Since 2019 and the ban in France of breast implants with a so-called macrotextured surface and a surface covered with polyurethane, the National Medicines Safety Agency (ANSM) has systematically carried out a control of the surface of new breast implants when they are placed on the French market.
It is thanks to this control protocol that the Agency noted the abnormal presence of microbeads obtained from the gel filling on the surface of smooth and microtextured B-Lite breast implants, manufactured by the company G&G Biotechnology Ltd.
“We have accordingly informed the manufacturer, the notified body responsible for European certification and the other European health authorities”, Detailed the ANSM in a press release dated March 23, 2021.“Pending the conclusions of the ongoing investigations to determine the cause of the presence of these microbeads, the notified body MDC (Medical Device Certification GmbH) suspended as a precaution the CE marking of B-Lite implants on February 12, 2021.”, She clarified.
These breast implants can therefore no longer be used and placed on the market, due to the suspension of the CE marking.
But make no mistake, this is not yet another scandal relating to breast implants, since the ANSM specifies that these implants are not currently marketed, and that only 4 of them were sold in 2016, of which only 2 were installed. The women concerned benefit from reinforced medical monitoring, although no specific risk associated with these prostheses has been identified to date.
However, the ANSM reminds all women with breast implants that they must consult a health professional every year (surgeon, gynecologist, attending physician), regardless of the model of breast implants placed. It is also possible for them to report an adverse effect suspected of being linked to breast implants on the vigilance portal of the Ministry of Health.