- Email: [email protected]
Vascular Compromise After Soft Tissue Facial Fillers: Case Report and Review of Current Treatment Protocols
Journal Pre-proof Vascular compromise following soft tissue facial fillers: Case report and review of current treatment protocols Steven Halepas, DMD, Scott M. Peters, DDS, Jenna L. Goldsmith, NP, MSN, BSN, Elie M. Ferneini, DMD, MD, MHS, MBA, FACS PII:
S0278-2391(19)31180-2
DOI:
https://doi.org/10.1016/j.joms.2019.10.008
Reference:
YJOMS 58943
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 20 August 2019 Revised Date:
13 October 2019
Accepted Date: 13 October 2019
Please cite this article as: Halepas S, Peters SM, Goldsmith JL, Ferneini EM, Vascular compromise following soft tissue facial fillers: Case report and review of current treatment protocols, Journal of Oral and Maxillofacial Surgery (2019), doi: https://doi.org/10.1016/j.joms.2019.10.008. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons
Vascular compromise following soft tissue facial fillers: Case report and review of current treatment protocols Steven Halepas, DMD (1) Scott M. Peters, DDS (2) Jenna L. Goldsmith, NP, MSN, BSN (3) Elie M. Ferneini, DMD, MD, MHS, MBA, FACS (4) 1
Resident, Department of Oral and Maxillofacial Surgery, New York Presbyterian Hospital/Columbia University Medical Center, New York, NY 2 Assistant Professor, Division of Oral and Maxillofacial Pathology, New York Presbyterian Hospital/Columbia University Medical Center, New York, NY 3 Director, Jenna L. Goldsmith NP Medical Spa, Cheektowaga, NY 4 Director, Beau Visage Med Spa/Greater Waterbury OMS/University of Connecticut, Cheshire, CT
*Corresponding Author: Elie. M. Ferneini, MD, DMD, MHS, MBA, FACS Editor in Chief AJCS Dentoalveolar Surgery Section Editor JOMS Associate Clinical Professor, University of Connecticut Medical Director, Beau Visage Med Spa Private Practice, Greater Waterbury OMS 435 Highland Avenue, Suite 100 Cheshire, CT 06410 Tel: (203) 272-7700 Fax: (203) 574-2460 [email protected]
Abstract The use of facial fillers for soft tissue augmentation is becoming a mainstream treatment modality for patients. Due to the relative ease of administration, as well as the lucrative nature of such procedures, the number of providers offering facial fillers has been expanding. While many of these are minor and localized to the site of injection, one potential serious, albeit uncommon, adverse effect of facial filler treatment is avascular necrosis. Herein, the authors report a review of soft tissue filler complications describing a case of a 52-year-old female who developed vascular compromise following facial filler administration. In addition to a review of complications and best practices for treatment management, the authors discuss anatomical considerations, an overview of the most common filler materials, histological changes with dermal fillers, and litigation consequences with the use of these minimally invasive procedures. Although facial filler treatment is regarded as a minimally invasive and extremely safe procedure, it is not without complications. Avascular necrosis following soft tissue augmentation with facial filler is exceedingly rare with only few cases reported in the literature, but practitioners who offer these procedures need to be well versed with treatment protocols.
Introduction The use of facial (cosmetic) fillers is rapidly expanding, with more than 2.6 million soft tissue fillers administered in the United States alone in 2018 [1]. With facial fillers becoming an increasingly mainstream—and lucrative—treatment modality, more healthcare providers of varying specialty training are beginning to offer these minimally invasive procedures. To this end, the number of dentists and dental specialists administering injectable facial augmentations is increasing, with some studies estimating that approximately 20% of practicing dentists have either received training in or routinely administer facial fillers in their offices [2]. Although facial filler administration is often regarded as a minor surgical or cosmetic procedure, it is not without risk of complications [3]. Specifically, vascular compromise following a filler injection is a serious, albeit uncommon, consequence of improper administration, which may result in tissue ischemia and necrosis [4]. Herein, we report a case of vascular compromise following facial filler administration, and review protocol for management of such episodes. Case Report A 52-year-old female presented 24-hours following a hyaluronic acid (HA) based facial filler administration to the marionettes and nasolabial folds performed at an outside location. The patient denied any previous history of or complications with facial filler injections. She reported no significant past medical history, and her surgical history was otherwise unremarkable. Upon her presentation, the patient provided images of the injection site approximately 12 hours following the facial filler administration, which showed an erythematous swelling of the left facial skin in the area lateral and inferior to the lower lip (Figure 1). The patient described this area as firm and tender to palpation. Extraoral examination at the time of her emergency visit revealed bilateral facial swelling and erythema (Figures 2a and 2b), which the patient reported as “extremely painful.” Based on
