The authorities fear undesirable effects. The National Agency for the Safety of Medicines and Health Products (ANSM) announced this Thursday the withdrawal of the CE certification, which allows the sale and circulation, of the 100 g Los Deline body fillers.
“The withdrawal of the CE certification was decided by the notified body due to unsatisfactory results of an intracutaneous reactivity test,” the ANSM reported.
For this reason, the Czech manufacturer Biorth sro and its distributors have withdrawn products that were in stock at healthcare professionals or healthcare establishments.
Not recommended since 2010.
These injectable and non-absorbable polyamide gel compound products are primarily used for aesthetic purposes “to increase body volume such as breasts and buttocks.”
Since 2010, the ANSM recommends not using non-absorbable injectable products for aesthetic purposes. These recommendations were made public after the appearance of an “uncontrolled risk of very delayed serious adverse effects.”
Additionally, breast filler injections have been banned in France since 2011.
If a patient has already received an injection of the recalled product, they are recommended to consult their treating doctor annually, keep all documents and report any adverse effects on a dedicated platform.
On a professional level, the ANSM asks its patients to quarantine products and undergo ultrasounds, depending on symptoms, every two years.
Source: BFM TV
