Evera Gets CE Mark Approval for Lip Implant

Evera Medical (formerly Juva Medical), of Foster City, CA, has received CE Mark approval for a saline-filled implant for facial soft tissue augmentation called FulFil. The first product will be a lip implant for permanent reversible enlargement. A cosmetic surgeon in London, the first physician to treat a patient with FulFil after Evera got the okay to market it in the European Union, said in a company-issued statement, “This implant represents a significant improvement over existing products such as temporary dermal fillers and facial implants made of stiffer synthetic material.”

FulFil is made from a multilayer polymer membrane. During treatment, it is filled with saline, which can be added or removed until the desired degree of enhancement is achieved. Currently, marketed lip implants can heal with excessive scarring, resulting in discomfort and stiffness. With FulFil, treated areas remain soft.

In the U.S., Evera has filed applications with FDA for multiple uses for FulFil. The status is pending.   

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