Avoiding Complications and Achieving Success in Filler Injections. Sammy Sinno, MD

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24TH Annual Meeting Avoiding Complications and Achieving Success in Filler Injections Sammy Sinno, MD Upon completion of this presentation, the participants will self-report an increase in knowledge about: A. Injection techniques and complications. Disclosure: Nothing to Disclose

Slide 1 Avoiding Complications and Achieving Success in Filler Injection Alan Matarasso MD 1, Sammy Sinno MD 2 1-Manhattan Eye, Ear, Throat Hospital Department of Plastic Surgery, New York, NY 2-Private Practice, TLKM Plastic Surgery, Chicago, IL Slide 2 Disclosure There are no relevant conflicts of interest to disclose. Slide 3 Vascular Complications of Soft Tissue Fillers (Not Fat) Overview I. Filler categories and characteristics II. III. IV. Vascular complications Strategies for avoiding complications Crash kit

Slide 4 Systematic review showing 61 patients with severe complications from soft-tissue fillers Skin necrosis Blindness FDA Warning Ozturk CN et al. Complications following injection of soft-tissue fillers. ASJ. 2013. Slide 5 FDA Safety Communication May 2015 Unintentional injection can block blood vessels and restrict blood supply to tissues. Soft tissue fillers should be injected only by health care providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the injection site. Slide 6 I. FILLER CATEGORIES AND CHARACTERISTICS

Slide 7 Soft Tissue Fillers Categories HA gel (Juvederm, Restylane, Belotero) Purified bovine collagen (Zyderm) PLLA (poly-l-lactic acid) (Sculptra) Calcium hydroxylapatite (Radiesse) PMMA (Bellafill) Slide 8 Filler Characteristics Are Responsible for Their Clinical Effect Cross-linking and concentration=viscosity and resistance to degradation by native hyaluronidase G prime= hardness The greater the G the deeper the injection should be Funt D. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Clin Cosmet Investig Dermatol. 2013. Slide 9 G Prime More lift Less lift Less spread More spread *Mathematical description of products tendency to be deformed elastically. May not match clinical results.

Slide 10 Common Fillers Brand Name Manufacturer Component Duration of Effect Restylane Silk Galderma HA gel 6-9 months Restylane Lyft 10-18 months Juvederm Ultra Allergan HA gel 1 year Juvederm Ultra Plus 1 year Voluma 1-2 years Belotero Balance Merz HA gel 1 year Zyderm Inamed Purified bovine 3 months collagen Sculptra Dermik PLLA 2 years Radiesse Merz Calcium 12-15 months hydroxylapatite Bellafil Suneva PMMA >2 years Slide 11 Adverse Events Early Complications Late Complications Injection site reactions Infection Infection Granuloma Hypersensitivity Lumps, asymmetries, contour irregularities Skin discoloration Migration Immune reaction Scarring Vascular occlusion Malar edema Funt D. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Clin Cosmet Investig Dermatol. 2013. Slide 12 II. VASCULAR COMPLICATIONS

Slide 13 Vascular Occlusion 1. Ischemia/skin necrosis 2. Stroke 3. Vision loss/blindness Slide 14 Signs and Symptoms of Intraarterial Injection Skin Eye Pain Nausea Skin blanching Slow capillary refill Demarcation Vision loss/blindness Stroke FAST : facial drooping, arm weakness, speech impediment, time (act fast!) Slide 15 Progression of Skin Changes Findings Blanching Reactive hyperemia or livedo pattern Blue-black discoloration Blister/bullae formation Skin breakdown, ulceration, slough Timing Seconds Minutes up to 10 minutes 10 minutes to hours Hours to days Days to weeks DeLorenzi C. Complications of injectable fillers, Part 2: Vascular Complications. ASJ. 2014.

