ReShape Integrated Dual Balloon System Implicated in FDA Warning

The ReShape Integrated Dual Balloon System is just one of the many gastric balloon devices that the FDA has recently warned about.

According to the FDA, gastric balloons may carry with them considerable risks that patients may not have been adequately warned about. The ReShape Integrated Dual Balloon System is one of the several gastric balloons currently under investigation for its serious side effects.

What Are Gastric Balloons?

Gastric balloons are a new kind of weight loss device. These implants are essentially balloons that are filled with liquid and implanted in a patient’s stomach. Their function is simple: these implants are meant to take up space in the stomach, which in turn helps patients to feel fuller and encourages them to eat less. One such device is the ReShape Integrated Dual Balloon System.

The Risks of Gastric Balloons

Though gastric balloon procedure is considered less invasive than surgery, the U.S. Food and Drug Administration has issued a warning about certain risks linked with the use of these devices, including the ReShape Integrated Dual Balloon System.

According to a letter from the federal agency to U.S. health care providers, there were two significant issues that have led to a number of adverse event report filings regarding the devices.

“We recommend that you closely monitor patients with these devices for adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices,” read the agency’s letter, cautioning providers.

One of the major risks of using gastric balloons is the possibility of overinflation of the device. Overinflation can occur when the balloon further inflates with either excess fluid or with air once it has been placed in the stomach. Overinflation usually necessitates removal of the device.

According the FDA’s adverse event reports, patients can suffer overinflation as soon as nine days after the original implantation of the device. Symptoms of device overinflation include abdominal distention, severe abdominal pain, breathing problems, and vomiting.

The other major complication linked with the use of gastric balloons is acute pancreatitis, which can occur when the balloons compress other parts of the gastrointestinal system. Symptoms include severe back and abdominal pain, which can start as soon as three days after implantation of the device.

Major gastric balloons linked with these complications are the ReShape Integrated Dual Balloon System from ReShape Medical and the Orbera Intragastric Balloon System from Apollo Endosurgery. Patients implanted with these devices claim that they were inadequately warned about the serious risks of using gastric balloons.

So far there have been five “unanticipated deaths” that may be linked with the devices, all occurring within one month of the initial procedure. In some of these cases, it took less than a month: three of these patients reportedly died within one to three days of the gastric balloon procedure. The FDA is currently investigating whether or not this link is substantial.

Filing a Lawsuit Over Complications With Gastric Balloons

If you or someone you love has suffered from complications from the ReShape Integrated Dual Balloon System or another gastric balloon device, you may be able to file a gastric balloon lawsuit. While filing a lawsuit cannot take away the pain and suffering caused by injuries or bring a loved one back to life, it can help to alleviate the financial burden caused by medical expenses and lost wages.