May 11, 2012
FDA has approved two gastric bands: Lap-Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. These devices are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making you feel full faster and potentially lose weight.
Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior modification, and have a BMI of at least 35 (217 pounds at 5-foot-6 inches) and at least one health condition linked to obesity, such as diabetes or high blood pressure.
Allergan’s Lap-Band is also approved for those with a BMI of 30 to 34 who have a health condition related to their obesity.
“Surgery itself has risks, including death, and those risks are heightened for people who are obese,” says Herbert Lerner, M.D., a general surgeon and supervisory medical officer at FDA.
There are risks after the surgery, too, including
- nausea and vomiting
- difficulty swallowing
- gastroesophageal reflux disease (GERD)
- upset stomach or pain
- stretching of the stomach pouch
- stretching of the esophagus
- moving of the gastric band, requiring another surgery to reposition it
- erosion of the band through the stomach wall and into the stomach, requiring another surger