Lap Band Surgery: Allergan Asks FDA to Approve Obesity Surgery for Teens

May 25, 2011— -- Jacy Johns had tried everything to lose weight -- from the Slim Fast diet to Special K. She hit the gym and read "books and books and books" on weight loss. But Johns, an 18-year-old high school student from Jacksonville, Fla., couldn't seem to shed the pounds. In her early teens, at 5 feet 5 inches, she weighed 225 pounds.

After years of trying, she'd had enough.

"I was scared because my health was getting so bad," said Johns. "I knew I was pre-diabetic and I kept having to go to the doctor's to get tested for diabetes."

With her mother's consent, Johns decided to undergo Lap-Band surgery, a procedure in which a silicone ring is placed around the top portion of the stomach to decrease food intake. The results thrilled Johns. She lost 95 pounds in the first nine months after surgery.

"I feel more upbeat and outgoing now, and I'm not so scared to be noticed," said Johns. "I don't try so hard to blend in anymore."

"If I hadn't done anything at that time, I was going to get diabetes," continued Johns. "I was almost past the point of saving. I was ready to just accept that that was how I was going to be the rest of my life."

And now, like Johns, more teenagers may have the opportunity to turn their weight around through Lap-Band procedures — possibly even with FDA approval. Currently, minors must have parent permission, but the Lap-Band creator, Allergan, has requested that the FDA approve Lap-Band procedures for anyone more than 14 years old.

Cathy Taylor, a spokesperson for Allergan, said the company made the request because of the increase in obese teenagers, and the disease's correlation to life-threatening conditions such as heart disease and type 2 diabetes.

"In addition, the prevalence of obesity continues to rise, making it a significant health epidemic," said Taylor. "Due to all of the above, Allergan continues to be committed to the research and development of the Lap-Band System to help those affected by obesity, to improve their health and lives."

Because the Lap-Band System is not currently FDA-approved for use in patients younger than 18, Taylor said, "Allergan does not promote the use of the product with adolescents. Therefore, we cannot elaborate on the potential benefit of Lap-Band in this patient population."

But that does not mean the company is not trying to prove that it is beneficial to adolescents. Amanda Sena, a spokesperson for the FDA, confirmed that Allergan is currently conducting clinical trials in the United States to determine the effectiveness of the Lap-Band in the morbidly obese teen population.

Sena said she could not comment on when the FDA would come to a decision for Lap-Band use in teens.

The Lap-Band procedure in teens remains a controversial issue. While some obesity experts agree that the surgery should be available for teens, others believe the procedure should be a last resort, if not forbidden altogether, in this age group.

Dr. John Holup, associate director of bariatric surgery at Beth Israel Medical Center in Manhattan, is one of the advocates for the approval of the teen procedure.

"If this is a safe, sustainable, significant way to lose weight, then why not do that?" said Holup, who does not perform pediatric Lap-Band procedures. "If you wait until 18, the cat's out of the bag. Many people will already have irreversible cardiac damage. Plus, the psychological damage is amazingly terrible for these kids."

Lap-Band May be Offered to 14-Year-Olds?

Experts said every surgery has risks, which include post-operative infection, bleeding and reaction to general anesthesia. Other risks specific to the Lap-Band procedure include device malfunction, and the shifting or wearing away of the Lap-Band.

But even so, Holup said that, because morbidly obese people have such a difficult time losing weight on their own, the benefits of the Lap-Band surgery far exceed the risks.

Dr. Caren Mangarelli, a pediatric obesity expert at Duke University Medical Center, agreed that the procedure is appropriate for a carefully selected group of mature teenagers as part of a comprehensive weight management program. But she said obesity needs to be evaluated carefully by examining genetics, lifestyle choices and environmental factors.

"In order to combat obesity, we need to come at it from multiple angles, including the use of more radical or invasive tools such as bariatric surgery," said Mangarelli. "That said, it is only one tool that needs to be used in the context of other lifestyle changes that the patients make."

Many people argue that Lap-Band surgery is more appropriate for teens than other surgeries, like gastric bypass, because it is reversible, it has a lower morbidity rate and it is less associated with nutritional deficiencies.

But other experts say there are not enough data to understand fully the long-term side effects and complications of the procedure.

"[This] is especially relevant when talking about putting the device in a younger patient population," said Mangarelli.

But other experts believe that the procedure is not dealing with the underlying causes of obesity and it should be used only as a last resort.

"As a society, we are woefully misguided if we rely on a surgical solution rather than do all we can to cultivate opportunities for every teen to be physically active and eat well every day," said Dr. David Katz, director of the Yale University Prevention Research Center.

"I think [these surgeries] are symptomatic of a society that looks to pounds of cure while neglecting ounces of prevention," Katz said. "The mindset that surgery for weight control is anything other than a last resort is potentially quite harmful."

But Dr. Christine Ren-Fielding, associate professor of surgery at NYU Langone Medical Center disagreed, and said that many people turn on a healthier path after the Lap-Band procedure.

"Lap-Band surgeries help promote healthy lifestyles because they initially take away appetite and improve a sense of fullness with smaller portions of food – resulting in weight loss," said Ren-Fielding. "Once a teenager begins losing, they become more comfortable in participating in exercise and daily activities. They are both more physically able to do it, and less socially inhibited to try."

As for Jacy Johns, she joined her school's cross-country running team after surgery. She said she is now extra-cautious about what she puts into her body.

"The surgery now has made me 100 percent more aware," said Johns. "It would have been way too easy to give up if I hadn't had the surgery, but I already went and had the surgery, so now I'm dedicated to my health and weight."