the patient’s presentation, an adverse reaction to the administered facial filler was favored. Specifically, consideration was given to a hematoma formation, edema with subsequent bruising, or possible vascular compromise. Although vascular compromise would be less likely given the bilateral distribution of the patient's lesions, a large bolus of filler administered bilaterally could cause compression of the local vasculature resulting in ischemic changes and tissue necrosis. In order to prevent any permanent ischemia, the patient was treated under the vascular compromise protocol. Although a hematoma formation could not be definitively excluded at this time, the severity of complications associated with avascular necrosis of the skin were considered significant enough to merit initiation of the vascular compromise protocol. Warm compresses were applied to the affected areas, and 600 units of hyaluronidase, a HA reversal agent, were given to degrade the facial filler [5]. 325 mg of aspirin and nitroglycerine paste were prescribed to help counteract the ischemic changes at the site [6]. The patient underwent one dive of hyperbaric oxygen therapy to improve the blood supply and prevent further necrosis. A Medrol Dose Pak® was also prescribed to minimize swelling. Additionally, the patient was placed on Keflex 500 mg TID x 7 days to prevent infection in the area [7, 8]. Following this protocol, the patient’s symptoms improved. Clinical photographs taken on post-injection day four (Figures 3a and 3b) showed a significant reduction in the initially observed swelling and erythema. However, at this time she began to complain of “floaters” in her eyes and other visual changes. An ophthalmology consult was obtained and was negative for any intravascular damage. A brain magnetic resonance imaging study was also procured which was negative for any vascular occlusion or compromise. The patient was seen again on post-injection day nine, and she reported neither ocular nor facial disturbances. Discussion
Dermal filler administration is burgeoning, due in large part to ease of use and minimal adverse reactions [9]. Most of these adverse effects arise from deposition techniques and are often minor and localized to the injection site. Most frequently, improper administration may lead to nodule formation secondary to clumping of the material or a foreign body reaction [10]. The incidence of severe complications following facial fillers, such as vascular compromise, is rare and estimated to be 0.001% [11]. It generally results from either intravascular injection of a facial filler or arterial compression during the procedure. While complications with soft tissue fillers are extremely low, they can be of devastating consequence. In a recent report by Ferneini and colleagues it was identified that 0.006-0.008% of Radiesse, Sculptra and Arteful/Bellafill injections resulted in necrosis. While the risk is extremely low, the authors found 11 lawsuits existed involving dermal filler where 6 cases ruled in favor of the defendant with a mean award of $636,800 [12]. In the cases of intravascular injection, the filler material may completely or partially occlude a vessel, while arterial compression results from injection of a large volume of facial filler within close proximity to a blood vessel [13]. In some instances, effects of vascular compromise are immediately apparent in the form of blanching of the site following injection. Tissue necrosis should be suspected when a bluish or violet discoloration develops over the course of several days, with the nose (33%) and nasolabial folds (31%) representing the most likely sites to undergo necrosis following vascular compromise [4, 10]. Accidental intravascular injection of facial fillers or arterial compression may also lead to blindness, with glabellar administration sites representing higher risk areas. In a recent study by Beleznay et al., 146 cases of visual disturbances following facial filler administration were reported [14]. In most cases, patients will report severe pain, either immediately or several hours after injection, with a facial filler. Prevention of vascular complications requires practitioners who perform facial filler injections to be cognizant of anatomical landmarks and facial anatomy to minimize potential adverse consequences.
The facial artery branches from the external carotid, giving off a submental branch and continuing over the mandible just beneath the platysma muscle. Once it crosses the lateral vermillion commissure, it branches into the inferior and superior labial arteries, and becomes the angular artery as it travels lateral to the nose. Here, it anastomoses with the dorsal nasal artery, a branch of the ophthalmic artery [15]. The lateral nasal artery is also formed at the junction of the facial and angular arteries, and is located approximately 2-3 mm superior to the alar groove [16]. To avoid these vascular structures, one can draw a vertical line from the medial canthus to the vertical commissure and inject all facial fillers lateral to this line. This is especially important when administering facial fillers in the marionettes and nasolabial folds, as the arteries near these locations are often very superficial and can be easily damaged during injection. In addition to knowledge of the relevant facial anatomy, proper facial filler administration technique is also necessary to reduce operative complications. The practitioner should use at least a 25-gauge needle to ensure adequate aspiration to avoid direct intravascular injection [17]. When available, the use of microcannulas may also help reduce bruising, pain, and vascular compromise [13, 18-21]. Administration of local anesthesia without epinephrine can also decrease the risk of vascular compromise because tissue blanching following epinephrine administration may mask early manifestations of necrosis. Furthermore, slow injection speeds with small bolus sizes will minimize swelling and bruising. Conversely, administration of large bolus sizes may not only increase postoperative discomfort, but also cause arterial compression secondary to heightened pressure [22, 23]. Although sound surgical technique and knowledge of important anatomical landmarks are integral to the prevention of facial filler administration complications, it is essential to have a sound necrosis protocol if a suspected vascular compromise event occurs. A sample protocol is provided in Table 1. A paper published by Fakih-Gomez et al. discussed the recommended components of a HA Filler Emergency Kit [24, 25]. A modified outline of the suggested contents can be found in Table 2.
