FulFil is a new type of saline-filled lip implant, which has great potential for
a softer permanent lip implant. One of the advantages of the FulFil lip implant
is that the size can be adjusted at the time of surgery by adding more saline
(much like breast implants). FulFil is made by Evera Medical is located in
Foster City, California and is not yet approved by the FDA. It is approved in
Europe under the name of FulFil, and once approved in the United States, it will
be called VeraFil. The FulFil Lip Implant has received approval for testing the
safety and effectiveness of the procedure, and the study is expected to begin by
September 2008 under the name EIFFEL – Evera Implant FulFil For Enhancement of
the Lip.
FulFil is designed as a permanent but reversible alternative to injectable
fillers. FulFil does not come with the side effect profile that have been
associated with previous implants that are on the market.
The FulFil™ Device – Image Courtesy of Evera Medical
FulFil is a dual membrane saline filled implant that is inflated to the
desired size one it is in place. The outer layer of the implant is made of
ePTFE (Expanded Polyolytetrafluoroethylene) which is a very porous and inelastic
material. This outer layer is attached at each end, to a very thin silicone
balloon which has a self sealing valve at one end. The ePTFE outer layer is only
50 microns (0.10mm) in thickness and is actually significantly larger than the
inner silicone balloon which allows this balloon to move independently of the
outer layer after implantation resulting in amore natural look and feel.
FulFil conforms to the shape of the lip, and does not force the lip to conform
to a rigid tube.
How the
Procedure is Performed
Under local anesthetic such as a dental or a nerve block, a metal tube is used
to guide the implant in place. Then, it's filled with saline solution. The
process takes about an hour. There are different sizes to the implant, so if you
put one in and it's too big or too small, you can take it out put a different
one in. You can vary the amount of saline that goes into it to get just the
right amount of lip augmentation.
Once the implant is inserted and inflated, the outer layer allows for tissue
in-growth to occur. This tissue in-growth then stops a capsule forming around
the implant, and so prevents the implant from hardening. Migration doesn’t occur
with this implant because it is anchored in place biologically with the
in-growth tissue. This also allows for ease of removal if the patient should
decide to want them any longer.
FulFil implants are great for creating a very natural looking appearance of the
lips, which will allow for unobstructed facial expressions as the implants
stretch to match the contours of the surrounding area. It is good for older
patients as well with reducing the appearance of fine lines and wrinkles around
the mouth. It is also good for people with both full and thin lips as the
implant can either define and shape or provide volume.
The cost has been
reported between $3,000 and $4,000.
The FulFil™ Device – Image Courtesy of Evera Medical