In January 2009, 18-year-old Ronalis Naveo weighed 331 pounds and was at high risk for type 2 diabetes. Dieting didn't help. So doctors recommended a procedure in which a slender, hollow belt of silicone was inserted through small cuts in his belly, looped around his stomach, and filled with saline solution. This Lap-Band, made by Allergan (AGN), left him feeling sated even as his food consumption plummeted.
Today, Naveo is 89 lb. lighter and no longer prediabetic. "When I lost my first 30 lb., I walked up the stairs and was like, 'Mom, I can breathe,' " says Naveo. "That was just, wow."
Doctors performed weight-loss surgery of various types on nearly 220,000 people over the age of 18 in the U.S. last year, according to the American Society for Metabolic & Bariatric Surgery, an organization of doctors who carry out the procedures. Many were fitted with gastric bands such as Allergan's, which brought the Irvine (Calif.) company close to $258 million in sales in 2009. Now Allergan, best known for Botox, is asking U.S. regulators to approve its Lap-Bands for teens as young as 14. As part of that push, the company is moving ahead with studies in adolescents.
While the U.S. Food & Drug Administration has approved gastric bands only for adults, doctors may perform the procedure on younger patients. Yet, without regulatory approval, Allergan can't market Lap-Bands for that group. A nod from the FDA could open an avenue to as many as 2 million new customers, says Christine Ren-Fielding, a surgeon at New York University's Langone Weight Management Program. That would be a big boost for Allergan, which has about 70% of the market, according to Leerink Swann analyst Gary Nachman, and for Johnson & Johnson, which makes a gastric band called Realize. Sanford C. Bernstein analyst Aaron Gal says approval for children could increase Lap-Band sales by as much as $20 million a year.
Are Lap-Bands good for kids? Data is scarce. In one study by Australian researchers, older teens fitted with Lap-Bands lost 28% of their total body weight, on average. In comparison, a diet and exercise group lost just 3.1%, according to the study, which was funded by Australia's National Health & Medical Research Council. Allergan supplied the Lap-Bands. The company is now awaiting results from its own trial, begun in February 2006, involving about 150 obese adolescents ages 14 to 17. Allergan declined to comment on the research. In an e-mail, a spokeswoman said the company "recognized the potential benefit of [the] Lap-Band to a greater patient population."
Young or old, patients face risks that include blood clots, infections, and gallstones. Edward Livingston, a surgeon at the University of Texas Southwestern Medical Center in Dallas, raises another concern. No data exist showing gastric bands are effective in the long term, either in adults or kids. Many of his patients regain weight 5 to 10 years after surgery, says Livingston, who has performed bariatric surgeries on adults for 17 years. The problem, he says, "is that you're treating a psychological disease with a knife." In addition, "you need warnings to counsel parents and patients about lifestyle changes," because even if the procedures cause no harm, the benefits may not stick.
David Ludwig, director of the obesity program at Children's Hospital in Boston, also stresses lifestyle. "Ultimately, we want to create a public health approach that makes surgery unnecessaryless junk food, better school lunch, physical education in school," he says. But until then, "surgery may be the necessary fallback for some of the most extreme cases."