- Email: [email protected]
Patient safety in procedural dermatology
Patient safety in procedural dermatology Part II. Safety related to cosmetic procedures Margarita Lolis, MD,a Scott W. Dunbar, MD,a David J. Goldberg, MD, JD,a,b,c,d,e Timothy J. Hansen, MD,f and Deborah F. MacFarlane, MD, MPHg,h New York, New York; Hackensack and Newark, New Jersey; Ames, Iowa; and Houston, Texas
Learning objectives After completing this learning activity, participants should be able to: 1) Critically assess potential safety issues within their specific cosmetic practice 2) Identify knowledge, competence, or performance gaps that may lead to these issues 3) Delineate strategies for minimizing complications for patients undergoing cosmetic procedures Disclosures Editors The editors involved with this CME activity and all content validation/peer reviewers of the journal-based CME activity have reported no relevant financial relationships with commercial interest(s). Authors The authors involved with this journal-based CME activity have reported no relevant financial relationships with commercial interest(s). Planners The planners involved with this journal-based CME activity have reported no relevant financial relationships with commercial interest(s). The editorial and education staff involved with this journal-based CME activity have reported no relevant financial relationships with commercial interest(s).
Cosmetic procedures are growing in popularity and are associated with unique risks. Considering potential complications and prioritizing patient safety will help practitioners improve outcomes of elective procedures. In part II of this continuing medical education article, we provide a comprehensive review of patient safety in cosmetic procedures, including medical and legal issues surrounding the supervision and training of physician extenders. ( J Am Acad Dermatol 2015;73:15-24.) Key words: botulinum toxins; lasers, light, and radiofrequency devices; patient safety; physician extenders; soft tissue fillers.
dvancements in dermatologic surgery over the past decade have led to an exponential increase in the number of cosmetic procedures. Between 2001 and 2007, the number of cosmetic and noncosmetic surgical procedures performed increased from 3.4 to 7.6 million—a 120.2% increase. Soft tissue augmentation and neurotoxin injections have grown most rapidly (405% and 324.4%, respectively). Not far behind, nonablative skin rejuvenation—which includes laser, light, and radiofrequency sources—saw a 330.7% growth rate,
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while ablative resurfacing procedures increased by 66.8%.1,2 According to the American Society for Aesthetic Plastic Surgery’s cosmetic surgery statistics, the top 3 nonsurgical procedures in the United States in 2013 were neurotoxin injection, soft tissue augmentation, and hair removal.3 Our understanding of the safety profile of various cosmetic procedures has also grown over the years, and techniques have therefore improved significantly. Awareness of the potential complications of cosmetic procedures and a focus on patient safety
From Skin Laser and Surgery Specialists of New York and New Jersey,a New York; Departments of Dermatology at Hackensack University Medical Center,b Mount Sinai School of Medicine,c New York, and Rutgers New Jersey Medical School,d Newark; Fordham Law School,e New York; McFarland Clinic,f Ames; and the Departments of Dermatologyg and Plastic Surgery,h MD Anderson Cancer Center, Houston. Funding sources: None. Conflicts of interest: None declared.
Reprint requests: Scott W. Dunbar, MD, Skin Laser and Surgery Specialists of New York and New Jersey, 115 E 57th St, Ste 400, New York, NY 10022. E-mail: [email protected]. 0190-9622/$36.00 Ó 2014 by the American Academy of Dermatology, Inc. http://dx.doi.org/10.1016/j.jaad.2014.11.036 Date of release: July 2015 Expiration date: July 2018
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has helped improve the outcomes and efficacy of these procedures and helped protect physicians from potential liability. Part II of this continuing medical education article will review the safety of various cosmetic procedures and explore potential issues and complications caused by physician extenders.
NEUROTOXIN SAFETY Key points d
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Botulinum toxin products were first developed in 1989 and were approved by the US Food and Drug Administration in 2002 for the treatment of glabellar lines The 3 botulinum toxin type A products used in the United States are onabotulinumtoxin A, abobotulinumtoxin A, and incobotulinumtoxin A Common side effects include injection site reactions, headaches, muscle weakness, and ptosis Noneinjection site complications result from the improper placement of toxin or from local diffusion into unintended adjacent muscles Injection technique, injection volumes, concentration gradients, and anatomic boundaries influence local diffusion
Botulinum neurotoxin products are the most popular nonsurgical cosmetic procedure. In 1989, the first neurotoxin onabotulinumtoxin A (BOTOX Cosmetic; Allergan Inc, Irvine, CA), was developed for the treatment of blepharospasm and strabismus, and was subsequently approved for the treatment of glabellar lines until 2002.4 Since then, its clinical uses (both on- and off-label) have broadened, and many products have been developed. In the United States, botulinum toxin type A derivatives used for facial lines also include abobotulinumtoxin A (Dysport; Medicis Aesthetics, Scottsdale, AZ) and incobotulinumtoxin A (Xeomin; Merz Aesthetics, Frankfurt, Germany). Overall, these products are associated with favorable side effect profiles. Common reported side effects include injection site reactions (ie, erythema, pain, pruritus, rash, and ecchymosis), short-term hyperesthesia, muscle weakness, ptosis, headache, and lack of intended cosmetic effect.4 A minority of patients (approximately 1%) may experience idiosyncratic severe headaches.5 Noneinjection site complications typically result from the improper placement of toxin or from local diffusion into unintended adjacent muscles. Injection technique, injection volumes, concentration gradients, and anatomic boundaries influence
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local diffusion. Lid ptosis is a well-known complication of glabellar injection. Various studies have been conducted to evaluate the frequency of its occurrence, which has ranged from 2% to 20%. A multicenter, double-blind, randomized clinical trial of the safety and tolerability of onabotulinumtoxin A reported ptosis at a rate of approximately 5%.6 However, injection techniques have advanced, and recent studies have reported rates as low as 1%. Another less common complication is drooping of the lips caused by weakening of the zygomaticus major muscle during crow’s feet injection. In a study of 1000 patients, only 3 patients developed this complication. In all 3 cases, 15 units (or 7.5 U/side) were used.7 Onabotulinumtoxin A Onabotulinumtoxin A injection is the most performed cosmetic procedure, and therefore its safety and tolerability have been widely studied. Complication rates differ between injection sites and with different doses. Generally, a higher risk of complications is associated with glabellar compared to lateral canthal injections. A metaanalysis of the safety of onabotulinumtoxin A for facial lines was published in the Journal in 20098 and included studies evaluating the treatment of both the glabella and lateral canthus (crow’s feet). The selected studies included 6 randomized, double blind, placebo-controlled and 3 open-label studies. Overall treatment-related adverse effects (TRAEs) were significantly more common in the onabotulinumtoxin A treatment group than the placebo group. Eyelid sensory abnormalities, edema, and lid ptosis reached statistical significance for the glabella but not for crow’s feet. There was no evidence of muscle weakness distant from the injection site or central nervous system effects. The most common adverse event was headache (9% glabella; 4% crow’s feet), but there was no significant difference in headache incidence between placebo and onabotulinumtoxin A injection (Table I). The authors interpreted the occurrence of headache as being related to the physical injection rather than the pharmacologic effect of the drug. Interestingly, the incidence of reported adverse events significantly decreased with subsequent treatments. All TRAEs were mild to moderate in severity; no serious TRAEs were documented. Abobotulinumtoxin A Abobotulinumtoxin A is a more recent formulation of botulinum toxin that is used to treat glabellar lines and crow’s feet. It is important to note that abobotulinum A is dosed approximately 3-fold
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Table I. Onabotulinumtoxin A complications*
Complication type
Percent affected after glabellar injection
Percent affected after periocular injection
20 U Toxin
Placebo
6-36 U Toxin
Placebo
16.1 8.5 0.4 0.0 1.3 0.0 0.4 0.0 0.0
21.1 4.8 0.0 0.0 0.5 0.5 3.3 4.3 0.5
16.7 1.7 0.0 0.0 1.7 0.0 6.7 1.7 0.0
y
Overall adverse events 23.6 Headache 9.0 Eyelid sensory disruption 2.6y Eyelid ptosis 2.4y Injection site pain 1.5 Eyelid edema 1.3y Injection site bruising 0.3 Injection site hematoma 0.0 Facial pain 1.1 *Data modified from Brin et al.8 y P \ .05.
between the 2 toxins.11 In 3 placebo-controlled trials in which 535 subjects with glabellar lines received incobotulinumtoxin A 20 U, the most frequent adverse events were headache (5.4%), brow ptosis (0.7%), inject site hematoma (0.6%), and eyelid edema (0.4%).12 In an open-label, multiple-dose trial,13 13.1% of subjects reported adverse events, with headache being the most common (7.1%), followed by injection side hematoma (1%). Brow ptosis, eyelid edema, elevation of the eyebrow was reported in \1% of patients.13 Neutralizing antibodies against incobotulinumtoxin A were not found in any patients.
