treatment options. Prevention has failed, medicines don't work terribly well so it's just wait until you are obese enough to have surgery and that is not a solution."
  • Embargoed: 11th August 2016 13:22
  • Keywords: obesity obesity device weightloss weightloss surgery FDA FDA approved weightloss device eating disorders binge eating bulimia
  • Location: BOSTON, MASSACHUSETTS, DELRAY BEACH, FLORIDA, UNITED STATES
  • City: BOSTON, MASSACHUSETTS, DELRAY BEACH, FLORIDA, UNITED STATES
  • Country: USA
  • Topics: Health/Medicine
  • Reuters ID: LVA0064SGN78B
  • Aspect Ratio: 16:9
  • Story Text: Lotta Bosynak is enjoying a yogurt. She's spends extra time chewing the blueberries. If she doesn't, the device she credits with saving her life won't work.
    "The most important thing to do in this method is to learn how to chew your food and that is the crucial point because you really need to do it, otherwise you can't use the tube," said Bosnyak, 52, one of the first people to trial the device in her native Sweden 4 years ago.
    The tube Bosnyak is referring to has been implanted into her stomach. She turns a valve and, standing over a toilet, the yogurt drains out.
    The device, called AspireAssist made by Pennsylvania-based biomedical company AspireBariatrics, was approved for use in the United States in June.
    It comprises a tube that is inserted into the stomach during an outpatient procedure. The tube exits the body through a small opening in the belly where a device that includes a water bag and draining tube is attached. The user squeezes water into the stomach and then drains it along with 1/3 of a recently eaten meal into a toilet bowl, lowering the caloric intake absorbed into the body.
    But critics are urging the Food & Drug Administration (FDA) to reverse its approval arguing the device is dangerous because it mimics, promotes and could lead to eating disorders such as bulimia nervosa and binge eating, both serious and potentially life threatening diseases.
    "This will likely prove to be yet another in a long line list of misguided, unsuccessful and dangerous products for losing weight," wrote Dr. Eva Trujillo, president of the Academy of Eating Disorders, in a draft of a letter to be submitted the Food & Drug Administration (FDA) next week that was seen in advance by Reuters.
    "Such a device may carry very serious physical and mental health consequences, including life threatening situations, and should not be approved by the FDA," Trujillo added in the letter.
    Advocates argue it's a less invasive and more cost-effective alternative to more invasive bariatric surgeries such as the gastric sleeve or gastric bypass and a powerful new weapon in the global fight against obesity.
    "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 depending on which part of the country the procedure takes place," said Kathy Crothall, CEO of AspireBariatrics in a phone interview. "That is three times less than the average weight loss surgery," she added.
    In the United States alone, 35 percent of the population is obese. It's a condition connected to heart disease, strokes, certain cancers and type 2 diabetes.
    Bosnyak was obese and suffered from hypertension and type 2 diabetes, both conditions she isn't diagnosed with any longer after losing 150 pounds over the course of a year using the device.
    In the multicenter trial that led to FDA approval, patients using the device along with lifestyle coaching lost nearly 3 times more weight than patients only receiving lifestyle coaching. After one year, patients using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.6 percent for patients in the coaching-only group.
    "It's one of the best ways to change your relationship to food because it does require a lot of work on the patient's part. It's not just a procedure that's done and then they're off and they don't think about it anymore," said Dr. Christopher Thompson, the Director of Therapeutic Endoscopy at Brigham Woman's Hospital in Boston and an Associate Professor of Medicine at Harvard Medical School.
    "This is something the patient is going to be thinking of every day, multiple times a day. This is something that they are living with and it's a tool for them to lose weight and to kind of get a better understanding on how to eat properly," he added.
    Thompson, who led the U.S. trials, says that unlike other weight loss procedures, it's reversible - meaning the tube can be taken out after the patient reaches a healthy weight and, he says, the relative ease of the procedure means more doctors have the skill set to implant the device.
    The Academy of Eating Disorders will continue attempts to persuade the FDA to reverse its approval, arguing the device sets a dangerous precedent. The FDA has agreed to meetings with critics in the near future, according to the Academy.
    Lotta Bosnyak still uses the device. She says she had an eating disorder, but thanks to her tube, she's cured.
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