Read: 474
The U.S. Food and Drug Administration FDA announced the implementation of a reorganization that impacts various facets of its regulatory process as of October 1, 2024. The agency is currently updating FDA.gov content to reflect these changes.
In addressing the epidemic of overweight and obesity in the United States, which are characterized by excess fat accumulation posing health risks linked to conditions such as heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems, weight-loss and weight-management devices play a crucial role.
BMI, calculated from an individual's weight and height, is used to define these conditions: BMI of 30 kgm2 or more signifies obesity, while overweight is characterized by a BMI range of 25.0 - 29.9 kgm2.
The FDA oversees three types of devices designed for weight loss:
Gastric Band: These consist of bands placed around the top section of the stomach, limiting food intake to a small portion.
Lap-Band Adjustable Gastric Banding System
External Link
Inflatable Gastric Balloon Systems: These balloons are introduced into the stomach to occupy space and slow gastric emptying.
ORBERA Intragastric Balloon System
External Link
TransPyloric ShuttleDevice: oscopic suturing devices used for altering gastric anatomy by placing permanent sutures that reduce stomach volume.
Apollo oscopic Sleeve Gastroplasty and Revise Systems
External Link
Spatz3 Adjustable Balloon System: This employs an oscopic suturing device to adjust gastric size.
There are two types of FDA-regulated devices med at weight management:
Oral Removable Palatal Space Occupying Device: Worn during meals, it limits bite size.
Ingestible, Transient, Space Occupying Device: An ingested material that temporarily occupies stomach space.
Before recomming weight-loss devices or surgery, healthcare providers typically require patients to demonstrate a commitment to healthy eating and increased physical activity. Continuous mntenance of healthy lifestyle practices post-treatment is essential. For some patients, the risk-benefit analysis suggests alternatives over surgical options.
In February 2017, August 2017, June 2018, and April 2020, the FDA issued letters to healthcare providers based on reports of adverse events related to liquid-filled gastric balloon systems. These issues included death, gastric perforation a hole in the stomach, acute pancreatitis sudden inflammation leading to severe abdominal pn, and spontaneous hyperinflation causing discomfort.
The FDA continues monitoring these complications, advising healthcare providers to closely monitor patients with liquid-filled balloons for signs of serious or life-threatening symptoms. Providers should instruct their patients on recognizing potential issues and actions to take if they occur.
UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers April 27, 2020
National Library of Medicine - Weight-loss Surgery
CDC - About BMI for Adults
National Institute of Mental Health - Eating Disorders
FDA Consumer Update - Medical Devices for Weight Loss and Weight Management: What to Know
These resources provide comprehensive insights into the FDA's ongoing efforts in regulating weight-loss and weight-management devices, as well as supporting materials on obesity management.
This article is reproduced from: https://www.fda.gov/medical-devices/products-and-medical-procedures/weight-loss-and-weight-management-devices
Please indicate when reprinting from: https://www.843z.com/Weight_loss_calories/FDA_WeightLoss_and_Management_Devices_Overview_2023.html
Weight Loss Devices FDA Regulation Gastric Banding Systems Overview Inflatable Balloon Weight Management TransPyloric Shuttle for Weight Loss Oral Removable Space Occupying Device FDA Monitored Weight Management Devices