I noticed that there is some concern about Plication surgery safety because it is not yet approved in the US by the FDA. I work in an industry where I have some but not extensive knowledge of how the FDA approvals work, so I am not claiming to be an expert. However, I know that the FDA does not allow the investigation or approval of drugs or procedures unless they are confident in the safety and benefits outweighing the risks.
Currently, there are a few studies going on in the US for the approval for Gastric Plication surgery. Once the studies are completed and findings are submitted, there is a long review process. Approval could be several years away considering the studies have not even been completed. All studies must be registered with the FDA and are published on a US government website. You can learn more at:
http://www.clinicaltrials.gov/ct2/results?term=gastric+plication
In the US, to qualify for a gastric procedure, a patient must be 40+ BMI for 5+ years, OR 35+ BMI with health concerns (diabetes, high BP, sleep apnea, etc…)
I am BMI 39 with no health risks. Thank the good Lord! I hope to never be able to qualify for surgery in the US because I would meet these standards. I want to find a solution to my weight issues before I get to that point. Once the Plication is approved here, it will have the same patient qualifications so many people who need help before getting to that point still would not qualify.
I was excited to learn about Plication surgery because I was not completely satisfied with the current options in the US. I knew people who had either by-pass or lap band surgery and although they were happy with the weight loss, they lived with daily limitations and restrictions. The approval process was VERY long and insurance either did not cover it or they still had significant out-of-pocket costs. The costs were still at least ½ of the OCC costs.
I am confident in gastric placation at OCC because it has been approved for investigation by the FDA, it less invasive and I am healthy, just fat. If I had the health risks need for qualification or was bigger, I would be concerned with the complications that would come with surgery, even in a US hospital.
I hope this helps build the confidence in people who are worried about the safety of gastric placation, just because it is not YET approved in the US. It will be! This is a great improvement to current treatments which will not be available for a few years to others who are not willing to travel over the border.
I am excited that a surgery is available to me that is more advanced than the US. I am able to stop my weight spiral downward before I have serious health concerns.