CONSEQUENCES AND LITIGATION Key point d
higher than the other 2 toxins discussed here. In a multicenter, phase II, randomized study comparing the efficacy of abobotulinum A toxin 50 U to placebo, 67% of patients experienced TRAEs, 4% of which were considered severe. The most frequently reported TRAEs were headaches, migraines, and eye disorders. The overall incidence of eyelid ptosis was 3.2%.9 In another phase III, randomized, placebocontrolled clinical trial on 544 patients receiving a single treatment of either 50, 60, 70, or 80 U, only 13 patients (2%) developed ptosis, which was mild in severity. The incidence of adverse events was not dose-related. This study also found that patients previously treated with abobotulinumtoxin A had a lower incidence of ocular and injection site TRAEs than patients who had not undergone any previous treatment.10 In a study by Kane et al,10 3% of patients (n = 105) treated with abobotulinumtoxin A 50 U developed eyelid ptosis and blepharospasm, in comparison to another 50-U, phase III, multicenter study that found a similar rate of 4% ptosis and 1% blepharospasm. The incidence of headaches in various clinical trials has ranged from 3% to 15%.9 Incobotulinumtoxin A Incobotulinumtoxin A is a novel neurotoxin that differs from the others discussed here in that it does not contain complexing proteins. This low protein content is theorized to produce fewer neutralizing antibodies and reduce treatment failure. Data supporting this claim are scarce. One randomized, double-blind, split-face trial compared head to head the safety and efficacy of onabotulinumtoxin A and incobotulinumtoxin A for periocular rhytids and masseter hypertrophy. These authors found no significant difference in efficacy or safety profile
The use of neurotoxins in dermatology is safe and is associated with a low incidence of adverse events and lawsuits
As shown in the aforementioned studies, the use of neurotoxins in dermatology is generally safe. Between 1989 and 2003, 36 serious adverse events and 0 deaths were reported to the US Food and Drug Administration (FDA) with the cosmetic use of onabotulinumtoxin A. More than one-third of these complications were related to off-label treatments. In contrast, during the same period, 217 serious adverse events were reported because of the therapeutic use of onabotulinumtoxin A. This is largely because of a 4-fold higher median dose (100 U vs 25 U) in therapeutic cases.14 Lawsuits related to botulinum toxins are uncommon. A study of litigation between 1985 and 2012 found 24 relevant cases, all involving onabotulinumtoxin A. Lawsuits were 5 times more likely in therapeutic use of toxins with cases citing up to 600 U dosed. Allergan, Inc was named in all cases; in only 3 cases were physicians named as codefendants. Only 1 case involved a dermatologist.4
SOFT TISSUE FILLER SAFETY Key points d
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The most common soft tissue fillers approved by the US Food and Drug administration are hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid Adverse events include small nodule formation, foreign body granulomas, noninflammatory nodules, hypersensitivity reactions, and vascular-mediated events
Soft tissue fillers have gained popularity over the past decade largely because of their desirable results and low side effect profiles, in comparison to their predecessors, silicone and bovine collagen, which
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Table II. Soft tissue filler adverse events Adverse event
Filler associated with event
Incidence
HA, PLLA, and CaHA Common Injection site reactions (ie, erythema, swelling, pain, and bruising) Foreign body granuloma HA Rare Nodule formation PLLA [ CaHA Rare Vascular compromise HA, PLLA, and CaHA Rare Hypersensitivity reactions HA, PLLA, and CaHA Rare Cellulitis CaHA Rare CaHA, Calcium hydroxyapatite; HA, hyaluronic acid; PLLA, poly-Llactic acid.
are associated with a high rate of delayed onset foreign body granulomas. There was a 324% increase in the number of soft tissue augmentation treatments between 2001 and 2007. Because of their popularity, an increasing number and variety of dermal fillers are being developed to treat wrinkles, scars, and lipodystrophy. Overall, filling agents are considered to be very safe, and each product has unique associated benefits and risks. The most commonly reported adverse events include transient reactions, namely swelling and bruising. Our understanding of these reactions can help improve patient outcome and satisfaction. The FDA-approved fillers commonly used for soft tissue augmentation included in this discussion are hyaluronic acid (HA) fillers, calcium hydroxylapatite (CaHA), and poly-L-lactic acid (PLLA). Complications may be categorized into injection site reactions, adverse effects from improper technique, allergy and hypersensitivity reactions, and vascular-mediated events (Table II). Injection site reactions include edema, pain, erythema, pruritus, and infection. Adverse effects from improper technique include small nodule formation, which is most commonly seen with superficial injection of HA fillers causing a Tyndall effect. Foreign body granulomas are inflammatory lesions that develop months to years after injection. They are rare and their incidence ranges based on the substance used. In a cohort study of [450 patients, HA fillers were associated with the highest rate of granuloma formation (;0.4%) in comparison to CaHA (0.001%).15 CaHA has the lowest rate of granuloma formation of all dermal fillers.16 In a multicenter clinical trial of 113 patients injected with CaHA, only 7 minor adverse reactions were reported, none of which were foreign body granulomas.17 Hypersensitivity or allergic reactions can occur depending on the type of filler used.18 Hypersensitivity reactions, such as facial angioedema, have been rarely reported, and an incidence of
0.5% has been proposed in the literature.19 Nodule formation sometimes occurs as product accumulates without generating an immune response, as in a granuloma. Nodule formation is typically delayed from the time of injection and is associated more commonly with PLLA and CaHA.18 Nodules may occur because of poor placement in highly mobile areas, such as the lips, or because of poor mixing of the product.20 A 5% to 8% rate of nodule formation has been reported in the literature when CaHA is injected in the lips.17 Nodules are most commonly seen with use of PLLA. The prevalence of nodule formation varies widely in clinical studies, from 6% to 52%. Two separate European studies have studied the occurrence of these nodules in patients treated with PLLA for HIV-related lipoatrophy. Nodule formation was documented in 52% and 31% of patients in each of these studies, respectively, and the average time of onset was 7 months.21,22 In 2 separate US studies, a lower incidence was noted, but patients were only followed for 1 year, in comparison to the European studies where patients had 2 years of follow-up. In these 2 studies, nodules occurred in 6% and 13% of patients.23,24 In a more recent study from 2011, 116 patients were treated with PLLA and followed for 13 months. Ten of 116 patients (8.6%) developed nodules \5 mm in diameter, and 8 of 116 patients (6.9%) developed nodules [5 mm in diameter. The mean duration of these nodules is unknown.25-28 One retrospective study reported spontaneous resolution in 23% (6/26) of patients over 2 years.24 Studies have shown that both proper preparation and injection technique can minimize the formation of nodules without compromising a given filler’s efficacy.24 Studies have shown that nodule formation is associated with a higher concentrated suspension of PLLA. Reconstituting with 3 to 4 mL of sterile water for injection was associated with a [30% rate of nodule formation in 2 large HIV studies.29,30 Another study noted that the use of a dilute suspension (approximately 5 mL) is associated with a reduction in nodule formation to \5%.31-33 Granulomas can be difficult to differentiate from fibrotic nodules, but characteristics more common of nodules include later onset, tenderness, swelling, and erythema. Nodule formation after treatment with HA has been reported but is much less common than the aforementioned products. Vascular-mediated events are perhaps the most dreaded complication of soft tissue augmentation, and they may result in skin necrosis. The glabella is a high-risk anatomic location for ischemic necrosis. Blood supply to the glabella is poor, being largely provided by small branches from the supratrochlear
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Fig 1. Filler necrosis.
