After successfully winning FDA approval to open up the gastric banding procedure to less-obese adults, Allergan is conducting clinical trials of its Lap-Band weight-loss system on another segment of the patient population: teenagers.
The possibility of Allergan winning FDA approval to market its minimally invasive weight-loss surgery to patients as young as 14 is still years away. The company applied for the expanded approval nearly 2 years ago, reports the Los Angeles Times, and doesn't expect clinical trials to be completed until 2013. Still, the move already has some in the healthcare community concerned about the implications of marketing Lap-Band surgery to teens.
Mary Brandt, MD, head of adolescent bariatric surgery at Texas Children's Hospital, sees gastric bypass surgery as a better option for young patients because it doesn't involve implanting a foreign body in the abdomen. "It's hard to imagine taking a device and putting it around he stomach and giving it a warranty for 50 or 60 years," she tells the Times, referring to Allergan's adjustable silicon ring. A recent European study cast doubt upon the long-term outcomes from gastric banding.
If the FDA does approve Allergan's application, teenagers seeking Lap-Band surgery would have to meet more stringent weight requirements than adult patients, would have to have at least one obesity-related co-morbidity and would have to prove they've tried other means of losing weight, Allergan spokeswoman Cathy Taylor tells the Times.
"You're looking at an adolescent who's morbidly obese, 100 pounds or more overweight, who has significant health problems because of their obesity," says Ms. Taylor. A 2009 survey showed that about 12% of high school students in the United States are obese.
Although the FDA currently doesn't allow Allergan to market Lap-Band for adolescent use, doctors can perform the gastric banding surgery on minors with parental consent. The Times highlights one Florida teenager's success with the Lap-Band procedure, as well as another teen in California who had the device removed after 2 years. Read the full report for more details.
Irene Tsikitas
