At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.
Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program. The root causes for the deaths are unknown, the agency said, "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 balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.
Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure.
Federal officials are warning health providers about weight loss balloon devices after five people died unexpectedly shortly after being treated with them.
The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.More news: Apple may drop the S from the iPhone
According to Apollo Endo-Surgery, there has been one additional death of a person who received its device.
The other two deaths occurred within a month or less of having the procedure. "While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the ORBERA device", the company said. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
They said that from January 2006 to March 2017, 21 patients using the Orbera device died.
In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety".
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.