Facial fillers can be divided into those derived from either natural or synthetic materials. Natural fillers are biologic substances and can be degraded by enzymatic and phagocytic activities. Natural fillers, such as hyaluronic acid, poly-L-lactic acid, and calcium hydroxyapatite, are biologic substances and can be degraded by enzymatic and phagocytic activities. This makes them safer to administer, albeit more temporary in effect. On the other hand, synthetic fillers are non-biodegradable and are associated with an increased risk of adverse reaction [26]. Interestingly, as demonstrated by Owosho et. al, the histologic presentation of facial fillers is variable, and the type of facial filler implicated in a foreign body reaction can be identified based on the microscopic appearance of the material [27, 28]. Examples of the histologic appearance of the more commonly administered natural facial fillers are demonstrated in Figure 4. Hyaluronic acid (brand names Juvederm, Hylaform, Restylane), the filler used in the current case, shows pools of amorphous, acellular, blue material surrounded by foreign body type giant cells (Figure 4a). Reactions to poly-L-lactic acid (brand names Sculptra, New-Fill) form spiked, elongated vacuoles which contain variable amounts of polarizable material and are associated with foreign body type giant cells (Figure 4b). Calcium hydroxyapatite based facial fillers (brand names Radiesse, Radiance) demonstrate uniform-sized spherules containing brown, granular material within a background of chronic inflammation and foreign body type giant cells (Figure 4c). The type of facial filler administered may also influence potential post-operative complications, including management of vascular compromise. As demonstrated in the present case, hyaluronic acid, which is a naturally based filler, has a reversal agent which can help degrade material which may be causing vascular occlusion [20, 29]. Conclusion Avascular necrosis following facial filler administration is an exceedingly rare, although serious, complication which may involve virtually any anatomical site where fillers are used. Prevention in the form of sound surgical technique and knowledge of relevant facial anatomy is important in minimizing
potential vascular compromise. In cases where vascular complications do occur, early intervention and close follow-up are essential for patient management. As the use of facial fillers for soft tissue augmentation continues to grow, it is important for dental providers who may be administering these agents to be familiar with how to minimize potential adverse events, recognize possible complications, and know the appropriate steps for management.
References 1. Surgeons ASoP: Cosmetic Plasic Surgery Statistics. (ed., 2018, 2. Nayyar P, Kumar P, Nayyar PV, Singh A: BOTOX: Broadening the Horizon of Dentistry. J Clin Diagn Res 8:ZE25, 2014 3. Bucking P, Ferneini M, Ferneini E: Ch. 13 Soft Tissue Fillers and an Overview of Their Potential Complications. In Ferneini E, Castiglione C, Banki M (eds), Complications in Maxillofacial Cosmetic Surgery, (ed. 1St). Springer, 2018, 4. Winslow CP: The management of dermal filler complications. Facial Plast Surg 25:124, 2009 5. Ferneini EM, Ferneini AM: An Overview of Vascular Adverse Events Associated With Facial Soft Tissue Fillers: Recognition, Prevention, and Treatment. J Oral Maxillofac Surg 74:1630, 2016 6. Kleydman K, Cohen JL, Marmur E: Nitroglycerin: a review of its use in the treatment of vascular occlusion after soft tissue augmentation. Dermatol Surg 38:1889, 2012 7. Cohen JL, Biesman BS, Dayan SH, DeLorenzi C, Lambros VS, Nestor MS, Sadick N, Sykes J: Treatment of Hyaluronic Acid Filler-Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations. Aesthet Surg J 35:844, 2015 8. Cohen JL, Brown MR: Anatomic considerations for soft tissue augmentation of the face. J Drugs Dermatol 8:13, 2009 9. Lemperle G, Morhenn V, Charrier U: Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesthetic Plast Surg 27:354, 2003 10. Ozturk CN, Li Y, Tung R, Parker L, Piliang MP, Zins JE: Complications following injection of softtissue fillers. Aesthet Surg J 33:862, 2013 11. Ferneini E, Gady J, Nuveen E: Complications Associated With Facial Soft-Tissue Fillers. Am J Cosmet Surg 31:238, 2014 12. Beauvais D, Ferneini EM: Complications and Litigation associated with injectable facial fillers: a cross sectional study. Journal of Oral and Maxillofacial Surgery, 13. Ferneini E, Boynton T, Almunajed H, Dimitrov K, Banki M: Review of Facial Fillers and Injectable Neurotoxins. Am J Cosmet Surg 30:53, 2013 14. Beleznay K, Carruthers JD, Humphrey S, Jones D: Avoiding and Treating Blindness From Fillers: A Review of the World Literature. Dermatol Surg 41:1097, 2015 15. Ferneini EM, Halepas S, Watras J, Ferneini AM, Weyman D, Fewins J: Surgeon's Guide to Facial Soft Tissue Filler Injections: Relevant Anatomy and Safety Considerations. J Oral Maxillofac Surg 75:2667.e1, 2017 16. Grunebaum LD, Reiter D: Perioperative antibiotic usage by facial plastic surgeons: national survey results and comparison with evidence-based guidelines. Arch