and supraorbital arteries. Necrosis can occur via vessel injury, compression, or occlusion of these branches and their tributaries.34 Retinal embolism with intravascular injection of the supratrochlear artery has also been described.21 Though less common, alar necrosis has also been reported after injection of the nasolabial fold. This likely occurs because of compression of the angular artery or branches in this region.22 In a retrospective review of 2089 soft tissue filler injections, 1 patient (\0.05%) experienced intravascular compromise and subsequent alar necrosis after CaHA injections.23 Given the morbidity of these complications, it is recommended that injectors withdraw the plunger of the syringe to examine for a flash of blood to mitigate the risk of intravascular injection. In the German Injectable Filler Study,35 20% of patients developed vascular compromise after injection with HA in the glabellar region. However, this rate appears higher than usual and may be caused in part by the small sample size of the study (n = 10) and changes in current injection techniques and volumes used. In another retrospective analysis of 139 patients, 40 patients reported adverse events, 10 of whom were injected with HA and 5 with PLLA. The most common adverse reaction was nodule/hardening in 80% of patients injected with PLLA, followed by pain, pruritus, discoloration, erythema, and swelling in 20% of cases. No ulceration or abscess formation was noted. Patients injected with HA fillers primarily experienced site reactions, such as erythema, swelling, and pain36 (Figs 1 and 2). A large systematic review of HA fillers that included 10 randomized, blinded clinical trials, 53 clinical reports, and several additional open-label and retrospective studies identified only 8 serious events of 4605 total patients, all of which were determined to be unrelated to filler injection.37 In a recently published 5-year retrospective review of 2089 soft tissue filler injections,23 CaHA was the filler most commonly associated with complications. This series consisted of 1047 HA, 811 PLLA, and
Fig 2. A 51-year-old woman who developed prolonged erythema and edema from hyaluronic acid filler placed in the nasolabial folds.
231 CaHA injections. The complications arising from CaHA injections included cellulitis in 3 patients, submucosal nodule formation in 1 patient, and 1 case of partial thickness alar necrosis after nasolabial fold injections. Five patients treated with PLLA developed subcutaneous nodules. HA injections were least likely associated with complications. One patient treated with HA developed an inflammatory granuloma after lip augmentation.23
LASERS, LIGHT, AND RADIOFREQUENCY DEVICE SAFETY Key points d
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Many organizations regulate laser operations in the United States, but these regulations are not strictly enforced The most frequently used regulatory document that provides guidance for the safe use of lasers in medicine is the American National Standards Institute document Z136.3 Laser safety includes the use of protective eyewear, laser signage, control of surgical smoke, tissue splatter and plume, and attention to nonbeam and beam hazards Cutaneous injuries are the most frequent complications, with laser hair removal being the most common procedure resulting in litigation
In the United States, laser standards and regulations are not strictly enforced. In fact, only 12 states have laser regulations.38 The requirements entail registration of lasers and the licensing of individual operations and institution, but physician-used medical lasers are exempt from these regulations. The national organizations that regulate laser operations are the American National Standards Institute (ANSI), the Center for Devices and Radiological Health (CDRH) of the FDA, the Department of Labor’s Occupational Safety and Health Administration
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(OSHA), and the Council of Radiation Control Program Directors (CRCPD).38 The ANSI Z136.3 is a regulatory document on laser safety most frequently used in health care environments that provides guidance for the safe use of lasers in medicine. Standards are implied, but there is no requirement for adherence; compliance is voluntary unless specifically mandated by an institution or organization. In addition, OSHA does not have a comprehensive laser standard. The only construction standard states ‘‘employees whose occupation or assignment requires exposure to laser beams shall be furnished suitable laser safety goggles which will protect for the specific wavelength of the laser and be of the optical density adequate for the energy involved.’’ Studies have shown that 70% of all laser accidents to operators result from inappropriate or absent use of protective eyewear. Ocular complications have resulted from both direct and indirect exposure; laser energy can be reflected. Types of ocular injuries are wavelength specific. The degree of ocular damage is dependent on the laser irradiance, exposure time, and beam size.39 Therefore, laser-protective eyewear is a well-recognized precaution, and includes wraparound glasses and goggles, which are rated by optical density (OD) at various wavelengths. An OD of $4 at the particular wavelength of laser used is considered safe for dermatologic lasers. A common misconception among laser users is that laser safety consists of the use of protective eyewear and signage of laser use only. National audits have revealed many misconceptions with laser safety, noncompliance, unsafe practices, and potential medicolegal issues. For example, plume and tissue splatter are potential safety issues that may be overlooked. The Centers for Disease Control and Prevention, OSHA, and state regulations have recognized the hazards of surgical smoke and have developed recommendations for its control. Particulates as small as 0.12 m, which include bacteria, human papillomavirus/HIV, carbon, and live cellular particles have been identified in surgical smoke.40 Human papillomavirus has been cultured from plume generated by the CO2 laser treatment of warts. The use of smoke evacuators, gloves, masks, and filters are important precautions. Tissue splatter is another potential hazard that may occur with Qswitched lasers. Other types of nonbeam hazards include fire and electrical hazards associated with high-voltage lasers. It is important to always be aware of the surgical or room setting, and special care must be taken to avoid exposure of flammable objects or liquids and drapes to the laser beam. Cutaneous injuries are the most frequent complications and the most common cause for legal action
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Fig 3. A 65-year-old woman who underwent intense pulsed-light treatment that resulted in a scar on the right upper lip.
Fig 4. A 42-year-old woman with glabellar necrosis after the use of a hyaluronic acid filler.
in laser surgery. A recent study investigated legal claims between 1985 and 2012 related to cutaneous laser surgery; 174 laser-induced injury lawsuits were found.41 The most common procedure that resulted in litigation was laser hair removal (n = 63). This may be because laser hair removal is the most frequent laser procedure and not necessarily because it has a high complication rate. The second most commonly litigated procedure was rejuvenation (n = 43). This includes conventional CO2 resurfacing, which has fallen largely out of favor, ablative and nonablative fractional resurfacing, and intense pulsed-light treatments. Vascular and leg vein treatments represented 8% and 7.5% of lawsuits, respectively. The most common injuries included burns (47%), scars (38.8%), and pigmentation (23.5%). Four eye injuries and 2 deaths have been reported41 (Figs 3-6). Common errors in cutaneous injuries associated with laser and light devices include improper laser
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Fig 5. A 58-year-old woman who underwent ablative laser treatment and subsequently developed a candidal infection.
Fig 6. A 45-year-old woman with a depressed scar caused by a burn sustained by intense pulsed-light therapy.
selection. In selecting a laser/light device for a treatment, it is important to consider the target chromophore but also the skin type of the patient. In treating patients with dark skin types, the use of longer wavelengths or higher cutoff filters as well as longer pulse durations and lower fluences are recommended. Appropriate precooling, cooling during the procedure, and postcooling should also be considered to provide an extra measure of epidermal protection. In addition, a detailed disclosure of potential side effects protects not only the patient but also the provider. The risk of scarring is low with pigment-specific, vascular, and nonablative lasers. Resurfacing lasers, such as the erbium and CO2, carry the greatest risk of scarring because of dermal destruction and a higher risk of infection, which can ultimately lead to scarring. The advent of fractional lasers has minimized this complication. The CO2 laser is particularly hazardous because its wavelength in the far infrared and invisible spectrum is not visible; injuries and hazards may go unnoticed. The neodymium-doped yttrium aluminium garnet (Nd:YAG) laser should be approached with even greater caution, because it penetrates deeply because of its wavelength and is also invisible.
Fig 7. A 55-year-old woman who developed a coloboma caused by ocular injury secondary to the use of inappropriate safety eyewear.
