Evera Medical, a Foster City, CA manufacturer of the facial saline-adjustable implant FulFil, is reporting that more than 670 of the devices have been implanted in the last two years with “no serious adverse events.” The company markets its implants under two names, with FulFil™ being an international product, which was issued the European CE Mark in April for “augmentation of facial soft tissue, including lip augmentation,” and in the US the device is called VeraFil™, and it was cleared by the FDA for “augmentation and reconstruction in and around the orbit of the eye,” according to Evera Medical.
We have not seen this device before, so here’s a quick look at the company’s technology:
The FulFil implant is made up of a very thin compliant and porous membrane. This membrane is made of ePTFE, which is 50 microns in thickness and surrounds a silicone balloon that is filled with normal saline. The pores within the ePTFE membrane allow limited tissue incorporation without a fibrotic response often causing painful and rigid encapsulation of the implant. A patented ‘slip plane’ technology allows full movement between the silicone balloon and the outer ePTFE layer, thereby contributing to discreet and limited tissue growth.
This novel technology is ideal for adding volume to the lips as flexibility and full animation of the mouth is maintained. Contrary to other implants made of thicker synthetic material, the lips remain full, soft and natural looking. Volume is added with normal saline to achieve the desired appearance.
Product page: FulFil implant …