Allergan Inc. has decided it will no longer seek approval from the Food and Drug Administration (FDA) to market its LAP-BAND weight loss device to obese teenagers.
The company had submitted its application seeking marketing approval of the LAP-BAND for teens to the FDA nearly three years ago and had expected to conclude clinical trials in 2013.
Doctors can already perform the LAP-BAND surgery on teens with parental consent, but gaining FDA approval would have allowed Allergan to market the product for use on adolescents. It also would have made it more likely for the procedure to be covered by health insurance.
Without elaborating on why the company is no longer seeking U.S. permission to market the LAP-BAND to younger patients, Allergan spokeswoman Naziah Lasi-Tejani wrote in an email that the decision was made at the beginning of the year.
The LAP-BAND has been used in Europe and Australia since 1993 and in the United States since 2001. Initial approval by the FDA in June 2001 indicated use for severely obese patients of at least 18 years or older with a BMI of at least 40, or a BMI of at least 35 and an obesity related condition such as diabetes, high blood pressure, or sleep apnea; FDA approval was expanded in February 2011 to include obese patients with a BMI of 30 to 34 with one or more obesity related comorbid conditions.
The procedure promotes weight loss by limiting food intake and controlling hunger sensations. It accomplishes this through the use of a specially designed silicone band that is surgically fitted around the upper stomach. An attached access port allows for adjustments to increase and decrease restriction without additional surgery. The body’s natural anatomy is kept intact and the procedure can be reversed if medically necessary.
According to statements given in an interview by Jaime Ponce, President of the American Society for Metabolic & Bariatric Surgery, the LAP-BAND is “the safest procedure we have. The procedure itself can have problems, but they get more pronounced if they don’t have the proper follow-up.” Patients selection and follow-up are important aspects of the Lap-Band surgery.
Despite the benefits and proven safety record of the LAP-BAND, the procedure has potential complications and risks that must be considered. Health advocacy groups and some doctors have expressed concerns that the procedure is too drastic for a young person’s developing body.
Although it is no longer seeking FDA approval for the use of the LAP-BAND in teens, Allergan is standing behind the safety and effectiveness of the LAP-BAND System. Company statements show that more than 650,000 procedures have been performed worldwide with proven results of safe and effective weight loss.
Of the more than 200,000 weight loss surgeries performed in the United States each year, about one-third use gastric banding. Although two systems are approved for use in the United States, the REALIZE Band by Johnson & Johnson and the LAP-BAND System by Allergan, the LAP-BAND System is more popular and widely used.