People are dying after getting these weight-loss implants

Ellen Mills
August 13, 2017

All 5 patients died within 1 month of receiving the weight-loss balloon.

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. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. In three cases, the person died within one to three days of treatment.

However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely. "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". They also confirmed this was the cause of the five deaths. Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System.

Apollo Endosurgery uses one balloon, while ReShape Medical uses two.

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.

Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.

Endoscopic placement of the balloon is temporary and reversible without surgical incisions.

In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety". Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.

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