Cosmetic product used to correct complications in hyaluronic acid fillers recalled in Spain

The Spanish medicines agency (Aemps) has denounced the company Proteos Biotech for manufacturing and marketing several products "for improper uses and by non-permitted routes of administration".

The products concerned are HA Corrector, Pbserum Enzymatic Solution and Pbserum HA. Although they are mainly distributed in clinics and their administering requires professionals, Aemps has not ruled out the possibility that they have been purchased outside official paths.

HA Corrector products are marketed as cosmetic products. However, according to Aemps, the company advertises them as products for application through injection for the correction of complications arising from hyaluronic acid fillers. "Such purpose and application are not permitted in cosmetic products," Aemps says.

In addition, Proteos Biotech promotes the joint use, through mixing and injection, of Pbserum Enzymatic Solution cosmetic products and Pbserum HA medical devices. This application is also not permitted for cosmetic products. Furthermore, the safety, quality and efficacy of the medical devices have not been proven for joint application with an aesthetic indication.

Aemps has adopted precautionary measures and has ordered that these products are withdrawn from the market. The agency has recommended that buyers return their purchases to the company from which they bought them. It has also requested the cessation of marketing and withdrawal of the above-mentioned medical devices.