There have been several reports of serious retinal injuries with Nd:YAG lasers42,43 (Fig 7). Radiofrequency energy has been used medically for years, but more recently has been applied cosmetically in tightening devices and in fractional ablative devices. These devices are billed as ‘‘sublative rejuvenation’’ in that they deliver energy focally to the dermis and spare the epidermis. This focused energy delivery preserves the epidermis and translates to fewer complications, especially in patients with darker skin types.44 Contraindications to radiofrequency devices include implantable medical devices, such as pacemakers and defibrillators, and active dermatologic conditions, including collagen vascular and autoimmune diseases. Device companies recommend avoiding treatment over areas of skin marked with tattoos and caution against use on areas of the body that may contain metal implants, hardware, and braces. In this era of cosmetic dermatology and diversity of laser operators, it is important to ensure that all staff handling and operating lasers are well trained and supervised to minimize the risk of injury.
COMPLICATIONS AND LEGAL ISSUES ARISING WITH COSMETIC EXTENDERS Key points d
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Lawsuits involving laser devices are commonly due to non-physician operators, however the supervising physician is commonly the defendant. Proper training and supervision is essential
The original role of physician extenders was to expand primary care in underserved regions. The passage of the Balanced Budget Act in 1997 enabled independent billing and payment to NPs and PAs. Subsequently, the number and role of physician extenders in dermatology has expanded greatly.
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When mid-level providers are supervised by a physician, they bill at and are reimbursed 100% of the contracted Medicare rate. When billing independently, MLPs are reimbursed at 85% of the contracted rate. In a 2012 analysis of NP and PA billing there were over four million procedures billed independently by NPs and PAs, with over half of these representing dermatology codes.45 Expanding this analysis to cosmetic procedures, a study of legal action in laser surgery identified 174 cases between 1985 and 2012. Of these cases a non-physician laser operator performed 40%, and though the physician operated the laser in only 57.5% of these suits, they were named defendants in 73.8% of these cases. State laws that assign liability to the supervising physicians explain this disparity. In addition, many mid-level providers do not carry malpractice insurance and naming the insured physician as a defendant increases the likelihood of a successful payment in a lawsuit.41 In 2014, the same authors performed another analysis of litigation related to laser surgery. They found an increase in cases involving a nonphysician operator from 36.3% in 2008 to 77.8% in 2011. Laser hair removal was the most commonly litigated procedure. Interestingly, though nonphysicians perform only one-third of laser hair removal procedures, this group represented 85.7% of hair removal lawsuits. Of these, 64% were performed outside a traditional medical setting, indicating that supervision by a physician may ameliorate some of this risk.46,47 One of the most feared complications of laser surgery regards pigmented lesions and melanoma. There have been several reports of melanoma diagnoses relating to laser treatment, though it is unknown whether these cases are caused by laser energy, or, as is more commonly suggested, misdiagnosed as benign lesions prior to laser treatment. One report is of a patient who paid 10 Euro for treatment of pigmented lesions at a laser spa in Japan, and was later diagnosed with metastatic melanoma with a large focus at the site of laser treatment.48 Accurate diagnosis of pigmented lesions is challenging, even for seasoned dermatologists, and there are several case reports of patients who presented for laser removal of lesions that were caught and diagnosed as melanoma by dermatologists.49 These studies suggest that the judgment of a well-trained dermatologist is vital to patient safety prior to laser treatment of pigmented lesions. A German study conducted in 2013 investigated the most frequent errors resulting from the use of laser or IPL devices by unsupervised medical laypeople (tattooists, cosmetologists, etc). This
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survey identified 50 patients who reported complications. The most reported complications were pigmentation changes in 81% of patients, scarring in 25% of patients, textural changes in 14%, and inadequate treatment in 5% of patients.50 The sources of error included excessive energy application in 63% of cases, improper laser selection in 40%, inappropriate use of laser on skin type in 21% of cases, inadequate cooling in 7%, and inadequate information to patients in 5% of cases. In a field like dermatology, where vast numbers of procedures are performed, complications are inevitable. Physician extension is becoming more common in our field and as studies have demonstrated, physicians who supervise extenders are often held liable when complications arise. It is imperative that all laser operators be properly trained and closely supervised to protect the patient from injury, increase efficacy, and avoid legal pitfalls. REFERENCES 1. Tierney EP, Hanke CW. Recent trends in cosmetic and surgical procedure volumes in dermatologic surgery. Dermatol Surg. 2009;35:1324-1333. 2. Ahn CS, Davis SA, Dabade TS, Williford PM, Feldman SR. Cosmetic procedures performed in the United States: a 16-year analysis. Dermatol Surg. 2013;39:1351-1359. 3. American Society for Aesthetic Plastic Surgery. Statistics. Available from: http://www.surgery.org/media/statistics. Accessed November 16, 2014. 4. Korman JB, Jalian HR, Avram MM. Analysis of botulinum toxin products and litigation in the United States. Dermatol Surg. 2013;39:1587-1591. 5. Vartanian AJ, Dayan SH. Complications of botulinum toxin A use in facial rejuvenation. Facial Plast Surg Clin North Am. 2005;13:1-10. 6. Carruthers JA, Lowe NJ, Menter MA, et al. A multicenter,double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002; 46:840-849. 7. Matarasso SL, Matarasso A. Treatment guidelines for botulinum toxin type A for the periocular region and partial upper lip ptosis following injections to the lateral canthal rhytids. Plast Reconstr Surg. 2001;108:208-214. 8. Brin MF, Boodhoo TI, Pogoda JM, et al. Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. J Am Acad Dermatol. 2009;61:961-970. 9. Rubin MG, Dover JS, Glogau RG, Goldberg DJ, Goldman MP, Schlessinger J. The efficacy and safety of a new US botulinum toxin type A in the retreatment of glabellar lines following open-label treatment. J Drugs Dermatol. 2009;8: 439-444. 10. Kane MAC, Brandt F, Rohric RJ, et al. Evaluation of variable-dose treatment with a new US botulinum toxin type A (Dysport) for correction of moderate to severe glabellar lines: results from a phase 3, randomized, double-blind, placebo-controlled study. Plast Reconstr Surg. 2009;124:1619-1629.
