Injectable Materials for Facial Rejuventation

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Published on August 21, 2007

Author: CoolDude26

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Injectable Materials for Facial Rejuvenation:  Injectable Materials for Facial Rejuvenation Raymond Lee, M.D. Julio Gallo, M.D. February 6, 2003 Overview:  Overview Skin Anatomy The Aging Face Atrophic Scars Biologic Injectables Bovine Collagen Zyderm I Zyderm II Zyplast Autologous Material Autologen Isolagen Allogeneic Material Dermalogen Cymetra (Alloderm) Particulate Fascia Lata Autologous Fat Injection Cost Alloplastic Injectables Silicone Botulinum Toxin Conclusion Skin Anatomy:  Skin Anatomy The Aging Face:  The Aging Face Dermal changes Dermal atrophy Loss of papillae Loss of fibrocytes Decrease collagen Loss of elastic fibers Adipose tissue Decrease in fat The Aging Face:  The Aging Face Aging Lips Loss of lip projection Lengthening of white lip Flattening of philtrum Flattening of cupid’s bow Dermal and subcutaneous atrophy Atrophy of orbicularis oris Atrophic Scars:  Atrophic Scars Etiology Surgery Trauma Acne vulgaris Varicella Injectable Materials for the aging face and soft tissue defects:  Injectable Materials for the aging face and soft tissue defects Injectable Materials for the aging face and soft tissue defects:  Injectable Materials for the aging face and soft tissue defects Ideal material Biocompatible Non immunogenic Non carcinogenic Non migratory Non re-absorbable Easily stored Easily obtainable Easily handled Reproducible results Low cost Injectable Materials for the aging face and soft tissue defects :  Injectable Materials for the aging face and soft tissue defects Intradermal, subdermal, and neuromuscular methods of wrinkle management Papel, I. Facial Plastic and Reconstructive Surgery, 2nd ed. 2002 Bovine Collagen:  Bovine Collagen Reconstituted bovine dermal collagen suspended in PBS with 0.3% lidocaine 'Gold standard' Degraded by collagenase and inflammatory cells in 3 months May stimulate local fibroblast to deposit new collagen Bovine Collagen:  Bovine Collagen Indications Facial Rhytids Crows feet Glabellar lines Forehead lines Nasolabial folds Atrophic Scars Post acne, past traumatic, post viral, post operative Lip augmentation Bovine Collagen:  Bovine Collagen Contraindications Autoimmune disease Anaphylactoid reactions Lidocaine hypersensitivity Previous bovine collagen hypersensitivity Immunosuppressive therapy Chronic Inflammatory Disease Sites of active inflammation and infection Bovine Collagen:  Bovine Collagen Allergic Reaction 3% allergic to bovine collagen Need skin test Positive: erythema, induration, tenderness, or swelling +/- pruritis at site within 48-72 hrs. Second skin test performed 2 to 4 weeks later Even with (-) test, 1-2% will have hypersensitivity Bovine Collagen:  Bovine Collagen Advantages Easy to use Readily available Office procedure Reasonable cost Minimal pain Disadvantages Reabsorbed Re-injections Q3-4 months Allergic reactions Bovine Collagen:  Bovine Collagen Zyderm I (INAMED Aesthetics, Santa Barbara, CA) FDA approved 1981 35mg/ml (95% type 1 collagen, 5% type 3 collagen) Superficial papillary dermis Uses: Filler for fine lines and wrinkles, shallow acne scars, and thin-skinned areas, adjunct to Zyplast Bovine Collagen:  Bovine Collagen Zyderm II (INAMED Aesthetics, Santa Barabara, CA) FDA 1983 65mg/ml, higher viscosity Superficial papillary dermis Uses: moderate lines, wrinkles and deeper acne scars, failed Zyderm I Bovine Collagen:  Bovine Collagen Zyplast (INAMED Aesthetics, Santa Barabara, CA) FDA 1985 35mg/ml Cross-linked by glutaraldehyde for less degradation. Mid-reticular / deep reticular dermis Uses: filling deeper defects such as nasolabial folds, in combo with Zyderm I; lip augmentation Bovine Collagen:  Bovine Collagen Technique Inject in a line or with beads Overcorrection mandatory Zyderm I 150% - 200% (blanching) Zyderm II less (blanching) Zyplast no / slight overcorrection (no blanching) Molded manually into place May need 2-3 treatment sessions at 2 week intervals Repeat 3-12 month intervals Bovine Collagen: Complications:  Bovine Collagen: Complications Localized hypersensitivity reactions 3% of treated patients Erythema, induration, discoloration, pruritis Onset: hours to weeks Mean duration 4 weeks Rx: Time, cool compress, antihistamines, NSAIDS, topical steroids, intralesional steroids, systemic