The following editorial first appeared in the Los Angeles Times:
Allergan, maker of the ubiquitously advertised Lap-Band, cautions on its website that the weight-loss device is “not recommended for non-adult patients.” The company would like to remove that warning, but to do so, it needs federal approval.
As Los Angeles Times staff writer Stuart Pfeifer recently reported, the Irvine, Calif.-based company is asking the U.S. Food and Drug Administration to approve the Lap-Band for use in obese teenagers as young as 14 who meet certain criteria. Approval would also allow the company — as well as clinics and doctors — to market the band, which is surgically fitted over part of the stomach to discourage overeating, to those teens. Despite the demand for new obesity-fighting methods, though, the FDA should take a conservative approach, holding fast to the warning against teen use at least until far more extensive study has been completed.
Doctors already can perform Lap-Band surgery on teenagers (with parental consent), just as they can prescribe drugs for “off-label” uses that have not received the FDA’s blessing. That’s because the FDA doesn’t regulate the actions of doctors in these matters but of manufacturers. In some cases Lap-Band surgery might be justified for a teenager: His or her weight might be so extreme, for example, and cause such troubling health problems that the risks of not doing the surgery outweigh the FDA’s recommendations.
But those cases are the exception. Most doctors think twice or more before doing a procedure that lacks FDA approval. And that’s how things should stand for now. The Lap-Band has helped many, but all surgery carries risks. Though studies have found that the device helps obese teens lose weight, not enough is known about the long-term benefits and risks for adolescents, whose bodies have not fully matured and who would have the band in place for more years than adults. As the Allergan website says, some people need additional surgeries, including removals. Taking ibuprofen and other anti-inflammatory drugs can contribute to erosion of the band, which over time might need to be removed or replaced. These are potentially serious concerns for patients who expect to have the band in place for 60 years or so.
Allergan is in the midst of clinical trials on the use of the Lap-Band in teenagers, which will be completed in 2013. But even that is not enough; approval should be based on multiple long-term studies.
What we do know is that marketing and advertising influence behavior; body-conscious teens, who want results now and who have little grasp of long-term consequences, are an especially impressionable group. The Lap-Band can be a useful tool for weight loss in many adults, but it’s not a cure for obesity. It must be accompanied by lifelong changes in eating and activity — changes that promote weight loss with or without the band.