SurgiSil LLP, a Texas based company that produces Plastic Surgery products, has received FDA 510K clearance on its Perma Facial Implant. This will allow formal training to begin for U.S. based surgeons.
The implant was developed over five years ago in reaction to Plastic Surgeons growing dissatisfaction with injectable fillers, which are costly, painful, and had to be repeated every few months. SurgiSil saw the desire for a safe, permanent, and easily reversible procedure for use in nose, chin, and cheek correction and augmentation.
Perma Facial Implant is made from soft, solid, silicone elastomer. It is used in an injection molding process and produces a naturally contoured implant that creates a smooth and non-porous look. The procedure is a most likely done in 30 minutes under local anesthesia in the surgeon's office.
The FDA 510K clearing allowed Perma Facial Implants to be commercially marketed in the U.S. as of September 2007 and will be marketed in Europe as Perma Lip, used for lip enhancements.
Dr. Barbara Marino, MD, FACOG, one of the first physicians in the Houston Area to offer the procedure, says "I am very excited to offer this new procedure in my office. It gives a very natural look and because of how it works, also reduces the lines around the mouth for a very pretty smile! I've been pleasantly surprised at how beautiful the results are as early as 5 days after placing the implants. It's nice to be able to offer an effective and permanent option for lip enhancement."
Currently the procedure is available in Houston, New York, California, Chicago and several clinics in the Dallas/Fort Worth area with future markets planned soon.