Evera Medical, maker of FulFil™—a saline-filled implant for tissue augmentation—has been granted the CE mark to market its FulFil implant throughout the European Union.
The CE mark certifies that FulFil complies with applicable safety and quality standards. The first product in the FulFil line is a saline-filled lip implant.
Lucy Glancey, MD, of Glancey Medical Associates, which operates a string of clinics across the UK, was the first in the European Union to treat a patient after Evera received the CE mark.
“This implant represents a significant improvement over existing products such as temporary dermal fillers and facial implants made of stiffer synthetic material,” Glancey says. “The patient that I treated had a great outcome and I look forward to treating more patients and following them up for long term satisfaction.”
The implant is constructed of 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 heal with excessive scarring, resulting in discomfort and stiffness. Because of the construction of FulFil, areas treated with the implant remain soft. Augmentation is permanent reversible, and patient outcomes are predictable.
Watch for Glancey’s article on hand rejuvenation in the June issue of PSP.
[www.cosmeticsurgery-news.com, April 20, 2007]