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US FDA Approval Concerns


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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.

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I looked up the study submission and completion dates. Plication studies will be completed in 2013, and then they will wait for approval which can take while. The FDA can ask for more safety or long-term data which then delays the process, sometimes for a couple of years.

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  • 4 months later...

I talked with a Gastroenterologist here in the US about getting my follow-up endoscopy. He told me that the gastric plication has been studied here in the US under what they called Endo-plication. It was studied for reflux control for an FDA approval to reduce acid reflux, however it was not as effective as the Nissen Fundoplication so it was not approved here for that purpose. However, patients were losing weight as a result of the surgery, so it was then explored as an option for weight loss. Although it was deemed safe, the FDA requires it to be studied again to show it is effective for approval for weightloss.

He also told me that typically after the plication reflux will actually get worse for a few months and then after it peaks, it will actually begin to sibside. The theory is that since a patient is eating less they pump out less acid and as a result they would have less to reflux.

Hope this is helpful info....

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When I got my band it was not approved in the US - now it's almost a gold standard. I think the plication will be a similar scenario. The US is typically far behind the rest of the world in medical procedures...probably due to our legal system.

DonnaC in Seattle

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On another forum, one poster was going on and on about how dangerous plication is...well with my daughter and I scheduled it, of course, concerned me. She said one of the doc that was approved for the study in the U.S. quit doing it due to the 'dangerous results" I decided to contact the office to see if that was true...it was NOT.

I have to remind myself as I read around the internet that EVERYTHING written on forum is one person's opinion...nothing more, nothing less. Often knowledge is helpful but I have found that one should be careful to not trust all that you read, most of what you hear and some of what you see.

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That was Dr. Montgomery...he was doing the plication in a different way - had one bad result and is now doing them the same way as Dr. Ortiez...and is having success.

Remember the internet is full of information - some good - some bad.

I totally trust Dr. Ortiez (have for over 8 years) - and if he says it is safe - you can bet it is...

DonnaC

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