According to reports, five stomach balloon deaths have been linked to the use of weight loss balloons.

Five patients who were allegedly treated for obesity purportedly suffered from stomach balloon deaths after they were implanted with intragastric silicone balloons.

According to the U.S. Food and Drug Administration (FDA), the deaths of the five patients occurred in 2014. The FDA later issued a cautionary letter to physicians and medical service providers iterating the risks involved with the liquid-filled intragastric balloons, due to these reported stomach balloon deaths.

According to the report, the function of the balloons was essentially to limit a patient’s appetite and make it easier to eat less. The patient undergoing the procedure is typically given a mild sedation, after which the balloon is then inserted through the throat and into the stomach. The balloons are implanted within the stomach, then filled with liquid to occupy physical space. Since there then becomes less space within the stomach for food, it causes a decrease in appetite.

The balloon, however, only lasts within the patient’s digestive system for six months. Patients complete this treatment by effectively maintaining a healthy diet and exercising along with the implantation of the balloon.

There are some adverse effects and complications that may result from being surgically implanted with the silicone balloons. As with any surgical procedure, over-inflation of the balloon is purported to occur, which may result in abdominal distension, causing shortness of breath and pain.

The report maintains that some of the causes of death include intestinal obstruction or esophageal perforation. These conditions can be very dangerous if not immediately responded to.

The report says the FDA has yet to discover the root cause of the unanticipated stomach balloon deaths. And despite speculation surrounding the intragrastic stomach balloon deaths, no concrete evidence sufficiently connects the deaths to this surgical procedure. The deaths, however, did occur which a month or so of the initial implantation.

Additionally, four of the five deaths include patients having been implanted with the Orbera Intragastric Balloon System, manufactured by Apollo Endosurgery, and the fifth patient death includes the patient being implanted with the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

The report maintains that the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, has a 0.01% mortality rate. Additionally, since its approval by the FDA in 2015, five patients have purportedly died and all cases were self-reported by Apollo to the FDA.

The CEO of Apollo, stated in a press release, moreover, that, “Apollo has not received any indication from physicians or hospitals that the deaths were caused by the Orbera device. That company has not received any product liability-related claims in connection with these cases either,” he stated.

In addition to the CEO’s press release, the FDA has also maintained that “[a]t 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.”

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