Yesterday, the FDA sent out a formal warning letter to a marketing company named 1-800-GET-THIN and to eight gastric banding surgery centers that use the 1-800-GET-THIN marketing service. The letter specifically referenced billboard advertising and marketing materials. The letter reads in part:
“These advertisements fail to reveal material facts, including relevant risk information regarding the use of the LapBand, age and other qualifying requirements for the LapBand procedure, and the need for ongoing modification of eating habits, as provided in the approved LapBand labeling. Therefore, the advertisements are misleading within the meaning of section 201 (n) of the Act and misbrand the LapBand under section 502(q) of the Act. In addition, while some of your advertisements make mention of risks and suggest a physician consultation, these advertisements do not adequately state the LapBand’s relevant warnings, precautions, side effects, and contraindications. Therefore, the advertisements also misbrand the LapBand under section 502(r) of the Act.”
“Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. Such action could include seizure, injunction, and civil money penalties.”
Some of the nasty side effects from gastric banding include nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease, indigestion, 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, and stretching of the esophagus.
However, the most serious problem with gastric band procedure is that it fails about 50% of the time. A long-term study that followed laparoscopic banding patients for a period of thirteen years found that “nearly 50 percent of the patients required removal of their bands” during that period.
