2024-08-06 16:31:42
“Allurion must immediately withdraw its internal balloons from the French market to protect the health and safety of patients,” the National Agency for the Safety of Medicines (ANSM) said on Tuesday in a press release with the administrative decision of withdrawal.
Intestinal obstruction, perforation of the stomach … Risks are known and reported for all stomach balloons but the product from the beginning Allurion is distinguished by two ingredients that warrant, according to the agency, its removal from the market. From its perspective, health authorities have recorded around twenty cases of serious complications.
Many copies of this balloon, which is drawn into the stomach, are planted each year, promising to help you lose weight. The procedure is similar to a ring, reducing the space available for food inside, except that the balloon requires little or no surgery.
In the case of the balloon developed by Allurion, a start-up based in the United States but very active in France, the device must be placed in capsule form. He then remained active for four months, before taking it again.
Using the balloon inside the argument
But its use is controversial. First, its effectiveness: internal balloons allow you to lose some weight immediately, but it is very unknown whether these effects last.
In France, where this balloon has been offered since 2016, the health authorities authorized it but did not recommend it, given the doubts about the long-term benefit even if Allurion ensures that its effectiveness lasts at least a year. Also in demand is its high price, which can reach several thousand euros. So the balloon will not be reimbursed by Social Security, which does not prevent several dozen private hospitals from offering its implantation.
Anger and limited advertising
The agency, which had already issued a warning in mid-July, criticized the total lack of follow-up after the balloon planting, as well as aggressive and inappropriate advertising. “Once the balloon is placed, patients live with it for four months, without any follow-up planned by the manufacturer,” Thierry Thomas, one of those responsible for medical device issues, told AFP within ANSM.
How many people are involved?
ANSM refrains, for legal reasons, from giving precise sales figures for Allurion, but specifies that its machine is the most of the indoor balloons sold in France.
Knowing that around 5,000 balloons in total are planted per year, we can estimate that many thousands of patients use Allurion’s product each year. However, besides the doubts about its effectiveness, the initial balloon presents risks. From its perspective, health authorities have recorded around twenty cases of serious complications.
Questions that arise now
Several questions arise now. As the suspension is irreversible, will Allurion take enough steps to put its ball back on the market? And what will be the legal consequences when patients are already considering legal action?
“The first files arrived a year and a half ago: usually, it’s a balloon that explodes,” lawyer Géraldine Adrai-Lachkar reported to AFP, who said she was satisfied with ANSM’s decision while ruling it “late few”. “I would be surprised if there were almost twenty cases, I think there are more,” he said.
When contacted, Allurion did not immediately respond.
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