2023-09-07 21:43:00
The Los Deline 100g injectable products have been withdrawn from the market by the ANSM. Health professionals who have them in stock are asked to quarantine them.
The authorities fear adverse effects. The National Agency for the Safety of Medicines and Health Products (ANSM) announced on Thursday to withdraw CE certification, allowing the sale and circulation of Los Deline 100g body volume fillers.
“The withdrawal of CE certification was decided by the notified body due to unsatisfactory results of an intracutaneous reactivity test”, communicated the ANSM.
The Czech manufacturer Biorth sro and distributors have thus recalled products in stock with healthcare professionals or healthcare establishments.
Deprecated since 2010
These injectable products and non-absorbable polyamide gel compounds are mainly used for aesthetic purposes “to increase body volume such as breasts and buttocks”.
Since 2010, the ANSM has advised once morest the use of non-absorbable injectable products for aesthetic purposes. These recommendations had been made public following the appearance of an “uncontrolled risk of very delayed serious adverse effects”.
In addition, injections of breast fillers have been banned in France since 2011.
If a patient has already received an injection of the product withdrawn from the market, he is advised to consult his doctor annually, to keep all the documents and to report any adverse effects on a dedicated platform.
On the professional side, the ANSM asks to quarantine the products and to have ultrasounds carried out, according to the symptoms, every two years to their patients.
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