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Complications of Injectable Fillers and Neurotoxins

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Complications of Injectable Fillers and Neurotoxins Dermatologic Therapy, Vol. 24, 2011, 524–536 © 2012 Wiley Periodicals, Inc. Printed in the United States · All rights reserved DERMATOLOGIC THERAPY ISSN 1396-0296 Complications of injectable fillers and neurotoxinsdth_1455 524..536 Sue Ellen Cox*&Chris G. Adigun† *Aesthetic Solutions and †Department of Dermatology, New York University Ronald O. Perelman, Chapel Hill, North Carolina ABSTRACT: All cosmetic injectable products are associated with the risk of both early and delayed complications. Early and expected side effects include swelling, bruising, and erythema at the injection. It is of utmost importance that patients are educated on the treatment they are consenting to receive and the potential risk of these therapies. Side effects of the various cosmetic injectable products, including both injectable neurotoxins and soft tissue fillers, are often technique associated, such as placing the filler too superficial or unintentional paralysis of facial muscles. Other complications, such as necrosis, intravascular injections, and infection may not be entirely technique-dependent, and must be managed swiftly and effectively. Finally, immunologic phenomena, such as delayed-type hypersen- sitivity reactions and foreign body granulomas, are complications that have no relationship to tech- nique, and thus proper counseling and knowledge of management is required. KEYWORDS: botulinum toxin, complications, injectables Introduction safety profiles with rare AEs associated with their use. However, despite their impressive safety pro- Cosmetic use of injectable fillers and neurotoxins is files, complications can and do occur. Given these a growing field, with utilization of these products are elective treatments, extreme care to prevent AEs increasing annually. Neurotoxins and soft tissue by practitioners is paramount. fillers were the top two minimally invasive cosmetic procedures performed in 2009 according to the American Society of Plastic Surgeons. Botulinum Adverse events toxin type A holds the number one top minimally invasive procedure with 4.8 million procedures in AEs may occur with injectable products used for 2009, growing by 509% since 2000. Soft tissue fillers cosmetic purposes. Rarely, severe adverse events are second in minimally invasive procedures, (SAEs) may occur. However, the probability of growing with 1.7 million procedures performed in either of these events occurring is very small. Often 2009, growing 164% since 2000 (1).The rapid growth times, normal or expected occurrences of in the use of these products is due to a number of injectables are confused as AEs. Normal occur- factors, including versatility and creative place- rences with injections include bleeding, bruising, ments beyond FDA indications, diminished social swelling, erythema, needle marks, asymmetry, skin stigma surrounding their use, and a larger range of lumpiness, and pain on injection. effective options available for cosmetic enhance- AEs and SAEs would include scarring, hyper/ ments. In addition, these products have favorable hypopigmentation, infection, damage to deeper structures, visible tissue filler material, accidental Address correspondence and reprint requests to: Sue Ellen intraarterial injection, vision loss, skin necrosis, Cox, Dermatologic Surgeon, Aesthetic Solutions, 5821 granulomas, allergic reactions and hypersensitiv- Farrington Rd. ste 101, Chapel Hill, NC 27517, or email: ity, migration of tissue filler or neurotoxin, chronic [email protected]. inflammation, lymphedema, or tissue stiffness. 524 Complications of injectable fillers and neurotoxin In addition, an unsatisfactory result is always a musculature. Reconstituting BTX with smaller possibility with cosmetic injectable products. The amounts of dilutent will translate to smaller outcome may not meet the patients’ expectations volumes per injection, and thus decreased local for improvement in wrinkles or soft tissue depres- toxin diffusion and side effects (2). sions. There is the possibility of poor or inadequate Patient selection is critical in minimizing AEs response that may be alleviated by additional with BTX. Absolute contraindications to BTX injections. For other patients, surgical procedures injection include known allergic reaction to or other treatments should be recommended in any of the components of the formulation and addition to the injectable treatment in order to preexisting infection at the injection site. meet their expectations. Furthermore, BTX should not be administered to patients with unrealistic expectations or any degree of hesitation to treatment. Relative con- Botulinum toxin traindications include preexisting neuromuscu- lar conditions of the neuromuscular