Amy J. Reed Collaborative/HARMS Petition HHS and FDA to Take Action on BariClip Bariatric Device

05.13.26 — Northeastern Law professors David A. Simon and Hooman Noorchashm, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC) and officers of Harmed Americans for Reform in Medical-Device Safety (HARMS), have filed a citizen petition with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) requesting urgent action regarding the BariClip (also known as the B-Clamp or Vertical Gastric Clip), an implantable bariatric device manufactured by Advanced Bariatric Technology, LLC.

“Implantable medical devices, especially ones that would be considered ‘high risk,’ require FDA clearance or approval before being introduced into U.S. interstate commerce,” said Noorchashm, an internationally recognized medical device safety expert. “Manufacturers or practitioners who do so without FDA authorization are in violation of federal law.”

The petition explains that BariClip — a titanium-and-silicone clip implanted around the stomach to restrict food intake as a treatment for obesity — is being used in the U.S. but does not appear to have any FDA clearance or authorization. Clinical studies of this device conducted both in the U.S. and abroad have documented serious complications including gastric perforation, clip slippage and migration, intragastric migration, rupture, and gastric outlet obstruction requiring reoperation. The petition calls on the FDA to issue letters informing healthcare providers, the manufacturer and the broader bariatric surgery community that the BariClip is not authorized for marketing or use in the United States, that its sale and promotion violate the Federal Food, Drug, and Cosmetic Act, and that any use or study of the device requires an FDA-approved IDE. The petition also requests that the FDA investigate the matter.
>> View the FDA Docket

“Compliance with federal law and regulations is crucial to protecting patients and the scientific enterprise,” said Simon, a healthcare law expert. “And so too is the FDA's oversight of new devices that touch the patients in the U.S.”

The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration, and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability. Harmed Americans for Reform in Medical-Device Safety (HARMS) is a 501(c)(3) not-for-profit corporation whose mission is to advance medical device safety through advocacy, outreach, and organizing.