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11. Lee JH, Park JH, Lee SK, et al. Efficacy and safety of incobotulinum toxin A in periocular rhytides and masseteric hypertrophy: side-by-side comparison with onabotulinum toxin A. J Dermatolog Treat. 2014;25:326-330. 12. Carruthers A, Carruthers J, Heinz M, et al. Multicenter, randomized phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. Dermatol Surg. 2013;39: 551-558. 13. Hanke CW, Narins RS, Heinz M, et al. IncobotulinumtoxinA, a botulinum toxin free from complexing proteins, in the treatment of glabellar frown lines. Dermatol Surg. 2013;39: 891-899. 14. Cote TR, Mohan AK, Polder JA, et al. Botulinum toxin type A injections: adverse effects reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005;53:407-415. 15. Lemperle G, Gauthier-Hazan N, Wolters M, Eisemann-Klein M, Zimmermann U, Duffy DM. Foreign body granulomas after all injectable dermal fillers: part 1. Possible causes. Plast Reconstr Surg. 2008;123:1864-1873. 16. Pavicic T. Calcium hydroxylapatite filler: an overview of safety and tolerability. J Drugs Dermatol. 2013;12: 996-1002. 17. Sadick NS, Katz BE, Roy D. A multicenter, 36-month study of safety and efficacy of calcium hydroxylapatite for soft tissue augmentation of nasolabial folds and other areas of the face. Dermatol Surg. 2007;33(suppl 2):S122-S126. 18. Lafaille P, Benedetto A. Fillers: contraindications, side effects and precautions. J Cutan Aesthet Surg. 2010;3:16-19. 19. Cosatti M, Fernandex Romero DS, Juri MC, Malbran A. Facial angioedema after filler injections. Description of five cases [in Spanish]. Medicina (B Aires). 2010;70:513-517. 20. Sclafani AP, Fagien S. Treatment of Injectable soft tissue filler complications. Dermatol Surg. 2009;35:1672-1680. 21. McCleve DE, Goldstein JC. Blindness secondary to injections in the nose, mouth, and face: cause and prevention. Ear Nose Throat J. 1995;74:182-188. 22. Grunebaum LD, Alleman IB, Dayan S, Mandy S, Baumann L. The risk of alar necrosis with dermal fillers. Dermatol Surg. 2009;35:1635-1640. 23. Daines SM, Williams EF. Complications associated with injectable soft-tissue fillers: a 5-year retrospective review. JAMA Facial Plast Surg. 2013;15:226-231. 24. Werschler P, Cosmetic Study Investigator Group. Efficacy of injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles. Presented at the American Society for Dermatologic Surgery, Palm Desert, CA, October 28, 2006. Abstract CS359. 25. Narins RS, Baumann L, Brandt FS, et al. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010;62: 448-462. 26. Moyle GJ, Lysakova L, Brown S, et al. A randomized open label study of immediate versus delayed polylactic acid injections for the cosmetic management of facial lipoatrophy in persons with HIV infection. HIV Med. 2004;5: 82-87. 27. Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV related facial lipoatrophy. HIV Med. 2006;7:181-185. 28. Brown SA, Rohrich RJ, Baumann L, et al. Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus
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human collagen for the correction of nasolabial fold wrinkles. Plast Reconstr Surg. 2011;127:1684-1692. Weinkle S. Minimizing the risk of adverse events with injectable poly-L-lactic acid. Int J Dermatol. 2007;6:2. Accessed March 20, 2014. Valantin MA, Aubron-Olivier C, Ghosn J, et al. Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA. Aids. 2003;17:2471-2477. Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006;118(3 suppl): 46S-54S. Borelli C, Kunte C, Weisenseel P, Thoma-Greber E, Korting HC, Konz B. Deep subcutaneous application of poly-L-lactic acid as a filler for facial lipoatrophy in HIV-infected patients. Skin Pharmacol Physiol. 2005;18:273-278. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIVassociated facial lipoatrophy. J Am Acad Dermatol. 2005;52: 233-239. Glaich AS, Cohen JL, Goldberg LH. Injection necrosis of the glabella: protocol for prevention and treatment after use of dermal fillers. Dermatol Surg. 2006;32:276-281. Wolber L, Zielke H, Wiest L, Rzany B. Adverse reactions to Injectable filler substances in aesthetic dermatology-results of the Injectable filler safety study. J Invest Dermatol. 2005; 125:855. Bachmann F, Erdmann R, Hartmann V, Weist L, Rzany B. The spectrum of adverse reactions after treatment with Injectable fillers in the glabellar regions: results from the Injectable Filler Safety Study. Dermatol Surg. 2009: 1629-1634. Cohen JL, Dayan SH, Brandt FS, et al. Systematic review of clinical trials of small- and large-gel-particle hyaluronic acid injectable fillers for the aesthetic soft tissue augmentation. Dermatol Surg. 2013;39:205-231. US Department of Labor, Occupational Safety and Health Administration website. OSHA Technical Manual, Section III, Chapter 6. Available at: https://www.osha.gov/dts/osta/otm/ otm_iii/otm_iii_6.html. Accessed November 16, 2014. Bader O, Lui H. Laser safety and the eye: hidden hazards and practical pearls. Poster presented at the American Academy of Dermatology Annual Meeting, 1996. Smalley PJ. Laser safety: beyond signs and goggles. The Dermatologist. 2008;12:7. Jalian HR, Jalian CA, Avram MM. Common causes of injury and legal action in laser surgery. JAMA Dermatol. 2013;149: 188-193. Sliney DH, Trokel SL. Medical lasers and their safe use. New York: Springer-Verlag; 1992 Sliney DH, Wolbarsht ML. Safety with lasers and other optical sources: a comprehensive handbook. New York: Plenum Press; 1980 Rongsaard N, Rummaneethorn P. Comparison of a fractional bipolar radiofrequency device and a fractional erbium-doped glass 1,550-nm device for the treatment of atrophic acne scars: a randomized split-face clinical study. Dermatol Surg. 2014;40:14-21. Coldiron B, Ratnarathorn M. Scope of physician procedures independently billed by mid-level providers in the office setting. JAMA Dermatol. 2014;150:1153-1159. Jalian HR, Jalian CA, Avram MM. Increased risk of litigation associated with laser surgery by nonphysician operators. JAMA Dermatol. 2014;150:407-411.
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47. Jalian HR, Avram MM. Mid-level practitioners in dermatology: a need for further study and oversight. JAMA Dermatol. 2014; 150:1149-1151. 48. Larsen TH, Nielsen M, Lindskov R, Hegelund BL, Haedersdal M. Metastases from malignant melanoma after laser treatment of undiagnosed pigmented skin lesions. Lasers Med Sci. 2013;28:1403-1404.
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49. Stankiewicz K, Chuang G, Avram M. Lentigines, laser and melanoma: a case series and discussion. Lasers Surg Med. 2012;44:112-116. 50. Hammes S, Karsal S, Metelmann HR, et al. Treatment errors resulting from the use of laser and IPL by medical laypersons: results of a nationwide survey. J Dtsch Dermatol Ges. 2013;11: 149-156.
Learning objectives After completing this learning activity, participants should be able to: 1) Critically assess potential safety issues within their specific cosmetic practice 2) Identify knowledge, competence, or performance gaps that may lead to these issues 3) Delineate strategies for minimizing complications for patients undergoing cosmetic procedures Disclosures Editors The editors involved with this CME activity and all content validation/peer reviewers of the journal-based CME activity have reported no relevant financial relationships with commercial interest(s). Authors The authors involved with this journal-based CME activity have reported no relevant financial relationships with commercial interest(s). Planners The planners involved with this journal-based CME activity have reported no relevant financial relationships with commercial interest(s). The editorial and education staff involved with this journal-based CME activity have reported no relevant financial relationships with commercial interest(s).
Cosmetic procedures are growing in popularity and are associated with unique risks. Considering potential complications and prioritizing patient safety will help practitioners improve outcomes of elective procedures. In part II of this continuing medical education article, we provide a comprehensive review of patient safety in cosmetic procedures, including medical and legal issues surrounding the supervision and training of physician extenders. ( J Am Acad Dermatol 2015;73:15-24.) Key words: botulinum toxins; lasers, light, and radiofrequency devices; patient safety; physician extenders; soft tissue fillers.
dvancements in dermatologic surgery over the past decade have led to an exponential increase in the number of cosmetic procedures. Between 2001 and 2007, the number of cosmetic and noncosmetic surgical procedures performed increased from 3.4 to 7.6 million—a 120.2% increase. Soft tissue augmentation and neurotoxin injections have grown most rapidly (405% and 324.4%, respectively). Not far behind, nonablative skin rejuvenation—which includes laser, light, and radiofrequency sources—saw a 330.7% growth rate,
A
while ablative resurfacing procedures increased by 66.8%.1,2 According to the American Society for Aesthetic Plastic Surgery’s cosmetic surgery statistics, the top 3 nonsurgical procedures in the United States in 2013 were neurotoxin injection, soft tissue augmentation, and hair removal.3 Our understanding of the safety profile of various cosmetic procedures has also grown over the years, and techniques have therefore improved significantly. Awareness of the potential complications of cosmetic procedures and a focus on patient safety
From Skin Laser and Surgery Specialists of New York and New Jersey,a New York; Departments of Dermatology at Hackensack University Medical Center,b Mount Sinai School of Medicine,c New York, and Rutgers New Jersey Medical School,d Newark; Fordham Law School,e New York; McFarland Clinic,f Ames; and the Departments of Dermatologyg and Plastic Surgery,h MD Anderson Cancer Center, Houston. Funding sources: None. Conflicts of interest: None declared.
Reprint requests: Scott W. Dunbar, MD, Skin Laser and Surgery Specialists of New York and New Jersey, 115 E 57th St, Ste 400, New York, NY 10022. E-mail: [email protected]. 0190-9622/$36.00 Ó 2014 by the American Academy of Dermatology, Inc. http://dx.doi.org/10.1016/j.jaad.2014.11.036 Date of release: July 2015 Expiration date: July 2018
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has helped improve the outcomes and efficacy of these procedures and helped protect physicians from potential liability. Part II of this continuing medical education article will review the safety of various cosmetic procedures and explore potential issues and complications caused by physician extenders.
