Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons
The Food and Drug Administration issued a warning Friday to medical providers to closely monitor patients undergoing a specific gastric-bypass procedure, following the deaths of five people shortly after they underwent the operation.
The U.S. Food and Drug Administration revealed on Thursday that at least five people have died after they were fitted with liquid-filled intragastric balloon created to help people lose weight. In the procedures, patients are mildly sedated as a deflated balloon made of silicone is inserted through the throat and into the stomach, after which it's filled with saline to take up space in the stomach. The balloons are left in the stomach for up to six months with the idea being they leave less room for food. "In three reports, death occurred as soon as one to three days after balloon placement", said the FDA.
In all five cases, death occurred within a month or less of the procedure to place the balloon.
The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths.
The agency, however, cautioned that it has yet to determine whether the devices or the way in which they were placed in the stomachs directly caused those deaths. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
According to NBC News, Apollo says it reported the deaths to the FDA itself.
Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.
An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.
Endoscopic placement of the balloon is temporary and reversible without surgical incisions.
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