ASMBS Policy Statement on Gastric Plication

[Alex Brecher 10,512]

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, <300 patients) and quality (prospective or retrospective case series) of the data available at this time is insufficient to draw any definitive conclusions regarding the safety and efficacy of this procedure. The Society will continue to monitor the data on this procedure as it emerges and will issue a formal evidence-based position statement at the appropriate time. We currently support the following recommendations regarding gastric plication for the treatment of obesity:

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.
   
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.

[chowchows 100]

I wish that someone would gather statistics and info from all the patients who have gone to Mexico and had it done. There are enough of us that, while the FDA and ASMBS probably wouldn't find it reliable, other people might be interested in following the path of our journey and seeing the weight loss as we all become "long term" patients.

[Alex Brecher 10,512]

I wish that someone would gather statistics and info from all the patients who have gone to Mexico and had it done. There are enough of us that, while the FDA and ASMBS probably wouldn't find it reliable, other people might be interested in following the path of our journey and seeing the weight loss as we all become "long term" patients.

My goal by the end of summer is to have a system (here) where all patients can register and we'll be able to track many stats, regardless of where their surgery took place. I agree, it would be really interesting to see these results.

[chowchows 100]

My goal by the end of summer is to have a system (here) where all patients can register and we'll be able to track many stats, regardless of where their surgery took place. I agree, it would be really interesting to see these results.

That would be very beneficial, IMO. Thank you!