FACETITE: SUBDERMAL RADIOFREQUENCY SKIN TIGHTENING AND FACE CONTOURING R. Stephen Mulholland, MD, FRCS(C)* and Michael Kreindel, PhD** *Private Plastic Surgery Practice, Toronto, Canada ** Chief Technology Officer, Invasix Ltd., Yokeneam, Israel Introduction The aging baby boomers are a formidable demographic force. There is a person turning 60 years old every 10 seconds, and it is estimated that over one-fourth of the total U.S. population in 2010 was between ages 42 and 60 years. (1) This represents over 100 million potential patients with skin laxity of the head, neck and body. Skin tightening procedures are one of the fastest growing market segments accounting for 56.9 million in device sales and 668,100 patient treatments. (2) Internal radiofrequency energy (Radio-Frequency Assisted Liposuction or RFAL) has shown significant contraction capability when deployed in liposuction and lipo-contouring procedures. (3-8) This paper will review our experiences with a novel, superficial bipolar radiofrequency energy device designed to provide significant skin tightening without the need for an excision. Materials Ten patients with brow, cheek, lower lid and/or jawline laxity presented for treatment. Age range was 45-66 years old and skin type included I-V. The FaceTite hand piece is part of and powered by the BodyTite device (Invasix, Israel). The applicator is a bipolar, solid probe radiofrequency device. The silicone coated internal electrode is passed directly under the skin in the hypodermal-subcutaneous fat space. (Figure 1) The internal and external electrodes are connected at the hand-grip. The hand piece is powered by the BodyTite platform. Figure 1 - The FaceTite applicator. The RF energy is emitted from the tip of the internal electrode from the small, uncoated region, behind the bullet shaped plastic dissector at the front (Figure 2). The RF energy from the internal electrode causes a coagulative necrosis of the subdermal fat and the reticular dermis, vascular and fibrous structures in this layer in the immediate vicinity of the tip of the FaceTite internal electrode. The RF energy passes up to 1
the external electrode, which in turn delivers gentle, subnecrotic RF energy across the epidermal surface back into the papillary dermis, while the internal electrode moves slowly, in tandem, through the superficial subdermal fat. Manual pressure on the spring-loaded connection between the internal and external electrodes controls the distance between them. Inside the external electrode are sensors that constantly measure the epidermal surface temperature, as well as the internal high and low hypodermal fat impedance. The external electrode is attached directly to the BodyTite platform and the treating physician can set parameters of RF energy and cut off values to the desired epidermal temperature. There are two clinical end points: (i) the first pass is done with a stamping technique where the hand piece is held in one spot (average time, depending upon the fat and skin thickness, is 1-2 seconds) until there is an audible or palpable popping sound. This popping sound represents the RF coagulative necrosis of the adipose tissue immediately under the dermis. Once all the skin in the treatment zone has been treated with the stamping technique, (ii) the FaceTite applicator is passed slowly and continuously through the same tissue again until an epidermal temperature of 38-42 o C is achieved. The FaceTite applicator is then moved to the next zone of treatment until all the lax skin has been treated. Achieving these two end points is critical to achieving the desired tightening effect. Figure 2 - The FaceTite coated tip compared to the NeckTite (another handpiece on the BodyTite device. Methods The face or skin surface to be treated is divided into zones of approximately 10x10 cm or smaller and each zone treatment is completed before moving on to the next. The FaceTite hand piece is moved through the soft tissue to be tightened. Figure 3a - Coagulative necrosis of the sub-dermal fat and reticular dermis along with papillary dermal noncoagulative thermal changes. 2