Slide 16 Discoloration Slide 17 Blister/Bullae Formation Slide 18 Skin Breakdown, Ulceration, Slough

Slide 19 Tissue Necrosis After Intra-arterial Injection of Permanent Filler (PMMA) Slide 20 Risk Factors For Accidental Intraarterial Injection Deep injection near named vessels or tributaries Rapid/forceful injection/high pressure injection Larger volume injected into 1 area Small sharp needles DeLorenzi C. Complications of injectable fillers, Part 2: Vascular Complications. ASJ. 2014. Slide 21 III. STRATEGIES FOR AVOIDING COMPLICATIONS

Slide 22 Even Low Volume Accidental Injection Can Lead to Arterial Occlusion if Injected Intraarterially DeLorenzi C. Complications of injectable fillers, Part 2: Vascular Complications. ASJ. 2014. Slide 23 High Injection Pressure with Large Volume Can Lead to Retrograde Filler Propagation DeLorenzi C. Complications of injectable fillers, Part 2: Vascular Complications. ASJ. 2014. Slide 24 How to Avoid Arterial Injection and Retrograde Filler Propagation Withdraw before injection Avoid deep injection near named vessels Low pressure injection Avoiding injecting excess volume in one area

Slide 25 Blunt cannulas Small bore Microcannula Strategies for Avoiding Complications Avoiding anatomic danger zones Carruthers JDA, Fagien S, Rohrich RJ, Weinkle S, Carruthers A. Blindness caused by cosmetic filler injection: a review of cause and therapy. PRS. 2015. Slide 26 Blunt Injection Cannula Slide 27 Carruthers JDA, Fagien S, Rohrich RJ, Weinkle S, Carruthers A. Blindness caused by cosmetic filler injection: a review of cause and therapy. PRS. 2015.

Slide 28 Locations of Iatrogenic Retinal Artery Occlusion Glabella (50%) Nose (33%) Forehead (8%) Periorbital (8%) Parks SW. Iatrogenic retinal artery occlusion caused by cosmetic facial filler injections. AM J Opth. 2012. Slide 29 Strategies for Avoiding Complications Inject slowly in small aliquots Avoid injection in previously traumatized areas Stop injection if complaints of pain/vision loss Slide 30 Blindness DeLorenzi C. Complications of injectable fillers, Part 2: Vascular Complications. ASJ. 2014.

Slide 31 How to Avoid Blindness Cautious injection in peri-orbital area Withdraw before injection Low pressure injection Small aliquots Slide 32 IV. CRASH KIT Slide 33 Office Staff Education Instruct staff on importance of patient phone calls with possible occlusion May present later in the day or the next day

Slide 34 A) Skin Crash Kit Ischemia/Necrosis What to do if patient suddenly develops severe pain with blanching or mottled skin discoloration ASAPS Patient Safety Committee. 2015. Slide 35 Crash Kit Warm compress Nitropaste Baby ASA Supplemental O2 HYALURONIDASE 400U into subcutaneous area (2cc in a 3cc syringe with 0.2cc plain lidocaine 2%, 27 g-needle) DeLorenzi C. Slide 36 Recombinant human hyaluronidase injection 150U (1cc) if concern for intraarterial injection Works only for HA s Juvederm Restylane Belotero Emervel Teosyal Hylenex

Slide 37 Managing Vascular Compromise Scalfani A, et al. Treatment of injectable filler soft tissue complications. Derm Surg. 2009. Slide 38 B) Stroke Crash Kit Thrombotic/Vision Standard emergency stroke protocol C) Vision loss/blindness Urgent ophthalmology consult Retrobulbar hyluronidase injection Slide 39 Vision Loss/Blindness Retrobulbar Injection Technique Small bleb of local anesthesia injected into lower eyelid over inferotemporal orbit Blunt, 25g cannula advanced in inferotemporal quadrant of orbit for 1 inch (will be inferior and lateral to optic nerve) 2-4cc hyaluronidase injected Carruthers JDA, Fagien S, Rohrich RJ, Weinkle S, Carruthers A. Blindness caused by cosmetic filler injection: a review of cause and therapy. PRS. 2015.

Slide 40 Retrobulbar Injection Technique Slide 41 Summary Awareness that vascular complications are a real event with soft tissue fillers Practice strategies to avoid these complications Post a protocol in office and have a filler crash kit available Slide 42 Thank You