--- title: The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons description: The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons --- - Search Search Close this search box. - Download Forms - [Make a Payment](https://secure.lawpay.com/pages/ironsandirons/trust) - [(252) 215-3000](tel:252-215-3000) [![Irons and Irons](https://blog.theironslawfirm.com/hs-fs/hubfs/irons-law-logo.png?width=178&height=46&name=irons-law-logo.png)](https://theironslawfirm.com/) - [Personal Injury](https://theironslawfirm.com/injury-law) - [Auto Accident](https://theironslawfirm.com/injury-law/personal-injury/car-accident) - [Motorcycle Accident](https://theironslawfirm.com/injury-law/personal-injury/motorcycle-accident) - [Nursing Home Abuse](https://theironslawfirm.com/injury-law/personal-injury/nursing-home-abuse) - [Rideshare Accidents](https://theironslawfirm.com/injury-law/personal-injury/rideshare-accidents) - [Slip and Fall](https://theironslawfirm.com/injury-law/personal-injury/slip-and-fall) - [Traumatic Brain Injury](https://theironslawfirm.com/injury-law/personal-injury/brain-injury) - [Truck Accident](https://theironslawfirm.com/injury-law/personal-injury/trucking-accident) - [Wrongful Death](https://theironslawfirm.com/injury-law/personal-injury/wrongful-death) - [Divorce](https://theironslawfirm.com/divorce) - [Separation Agreements](https://theironslawfirm.com/divorce/separation-agreements) - [Divorce Options](https://theironslawfirm.com/divorce/options) - [Absolute Divorce](https://theironslawfirm.com/divorce/absolute) - [Collaborative Divorce](https://theironslawfirm.com/divorce/collaborative) - [High Net Worth Divorce](https://theironslawfirm.com/divorce/high-net-worth) - [Military Divorce](https://theironslawfirm.com/divorce/military-divorce) - [Division of Pensions, 401(k) & Retirement Accounts](https://theironslawfirm.com/divorce/division-of-pension-and-retirement-accounts) - [Post Separation Support and Alimony](https://theironslawfirm.com/divorce/support-and-alimony) - [Property Distribution](https://theironslawfirm.com/divorce/property-distribution) - [5 Critical Questions For Your Initial Consultation](https://theironslawfirm.com/5-consultation-questions) - [Family Law](https://theironslawfirm.com/family-law) - [Child Custody](https://theironslawfirm.com/family-law/child-custody) - [Child Custody Modification](https://theironslawfirm.com/family-law/child-custody-modification) - [Child Support / Modification](https://theironslawfirm.com/family-law/child-support-modification) - [Collaborative Family Law](https://theironslawfirm.com/family-law/collaborative-family-law) - [5 Critical Questions For Your Initial Consultation](https://theironslawfirm.com/5-consultation-questions) - [Education Law](https://theironslawfirm.com/education-law) - [East Carolina University/Pitt Community College Disputes](https://theironslawfirm.com/education-law/ecu-college-disputes) - [Public And Private School Disputes](https://theironslawfirm.com/education-law/school-disputes) - [Malpractice](https://theironslawfirm.com/injury-law/medical-malpractice) - [Medical Malpractice](https://theironslawfirm.com/injury-law/medical-malpractice) - [Dental Malpractice](https://theironslawfirm.com/injury-law/personal-injury/dental-malpractice) - [Pharmaceutical Malpractice](https://theironslawfirm.com/injury-law/pharmaceutical-malpractice) - Attorneys - [Gib Irons](https://theironslawfirm.com/about/gib-irons) - [Ben G. 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Blog](https://blog.theironslawfirm.com) [Subscribe](https://blog.theironslawfirm.com/the-fda-alerts-health-care-providers-about-potential-risks-with-fluid-filled-intragastric-balloons#popup-form) ### Subscribe via Email [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) # The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons May 18, 2017 Written by: Harry Albritton - Share - Share - Share - [Copy](https://blog.theironslawfirm.com/the-fda-alerts-health-care-providers-about-potential-risks-with-fluid-filled-intragastric-balloons) Copied the Url The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices. The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal. The second type of adverse event is the development of acute pancreatitis, which has also resulted in the need for premature device removal. The FDA wants to ensure you are aware of these potential complications that have been observed in patients treated with FDA-approved obesity treatment devices, although the root cause and incidence of these complications is not known. **BACKGROUND AND SUMMARY OF THE TWO ISSUES** Intragastric balloon systems are weight-loss systems to treat obesity, which function by taking up space in a patient’s stomach. In 2015, the FDA approved two intragastric balloon systems in the U.S. The *ReShape* Integrated Dual Balloon System is manufactured by *ReShape* Medical Inc., and uses two balloons. The *Orbera* Intragastric Balloon System manufactured by Apollo Endo-Surgery uses one balloon. Both brands are fluid-filled balloon systems, and are indicated for use in conjunction with diet and exercise. The balloons are placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the *Orbera* balloon is filled with saline only, and the *ReShape* balloons are filled with saline and methylene blue dye. The maximum placement period for both brands is six months. In 2016, the FDA approved the *Obalon* Balloon System, which consists of up to three balloons that are delivered to the stomach inside a swallowable capsule. The capsule is attached to a thin inflation catheter used to inflate the balloons with air. To date, the concerns addressed in this letter have only been observed with the use of fluid-filled intragastric balloons and have not been reported for the *Obalon* Balloon System. **Over-Inflation** – The FDA has received several dozen adverse event reports regarding balloon over-inflation of fluid-filled systems. Most have involved the *Orbera* Balloon System although this type of event has also been reported with the *ReShape* Balloon