FDA reveals five dead after anti-obesity balloon surgery
13 August, 2017, 01:09 | Author: Kelly Sanders
Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food.
The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight. The agency said two moredeath reports it received happened within the same time frame and are potentially related to complications from the balloon treatment. In three reports, the patients died in as little as one to three days later.
The FDA said on Thursday that doctors should stay alerted when placing this expensive balloon system and to monitor the patient really close.
Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery. The other is a dual balloon system made by ReShape. However, the FDA says it hasn't determined if the deaths were, in fact, caused by the silicone balloons or the procedure to insert them. The use of the balloon is complemented with counseling and nutritional support or advice.
Apollo Endo-Surgery said in a press conference they are responsible for one death in the United States, one in Great Britain, one in Mexico, and two in Brazil.
In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.
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An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States.
"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement.
The FDA update comes six months after the agency issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape's devices.
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