steroids Bovine Collagen: Complications:  Bovine Collagen: Complications Systemic Hypersensitivity Reaction Type III serum sickness reaction 48-72 hours after injection Fever, malaise, urticaria Rx: prednisone for 3-6 weeks Bovine Collagen: Complications:  Bovine Collagen: Complications Granulomatous Reaction Rare granulomatous palpable nodules Rx: Time Bovine Collagen: Complications:  Bovine Collagen: Complications Sterile Abscess Type IV delayed hypersensitivity 4/10,000 Onset: 8-12 weeks Fluctuant, painful, small, draining papules or large erythematous indurated nodules Rx: time, needle aspiration, Iandamp;D, intralesional steroids, oral antibiotics Bovine Collagen: Complications:  Bovine Collagen: Complications Local Tissue necrosis Vaso-occlusive effect Usually in glabella 9/10,000 Immediate blanching or cyanosis progressing to white or blackened appearance Avoid vessels, inject more superficially in furrow (danger zone) Rx: massage, warm compress, nitro gel Bovine Collagen: Complications:  Bovine Collagen: Complications Reactivation of Herpes Simplex Antiviral prophylaxis if (+) history Valtrex 500 mg bid x 5 days Famvir 250 mg bid x 5 days May mimic vaso-occlusive necrosis Tzanck smear, antibody test, cultures to differentiate Bovine Collagen: Complications:  Bovine Collagen: Complications Unilateral vision loss Rare retinal artery occlusion Stay outside orbital rim, aspirate before injecting Ectopic collagen implantation Most commonly from lip augmentation Temporary papulonodule formation Massage post-injection to minimize May be excised if patient is disturbed Autologous Collagen:  Autologous Collagen Autologen (Collagenesis, Beverly, MA) Isolagen (Isolagen Technologies, Paramus, NJ) Autologous Collagen:  Autologous Collagen Autologen (Collagenesis, Beverly, MA) Autologous human matrix composed of 'intact collagen fibrils' Injection of 'intact collagen fibrils' may enhance collagenesis and show greater resistance to protease degradation Not FDA approved Autologous Collagen - Autologen:  Autologous Collagen - Autologen Indications Similar to bovine collagen Rhytids Depressed scars Nasolabial folds Lip augmentation Autologous Collagen - Autologen:  Autologous Collagen - Autologen Patient’s skin from face/browlift, abdominoplasty, etc 2 inches2 of skin for 1 ml of Autologen Processing time 3-4 weeks Warm to room temperature before use. Refrigerate up to 6 months Autologous Collagen - Autologen:  Autologous Collagen - Autologen Technique +/- Nerve block, local, or topical anesthesia Inject with 30-gauge into mid dermis. Overcorrect by at least 20-30% Need three repeat injections over several weeks. Lasts 3-6 months Autologous Collagen - Autologen:  Autologous Collagen - Autologen Advantages No disease transmission No allergic reaction No skin testing Disadvantages More painful No lidocaine High viscosity Limited by amount of donated skin Time for harvesting and processing Serial injections Unknown duration Autologous Fibroblasts:  Autologous Fibroblasts Isolagen (Isolagen Technologies, Paramus, NJ) Living autologous fibroblasts cultured for 4-6 weeks Injection of collagen producing cells results in longer duration of correction Harvested cells may be cryopreserved for future injections In U.S. 1996-1999, now FDA has temporarily withdrawn, approval pending Autologous Fibroblasts - Isolagen:  Autologous Fibroblasts - Isolagen Indications: Shallow rhytids and creases Soft shouldered, saucer shaped scars Atrophic lips Autologous Fibroblasts - Isolagen :  Autologous Fibroblasts - Isolagen Technique: Harvest and Culturing 3mm punch biopsy from post auricular scalp. Type 1 collagen and fibroblast cultured 4-6 weeks Test dose, in forearm Two weeks later, 1 ml autologous material available Additional injections available every 2 weeks Autologous Fibroblasts - Isolagen:  Autologous Fibroblasts - Isolagen Technique: Injecting 30 gauge needle at 20 degree angle Inject into upper dermis Overcorrect by 300% Onset of correction may be delayed up to 3 months May need 2 – 4 repeat injection sessions Autologous Fibroblasts - Isolagen :  Autologous Fibroblasts - Isolagen Advantages No reported allergic reactions Use if allergic to bovine collagen Disadvantages Cosmetically not as dramatic as collagen Delayed onset Expensive Potential transport problems No shelf live Must be used immediately Allogeneic Collagen:  Allogeneic Collagen Dermalogen (Collagenesis, Beverly, MA) Cymetra,'micronized' Alloderm (LifeCell, Branchburg, NJ) Allogeneic Collagen - Dermalogen:  Allogeneic Collagen - Dermalogen Dermalogen Cadaver human tissue collagen matrix (decellularized collagen fibers, elastin, glycosaminoglycans) FDA approved Refrigerated up to 6 months Warm to room temperature before use Allogeneic Collagen – Dermalogen:  Allogeneic Collagen – Dermalogen Indications Prominent nasolabial folds Perioral rhytids Vermilion ridge atrophy Glabellar frown lines Pronounced oral commissures Depressed scars Contraindications Fine perioral and periorbital rhytids Allogeneic Collagen - Dermalogen:  Allogeneic Collagen - Dermalogen Advantages No reported cases of allergic reaction No skin testing needed Use with patients allergic to bovine collagen Disadvantages Lack of permanency Cost 2-3x more than collagen Serial injections Allogeneic Collagen - Dermalogen:  Allogeneic Collagen - Dermalogen Technique +/- Nerve block, local, or topical anesthesia Inject 30 gauge into mid-dermis along target dermal depression Overcorrect by at least 20-30% Need three repeat injections over several weeks Lasts 3-6 months Allogeneic Collagen - Cymetra:  Allogeneic Collagen - Cymetra Cymetra (micronized Alloderm) Cadaveric acellular matrix of collagen, elastin, glycosaminoglycans. No reported disease transmission Provides template for host fibroblast in growth and collagen deposition Allogeneic Collagen - Cymetra:  Allogeneic Collagen - Cymetra Indications: similar to collagen Technique Reconstitute in 1 ml of lidocaine then use within 2 hours Inject in subdermis with 26 gauge needle Allogeneic Collagen - Cymetra:  Allogeneic Collagen - Cymetra Sclafani, et al (2000) compared subdermal (SD) and intradermal (ID) cymetra placement versus ID Zyplast. Methods: 25 adults injected behind ear with SD, ID Cymetra and ID Zyplast. Measured by photo at day 0, 1 week, 4 weeks Sites biopsied at 3 months. Sclafani, et al. Evaluation of Acellular Dermal Graft in Sheet (Alloderm) and Injectable (Micronized Alloderm) Forms for Soft Tissue Augmentation. Arch Facial Plast Surg. 2000; 2:130-136. Sclafani Cymetra Study:  Sclafani Cymetra Study Results: ID Cymetra lasts longer than SD Cymetra and ID Zyplast. Cymetra showed extensive fibroblast ingrowth. No fibroblast ingrowth seen with Zyplast. Preserved Particulate Fascia Lata:  Preserved Particulate Fascia Lata Fascian (Fascia Biosystems, Beverly Hills, CA) Irradiated human cadaver fascia lata 'Recollagenation' process Process of inducing an endogenous collagen reaction in an area of prior collagen loss in response to stimulator material FDA approved Preserved Particulate Fascia Lata - Fascian:  Preserved Particulate Fascia Lata - Fascian No skin testing Rehydrate with 3ml of 0.3% lidocaine or saline. Inject intradermal or subdermal Autologous Fat Injection:  Autologous Fat Injection Microlipoinjection Injection into subcutaneous fat Lipocytic Dermal Augmentation 'Autologous Collagen' by Fournier Injected into dermis Adipocytes ruptured, triglycerides removed, and remaining intracellular fibrous septae used as fibrous tissue filler for dermis Autologous Fat Injection:  Autologous Fat Injection Indications Nasolabial folds Melolabial folds Glabellar furrows Lips Hemifacial atrophy Autologous Fat Injection:  Autologous Fat Injection Technique Harvesting (submental, umbilical, thigh) Washing and straining in saline or LR Loading into syringe Freeze or inject subcutaneously and overcorrect by at least 50%-85% May need to repeat Autologous Fat Injection:  Autologous Fat Injection Advantages Autologous, non allergenic Abundant No testing Alternative to bovine collagen if allergic Longer persistence than collagen Disadvantages Time consuming Donor site morbidity Calcification of injected fat Unpredictable resorption 30%-60% resorption in 10-12 months Alloplastic Implants – Silicone:  Alloplastic Implants – Silicone Silicone Medical grade silicon released in 1962 by Dow Corning (Midland, MI) Considered ideal soft tissue filler at the time Severe complications lead to ban by FDA Still used in Asia, Europe, S. America Alloplastic Implants – Silicone:  Alloplastic Implants – Silicone Technique Injected in micodroplets of 0.01 ml in subdermis Fibroblastic response results in augmentation Under correct with repeat injections Permanent effect but unable to remove Complications Inflammation, induration, ulceration, migration, silicone granulomas Many complications may have been due to widespread adulterated silicone use. Cost of Injectable Filling Substances:  Cost of Injectable Filling Substances Alster T, West T., Human-Derived and New Synthetic Injectable Materials for Soft-Tissue Augmentation: Current Status and Role in Cosmetic Sugery. Plastic and Reconstructive Surgery 2000. 