FDA Issues Alert In the battle to lose unwanted pounds, people try various methods to achieve their weight-loss goals. Fluid-filled stomach balloons have been one method with potentially risky consequences. The ReShape and Orbera fluid-filled stomach balloons have been associated with five deaths and dozens of reports of pancreatitis and spontaneously over-filling with fluid or air, sometimes in a matter of days.
The U.S. Food and Drug Administration (FDA) issued an update to inform healthcare providers of five deaths that occurred in patients with liquid-filled stomach balloons since 2016. Four of those deaths are linked to the Orbera® Intragastric Balloon System manufactured by Apollo Endosurgery and one death involves the ReShape® Integrated Dual Balloon System made by Reshape Medical, reports the Daily Hornet.
Three of the patients died between one and three days after the balloon was placed. All five patients died within just one month of receiving the weight-loss balloon.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits involving medical devices, including intragastric balloons. Attorneys at the firm are available to answer questions for individuals seeking information for a potential lawsuit.
According to the FDA: “At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”
The FDA warning on August 11, comes on the heels of another alert in February 2017, after dozens of patients experienced life-threatening side effects when their balloon spontaneously over-inflated with fluid or air, according to the Daily Hornet.
The FDA also cautioned that several patients developed acute pancreatitis (pancreas inflammation) because the fluid-filled balloons compressed their internal organs, and as a result, four patients had to be hospitalized.
Single or Two Balloon System
The majority of adverse events involve Orbera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that employs two balloons filled with saline and a blue dye. Both systems may be placed in the stomach for a maximum of six months as an aid to help obese people lose weight, the Daily Hornet reports. The balloons are meant to be used in conjunction with diet and exercise.
How Intragastric Balloons Work
The balloons are designed to battle obesity by taking up space in the stomach. This helps to lose weight by limiting how much you can eat and makes you feel fuller faster. The procedure to place the balloons into the stomach is minimally invasive. It is done endoscopically through the mouth while the patient is mildly sedated, according to the FDA.
In 2010, the World Health Organization (WHO) reported that 43 million children were estimated to be overweight and obesity is a worldwide epidemic. Methods range from lifestyle and dietary modifications, to bariatric procedures and intragastric balloons. These balloons have been available since the 1980s. Due to the relatively easy insertion, modification and retrieval, it was seen as a viable option for doctors and patients.
Symptoms of Balloon Complications
Symptoms of hyperinflation include “intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting,” according to the FDA.
“All of these cases required premature device removal, and four of the patients required hospitalization,” the FDA said. “Pancreatitis is not listed as a potential complication in the labeling information for the Orbera or for the ReShape balloon systems,” said the FDA. “Therefore, health care providers, including ER professionals, may be unaware that acute pancreatitis could develop following balloon placement.”
On occasion, a rupture or bleeding in the stomach or windpipe may occur, caused by a faulty insertion of the balloon, according to medic8.com.
Other complication may include a risk of infection caused by bacteria growth within the balloon. The infection will usually occur once the balloon has been deflated and removed or if a leak is caused. Signs of infection are typically nausea, cramping, fever, vomiting, and diarrhea.
In addition, intestinal obstruction caused by the balloon leaking and deflating, may cause the balloon to pass through the intestines like normal food. It can on its way cause obstruction which can be serious and would require additional surgery to remove the balloon, reports UK Health Center.
Legal Information and Advice for Intragastric Balloon Issues
If you or someone you know suffered injuries associated with the use of a medical device, such as a stomach balloon, you may be eligible for compensation. Parker Waichman LLP offers free, no-obligation case evaluations. For more information, we urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).