If you have had an intra-gastric balloon implanted to help you lose weight, your doctor may be monitoring you more closely.
That's because the U.S. Food and Drug Administration(FDA) sent a letter to healthcare providers Feb. 9, cautioning them about two potential risks to two systems, the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System.1 Both systems were FDA approved in 2015.
One risk is overinflation of the balloon, potentially causing abdominal pain, swelling, breathing difficulties and vomiting. The FDA received several dozen such reports.
The other, viewed as more serious, is acute pancreatitis (inflammation of the pancreas), which can be deadly. Several patients had this complication, including four who needed to be hospitalized.
The complications are not listed on current labeling, so the FDA is hoping to make all doctors, including ER physicians, aware that the symptoms could be related to the balloons. Currently, Obera reports 220,000 patients globally have had their intra-gastric balloon implanted. ReShape does not currently have estimates available.
A third gastric balloon on the market, Obalon, approved in 2016, is not involved in the communication about risks.
Awareness is key, says J. Michael Gonzalez-Campoy, MD, PhD, FACE, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology, and an editorial board member of EndocrineWeb.
"Patients who have the fluid-filled balloon systems in place should be aware of the symptoms (abdominal pain, vomiting, breathing problems), which may develop a few days after balloon implantation," Dr. Gonzalez-Campoy says. "Should these symptoms develop they should seek medical care. Although uncomfortable, balloon over-inflation is relatively benign.'' However, pancreatitis can be severe, sometimes requiring patients to be hospitalized, he says.
Neither complication is common. Dr. Gonzalez-Campoy put the risks in perspective this way. "Patients should think of the risk of over-inflation like they would of the risk of having a flat tire on the way home from work," he says. "The risk of acute pancreatitis is lower, like the risk of a fender-bender accident while driving. Although awareness of the risk is important, it is riskier not to treat obesity," he tells EndocrineWeb.
The new information should motivate doctors to be sure their patients know exactly what to expect after the balloon systems are placed, says Scott Cunneen, MD, FACS, FASMBS, director of metabolic and bariatric surgery at Cedars-Sinai Medical Center, Los Angeles, and a member of the EndocrineWeb editorial board.
"When these things are put in,'' he says, ''the patients are generally pretty miserable for the first few days." They commonly complain about feeling nauseated, sick and not very hungry, he says. He will now tell patients if they feel bad for more than the first few days, they must call and report in so he can decide if evaluation is needed.
"We have to be careful to look for serious but infrequent complications," says Dr. Cunneen, co-author of 21 Things You Need to Know About Diabetes & Weight Loss Surgery (American Diabetes Association, January 2017).
Both the ReShape and the Orbera systems are fluid-filled balloon systems, approved for use in tandem with diet and exercise for those whose body mass index (BMI) is 30 or higher and have been unable to lose weight through diet and exercise alone. The Orbera balloon is filled with saline and the ReShape balloons (two are used) are filled with saline and methylene blue dye. Both were approved for six months' time maximum. The systems are placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, done under light sedation.2,3 After six months, the devices are deflated and removed.
The third system, not included in the communication to doctors, is the Obalon system, which includes three balloons. They are delivered to the stomach inside a capsule that is swallowed. A catheter attached to the capsule inflates the balloons with air.4
The risks of overinflation and pancreatitis ''had not been identified in the FDA approval studies for the two currently approved fluid filled balloons and was not included as a risk in either product's labeling," says Todd Newton, CEO of Apollo Endosurgery, which makes the Orbera system.
Both risks are known from international experience, he says, although both are rare. In a letter to its physicians who use the system, Apollo says that over inflation occurs about .4% of the time and since August, 2015, when Orbera was approved, the reported rate is less than .2%. It says globally two cases of acute pancreatitis have been reported after Orbera placement.
ReShape declined to comment on the FDA communication.
The FDA says it will continue to work with both companies to understand the issues.1 Besides closer monitoring of patients, physicians would be wise to inflate the balloons less, Dr. Cunneen says, to err on the side of caution.
He can't speculate as to whether the newest system, just approved in 2016, may have the same issues with pancreatitis. That's because it is not known exactly what causes the issue of pancreatitis. If it turns out to be the compression, the weight of the fluid-filled balloons pressing against the pancreas, the gas-filled balloon may have an advantage, he says. But no one can say for sure at this point.