System. Symptoms of balloon over-inflation included intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting. The event may require premature removal of the balloon to resolve the patient’s symptoms. The reports indicate that balloon over-inflation can occur as soon as nine days after implantation. As the current labeling for fluid-filled intragastric balloons does not address the issue of spontaneous over-inflation, health care providers, including ER professionals, may not be aware that the symptoms listed above could potentially be related to an over-inflated balloon. At this moment there is not enough information to determine what is causing the balloon to over-inflate. **Acute Pancreatitis** – A separate set of reports involving both brands of fluid-filled balloons (*Orbera* and *ReShape*) indicate that acute pancreatitis developed in several patients due to the compression of gastrointestinal structures created by the implanted balloon(s). All of these cases required premature device removal, and four of the patients required hospitalization. Symptoms of acute pancreatitis in the presence of a fluid-filled intragastric balloon system included severe abdominal and back pain. The reports indicated that pancreatitis can occur as soon as three days after implantation. Pancreatitis is not listed as a potential complication in the labeling information for the *Orbera* or for the *ReShape* balloon systems. Therefore, health care providers, including ER professionals, may be unaware that acute pancreatitis could develop following balloon placement. This could lead to unsuitable or delayed treatment for pancreatitis in patients with balloons who may have acute abdominal pain. **RECOMMENDATIONS** The FDA recommends that health care providers: - Recognize that patients with implanted fluid-filled intragastric balloons may develop balloon-related symptoms or other abnormalities following balloon placement, and throughout the duration of their treatment. Consider spontaneous over-inflation and/or pancreatitis in the differential diagnosis of patients presenting with the symptoms noted in this communication. If abnormalities are found, perform any confirmatory diagnostic studies. If the device is removed, follow the manufacturer’s instructions for device returns or evaluations. - Report any adverse events related to intragastric balloon systems that come to your attention. Voluntary reports can be submitted through [MedWatch, the FDA Safety Information and Adverse Event Reporting program](https://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm). Device manufacturers and user facilities must comply with the applicable [Medical Device Reporting (MDR)](https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm) regulations. Health care personnel employed by facilities that are subject to [FDA's user facility reporting requirements](https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm) should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. FDA ACTIONS The FDA continues to work with *ReShape* Medical Inc. and Apollo Endo-Surgery to better understand these issues of acute pancreatitis and over-inflation in patients with fluid-filled intragastric balloons. We are committed to providing additional information as our investigation continues. CONTACT US If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at [DICE@FDA.HHS.GOV](mailto:DICE@FDA.HHS.GOV), 800-638-2041 or 301-796-7100. ### [Harry Albritton](https://blog.theironslawfirm.com/author/harry-albritton) Harry H. Albritton, Jr. is a passionate attorney representing victims of negligence and malpractice, with deep roots in eastern North Carolina. A graduate of East Carolina University, he returned to practice law in Pitt County after obtaining his law degree from Ohio Northern University. Throughout his career, he has successfully handled a diverse range of cases, from minor car accidents to multi-million dollar catastrophic injuries, and has been recognized for his legal abilities by Super Lawyers and The National Trial Lawyers. When not practicing law, he prioritizes spending time with his wife and three sons, engaging in outdoor activities such as hiking, biking, and kayaking. ### Related Posts [Pharmaceutical Malpractice](https://blog.theironslawfirm.com/tag/pharmaceutical-malpractice-articles) 1 min read #### [Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance](https://blog.theironslawfirm.com/compounded-drug-products-from-cantrell-drug-company-fda-warning-serious-deficiencies-in-quality-and-sterility-assurance) [Read more](https://blog.theironslawfirm.com/compounded-drug-products-from-cantrell-drug-company-fda-warning-serious-deficiencies-in-quality-and-sterility-assurance) [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) 2 min read #### [Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath](https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath) [Read more](https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath) [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) 1 min read #### [FDA Alert - Acrodose PLus and PL Systems by Haemonetics](https://blog.theironslawfirm.com/fda-alert-acrodose-plus-and-pl-systems-by-haemonetics) [Read more](https://blog.theironslawfirm.com/fda-alert-acrodose-plus-and-pl-systems-by-haemonetics) [![IRONS & IRONS P.A.](https://blog.theironslawfirm.com/hs-fs/hubfs/Irons%20and%20Irons/Pillar-Graphic.png?width=134&height=67&name=Pillar-Graphic.png)](https://theironslawfirm.com/) Irons & Irons P.A. 620 Lynndale Ct Suite A Greenville, NC 27858 Monday-Friday 9am-5pm Phone: [252-215-3000](tel:252-215-3000) PRACTICE AREAS - [Personal Injury](https://theironslawfirm.com/injury-law) - [Medical Malpractice](https://theironslawfirm.com/injury-law/medical-malpractice) - [Divorce](https://theironslawfirm.com/divorce) - [Family Law](https://theironslawfirm.com/family-law) - [Education Law](https://theironslawfirm.com/education-law) ATTORNEYS - [Gib Irons](https://theironslawfirm.com/about/gib-irons) - [Ben G. 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