Select Page

The FDA has released a warning concerning the gastric balloons ReShape and Orbera. Twelve people have died after the weight loss device hyperinflated soon after implantation. The weight loss devices have injured many more.

About Gastric Balloons

Orbera Fda 300x148
Intragastric weight-loss balloons, also known as “stomach balloons”, are non-surgical devices that treat obesity. A doctor inserts the silicone balloon down the throat with an endoscope. Once in the stomach, doctors fill the device with air or salt-water (saline) to about the size of a grapefruit. Gastric balloons physically fill up the stomach. This makes a person feel full and limits the amount of food they can eat. Patients also have to exercise, follow a strict diet, and remove the balloon after six months.
In August 2015, the FDA approved the Orbera Intragastric Balloon System made by the Texas-based medical device company Apollo Endosurgery Inc. The system is a single silicone balloon with 400-700 cc saline.
In July 2015, the FDA approved the ReShape Integrated Dual Balloon System made by the California-based device company ReShape Medical Inc. The system has two silicone balloons attached to each other. The doctor fills the balloons with saline and methylene blue. This is a dye that causes the patient’s urine to turn blue if the balloon pops.

FDA Warnings

On February 9, 2017, the FDA warned doctors to closely monitor patients for symptoms of pancreatitis and over-filled gastric balloons after dozens of serious injuries were linked to Orbera and Re-Shape. These gastric balloons have injured dozens of people from spontaneous hyperinflation as soon as nine days after implantation. Then, four others went to the hospital after contracting pancreatitis as soon as three days after implantation. Doctors suspect the balloon compressed the pancreas or other organs.

There Have Been 12 Deaths Since 2016

The FDA in June 2018 warned that a total of 12 patients have died since 2016 from weight loss balloons surgery.  All of the patients died within a month from surgery. Then, three died within three days of balloon placement. The FDA is also investigating two additional people who died after their stomach balloon perforated their stomach.

We Want to Help Victims of Gastric Balloons

Sad Woman 300x150Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. Of course, we want to help send a message that this is not acceptable. We are advocates for consumers harmed by dangerous products. Likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.

What Our Clients Are Saying