Facial Plast Surg 8:88, 2006 17. Casabona G: Blood Aspiration Test for Cosmetic Fillers to Prevent Accidental Intravascular Injection in the Face. Dermatol Surg 41:841, 2015 18. Signorini M, Liew S, Sundaram H, De Boulle KL, Goodman GJ, Monheit G, Wu Y, Trindade de Almeida AR, Swift A, Vieira Braz A, Group GAC: Global Aesthetics Consensus: Avoidance and Management of Complications from Hyaluronic Acid Fillers-Evidence- and Opinion-Based Review and Consensus Recommendations. Plast Reconstr Surg 137:961e, 2016 19. Ferneini E, Banki M, Ferneini C, Castiglione C: Hypersensitivity Reaction to Facial Augmentation With a Hyaluronic Acid Filler. Am J Cosmet Surg 30:231, 2013 20. Ferneini E, Jackson T, Ferneini C, Banki M: A Review of New Facial Filler Techniques for Facial Rejuvenation. Am J Cosmet Surg 31:166, 2014 21. Ferneini EM, Beauvais D, Aronin SI: An Overview of Infections Associated With Soft Tissue Facial Fillers: Identification, Prevention, and Treatment. J Oral Maxillofac Surg 75:160, 2017
22. Heydenrych I, Kapoor KM, De Boulle K, Goodman G, Swift A, Kumar N, Rahman E: A 10-point plan for avoiding hyaluronic acid dermal filler-related complications during facial aesthetic procedures and algorithms for management. Clin Cosmet Investig Dermatol 11:603, 2018 23. Halepas S, Weyman D, Ferneini EM: Complications in Minimally Invasive Facial Cosmetic Surgery. Journal of Oral and Maxillofacial Surgery 76:e44, 2018 24. Fakih-Gomez N, Orte-Aldea MdC, Poonja K, Khanna D: Hyaluronic Acid Filler Emergency Kit. The American Journal of Cosmetic Surgery 0:0748806818825214, 25. Povolotskiy R, Oleck NC, Hatzis CM, Paskhover B: Adverse Events Associated With Aesthetic Dermal Fillers: A 10-Year Retrospective Study of FDA Data. The American Journal of Cosmetic Surgery 35:143, 2018 26. Boulos M, Halepas S: Chapter 6 Facial Fillers. In Ferneini E, Goupil M (eds), Office Based Maxillofacial Surgical Procedures- A Step-by-Step Approach, (ed. 1st). Springer, 2019, 27. Owosho AA, Tsai CJ, Lee RS, Freymiller H, Kadempour A, Varthis S, Sax AZ, Rosen EB, Yom SK, Randazzo J, Drill E, Riedel E, Patel S, Lee NY, Huryn JM, Estilo CL: The prevalence and risk factors associated with osteoradionecrosis of the jaw in oral and oropharyngeal cancer patients treated with intensity-modulated radiation therapy (IMRT): The Memorial Sloan Kettering Cancer Center experience. Oral Oncol 64:44, 2017 28. Florin W, Mandel L: Foreign body reaction to facial dermal fillers: case report. J Oral Maxillofac Surg 70:2352, 2012 29. Glaich AS, Cohen JL, Goldberg LH: Injection necrosis of the glabella: protocol for prevention and treatment after use of dermal fillers. Dermatol Surg 32:276, 2006
Agent Warm compress Filler reversal agent* Aspirin 325 mg Nitro paste Hyperbaric oxygen
Rationale Reduce swelling Degrade filler causing obstruction Inhibit platelet cascade Precipitate vasodilation to counteract ischemia Improve blood supply and prevent permanent necrosis Prednisone Minimize Swelling Cephalexin Prevent infection Table 1: Sample necrosis protocol in cases of suspected vascular compromise following facial filler administration * A filler reversal agent is specific for the type of injectable material use and is only available for natural based facial fillers
Skin Necrosis 1. 250 cc of 0.9% NaCL for dilution of hyaluronidase 2. 1 cc syringe 3. 3 cc syringe 4. 5 cc syringe 5. 25 G x 38 mm canula 6. 25 G x 50 mm canula 7. 18 G x 25 mm needle 8. 23G x 25 mm needle 9. 33G x 9 mm needle 10. Alcohol prep 11. Providone-iodine prep pads 12. 50 cc of 2% lidocaine 13. 325 mg Aspirin tablets 14. 8 mg IM Dexamethasone 15. Hyaluronidase
Blindness All from previous column plus: 1. 22G x 25 mm Angiocath 2. 0.25% Timolol Drops 3. Mannitold 20% 4. 500 mg/vial Acetazolamide
Anaphylaxis All from Previous column plus: 1. 100 mg Hydrocortisone 2. 50 cc Promethazine 3. Adrenaline 1mg/ml 1:1000 4. Salbutamol 100 µg/dose
Table 2: Components needed in a soft tissue filler emergency kit, modified from Fakih-Gomez et al.
Figure Legend Figure 1: Photograph taken by patient following her facial filler treatment (prior to her emergency visit) demonstrating an erythematous swelling of the left facial skin in the area lateral and inferior to the lower lip. Figure 2: (a) Frontal and (b) lateral views showing bilateral facial swelling and erythema, taken at the time of the patient’s presentation. Figure 3: (a) Left and (b) right sided photographs taken four days after initiation of necrosis protocol demonstrate near complete resolution of the patient’s facial erythema and swelling. Figure 4: (a) Reactions to hyaluronic acid based facial fillers show pools of amorphous, acellular, blue material surrounded by foreign body type giant cells (H&E, x100). (b) Poly-L-lactic acid facial fillers demonstrate spiked, elongated vacuoles which contain variable amounts of polarizable material and are associated with foreign body type giant cells (H&E, x100). (c) Calcium hydroxyapatite based facial fillers show uniform-sized spherules containing brown, granular material within a background of chronic inflammation and foreign body type giant cells (H&E, x100).