NEUROTOXIN SAFETY Key points d
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Botulinum toxin products were first developed in 1989 and were approved by the US Food and Drug Administration in 2002 for the treatment of glabellar lines The 3 botulinum toxin type A products used in the United States are onabotulinumtoxin A, abobotulinumtoxin A, and incobotulinumtoxin A Common side effects include injection site reactions, headaches, muscle weakness, and ptosis Noneinjection site complications result from the improper placement of toxin or from local diffusion into unintended adjacent muscles Injection technique, injection volumes, concentration gradients, and anatomic boundaries influence local diffusion
Botulinum neurotoxin products are the most popular nonsurgical cosmetic procedure. In 1989, the first neurotoxin onabotulinumtoxin A (BOTOX Cosmetic; Allergan Inc, Irvine, CA), was developed for the treatment of blepharospasm and strabismus, and was subsequently approved for the treatment of glabellar lines until 2002.4 Since then, its clinical uses (both on- and off-label) have broadened, and many products have been developed. In the United States, botulinum toxin type A derivatives used for facial lines also include abobotulinumtoxin A (Dysport; Medicis Aesthetics, Scottsdale, AZ) and incobotulinumtoxin A (Xeomin; Merz Aesthetics, Frankfurt, Germany). Overall, these products are associated with favorable side effect profiles. Common reported side effects include injection site reactions (ie, erythema, pain, pruritus, rash, and ecchymosis), short-term hyperesthesia, muscle weakness, ptosis, headache, and lack of intended cosmetic effect.4 A minority of patients (approximately 1%) may experience idiosyncratic severe headaches.5 Noneinjection site complications typically result from the improper placement of toxin or from local diffusion into unintended adjacent muscles. Injection technique, injection volumes, concentration gradients, and anatomic boundaries influence
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local diffusion. Lid ptosis is a well-known complication of glabellar injection. Various studies have been conducted to evaluate the frequency of its occurrence, which has ranged from 2% to 20%. A multicenter, double-blind, randomized clinical trial of the safety and tolerability of onabotulinumtoxin A reported ptosis at a rate of approximately 5%.6 However, injection techniques have advanced, and recent studies have reported rates as low as 1%. Another less common complication is drooping of the lips caused by weakening of the zygomaticus major muscle during crow’s feet injection. In a study of 1000 patients, only 3 patients developed this complication. In all 3 cases, 15 units (or 7.5 U/side) were used.7 Onabotulinumtoxin A Onabotulinumtoxin A injection is the most performed cosmetic procedure, and therefore its safety and tolerability have been widely studied. Complication rates differ between injection sites and with different doses. Generally, a higher risk of complications is associated with glabellar compared to lateral canthal injections. A metaanalysis of the safety of onabotulinumtoxin A for facial lines was published in the Journal in 20098 and included studies evaluating the treatment of both the glabella and lateral canthus (crow’s feet). The selected studies included 6 randomized, double blind, placebo-controlled and 3 open-label studies. Overall treatment-related adverse effects (TRAEs) were significantly more common in the onabotulinumtoxin A treatment group than the placebo group. Eyelid sensory abnormalities, edema, and lid ptosis reached statistical significance for the glabella but not for crow’s feet. There was no evidence of muscle weakness distant from the injection site or central nervous system effects. The most common adverse event was headache (9% glabella; 4% crow’s feet), but there was no significant difference in headache incidence between placebo and onabotulinumtoxin A injection (Table I). The authors interpreted the occurrence of headache as being related to the physical injection rather than the pharmacologic effect of the drug. Interestingly, the incidence of reported adverse events significantly decreased with subsequent treatments. All TRAEs were mild to moderate in severity; no serious TRAEs were documented. Abobotulinumtoxin A Abobotulinumtoxin A is a more recent formulation of botulinum toxin that is used to treat glabellar lines and crow’s feet. It is important to note that abobotulinum A is dosed approximately 3-fold
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Table I. Onabotulinumtoxin A complications*
Complication type
Percent affected after glabellar injection
Percent affected after periocular injection
20 U Toxin
Placebo
6-36 U Toxin
Placebo
16.1 8.5 0.4 0.0 1.3 0.0 0.4 0.0 0.0
21.1 4.8 0.0 0.0 0.5 0.5 3.3 4.3 0.5
16.7 1.7 0.0 0.0 1.7 0.0 6.7 1.7 0.0
y
Overall adverse events 23.6 Headache 9.0 Eyelid sensory disruption 2.6y Eyelid ptosis 2.4y Injection site pain 1.5 Eyelid edema 1.3y Injection site bruising 0.3 Injection site hematoma 0.0 Facial pain 1.1 *Data modified from Brin et al.8 y P \ .05.
between the 2 toxins.11 In 3 placebo-controlled trials in which 535 subjects with glabellar lines received incobotulinumtoxin A 20 U, the most frequent adverse events were headache (5.4%), brow ptosis (0.7%), inject site hematoma (0.6%), and eyelid edema (0.4%).12 In an open-label, multiple-dose trial,13 13.1% of subjects reported adverse events, with headache being the most common (7.1%), followed by injection side hematoma (1%). Brow ptosis, eyelid edema, elevation of the eyebrow was reported in \1% of patients.13 Neutralizing antibodies against incobotulinumtoxin A were not found in any patients.
CONSEQUENCES AND LITIGATION Key point d
higher than the other 2 toxins discussed here. In a multicenter, phase II, randomized study comparing the efficacy of abobotulinum A toxin 50 U to placebo, 67% of patients experienced TRAEs, 4% of which were considered severe. The most frequently reported TRAEs were headaches, migraines, and eye disorders. The overall incidence of eyelid ptosis was 3.2%.9 In another phase III, randomized, placebocontrolled clinical trial on 544 patients receiving a single treatment of either 50, 60, 70, or 80 U, only 13 patients (2%) developed ptosis, which was mild in severity. The incidence of adverse events was not dose-related. This study also found that patients previously treated with abobotulinumtoxin A had a lower incidence of ocular and injection site TRAEs than patients who had not undergone any previous treatment.10 In a study by Kane et al,10 3% of patients (n = 105) treated with abobotulinumtoxin A 50 U developed eyelid ptosis and blepharospasm, in comparison to another 50-U, phase III, multicenter study that found a similar rate of 4% ptosis and 1% blepharospasm. The incidence of headaches in various clinical trials has ranged from 3% to 15%.9 Incobotulinumtoxin A Incobotulinumtoxin A is a novel neurotoxin that differs from the others discussed here in that it does not contain complexing proteins. This low protein content is theorized to produce fewer neutralizing antibodies and reduce treatment failure. Data supporting this claim are scarce. One randomized, double-blind, split-face trial compared head to head the safety and efficacy of onabotulinumtoxin A and incobotulinumtoxin A for periocular rhytids and masseter hypertrophy. These authors found no significant difference in efficacy or safety profile
The use of neurotoxins in dermatology is safe and is associated with a low incidence of adverse events and lawsuits
As shown in the aforementioned studies, the use of neurotoxins in dermatology is generally safe. Between 1989 and 2003, 36 serious adverse events and 0 deaths were reported to the US Food and Drug Administration (FDA) with the cosmetic use of onabotulinumtoxin A. More than one-third of these complications were related to off-label treatments. In contrast, during the same period, 217 serious adverse events were reported because of the therapeutic use of onabotulinumtoxin A. This is largely because of a 4-fold higher median dose (100 U vs 25 U) in therapeutic cases.14 Lawsuits related to botulinum toxins are uncommon. A study of litigation between 1985 and 2012 found 24 relevant cases, all involving onabotulinumtoxin A. Lawsuits were 5 times more likely in therapeutic use of toxins with cases citing up to 600 U dosed. Allergan, Inc was named in all cases; in only 3 cases were physicians named as codefendants. Only 1 case involved a dermatologist.4
SOFT TISSUE FILLER SAFETY Key points d
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The most common soft tissue fillers approved by the US Food and Drug administration are hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid Adverse events include small nodule formation, foreign body granulomas, noninflammatory nodules, hypersensitivity reactions, and vascular-mediated events
Soft tissue fillers have gained popularity over the past decade largely because of their desirable results and low side effect profiles, in comparison to their predecessors, silicone and bovine collagen, which
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Table II. Soft tissue filler adverse events Adverse event
Filler associated with event
Incidence
HA, PLLA, and CaHA Common Injection site reactions (ie, erythema, swelling, pain, and bruising) Foreign body granuloma HA Rare Nodule formation PLLA [ CaHA Rare Vascular compromise HA, PLLA, and CaHA Rare Hypersensitivity reactions HA, PLLA, and CaHA Rare Cellulitis CaHA Rare CaHA, Calcium hydroxyapatite; HA, hyaluronic acid; PLLA, poly-Llactic acid.
