FDA Advisory Panel Recommends Disapproval of Obesity Treatment Device
The Lap-Band adjustable gastric banding system is designed to surgically treat people who are at least 100 pounds overweight. The system comprises a silicone band that is placed near the top of the stomach, creating a new, smaller stomach pouch. The inner surface of the band is inflated periodically with saline through an injection port that is placed in the abdominal muscle, thereby tightening the device and allowing less food to pass through the digestive system. Adjustments to the band are made by adding or removing saline through the injection port in an out-patient, non-surgical procedure. The original insertion of the band and injection port is done in a hospital-based, laparoscopic surgical procedure which typically takes less than an hour.
The PMA filing included the results of a U.S. clinical study involving eight centers and 299 patients and an international study involving six centers and 441 patients. According to the company, the studies showed that average weight loss measured at two years after placement of the system was between 38% and 50%. The studies also showed a significant reduction in the risk of complications compared to stomach stapling and gastric bypass procedures.
The panel's decision was based on the view that the two years of clinical data presented by the company was not sufficient. The panel suggested three years of data.
Inamed is based in Santa Barbara, CA.