Is procedure worth associated acute pancreatitis or spontaneous over-inflation?
Obesity is a common, serious, and costly condition that can lead to heart disease, stroke, type 2 diabetes (T2D), cancer, and preventable death.4 Studies show an increase in obesity prevalence from 27.5% in 2001 to 31.6% in 2005, stable from 2005 through 2010, and decreased from 31.6% in 2010 to 28.5% in 2013. However, prevalence remains higher than in 2001, with persistent prevalence in demographic and socioeconomic disparities. Variety of treatment options from healthy eating with exercise to medication and surgeries exist. The US Food and Drug Administration (FDA) approved four devices — gastric band, electrical stimulation system, gastric emptying system, and gastric balloon system — to treat obesity.
Intragastric balloons weight loss systems were developed 30 years ago to treat obesity.2 The device is made of soft, smooth silicone rubber filled with either air or fluid to take up space in the stomach to induce early satiety. In a meta-analyses study, use of OBERA balloons resulted in 11.3% weight loss and 25.4% excess weight loss; however, there are several limitations, such as migration, rupture, gastric erosion, ulcers, perforation, technical problems, and clinical intolerance.1 Some common adverse effects associated are abdominal pain, gastroesophageal reflux disease, anorexia, and nausea. On the other hand, some less common severe complications include gastric ulcers, small bowel obstruction, perforation, balloon migration, and death.
Recently, the FDA has received several reports regarding two adverse events associated with air or fluid-filled intragastric balloons. The complications included spontaneous over-inflation and acute pancreatitis and the resolution of symptoms was achieved through premature device removal. However, in some cases, patients were hospitalized. In 2015, the FDA approved the reported devices ReShape and Orbera. The ReShape balloon system manufactured by ReShape Medical Inc. uses two balloons, whereas, the Orbera balloon system manufactured by Apollo Endo-Surgery uses one balloon. However, both systems are indicated for use in combination with diet and exercise. The patient is mildly sedated in order to place the balloon in the stomach through the mouth and then the balloon is either filled with saline only (Orbera) or with saline and methylene blue (ReShape) for up to six months.
Spontaneous over-inflation of the fluid-filled system resulted in intense abdominal pain and swelling with or without discomfort, labored breathing, and/or vomiting. Reports indicated that balloon over-inflation could occur by the ninth day after implantation. Acute pancreatitis was reported as soon as three days after implantation due to compression of gastrointestinal structures created by the balloons. The reported symptoms were severe abdominal and back pain. Since both adverse events are currently not included in the package insert for the Orbera or the ReShape balloon systems, health care providers may not associate the symptoms with either hyperinflation or acute pancreatitis resulting in unsuitable or delayed treatment options.
Presently, due to lack of information, it is hard to determine the definite causes of both spontaneous hyperinflation and acute pancreatitis. Thus, close monitoring and submission of reports are recommended for better understanding of these two complications. Also, the FDA recommends that health care providers identify patients with implanted intragastric balloons as they may develop balloon-related symptoms or other abnormalities following the procedure and throughout the treatment duration. In patients presenting with the symptoms, it is recommended to consider differential diagnosis and confirmatory diagnostic studies must be performed if abnormalities are identified.
Additionally, last year, FDA approved the Obalon Balloon System, which consists of up to three balloons in a swallowable capsule attached to a thin inflation catheter used to inflate the balloons with air. Fortunately, the adverse events with the use of fluid-filled intragastric balloons have not been reported for the Obalon Balloon System. Overall, it is advised to submit the adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting Program and health care professionals are subject to FDA’s user facility reporting requirements to follow the reporting procedures established by their facilities. Submission of reports will help FDA identify the root cause and better understand the risks associated with these medical devices.
- Health care professionals must recognize patients with implanted fluid-filled intragastric balloons and the possibility of developing balloon-related symptoms or other abnormalities following balloon placement, and throughout the treatment duration.
- Health care professionals must perform confirmatory diagnostic studies, if reported adverse events are found.
- Voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting Program will help FDA understand and identify the causes of hyperinflation and acute pancreatitis.
1. ASGE Bariatric Endoscopy Task Force., ASGE Technology Committee., Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, and Banerjee S. Gastrointest Endosc. 2015 May; 81(5):1073-86.
2. Choi HS and Chun JH. Recent Trends in Endoscopic Bariatric Therapies. Clin Endosc. Jan 30 2017; 50(1): 11-16. doi:10.5946/ce.2017.007
3. “Health Care Providers (Medical Devices) – The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons.” Center for Devices and Radiological Health. Center for Devices and Radiological Health, n.d. Web. 21 Feb. 2017.
4. Kamali A, Hameed H, Shih M, Simon P. Turning the Curve on Obesity Prevalence Among Fifth Graders in the Los Angeles Unified School District, 2001–2013. Prev Chronic Dis 2017; 14: 160377. DOI: https://doi.org/10.5888/ pcd14.160377.