Apollo’s Weight Loss Balloon May Be Linked To 4 Obese Patients' Death

Food and Drug Administration reported on Thursday that it is investigating five deaths that occurred in 2016 after patients underwent weight loss procedures that involved specialized balloons being fitted inside their stomachs.

Four out of the five deceased patients were using the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, to lose excess fat from their bodies.

According to Orbera's official website, it “is a durable gastric balloon made out of soft silicone. While it is temporarily in your stomach for six months it encourages your body to adapt to healthier portion sizes. The shape and volume of the stomach balloon takes up enough space in your stomach to help you adapt to healthier portion sizes. The technology and design of the balloon help patients lose up to 3x the weight of diet and exercise alone.”

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A spokeswoman for Apollo said that none of the deaths being investigated by the FDA, regarding their weight loss product, occurred in the United States. Apart from Orbera, another device that was also allegedly responsible for one of the five deaths was the ReShape Integrated Dual Balloon System.

The website further highlights the convenience of the weight loss device: The deflated balloon can be swallowed whole, without any surgical procedures and is inserted into the patient’s stomach while mildly sedated and hence does not require incisions.

After the balloon is inserted into the stomach, a syringe is used to fill the balloon with a sterile saline solution. The procedure takes an estimated 20 to 30 minutes to be carried out. The balloon inflates to the size of a grapefruit after being filled. The patients are allowed to go home after they are amply rested for a couple of hours.

The company also states that their device carries minimal risk since each patient has to complete a diagnostic endoscopy to ensure that there are no contraindications before being cleared to undergo the procedure. Also, the balloon is removed from the patient’s stomach after six months and the aftercare program begins.

However, according to the FDA, the five patients who died after undergoing the procedure did so within the first month of the balloon placement. In three of the cases, deaths occurred within one to three days of placing the devices. Nevertheless, the organization added that it has not been established beyond a doubt that the deaths have occurred due to the medical procedure.

“In three reports, death occurred as soon as one to three days after balloon placement. 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,” the FDA said in a statement.

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Doctors have been advised to inform anyone who wants to opt for such procedures, about the adverse effects of these weight-loss devices. “Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the U.S. clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death,” FDA’s report on Orbera stated.

FDA had also issued a letter to health care providers in February this year that recommended that they keep a watchful eye on patients undergoing weight loss treatment using liquid-filled intragastric balloon systems. Since then, both Orbera and ReShape have revised the labels on their products to reflect the risks involved in using them.