FDA Approval Status for Bariatric Surgery

The U.S. Food and Drug Administration's (FDA) approvals and regulations of bariatric surgery are limited to the devices and materials used before, during and after the surgical procedure. The FDA approves life sustaining devices, monitoring equipment, medications, surgical tools and devices placed within the body.ᅠ

Surgical Gastric Bypass without Gastric Banding

Surgical bypass procedures may involve restricting the size of the stomach and/or the surgical diversion or shortening of the small intestine. In these procedures, the surgeon may use an FDA approved surgical stapling device and staples, or FDA approved suture material.ᅠ

Gastric Banding

Gastric banding is a less invasive form of bariatric surgery. Using a laparoscope, the surgeon places a band around the stomach and adjusts it to the desired size. Several adjustable bands have been developed, but only two bands have FDA approval for use in the U.S. The LAP-BANDᆴ System received approval in 2001 and the Realize Band acquired approval in 2007.ᅠ

Gastric Devices not Currently Approved

The Intragastric balloon is placed in the stomach and inflated. Although it is currently used in several countries, it is not approved by the FDA for use in the U.S.ᅠ

The Gastric Electrical Stimulation System is a device used to treat gastroparesis; however, at this time, it does not have FDA approval for use in bariatric surgery.ᅠᅠᅠ

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