ASMBS Statement on Plication
Waldrep WRAP follows guidelines which were granted an Institutional Review Board Certificate of Approval (August 2010), prior to the recommendation by ASMBS.
March 8, 2011
The following statement is issued by the American Society for Metabolic and Bariatric Surgery in response to numerous inquires made to the Society by patients, physicians, society members, hospitals, and others regarding laparoscopic gastric plication as a treatment for obesity. The recommendation is based on current clinical knowledge, expert opinion, and published peer-reviewed scientific evidence available at this time. The statement is not intended as, and should not be construed as, stating or establishing a local, regional, or national standard of care. Laparoscopic gastric plication, also known as laparoscopic greater curvature plication, has recently emerged as a new bariatric procedure. The rationale for this procedure addresses issues that may limit the acceptance of other bariatric procedures. Specifically, the gastric plication does not involve gastric resection, intestinal bypass, or placement of a foreign body, and this could potentially provide a lower risk alternative that will appeal to patients and referring physicians. The operation involves mobilizing the greater curvature of the stomach similar to the dissection for a sleeve gastrectomy and infolding or imbricating the stomach to achieve gastric restriction. There are increasing numbers of gastric plication procedures being performed worldwide and this operation is being marketed as a new option for surgical weight loss by some practices. The quantity (4 studies, 1. Gastric plication procedures should be considered investigational at this time. This procedure should be performed under a study protocol with third party oversight (local or regional ethics committee, Institutional Review Board, Data Monitoring and Safety Board, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes. [See note above] 2. Reporting of short- and long-term safety and efficacy outcomes in the medical literature is strongly encouraged. Data for these procedures should also be reported to a program’s center of excellence database. 3. Any marketing or advertisement for this procedure should include a statement to the effect that this is an investigational procedure. These recommendations are not intended to impede innovation within our field. Rather, the Society encourages and supports the development of new and innovative procedures that can benefit our patient population. It is imperative, though, that these procedures be conducted responsibly under appropriate supervision and after appropriate training.