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# Petition Urges Actions Against Weight Loss Device
- URL: https://www.fdaweb.com/petition-urges-actions-against-weight-loss-device/
- Published: 2026-05-14T12:00:00.000Z
- Updated: 2026-09-14T13:39:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161148

A newly filed citizen petition is urging FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say is being marketed and used in the U.S. without FDA authorization. The device, which is manufactured by Advanced Bariatric, is described as a reversible, non-cutting alternative to traditional weight loss surgeries.

The [petition](https://downloads.regulations.gov/FDA-2026-P-5453-0001/attachment%5F1.pdf?ref=fdaweb.com) asks the agency to issue a series of warning communications stating that the BariClip — also referred to as the B-Clamp or Vertical Gastric Clip — is not cleared or approved for sale or marketing in the U.S. and may only be studied under an FDA-approved IDE. It requests that the agency issue:

- a letter to healthcare providers warning physicians against promoting or using the device;
- an “It Has Come to Our Attention” letter directed at Advanced Bariatric Technology and related entities;
- a formal FDA safety communication to surgeons, patients, and the medical device industry; and
- an investigation into any U.S.-based promotion, studies, or clinical use of the device.

According to the filing, the petitioners searched FDA databases and could find no evidence that the BariClip has received clearance or approval through a 510(k), *De Novo*, or PMA pathway.

The bariatric implant comprises a titanium backbone coated in silicone that is designed to reduce stomach volume for weight loss. The petition states that Advanced Bariatric Technology controls the device’s patent portfolio, while manufacturing may involve entities tied to the Dominican Republic.

The filing argues that the device should be treated as a “significant risk device” under FDA regulations because it is an implant intended to treat obesity and carries risks including gastric obstruction, clip migration, perforation, tissue erosion, and reoperation.

The petition notes that one published study reported complications including clip slippage, obstruction, gastric perforation, intragastric migration, food intolerance, and clip rupture.

The filing further alleges that at least one U.S. bariatric practice is already advertising the BariClip as a routine treatment option for patients with obesity, despite the absence of apparent FDA authorization.

The petition comes amid heightened FDA scrutiny of obesity-related medical products and growing regulatory attention on medical device promotion outside approved pathways. The agency has increasingly emphasized enforcement against unauthorized devices and improper clinical investigations in recent years.