epinephrine effect, the FaceTite procedure was performed. The access ports (a #11 blade or 1mm dermatologic punch) were the hairline for the brow, crows feet for the lower lids, commissural for the nasolabial fold, the cheek-upper lipnasolabial, and marionette lines. The jaw-line was treated from a sub-lobular port and neck from a sub-mental port. Figure 3b - Controlled, localized coagulative necrosis of the reticular dermal collagen fibers, the sub-dermal adipocytes and small and fibrous septa. Figure 3c - Localized coagulative thermal necrosis of the hypodermal adipose tissue and deep reticular dermis. For pain control, all procedures were performed under local anesthesia. The local anesthetic solution was a mixture of 1 bottle of 1% lidocaine mixed in 1 liter of Ringers lactate and 2ml of epinephrine 1:1000. Approximately 150 cc of infiltrate was used for the brow, cheek, lower face and another 100 cc was used if the neck was treated. Prior to the tumescent anesthesia, supra-orbital, infra-orbital, zygomatico-facial temporal and mental nerve blocks were performed with 1% lidocaine. After waiting 8-10 minutes for the vasoconstrictive Results The histological effects of the FaceTite applicator are shown in figures 3a-3c. There is a controlled and localized coagulative necrosis of the subdermal fat and deep reticular dermis, as well as a non-coagulative thermal stimulation of the upper dermis (Figure 3a). Figures 3b and 3c show the coagulative necrosis of the reticular dermal collagen fibers and sub-dermal coagulation of the adipocyte and small vessels and coagulation, as well as shortening of the fibrous septa. All patients were followed up for a minimum of 6 months and all before and after photos were analyzed. Significant tightening of the brow and lower lid fat and malar pads was observed in all patients. (Figure 4) Cheek, jaw line and neck enhancement and tightening was clinically apparent in all patients. (Figures 5 and 6) Patients experienced only mild discomfort post operatively, but edema and swelling was present for 5-7 days, There were no burns or major complications and all patients were happy with the degree of tightening achieved with their nonexcisional FaceTite procedure. 3
Figure 4 - FaceTite of the brow, lower lids and cheeks. Figure 5 - FaceTite of the cheek, jaw line and submentum. Figure 6 - FaceTite of the lower neck. 4
Discussion The FaceTite was able to provide clinically significant tightening and lifting of the brow, lower lid, cheek and neck. The applicator has thermal controls that ensure safety with the proper training and deployment. Histology reveals a true localized, controlled coagulative necrosis of the sub-dermal fat layer and the reticular dermis with immediate tightening, followed by a secondary remodeling and contraction over 6 months. To some degree, the sub-necrotic coagulation of the papillary dermis also contributes to this effect. There was also a strong coagulative effect on hypodermal blood vessels, which did not result in any instances of thermal necrosis, but substantially reduced the expected postoperative incidence of ecchymosis one would experience in a non-thermal soft tissue undermining procedure. There is an obvious clinical need for a powerful, efficacious yet safe skin tightening device like FaceTite. The FaceTite also has potentially valuable applications in the predissection of facelift flaps, the management of the central face zones with lateral lifting techniques, as well as minor anterior neck compartment re-do surgery for recurrent cervical laxity. The FaceTite may be combined synchronously with fractional resurfacing for an inside out and outside in thermal stimulation of the papillary and reticular dermis, as well as the hypodermal superficial adipose layer. There is a tremendous market opportunity for the FaceTite non-excisional lifting technology. The non-face, nonexcisional body skin tightening applications of FaceTite will make this BodyTite hand-piece even more versatile. References 1. Selected Characteristics of Baby Boomers 42 to 60 years Old in 2006. US Census Bureau. 2. Skin Tightening: Softening Demand in a Weak Economy. Medical Insight Inc. May, 2008. 3. Blugerman G, Schavelzon D and Paul M. A safety and feasibility study of a novel radiofrequency-assisted liposuction technique. Plast Reconstr Surg. 2010;125:998-1006. 4. Paul M, Mulholland RS, A new approach for adipose tissue treatment and body contouring using radiofrequency assisted liposuction. Aesth Plast Surg. Online June 2009 DOI 10.1007/s00266-009-9342-z. 5. Paul M, Blugerman G, Kreindel M and Mulholland RS. Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesth Plast Surg accepted July 2010 published with open access. 6. Kreindel M, Mulholland RS. Radiofrequency Energy. Body Language 2009; VOL:23-4. 7. Mulholland RS. An in-depth examination of radiofrequency assisted liposuction (RFAL) J of Cosmetic Surg and Medicine 2009;4:14-18. 8. Paul MD. Radiofrequency assisted liposuction comes of age: An emerging technology offers an exciting new vista in non-excisional body contouring. Plastic Surgery Practice 2009; 2:18-19. 5