Self-sealed lips: Saline-filled implant shows promise for permanent lip augmentation

Cheryl Guttman Krader 

National report — Early experience with a saline-filled implant (FulFil, Juva Medical) suggests it provides safe and predictable permanent lip augmentation with important advantages compared to existing alternatives, Miles H. Graivier, M.D., a plastic surgeon in private practice in Roswell, Ga., tells Cosmetic Surgery Times .

The device, currently approved by the U.S. Food and Drug Administration (FDA) for use as an intranasal splint, is being employed in an off-label capacity for lip augmentation and in other facial soft tissue augmentation procedures. Consisting of a very thin, outer expanded polytetrafluoroethylene (ePTFE) sheath with an inner silicone liner, the implant is filled intra-operatively with saline through a self-sealing tube.

EARLY RESULTS Dr. Graivier performed his first lip augmentation using the saline-filled implant in September 2006 and presented the procedure in October at the annual meeting of the American Society of Plastic Surgeons in San Francisco. Over the next three months, he has placed 30 implants in 16 patients. The procedure has no contraindications for patient selection and is minimally invasive. Under local nerve block anesthesia, the device is implanted through a single small vermilion incision. Implantation into both the upper and lower lip can be completed within 15 to 30 minutes, is associated with minimal postoperative morbidity, and achieves natural-looking results that translate into high patient satisfaction, according to Dr. Graivier.

"With the introduction of the hyaluronic acid-based products, we currently have some very good injectable fillers for use in lip augmentation, but the improvement achieved with those materials lasts only for four to six months. Options for permanent lip augmentation have been less than satisfactory. For example, Goretex is firm, palpable and immobile. Implantation of a rolled Alloderm graft can result in a more natural appearance, but the outcome is unpredictable, especially in patients older than age 55 where there is a greater tendency for it to disappear over time," says Dr. Graivier. "In contrast to those latter modalities, the saline-filled lip implant is soft, pliable and stretches with lip movement to produce a cosmetic outcome that both looks and feels completely natural."

Dr. Graivier is working as a consultant to Juva Medical regarding product development and surgical technique. The implants now being used are available in two lengths — 5 cm and 4 cm — used for the upper and lower lip, respectively. Each length is available in diameters of 4.5 mm or 6.5 mm; width selection is based on the desired amount of augmentation. Recommended fill volumes for the four different versions range from 0.3 cc for the smallest (4-cm x 4.5-mm) implant to 0.6 cc for the largest (5-cm x 6.5-mm) implant.

"These fill volumes are guidelines, but the surgeon can slightly under or overfill the implant to achieve the desired result," Dr. Graivier says.

To implant the device, once the incision is made, a dissection is performed above the orbicularis muscle, in the potential space between the muscle and subdermal plane, using a small curved scissors that is advanced across the midline to the opposite end of the lip. The deflated implant is placed into the pocket and filled with saline. After checking that the position and size are correct, the fill tube is removed and the fill hole seals itself.

After surgery, patients receive a short course of oral antiviral and antibiotic prophylaxis, and are instructed to apply ice and avoid excessive puckering movements of their lips.