105(7) 2515-2538. Botulinum A Exotoxin:  Botulinum A Exotoxin Treatment in hyperfunctional facial lines Glabella, forehead, crow’s feet, platysmal neck bands Treat Q 4 – 6 months Protease from anaerobic bacteria Clostridium Botulinum Botulinum A Exotoxin:  Botulinum A Exotoxin Blocks presynaptic release of acetylcholine at neuromuscular junction Protease cleaves the synaptic fusion complex involved in exocytosis of Ach. Results in flaccid paralysis Blitzer, A. Botulinum Toxin: Basic Science and Clinical Uses in Otolaryngology. Laryngoscope 2001; 112(2) 219-226 Botulinum A Exotoxin:  Botulinum A Exotoxin Botox (Allergan Inc., Irvine, CA) Vials of 100 U of freeze-dried toxin ($417) Store at -5o C on arrival Reconstitute in non-preserved sterile NS. Avoid vigorous shaking and store in refrigerator 4 ml of saline to make 2.5 U/0.1 ml 2 ml of saline to make 5 U/0.1 ml Inject with 27- or 30- gauge needle on 1 ml tuberculin syringe. Monopolar EMG needle optional Botulinum A Exotoxin: Contraindications:  Botulinum A Exotoxin: Contraindications Allergy to the drug Infection or inflammation at injection site Lactating or pregnant mothers Neuromuscular junction disorders Myasthenia gravis, Eaton Lambert, etc. Botulinum A Exotoxin: Glabellar Lines:  Botulinum A Exotoxin: Glabellar Lines Hyperactive corrugator and procerus muscles 5 sites with 12.5 to 20 U Stay within mid-pupillary line prevents brow and lid ptosis Procerus Corrugator Botulinum A Exotoxin: Forehead:  Botulinum A Exotoxin: Forehead Hyperactive Frontalis Muscle Points 1 to 1.5 cm apart across forehead lines Inject 2.5 to 5 U each point Stay away from brow to prevent brow and lid ptosis Laterally, stay away from brow to preserve some expression Frontalis Botulinum A Exotoxin: Crow’s Feet:  Botulinum A Exotoxin: Crow’s Feet Hyperactive lateral Orbicularis Oculi Muscle Sites marked 1 cm lateral to lateral canthus, above and below following curvature of orbital rim Do not go medial to mid pupillary line causing decrease tearing Do not go too low into zygomatis causing change in smile Inject 2.5 to 5 U per site Orbicularis Oculi Botulinum A Exotoxin: Nasal Scrunch or “Bunny” Lines:  Botulinum A Exotoxin: Nasal Scrunch or 'Bunny' Lines Hyperactive Nasalis Muscle Inject superior to nasofacial groove to avoid lip ptosis Dose 5 U in each site Nasalis Botulinum A Exotoxin: “Marionette” and “Lipstick” Lines:  Botulinum A Exotoxin: 'Marionette' and 'Lipstick' Lines Marionette Lines Hyperactive Depressor Anguli Oris Muscle 7-10 mm lat to commisure and 8 to 10 cm inferior 2 to 4 U in 0.1 ml Overdose causes drooling and speech change Lipstick Lines Hyperactive Orbicularis Oris Muscle Inject 1 U in 4 sites (combine with filler) Overdose causes drooling and speech changes Depressor Anguli Oris Orbicularis Oris Botulinum A Exotoxin: Platysmal Bands:  Botulinum A Exotoxin: Platysmal Bands Hyperactive Platysma Muscle Horizontal parallel lines starting 2 cm below mandible. Sites spaced 1.5 to 2 cm apart, 3 or 4 injection sites per side Inject 2.5 to 5 U per site Overdose: dysphagia (sternohyoid m.), change in voice pitchness (cricothyroid m.) Platysma Botulinum A Exotoxin: Popply Chin:  Botulinum A Exotoxin: Popply Chin Hyperactive Mentalis and Orbicularis Oris muscle 2.5 – 5 U in each mentalis m. Halfway between lower lip and chin Overdose or too superior injection may cause drooling Mentalis Botulinum A Exotoxin: Complications:  Botulinum A Exotoxin: Complications No deaths reported Estimated lethal dose 40U/kg = 2,800 U Weakness of adjacent musculature. Resistance from IgG antibody formation Use smallest doses Extend dose intervals Localized reaction (urticaria, erythema, edema) Headache Conclusion:  Conclusion Rhytids and atrophic scarring result from dermal and subcutaneous fat atrophy or loss Dermal and subcutaneous fillers and neuromuscular paralysis can rejuvenate the face or correct defects No single ideal injectable New products constantly being researched and developed, marketed, and removed Important to understand how each works and their potential adverse effects

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