Experience and Evaluation of a New, Saline-Filled Implant for Cosmetic Lip Augmentation

Abstract

Purpose: The purpose of this article is to discuss the author's experience with a new saline-filled lip implant technology in an initial series of patients. Materials and Methods: The novel saline-fillable implant (VeraFil; Evera Medical) is composed of a thin expanded polytetrafluoroethylene outer membrane bonded, only at the ends of the device, to a silicone inner membrane creating a slip plane between layers and is intended to heal with mild cellular incorporation and to remain soft and elastic over time. At implantation, the saline volume is adjusted as desired through a temporary fill tube and a self-sealing microvalve. The author's previous experience with lip implants is presented as a detail of the surgical placement of this technologically unique implant. The author's series of 25 implants over a 7-month period is reviewed as well as international experience with more than 475 implants of the same type. Results: In the author's series of 25 implants, there was no mechanical failure or displacement, and there was no incidence of extrusion or infection. Two implants were removed and repositioned because of improper placement. In the worldwide experience, 475 implants have been placed by 41 surgeons. A total of 399 implants were placed in the lips, 90 in the nasolabial folds, 4 in the tear trough region, and 2 in the chin. As of November 10, 2007, 139 implants have been in place for more than 18 months, 32 of which have been in place for more than 2 years. There has been 1 confirmed infection and 1 suspected infection as well as a single case of dehiscence (surgeon's first case) through the incision. One implant shifted superiorly in the lip and was removed and replaced. There have been no cases of late extrusions. No implants have ruptured, and none have been surrounded by thick capsules. Conclusion: The VeraFil saline-filled implant is a new technology for lip augmentation. The implant is unique in design and materials and can be placed in less than 15 minutes. All patients in the author's initial series have been happy with the augmentation result and the natural look and feel, and no patient has complained about loss or change of oral function. There has been no incidence of infection, rejection, implant deflation, migration, or device failure in the author's series, which has mirrored the worldwide experience of at least 475 implants. The VeraFil saline-filled lip implant appears to be a viable and promising technology that could be a welcomed addition to the armamentarium of the cosmetic surgeon dealing with lip enhancement.