The FDA has added new warnings to Obera and ReShape weight loss balloons following reports of acute pancreatitis, surgical complications and deaths.
The FDA is requiring new label warnings of intragastric weight loss balloon surgeries, which have been linked to a number of deaths in recent years.
The FDA warns that at least five patient deaths have been linked to complications with intragastric weight loss balloons and investigators are still trying to ascertain the cause of those…
The FDA warns that surgical balloons implanted in the stomach to promote weight loss can overinflate and could also cause cases of acute pancreatitis.