Table Legend Table 1: Sample necrosis protocol in cases of suspected vascular compromise following facial filler administration Table 2: Components needed in a soft tissue filler emergency kit, modified from Fakih-Gomez et al.
S0278-2391(19)31180-2
DOI:
https://doi.org/10.1016/j.joms.2019.10.008
Reference:
YJOMS 58943
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 20 August 2019 Revised Date:
13 October 2019
Accepted Date: 13 October 2019
Please cite this article as: Halepas S, Peters SM, Goldsmith JL, Ferneini EM, Vascular compromise following soft tissue facial fillers: Case report and review of current treatment protocols, Journal of Oral and Maxillofacial Surgery (2019), doi: https://doi.org/10.1016/j.joms.2019.10.008. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons
Vascular compromise following soft tissue facial fillers: Case report and review of current treatment protocols Steven Halepas, DMD (1) Scott M. Peters, DDS (2) Jenna L. Goldsmith, NP, MSN, BSN (3) Elie M. Ferneini, DMD, MD, MHS, MBA, FACS (4) 1
Resident, Department of Oral and Maxillofacial Surgery, New York Presbyterian Hospital/Columbia University Medical Center, New York, NY 2 Assistant Professor, Division of Oral and Maxillofacial Pathology, New York Presbyterian Hospital/Columbia University Medical Center, New York, NY 3 Director, Jenna L. Goldsmith NP Medical Spa, Cheektowaga, NY 4 Director, Beau Visage Med Spa/Greater Waterbury OMS/University of Connecticut, Cheshire, CT
*Corresponding Author: Elie. M. Ferneini, MD, DMD, MHS, MBA, FACS Editor in Chief AJCS Dentoalveolar Surgery Section Editor JOMS Associate Clinical Professor, University of Connecticut Medical Director, Beau Visage Med Spa Private Practice, Greater Waterbury OMS 435 Highland Avenue, Suite 100 Cheshire, CT 06410 Tel: (203) 272-7700 Fax: (203) 574-2460 [email protected]
Abstract The use of facial fillers for soft tissue augmentation is becoming a mainstream treatment modality for patients. Due to the relative ease of administration, as well as the lucrative nature of such procedures, the number of providers offering facial fillers has been expanding. While many of these are minor and localized to the site of injection, one potential serious, albeit uncommon, adverse effect of facial filler treatment is avascular necrosis. Herein, the authors report a review of soft tissue filler complications describing a case of a 52-year-old female who developed vascular compromise following facial filler administration. In addition to a review of complications and best practices for treatment management, the authors discuss anatomical considerations, an overview of the most common filler materials, histological changes with dermal fillers, and litigation consequences with the use of these minimally invasive procedures. Although facial filler treatment is regarded as a minimally invasive and extremely safe procedure, it is not without complications. Avascular necrosis following soft tissue augmentation with facial filler is exceedingly rare with only few cases reported in the literature, but practitioners who offer these procedures need to be well versed with treatment protocols.
Introduction The use of facial (cosmetic) fillers is rapidly expanding, with more than 2.6 million soft tissue fillers administered in the United States alone in 2018 [1]. With facial fillers becoming an increasingly mainstream—and lucrative—treatment modality, more healthcare providers of varying specialty training are beginning to offer these minimally invasive procedures. To this end, the number of dentists and dental specialists administering injectable facial augmentations is increasing, with some studies estimating that approximately 20% of practicing dentists have either received training in or routinely administer facial fillers in their offices [2]. Although facial filler administration is often regarded as a minor surgical or cosmetic procedure, it is not without risk of complications [3]. Specifically, vascular compromise following a filler injection is a serious, albeit uncommon, consequence of improper administration, which may result in tissue ischemia and necrosis [4]. Herein, we report a case of vascular compromise following facial filler administration, and review protocol for management of such episodes. Case Report A 52-year-old female presented 24-hours following a hyaluronic acid (HA) based facial filler administration to the marionettes and nasolabial folds performed at an outside location. The patient denied any previous history of or complications with facial filler injections. She reported no significant past medical history, and her surgical history was otherwise unremarkable. Upon her presentation, the patient provided images of the injection site approximately 12 hours following the facial filler administration, which showed an erythematous swelling of the left facial skin in the area lateral and inferior to the lower lip (Figure 1). The patient described this area as firm and tender to palpation. Extraoral examination at the time of her emergency visit revealed bilateral facial swelling and erythema (Figures 2a and 2b), which the patient reported as “extremely painful.” Based on
