FDA Warns Companies of Deceptive Lap-Band Advertising

Almost everyone wants to be thin, and many people would do anything to have the body of their dreams. For people who are “morbidly obese” or who have one or more obesity-related conditions (such as diabetes or high blood pressure), one option is gastric banding.

Gastric banding, such as the popular Lap-Band, is a surgical procedure that reduces the size of the stomach. A silicone band is placed around the upper part of the stomach, creating a small pouch that fills up faster and supposedly makes you feel full much more quickly. The band is not solid like a rubber band–it is more like a balloon that is filled with salt water (saline). The more water in the band, the tighter it squeezes the stomach. The amount of saline in the band can be adjusted because the band is attached to a long tube, ending at a small button-like knob that is placed just below the skin during surgery. A doctor can draw fluid out of the band, or add more fluid in, just by inserting a syringe into the knob.

FDA Warning

Last week, the U.S. Food & Drug Administration (FDA) announced that it has taken action against eight California surgical centers and a marketing firm for misleading advertising of the Lap-Band. At issue is the idea of advertising a very serious surgical procedure without proper warnings and cautions, making gastric banding look like a simple fix for a lifelong problem.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”

According to the FDA, the risks of any surgery—including gastric banding—include the possibility of death. In addition, known complications of gastric banding include:

  • Nausea
  • vomiting or spitting-up food you just ate
  • difficulty swallowing
  • gastroesophageal reflux disease (GERD)
  • indigestion or upset stomach
  • abdominal pain
  • leaking of the gastric band
  • stretching of the new stomach pouch, so it no longer restricts the amount of food you can eat
  • moving of the gastric band from its original position, requiring another surgery to reposition it
  • erosion of the band through the stomach wall, and into the stomach, requiring additional surgery
  • stretching of the esophagus
  • Eating with a Gastric Band

    When people hear that gastric banding will force them to eat less, they may not realize exactly what that means. According to the University of California San Diego (UCSD) Bariatric and Metabolic Institute, you need to eat only soft foods (like mashed potatoes or baby food) for the first five weeks after surgery. Then, you will still need to ay close attention to your diet—gastric banding isn’t a miracle fix; you’ll still need to eat well. Many patients have difficulty with solid foods in the morning. In addition, eating too much food or big chunks of food can block the outlet–the outlet is about the size of a dime, so food needs to be eaten in small bits and thoroughly chewed.

    In addition, the stomach pouch can only hold about 1/4 cup of food. Visually, that’s about the size of a deck of cards. That’s the total amount of each meal—any more than that can stretch out the pouch and potentially cause health problems.

    The Institute also recommends that you avoid high-fiber foods, including (but not limited to):

    • dried fruits
    • asparagus
    • pineapple
    • corn (especially popcorn)
    • grapes
    • nuts and seeds
    • carbonated beverages

    Glamorizing Lap-Band

    For some people, gastric banding can be a literal life-saver. But some people are attracted by what might be considered a simple way to lose weight.

    “FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

    Gastric banding is anything but simple. In fact, according to an article in the Los Angeles Times, at least four people have died of Lap-Band complications at the eight California surgical centers involved in the FDA warning. This is not a surgery to be undertaken lightly.

    If you are considering gastric banding, talk with your doctors about all the pros and cons…and ask to talk with people who have already had the surgery. There may be a support group that meets in your area. Understand that your life will change dramatically after the surgery, and not just because you might lose weight.

    Location Icon

    Raleigh Office

    3110 Edwards Mill Rd Suite 100,
    Raleigh, NC 27612
    P (919) 781-1107
    F (919) 781-8048

    Rocky Mount Office

    2317 Sunset Ave,
    Rocky Mount, NC 27804
    P (252) 443-2111
    F (252) 443-9429

    Jacksonville Office

    Appointment Only
    P (910) 377-7671
    Scroll to Top