Post-marketing Surveillance Study of A.M.I. Protector Adjustable Gastric Band

The laparoscopic adjustable gastric band (LAGB) is a safe and effective surgical intervention for chronically obese patients who have exhausted all non-surgical weight loss treatments. Numerous published studies have confirmed both the safety and efficacy of the LAGB and its beneficial impact on obesity-associated conditions, such as type 2 diabetes, joint and back pain and hypertension. The A.M.I. Protector Band is a modification of an existing gastric band (the A.M.I. Soft Gastric Band) which has been in use since 2001 and which has been shown to be both safe and effective. The specific design modification is in the form of a section of mesh, which provides support to the gastric pouch and which further restricts food portion sizes. The expectation is that this will deliver optimal weight loss whilst having the maximum possible impact on obesity-associated conditions such as type 2 diabetes and hypertension. In the longer term, there is also the possibility that the Protector Band will reduce the incidence of band complications such as slippage and dilatation (or stretching) of the gastric pouch. In this study we will recruit approximately 200 patients who will then undergo surgical implantation of the A.M.I. Protector Band. The study participants will then be followed for a period of 3-years, during which time we will record weight loss, changes in co-morbid conditions such as diabetes and the incidence of band complications, including slippage and pouch dilatation.