the patient’s presentation, an adverse reaction to the administered facial filler was favored. Specifically, consideration was given to a hematoma formation, edema with subsequent bruising, or possible vascular compromise. Although vascular compromise would be less likely given the bilateral distribution of the patient's lesions, a large bolus of filler administered bilaterally could cause compression of the local vasculature resulting in ischemic changes and tissue necrosis. In order to prevent any permanent ischemia, the patient was treated under the vascular compromise protocol. Although a hematoma formation could not be definitively excluded at this time, the severity of complications associated with avascular necrosis of the skin were considered significant enough to merit initiation of the vascular compromise protocol. Warm compresses were applied to the affected areas, and 600 units of hyaluronidase, a HA reversal agent, were given to degrade the facial filler [5]. 325 mg of aspirin and nitroglycerine paste were prescribed to help counteract the ischemic changes at the site [6]. The patient underwent one dive of hyperbaric oxygen therapy to improve the blood supply and prevent further necrosis. A Medrol Dose Pak® was also prescribed to minimize swelling. Additionally, the patient was placed on Keflex 500 mg TID x 7 days to prevent infection in the area [7, 8]. Following this protocol, the patient’s symptoms improved. Clinical photographs taken on post-injection day four (Figures 3a and 3b) showed a significant reduction in the initially observed swelling and erythema. However, at this time she began to complain of “floaters” in her eyes and other visual changes. An ophthalmology consult was obtained and was negative for any intravascular damage. A brain magnetic resonance imaging study was also procured which was negative for any vascular occlusion or compromise. The patient was seen again on post-injection day nine, and she reported neither ocular nor facial disturbances. Discussion
Dermal filler administration is burgeoning, due in large part to ease of use and minimal adverse reactions [9]. Most of these adverse effects arise from deposition techniques and are often minor and localized to the injection site. Most frequently, improper administration may lead to nodule formation secondary to clumping of the material or a foreign body reaction [10]. The incidence of severe complications following facial fillers, such as vascular compromise, is rare and estimated to be 0.001% [11]. It generally results from either intravascular injection of a facial filler or arterial compression during the procedure. While complications with soft tissue fillers are extremely low, they can be of devastating consequence. In a recent report by Ferneini and colleagues it was identified that 0.006-0.008% of Radiesse, Sculptra and Arteful/Bellafill injections resulted in necrosis. While the risk is extremely low, the authors found 11 lawsuits existed involving dermal filler where 6 cases ruled in favor of the defendant with a mean award of $636,800 [12]. In the cases of intravascular injection, the filler material may completely or partially occlude a vessel, while arterial compression results from injection of a large volume of facial filler within close proximity to a blood vessel [13]. In some instances, effects of vascular compromise are immediately apparent in the form of blanching of the site following injection. Tissue necrosis should be suspected when a bluish or violet discoloration develops over the course of several days, with the nose (33%) and nasolabial folds (31%) representing the most likely sites to undergo necrosis following vascular compromise [4, 10]. Accidental intravascular injection of facial fillers or arterial compression may also lead to blindness, with glabellar administration sites representing higher risk areas. In a recent study by Beleznay et al., 146 cases of visual disturbances following facial filler administration were reported [14]. In most cases, patients will report severe pain, either immediately or several hours after injection, with a facial filler. Prevention of vascular complications requires practitioners who perform facial filler injections to be cognizant of anatomical landmarks and facial anatomy to minimize potential adverse consequences.
The facial artery branches from the external carotid, giving off a submental branch and continuing over the mandible just beneath the platysma muscle. Once it crosses the lateral vermillion commissure, it branches into the inferior and superior labial arteries, and becomes the angular artery as it travels lateral to the nose. Here, it anastomoses with the dorsal nasal artery, a branch of the ophthalmic artery [15]. The lateral nasal artery is also formed at the junction of the facial and angular arteries, and is located approximately 2-3 mm superior to the alar groove [16]. To avoid these vascular structures, one can draw a vertical line from the medial canthus to the vertical commissure and inject all facial fillers lateral to this line. This is especially important when administering facial fillers in the marionettes and nasolabial folds, as the arteries near these locations are often very superficial and can be easily damaged during injection. In addition to knowledge of the relevant facial anatomy, proper facial filler administration technique is also necessary to reduce operative complications. The practitioner should use at least a 25-gauge needle to ensure adequate aspiration to avoid direct intravascular injection [17]. When available, the use of microcannulas may also help reduce bruising, pain, and vascular compromise [13, 18-21]. Administration of local anesthesia without epinephrine can also decrease the risk of vascular compromise because tissue blanching following epinephrine administration may mask early manifestations of necrosis. Furthermore, slow injection speeds with small bolus sizes will minimize swelling and bruising. Conversely, administration of large bolus sizes may not only increase postoperative discomfort, but also cause arterial compression secondary to heightened pressure [22, 23]. Although sound surgical technique and knowledge of important anatomical landmarks are integral to the prevention of facial filler administration complications, it is essential to have a sound necrosis protocol if a suspected vascular compromise event occurs. A sample protocol is provided in Table 1. A paper published by Fakih-Gomez et al. discussed the recommended components of a HA Filler Emergency Kit [24, 25]. A modified outline of the suggested contents can be found in Table 2.
