“Weight Loss Implant Causes Possible Deaths”
NATIONWIDE (August 11, 2017) – At least five people have died within a month after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.
The balloons were made by the Apollo Endo-Surgery. There have been five reported deaths of patients who had received the Orbera intragastric balloon in four different countries since Orbera’s FDA approval in August of 2015, according to Apollo. Apollo self-reported all five cases to the FDA as part of its Global Product Surveillance program.
“All five reports indicate that patient deaths occurred within a month or less of balloon placement,” the FDA said in a statement.
“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 says it doesn’t know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.
“Some products are manufactured in a way that makes them inherently unsafe in order to simply save money during the manufacturing process. Shortcuts cannot be made or lives may be put in danger. Consumer Safety should never be optional,” said the attorneys from Lexton Law Firm.”