The battle against adolescent obesity has been elevated to the status of war. “The incidence of adolescent obesity is rising meteorically and represents the largest healthcare crisis in young adults since Vietnam,” Dr. Robert Cywes said at the annual meeting of the American Society for Metabolic & Bariatric Surgery.
That being the case, he wondered, where is the outrage? Why — in the face of mounting evidence that procedures such as adjustable gastric banding are not only safe and effective, but may represent the most realistic option for achieving significant weight loss and improving multiple metabolic risk factors in adolescents — has the FDA not yet approved these procedures for use in adolescents?
Dr. Cywes of Jacksonville Surgical Associates in Florida — who does have a financial relationship with gastric band maker Allergan — presented data from a retrospective study looking at the outcomes of 402 obese adolescents (mean BMI 43) who underwent “off-label” adjustable gastric banding from 2005-2009 following extensive pre-operative psychological, nutritional, and lifestyle assessment and counseling, and showed that patients’ mean BMI declined to 35.7 and 31.9, respectively, at six months and one year. Additionally, of the 38 patients who had complete follow-up data at 4 years, the mean BMI was 27.8.
In a separate study looking at the outcomes of 17 morbidly obese adolescents who underwent gastric banding surgery as part of an FDA investigational device exemption study, Dr. Kirk Reichard of Nemours, A. I. Dupont Hospital for Children in Wilmington, Del., and his colleagues observed significant improvements in weight, waist circumference, systolic blood pressure, and HDL cholesterol—all “clinically significant changes given the difficulty of achieving these results in an otherwise treatment-resistant population,” he said.
While the sustainability of these observed changes still need to be evaluated over time, the findings suggest that the “the FDA should accelerate the lifting of barriers to banding in this population,” said Dr. Cywes. “The question is no longer whether laparoscopic adjustable gastric banding is safe or effective [in adolescents]. The question is whether it is negligent not to offer it as an option for the treatment of severely obese children.”
— Diana Mahoney