are associated with a high rate of delayed onset foreign body granulomas. There was a 324% increase in the number of soft tissue augmentation treatments between 2001 and 2007. Because of their popularity, an increasing number and variety of dermal fillers are being developed to treat wrinkles, scars, and lipodystrophy. Overall, filling agents are considered to be very safe, and each product has unique associated benefits and risks. The most commonly reported adverse events include transient reactions, namely swelling and bruising. Our understanding of these reactions can help improve patient outcome and satisfaction. The FDA-approved fillers commonly used for soft tissue augmentation included in this discussion are hyaluronic acid (HA) fillers, calcium hydroxylapatite (CaHA), and poly-L-lactic acid (PLLA). Complications may be categorized into injection site reactions, adverse effects from improper technique, allergy and hypersensitivity reactions, and vascular-mediated events (Table II). Injection site reactions include edema, pain, erythema, pruritus, and infection. Adverse effects from improper technique include small nodule formation, which is most commonly seen with superficial injection of HA fillers causing a Tyndall effect. Foreign body granulomas are inflammatory lesions that develop months to years after injection. They are rare and their incidence ranges based on the substance used. In a cohort study of [450 patients, HA fillers were associated with the highest rate of granuloma formation (;0.4%) in comparison to CaHA (0.001%).15 CaHA has the lowest rate of granuloma formation of all dermal fillers.16 In a multicenter clinical trial of 113 patients injected with CaHA, only 7 minor adverse reactions were reported, none of which were foreign body granulomas.17 Hypersensitivity or allergic reactions can occur depending on the type of filler used.18 Hypersensitivity reactions, such as facial angioedema, have been rarely reported, and an incidence of
0.5% has been proposed in the literature.19 Nodule formation sometimes occurs as product accumulates without generating an immune response, as in a granuloma. Nodule formation is typically delayed from the time of injection and is associated more commonly with PLLA and CaHA.18 Nodules may occur because of poor placement in highly mobile areas, such as the lips, or because of poor mixing of the product.20 A 5% to 8% rate of nodule formation has been reported in the literature when CaHA is injected in the lips.17 Nodules are most commonly seen with use of PLLA. The prevalence of nodule formation varies widely in clinical studies, from 6% to 52%. Two separate European studies have studied the occurrence of these nodules in patients treated with PLLA for HIV-related lipoatrophy. Nodule formation was documented in 52% and 31% of patients in each of these studies, respectively, and the average time of onset was 7 months.21,22 In 2 separate US studies, a lower incidence was noted, but patients were only followed for 1 year, in comparison to the European studies where patients had 2 years of follow-up. In these 2 studies, nodules occurred in 6% and 13% of patients.23,24 In a more recent study from 2011, 116 patients were treated with PLLA and followed for 13 months. Ten of 116 patients (8.6%) developed nodules \5 mm in diameter, and 8 of 116 patients (6.9%) developed nodules [5 mm in diameter. The mean duration of these nodules is unknown.25-28 One retrospective study reported spontaneous resolution in 23% (6/26) of patients over 2 years.24 Studies have shown that both proper preparation and injection technique can minimize the formation of nodules without compromising a given filler’s efficacy.24 Studies have shown that nodule formation is associated with a higher concentrated suspension of PLLA. Reconstituting with 3 to 4 mL of sterile water for injection was associated with a [30% rate of nodule formation in 2 large HIV studies.29,30 Another study noted that the use of a dilute suspension (approximately 5 mL) is associated with a reduction in nodule formation to \5%.31-33 Granulomas can be difficult to differentiate from fibrotic nodules, but characteristics more common of nodules include later onset, tenderness, swelling, and erythema. Nodule formation after treatment with HA has been reported but is much less common than the aforementioned products. Vascular-mediated events are perhaps the most dreaded complication of soft tissue augmentation, and they may result in skin necrosis. The glabella is a high-risk anatomic location for ischemic necrosis. Blood supply to the glabella is poor, being largely provided by small branches from the supratrochlear
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Fig 1. Filler necrosis.
and supraorbital arteries. Necrosis can occur via vessel injury, compression, or occlusion of these branches and their tributaries.34 Retinal embolism with intravascular injection of the supratrochlear artery has also been described.21 Though less common, alar necrosis has also been reported after injection of the nasolabial fold. This likely occurs because of compression of the angular artery or branches in this region.22 In a retrospective review of 2089 soft tissue filler injections, 1 patient (\0.05%) experienced intravascular compromise and subsequent alar necrosis after CaHA injections.23 Given the morbidity of these complications, it is recommended that injectors withdraw the plunger of the syringe to examine for a flash of blood to mitigate the risk of intravascular injection. In the German Injectable Filler Study,35 20% of patients developed vascular compromise after injection with HA in the glabellar region. However, this rate appears higher than usual and may be caused in part by the small sample size of the study (n = 10) and changes in current injection techniques and volumes used. In another retrospective analysis of 139 patients, 40 patients reported adverse events, 10 of whom were injected with HA and 5 with PLLA. The most common adverse reaction was nodule/hardening in 80% of patients injected with PLLA, followed by pain, pruritus, discoloration, erythema, and swelling in 20% of cases. No ulceration or abscess formation was noted. Patients injected with HA fillers primarily experienced site reactions, such as erythema, swelling, and pain36 (Figs 1 and 2). A large systematic review of HA fillers that included 10 randomized, blinded clinical trials, 53 clinical reports, and several additional open-label and retrospective studies identified only 8 serious events of 4605 total patients, all of which were determined to be unrelated to filler injection.37 In a recently published 5-year retrospective review of 2089 soft tissue filler injections,23 CaHA was the filler most commonly associated with complications. This series consisted of 1047 HA, 811 PLLA, and
Fig 2. A 51-year-old woman who developed prolonged erythema and edema from hyaluronic acid filler placed in the nasolabial folds.
231 CaHA injections. The complications arising from CaHA injections included cellulitis in 3 patients, submucosal nodule formation in 1 patient, and 1 case of partial thickness alar necrosis after nasolabial fold injections. Five patients treated with PLLA developed subcutaneous nodules. HA injections were least likely associated with complications. One patient treated with HA developed an inflammatory granuloma after lip augmentation.23
LASERS, LIGHT, AND RADIOFREQUENCY DEVICE SAFETY Key points d
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Many organizations regulate laser operations in the United States, but these regulations are not strictly enforced The most frequently used regulatory document that provides guidance for the safe use of lasers in medicine is the American National Standards Institute document Z136.3 Laser safety includes the use of protective eyewear, laser signage, control of surgical smoke, tissue splatter and plume, and attention to nonbeam and beam hazards Cutaneous injuries are the most frequent complications, with laser hair removal being the most common procedure resulting in litigation
In the United States, laser standards and regulations are not strictly enforced. In fact, only 12 states have laser regulations.38 The requirements entail registration of lasers and the licensing of individual operations and institution, but physician-used medical lasers are exempt from these regulations. The national organizations that regulate laser operations are the American National Standards Institute (ANSI), the Center for Devices and Radiological Health (CDRH) of the FDA, the Department of Labor’s Occupational Safety and Health Administration
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(OSHA), and the Council of Radiation Control Program Directors (CRCPD).38 The ANSI Z136.3 is a regulatory document on laser safety most frequently used in health care environments that provides guidance for the safe use of lasers in medicine. Standards are implied, but there is no requirement for adherence; compliance is voluntary unless specifically mandated by an institution or organization. In addition, OSHA does not have a comprehensive laser standard. The only construction standard states ‘‘employees whose occupation or assignment requires exposure to laser beams shall be furnished suitable laser safety goggles which will protect for the specific wavelength of the laser and be of the optical density adequate for the energy involved.’’ Studies have shown that 70% of all laser accidents to operators result from inappropriate or absent use of protective eyewear. Ocular complications have resulted from both direct and indirect exposure; laser energy can be reflected. Types of ocular injuries are wavelength specific. The degree of ocular damage is dependent on the laser irradiance, exposure time, and beam size.39 Therefore, laser-protective eyewear is a well-recognized precaution, and includes wraparound glasses and goggles, which are rated by optical density (OD) at various wavelengths. An OD of $4 at the particular wavelength of laser used is considered safe for dermatologic lasers. A common misconception among laser users is that laser safety consists of the use of protective eyewear and signage of laser use only. National audits have revealed many misconceptions with laser safety, noncompliance, unsafe practices, and potential medicolegal issues. For example, plume and tissue splatter are potential safety issues that may be overlooked. The Centers for Disease Control and Prevention, OSHA, and state regulations have recognized the hazards of surgical smoke and have developed recommendations for its control. Particulates as small as 0.12 m, which include bacteria, human papillomavirus/HIV, carbon, and live cellular particles have been identified in surgical smoke.40 Human papillomavirus has been cultured from plume generated by the CO2 laser treatment of warts. The use of smoke evacuators, gloves, masks, and filters are important precautions. Tissue splatter is another potential hazard that may occur with Qswitched lasers. Other types of nonbeam hazards include fire and electrical hazards associated with high-voltage lasers. It is important to always be aware of the surgical or room setting, and special care must be taken to avoid exposure of flammable objects or liquids and drapes to the laser beam. Cutaneous injuries are the most frequent complications and the most common cause for legal action
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Fig 3. A 65-year-old woman who underwent intense pulsed-light treatment that resulted in a scar on the right upper lip.