Facial fillers can be divided into those derived from either natural or synthetic materials. Natural fillers are biologic substances and can be degraded by enzymatic and phagocytic activities. Natural fillers, such as hyaluronic acid, poly-L-lactic acid, and calcium hydroxyapatite, are biologic substances and can be degraded by enzymatic and phagocytic activities. This makes them safer to administer, albeit more temporary in effect. On the other hand, synthetic fillers are non-biodegradable and are associated with an increased risk of adverse reaction [26]. Interestingly, as demonstrated by Owosho et. al, the histologic presentation of facial fillers is variable, and the type of facial filler implicated in a foreign body reaction can be identified based on the microscopic appearance of the material [27, 28]. Examples of the histologic appearance of the more commonly administered natural facial fillers are demonstrated in Figure 4. Hyaluronic acid (brand names Juvederm, Hylaform, Restylane), the filler used in the current case, shows pools of amorphous, acellular, blue material surrounded by foreign body type giant cells (Figure 4a). Reactions to poly-L-lactic acid (brand names Sculptra, New-Fill) form spiked, elongated vacuoles which contain variable amounts of polarizable material and are associated with foreign body type giant cells (Figure 4b). Calcium hydroxyapatite based facial fillers (brand names Radiesse, Radiance) demonstrate uniform-sized spherules containing brown, granular material within a background of chronic inflammation and foreign body type giant cells (Figure 4c). The type of facial filler administered may also influence potential post-operative complications, including management of vascular compromise. As demonstrated in the present case, hyaluronic acid, which is a naturally based filler, has a reversal agent which can help degrade material which may be causing vascular occlusion [20, 29]. Conclusion Avascular necrosis following facial filler administration is an exceedingly rare, although serious, complication which may involve virtually any anatomical site where fillers are used. Prevention in the form of sound surgical technique and knowledge of relevant facial anatomy is important in minimizing
potential vascular compromise. In cases where vascular complications do occur, early intervention and close follow-up are essential for patient management. As the use of facial fillers for soft tissue augmentation continues to grow, it is important for dental providers who may be administering these agents to be familiar with how to minimize potential adverse events, recognize possible complications, and know the appropriate steps for management.
References 1. Surgeons ASoP: Cosmetic Plasic Surgery Statistics. (ed., 2018, 2. Nayyar P, Kumar P, Nayyar PV, Singh A: BOTOX: Broadening the Horizon of Dentistry. J Clin Diagn Res 8:ZE25, 2014 3. Bucking P, Ferneini M, Ferneini E: Ch. 13 Soft Tissue Fillers and an Overview of Their Potential Complications. In Ferneini E, Castiglione C, Banki M (eds), Complications in Maxillofacial Cosmetic Surgery, (ed. 1St). Springer, 2018, 4. Winslow CP: The management of dermal filler complications. Facial Plast Surg 25:124, 2009 5. Ferneini EM, Ferneini AM: An Overview of Vascular Adverse Events Associated With Facial Soft Tissue Fillers: Recognition, Prevention, and Treatment. J Oral Maxillofac Surg 74:1630, 2016 6. Kleydman K, Cohen JL, Marmur E: Nitroglycerin: a review of its use in the treatment of vascular occlusion after soft tissue augmentation. Dermatol Surg 38:1889, 2012 7. Cohen JL, Biesman BS, Dayan SH, DeLorenzi C, Lambros VS, Nestor MS, Sadick N, Sykes J: Treatment of Hyaluronic Acid Filler-Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations. Aesthet Surg J 35:844, 2015 8. Cohen JL, Brown MR: Anatomic considerations for soft tissue augmentation of the face. J Drugs Dermatol 8:13, 2009 9. Lemperle G, Morhenn V, Charrier U: Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesthetic Plast Surg 27:354, 2003 10. Ozturk CN, Li Y, Tung R, Parker L, Piliang MP, Zins JE: Complications following injection of softtissue fillers. Aesthet Surg J 33:862, 2013 11. Ferneini E, Gady J, Nuveen E: Complications Associated With Facial Soft-Tissue Fillers. Am J Cosmet Surg 31:238, 2014 12. Beauvais D, Ferneini EM: Complications and Litigation associated with injectable facial fillers: a cross sectional study. Journal of Oral and Maxillofacial Surgery, 13. Ferneini E, Boynton T, Almunajed H, Dimitrov K, Banki M: Review of Facial Fillers and Injectable Neurotoxins. Am J Cosmet Surg 30:53, 2013 14. Beleznay K, Carruthers JD, Humphrey S, Jones D: Avoiding and Treating Blindness From Fillers: A Review of the World Literature. Dermatol Surg 41:1097, 2015 15. Ferneini EM, Halepas S, Watras J, Ferneini AM, Weyman D, Fewins J: Surgeon's Guide to Facial Soft Tissue Filler Injections: Relevant Anatomy and Safety Considerations. J Oral Maxillofac Surg 75:2667.e1, 2017 16. Grunebaum LD, Reiter D: Perioperative antibiotic usage by facial plastic surgeons: national survey results and comparison with evidence-based guidelines. Arch Facial Plast Surg 8:88, 2006 17. Casabona G: Blood Aspiration Test for Cosmetic Fillers to Prevent Accidental