What is the FDA?
FDA stands for the United States Food and Drug Administration. The FDA is a federal agency and their ruling is generally considered the gold-standard world-wide when it comes to judging the safety of medical devices for consumers. The FDA can trace its lineage back to the Agricultural Division in the Patent Office in 1868, but its origins as a consumer food protection agency on a federal level started with the 1906 Pure Food and Drugs Act. The Food and Drug Administration is key when it comes to advancing public health in the United States (and by extension the world) by ‘helping to speed innovations that make medical products more effective, safer, and more affordable’. They do this by ensuring the public get ‘public get the accurate, science-based information’.
Why is FDA Approval Important?
FDA approval is important for several reasons, namely because it indicates to consumers that a product is safe as judged by an organisation with some of the strictest processes on the planet. In turn, this makes any FDA approved medical device one that can be trusted by medical centres, Doctors, and patients alike. This is what makes FDA approval for the Orbera 365 so important, providing medical professionals and patients an avenue in which to judge the proficiency and safety of a device with the necessary, accurate research to back that judgement up.
The Orbera 365 Gastric Balloon, FDA Approved
The Orbera 365 is an intragastric balloon that has FDA approval to stay in the stomach for up to 12 months. This means that patients are able to maximise their time with the balloon, whilst having the flexibility to arrange removal at any point prior. With the Orbera 365 in place, patients can work with an Allure Dietitian in order to help change those lifestyle choices that have been holding them back. A change to our daily habits, especially around food, is the key to success with long-term maintenance of weight loss.
12 month gastric balloon patients can look forward to an average total body weight of between 10 and 18% if they work with the weight loss tool. With twenty years of research and placements behind it, the Orbera 365 is the most popular gastric balloon globally with over 400,000 placements. Made of silicone, the gastric balloon is designed to occupy 60% of the stomach, delay gastric emptying, and suppress the hunger hormone known as ghrelin.
Start or Boost Your Weight Loss Journey
As about gastric balloon and bariatric surgery weight loss options today by emailing email@example.com or calling 0345 512 0094 for more information. Alternatively, you can fill out our enquiry form. Either way, a member of our team will get back to you as soon as they can.
Allure Weightloss is a CQC registered provider of gastric balloons and bariatric surgery in the UK.