junction, Injection of botulinum toxin (BTX) is utilized for peripheral motor neuropathies, women who are treatment of hyperdynamic facial lines. BTX prod- lactating, pregnant, or planning to become preg- ucts are presynaptic nerve blockers that relax nant, patients with inflammatory skin conditions selected injected muscles. It is a fast, relatively non- at the site of injection (such as psoriasis, contact invasive procedure that produces significant aes- dermatitis, and atopic dermatitis), and in patients thetic improvement with minimal recovery. It is with a history of previous lower eyelid surgery, as incredibly safe, with recent surveys indicating that use of BTX in the periocular area in these patients greater than 80% found the treatment beneficial. carries risk of ectropion. In addition, BTX should The duration of effect lasts from 3 to 4 months (2). not be administered to patients taking medica- Complications of cosmetic use are uncommon, tions known to interfere with the neuromuscular with the majority of events being both mild and junction, such as aminoglycosides, cholinesterase temporary. The most common complication fol- inhibitors, succinylcholine, curare-like depolariz- lowing injection is ecchymosis. Other common ing blockers, magnesium sulfate, quinidine, short-term complications include pain, edema, calcium channel blockers, lincosamides, and purpura, short-term hypesthesia, short-term polymyxins (2). postinjection headaches, and infrequently, pro- A recently published report of AEs associated longed migraine headaches (3). Dysesthesia and with BTX-A reported to the FDA revealed that 30 purpura development may be minimized with of the 1031 cosmetic cases were listed as serious careful use of preinjection topical anesthetic and potential complications, and included headaches, the application of ice both before and after injec- focal facial paralysis, muscle weakness, dysphagia, tion. Wearing loupes when injecting helps to flu-like symptoms, and allergic reactions (4,5). No indentify and avoid vessels especially in the perio- deaths were reported. Of the 995 cases classified cular area. Postinjection headache can be cate- as nonserious, the most common AE was lack of gorized into to two types: minor and severe intended cosmetic effect. Other reported events headaches. Minor headaches can be managed with included injection site reaction (19%), ptosis (11%), standard over the counter analgesics, whereas muscle weakness (5%), and headache (5%). Many severe headaches can be managed with stronger clinicians would not consider focal facial paralysis analgesics and systemic corticosteroids when nec- and muscle weakness as AEs, as the therapeutic essary (4). effect of BTX relies on these properties. In addition, Typically, the majority of AEs related to BTX are lack of intended cosmetic effect may be due to judi- due to improper injection technique rather than cious use of the BTX product, with intentional the neurotoxin itself. This is encouraging, as these underdosing by the clinician in order to avoid AEs are thus preventable with complete knowledge excessive muscle paralysis with the option of offer- of muscle anatomy and adequate training in tech- ing touch-up at a later time. nique. The remaining cases of AEs are due to local Injection site reactions may include pain, diffusion of injected BTX, leading to weakness of erythema, edema, and bruising. Using smaller adjacent muscles. The radius of diffusion of BTX gauge needles, applying topical anesthetic 10–15 ranges from 1 to 3 cm from the injection site. minutes prior to injection, and reconstituting the Avoiding laser treatments that produce severe BTX with preservative-containing saline may all swelling on the day of BTX injections is beneficial serve to lessen the pain on injection. In order to to decrease the chance of diffusion to unwanted minimize bruising, patients should abstain from 525 Cox & Adigun aspirin for at least a week and NSAIDS for at least several days prior to treatment. Additionally, patients should avoid vitamin E and herbal supple- ments, especially those with known blood- thinning properties. Postinjection headache associated with BTX has been studied extensively. In placebo-controlled trials, the incidence of headache among BTX is much lower than previously reported, because many patients receiving the placebo injection also complained of postinjection headache. Incidence of severe headache following treatment with BTX-A in a large series was 1%, with resolution of symp- toms within 2–4 weeks among all patients. Should a patient experience a postinjection headache, FIG. 1. “Cocked eyebrow” from residual lateral frontalis function. appropriate analgesics should be offered, espe- cially if the pain is not relieved by over the counter medications (3). drops containing alpha-adrenergic agonists as out- Depending
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