1. HNO Page 1 Vent et al.: European Academy of Facial Plastic Surgery, Rome, May 9-12, 2012 Do you know where your fillers go? An ultrasonographic investigation of the lips Julia Vent 1, F. Lefarth 2a, Th. Massing 2b, W. Angerstein 2a 1) University of Cologne Medical Center, Department of Otorhinolaryngology, Head and Neck Surgery, Cologne, Germany 2a) University of Duesseldorf Medical Center, Department of Phoniatrics and Pedaudiology, Duesseldorf, Germany 2b) University of Duesseldorf Medical Center, Department of Phoniatrics and Pedaudiology, Medical Acoustics and Audiology Unit, Duesseldorf, Germany Fig. 1: lips of Nefertiti, Berlin, 2012

2. HNO Page 2 Vent et al.: European Academy of Facial Plastic Surgery, Rome, May 9-12, 2012 Background Augmenting the perioral region with injectable fillers is most often performed by experience and palpation, without knowing the exact, final position of the injected material. To date, there are no in vivo investigations on the exact positioning of injectable hyaluronic acid fillers within the lips, and severe complications such as lip hematoma or thromboembolism were rarely published 2,4. The lips, and especially the modiolar region, have vivid blood supply. Thus, it was our aim to define the exact position of hyaluronic acid in the lips immediately after injection, and 18 days post- injection. Fig. 2: blood supply of the lips 1

3. HNO Page 3 Vent et al.: European Academy of Facial Plastic Surgery, Rome, May 9-12, 2012 Material and Methods After a thorough history taking, photo-documentation was performed. A status quo via ultrasonography as well as informed written consent were obtained. Included in this pilot study were volunteers who agreed to have the lower third of the face augmented. Excluded were subjects who had undergone augmentation in the past 6 months, with known allergies/ intolerance against lidocaine, and who suffered from coagulopathies. Dysmorphophobic and psychic instable persons were also discouraged to have injection augmentation. Nine females (mean age 55.0 years, range 41.2-66.1 years) participated in this pilot study. Three women were injectable-naive, 6 had previously received injectable filler augmentations. All 9 patients were injected with Juvederm Ultra III ® and Ultra Smile ®, and 7 additionally with unlinked hyaluronic acid (Juvederm Hydrate ® ). The exact amounts, locations and injection techniques were recorded. Photographic documentation, as well as high resolution ultrasonography were performed. A Hitachi Hi Vision Avius ultrasound system with linear scanner (frequency range: 6- 14 MHz) supplied images of the orbicularis oris muscle and the surrounding lip tissue. Blood vessels were detected by colour Doppler flow mapping. The examinations were performed before, immediately after and 18 days after injection in 5 patients. Due to time constraints, 4 patients were examined only once on day 1 and on day 18.

4. HNO Page 4 Vent et al.: European Academy of Facial Plastic Surgery, Rome, May 9-12, 2012 T T S S S S S Fig. 3: systematic B-mode ultrasonography of the lips 1.static, at seven defined points (bars, T= transverse plane, S= sagittal plane) 2.dynamic (from midline to right and from midline to left modiolus) 3.Doppler sonography for identification of flow and vessels Ultrasound Fig 3 T T S S S S S cutis muscle muscle air in vestibulum teeth Fig. 4: transverse B-mode scan of augmented lower lip, orbiculars oris muscle relaxed

5. HNO Page 5 Vent et al.: European Academy of Facial Plastic Surgery, Rome, May 9-12, 2012 Results Minor bruising occurred, which resolved within 7 to 9 days. No hemorrhage could be detected on day 18. Patients showed no dysfunction of the lips, and pain only immediately after injection. All 9 patients were satisfied with the results and would come back for injection therapy. Graph 1 shows these patient ratings of side effects on a visual analogous scale (VAS): time 1: during injection, time 2: day of injection, time 3: days 1-4 post injection (pi), time 4: days 5-9 pi, time 5: days 10-14 pi Injected material distributed well within the lip tissue, and no embolism or thrombosis occurred. Some of this filler material was deposited in the deep layer (pars peripheralis) of the orbicularis oris muscle. However, the injected material came up to 1 mm close to the arteries and veins of the lips. Fig. 5: paramedian, sagittal sonography scan of the right upper lip on day 1: a) before and b) immediately after injection, with multiple intramuscular filler deposits; muscle structure bulged and thickened by injected material (female patient, aged 64 years). Orbicularis oris muscle: 1) superficial and deep layer [divided into 2) pars peripheralis and 3) pars marginalis], * filler deposits. cutis cavum oris 1 2 3 a 2 3 b * * * * b cutis 1 2 3 * *

6. HNO Page 6 Vent et al.: European Academy of Facial Plastic Surgery, Rome, May 9-12, 2012 Conclusions and Discussion In our 9 patients, no compression of lip structures occurred, nor did any severe complications result from injection. It is crucial to know the exact anatomy to minimize complications and risks when injecting fillers. Position of injectables depends on the technique such as depot, channel or tower ². Adverse events such as bruising or thrombosis can be avoided by ultrasonographic control. One should always have hyaluronidase as a rescue medication at hand. When in doubt, the exact location of injected fillers should be controlled by Doppler ultrasound to avoid injury of arteries or veins. Maybe intramuscular depots cannot be so well massaged and distributed as depots in connective tissue. In our opinion, intramuscular injections are not absolute contraindications as stated by Lemperle et al. ³. They may sometimes be necessary for an effective augmentation. Because it was never monitored before, there are no limits or guidelines yet as to how deep and how much substance may be injected. Further studies must quantify the exact depth and the amount of injected filler materials by simultaneous ultrasonography during injection. Acknowledgements: We thank Hitachi for providing the ultrasonograph and Allergan for providing Juvederm Ultra III ®, Ultra Smile ® and Hydrate ®. References: 1.R. Radlanski, K. Wesker: Das Gesicht. Bildatlas klinische Anatomie, KVM, Berlin 2012 2.G. Sattler, B. Sommer: Bildatlas der ästhetischen Augmentationsverfahren mit Fillern, KVM, Berlin 2010 3.G. Lemperle, P. Rullan, N. Gauthier-Hazan: Avoiding and Treating Dermal Filler Complications, Plastic Reconstr Surg 2006 (Sept, Suppl1) 92S-107S 4.J. Niamtu III: Complications in Fillers and Botox, Oral Maxillofacial Surg Clin N Am 21 (2009) 13-21