Intravascular Injection in the Face. Dermatol Surg 41:841, 2015 18. Signorini M, Liew S, Sundaram H, De Boulle KL, Goodman GJ, Monheit G, Wu Y, Trindade de Almeida AR, Swift A, Vieira Braz A, Group GAC: Global Aesthetics Consensus: Avoidance and Management of Complications from Hyaluronic Acid Fillers-Evidence- and Opinion-Based Review and Consensus Recommendations. Plast Reconstr Surg 137:961e, 2016 19. Ferneini E, Banki M, Ferneini C, Castiglione C: Hypersensitivity Reaction to Facial Augmentation With a Hyaluronic Acid Filler. Am J Cosmet Surg 30:231, 2013 20. Ferneini E, Jackson T, Ferneini C, Banki M: A Review of New Facial Filler Techniques for Facial Rejuvenation. Am J Cosmet Surg 31:166, 2014 21. Ferneini EM, Beauvais D, Aronin SI: An Overview of Infections Associated With Soft Tissue Facial Fillers: Identification, Prevention, and Treatment. J Oral Maxillofac Surg 75:160, 2017
22. Heydenrych I, Kapoor KM, De Boulle K, Goodman G, Swift A, Kumar N, Rahman E: A 10-point plan for avoiding hyaluronic acid dermal filler-related complications during facial aesthetic procedures and algorithms for management. Clin Cosmet Investig Dermatol 11:603, 2018 23. Halepas S, Weyman D, Ferneini EM: Complications in Minimally Invasive Facial Cosmetic Surgery. Journal of Oral and Maxillofacial Surgery 76:e44, 2018 24. Fakih-Gomez N, Orte-Aldea MdC, Poonja K, Khanna D: Hyaluronic Acid Filler Emergency Kit. The American Journal of Cosmetic Surgery 0:0748806818825214, 25. Povolotskiy R, Oleck NC, Hatzis CM, Paskhover B: Adverse Events Associated With Aesthetic Dermal Fillers: A 10-Year Retrospective Study of FDA Data. The American Journal of Cosmetic Surgery 35:143, 2018 26. Boulos M, Halepas S: Chapter 6 Facial Fillers. In Ferneini E, Goupil M (eds), Office Based Maxillofacial Surgical Procedures- A Step-by-Step Approach, (ed. 1st). Springer, 2019, 27. Owosho AA, Tsai CJ, Lee RS, Freymiller H, Kadempour A, Varthis S, Sax AZ, Rosen EB, Yom SK, Randazzo J, Drill E, Riedel E, Patel S, Lee NY, Huryn JM, Estilo CL: The prevalence and risk factors associated with osteoradionecrosis of the jaw in oral and oropharyngeal cancer patients treated with intensity-modulated radiation therapy (IMRT): The Memorial Sloan Kettering Cancer Center experience. Oral Oncol 64:44, 2017 28. Florin W, Mandel L: Foreign body reaction to facial dermal fillers: case report. J Oral Maxillofac Surg 70:2352, 2012 29. Glaich AS, Cohen JL, Goldberg LH: Injection necrosis of the glabella: protocol for prevention and treatment after use of dermal fillers. Dermatol Surg 32:276, 2006
Agent Warm compress Filler reversal agent* Aspirin 325 mg Nitro paste Hyperbaric oxygen
Rationale Reduce swelling Degrade filler causing obstruction Inhibit platelet cascade Precipitate vasodilation to counteract ischemia Improve blood supply and prevent permanent necrosis Prednisone Minimize Swelling Cephalexin Prevent infection Table 1: Sample necrosis protocol in cases of suspected vascular compromise following facial filler administration * A filler reversal agent is specific for the type of injectable material use and is only available for natural based facial fillers
Skin Necrosis 1. 250 cc of 0.9% NaCL for dilution of hyaluronidase 2. 1 cc syringe 3. 3 cc syringe 4. 5 cc syringe 5. 25 G x 38 mm canula 6. 25 G x 50 mm canula 7. 18 G x 25 mm needle 8. 23G x 25 mm needle 9. 33G x 9 mm needle 10. Alcohol prep 11. Providone-iodine prep pads 12. 50 cc of 2% lidocaine 13. 325 mg Aspirin tablets 14. 8 mg IM Dexamethasone 15. Hyaluronidase
Blindness All from previous column plus: 1. 22G x 25 mm Angiocath 2. 0.25% Timolol Drops 3. Mannitold 20% 4. 500 mg/vial Acetazolamide
Anaphylaxis All from Previous column plus: 1. 100 mg Hydrocortisone 2. 50 cc Promethazine 3. Adrenaline 1mg/ml 1:1000 4. Salbutamol 100 µg/dose
Table 2: Components needed in a soft tissue filler emergency kit, modified from Fakih-Gomez et al.
Figure Legend Figure 1: Photograph taken by patient following her facial filler treatment (prior to her emergency visit) demonstrating an erythematous swelling of the left facial skin in the area lateral and inferior to the lower lip. Figure 2: (a) Frontal and (b) lateral views showing bilateral facial swelling and erythema, taken at the time of the patient’s presentation. Figure 3: (a) Left and (b) right sided photographs taken four days after initiation of necrosis protocol demonstrate near complete resolution of the patient’s facial erythema and swelling. Figure 4: (a) Reactions to hyaluronic acid based facial fillers show pools of amorphous, acellular, blue material surrounded by foreign body type giant cells (H&E, x100). (b) Poly-L-lactic acid facial fillers demonstrate spiked, elongated vacuoles which contain variable amounts of polarizable material and are associated with foreign body type giant cells (H&E, x100). (c) Calcium hydroxyapatite based facial fillers show uniform-sized spherules containing brown, granular material within a background of chronic inflammation and foreign body type giant cells (H&E, x100).
Table Legend Table 1: Sample necrosis protocol in cases of suspected vascular compromise following facial filler administration Table 2: Components needed in a soft tissue filler emergency kit, modified from Fakih-Gomez et al.