Fig 4. A 42-year-old woman with glabellar necrosis after the use of a hyaluronic acid filler.
in laser surgery. A recent study investigated legal claims between 1985 and 2012 related to cutaneous laser surgery; 174 laser-induced injury lawsuits were found.41 The most common procedure that resulted in litigation was laser hair removal (n = 63). This may be because laser hair removal is the most frequent laser procedure and not necessarily because it has a high complication rate. The second most commonly litigated procedure was rejuvenation (n = 43). This includes conventional CO2 resurfacing, which has fallen largely out of favor, ablative and nonablative fractional resurfacing, and intense pulsed-light treatments. Vascular and leg vein treatments represented 8% and 7.5% of lawsuits, respectively. The most common injuries included burns (47%), scars (38.8%), and pigmentation (23.5%). Four eye injuries and 2 deaths have been reported41 (Figs 3-6). Common errors in cutaneous injuries associated with laser and light devices include improper laser
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Fig 5. A 58-year-old woman who underwent ablative laser treatment and subsequently developed a candidal infection.
Fig 6. A 45-year-old woman with a depressed scar caused by a burn sustained by intense pulsed-light therapy.
selection. In selecting a laser/light device for a treatment, it is important to consider the target chromophore but also the skin type of the patient. In treating patients with dark skin types, the use of longer wavelengths or higher cutoff filters as well as longer pulse durations and lower fluences are recommended. Appropriate precooling, cooling during the procedure, and postcooling should also be considered to provide an extra measure of epidermal protection. In addition, a detailed disclosure of potential side effects protects not only the patient but also the provider. The risk of scarring is low with pigment-specific, vascular, and nonablative lasers. Resurfacing lasers, such as the erbium and CO2, carry the greatest risk of scarring because of dermal destruction and a higher risk of infection, which can ultimately lead to scarring. The advent of fractional lasers has minimized this complication. The CO2 laser is particularly hazardous because its wavelength in the far infrared and invisible spectrum is not visible; injuries and hazards may go unnoticed. The neodymium-doped yttrium aluminium garnet (Nd:YAG) laser should be approached with even greater caution, because it penetrates deeply because of its wavelength and is also invisible.
Fig 7. A 55-year-old woman who developed a coloboma caused by ocular injury secondary to the use of inappropriate safety eyewear.
There have been several reports of serious retinal injuries with Nd:YAG lasers42,43 (Fig 7). Radiofrequency energy has been used medically for years, but more recently has been applied cosmetically in tightening devices and in fractional ablative devices. These devices are billed as ‘‘sublative rejuvenation’’ in that they deliver energy focally to the dermis and spare the epidermis. This focused energy delivery preserves the epidermis and translates to fewer complications, especially in patients with darker skin types.44 Contraindications to radiofrequency devices include implantable medical devices, such as pacemakers and defibrillators, and active dermatologic conditions, including collagen vascular and autoimmune diseases. Device companies recommend avoiding treatment over areas of skin marked with tattoos and caution against use on areas of the body that may contain metal implants, hardware, and braces. In this era of cosmetic dermatology and diversity of laser operators, it is important to ensure that all staff handling and operating lasers are well trained and supervised to minimize the risk of injury.
COMPLICATIONS AND LEGAL ISSUES ARISING WITH COSMETIC EXTENDERS Key points d
d
Lawsuits involving laser devices are commonly due to non-physician operators, however the supervising physician is commonly the defendant. Proper training and supervision is essential
The original role of physician extenders was to expand primary care in underserved regions. The passage of the Balanced Budget Act in 1997 enabled independent billing and payment to NPs and PAs. Subsequently, the number and role of physician extenders in dermatology has expanded greatly.
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When mid-level providers are supervised by a physician, they bill at and are reimbursed 100% of the contracted Medicare rate. When billing independently, MLPs are reimbursed at 85% of the contracted rate. In a 2012 analysis of NP and PA billing there were over four million procedures billed independently by NPs and PAs, with over half of these representing dermatology codes.45 Expanding this analysis to cosmetic procedures, a study of legal action in laser surgery identified 174 cases between 1985 and 2012. Of these cases a non-physician laser operator performed 40%, and though the physician operated the laser in only 57.5% of these suits, they were named defendants in 73.8% of these cases. State laws that assign liability to the supervising physicians explain this disparity. In addition, many mid-level providers do not carry malpractice insurance and naming the insured physician as a defendant increases the likelihood of a successful payment in a lawsuit.41 In 2014, the same authors performed another analysis of litigation related to laser surgery. They found an increase in cases involving a nonphysician operator from 36.3% in 2008 to 77.8% in 2011. Laser hair removal was the most commonly litigated procedure. Interestingly, though nonphysicians perform only one-third of laser hair removal procedures, this group represented 85.7% of hair removal lawsuits. Of these, 64% were performed outside a traditional medical setting, indicating that supervision by a physician may ameliorate some of this risk.46,47 One of the most feared complications of laser surgery regards pigmented lesions and melanoma. There have been several reports of melanoma diagnoses relating to laser treatment, though it is unknown whether these cases are caused by laser energy, or, as is more commonly suggested, misdiagnosed as benign lesions prior to laser treatment. One report is of a patient who paid 10 Euro for treatment of pigmented lesions at a laser spa in Japan, and was later diagnosed with metastatic melanoma with a large focus at the site of laser treatment.48 Accurate diagnosis of pigmented lesions is challenging, even for seasoned dermatologists, and there are several case reports of patients who presented for laser removal of lesions that were caught and diagnosed as melanoma by dermatologists.49 These studies suggest that the judgment of a well-trained dermatologist is vital to patient safety prior to laser treatment of pigmented lesions. A German study conducted in 2013 investigated the most frequent errors resulting from the use of laser or IPL devices by unsupervised medical laypeople (tattooists, cosmetologists, etc). This
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survey identified 50 patients who reported complications. The most reported complications were pigmentation changes in 81% of patients, scarring in 25% of patients, textural changes in 14%, and inadequate treatment in 5% of patients.50 The sources of error included excessive energy application in 63% of cases, improper laser selection in 40%, inappropriate use of laser on skin type in 21% of cases, inadequate cooling in 7%, and inadequate information to patients in 5% of cases. In a field like dermatology, where vast numbers of procedures are performed, complications are inevitable. Physician extension is becoming more common in our field and as studies have demonstrated, physicians who supervise extenders are often held liable when complications arise. It is imperative that all laser operators be properly trained and closely supervised to protect the patient from injury, increase efficacy, and avoid legal pitfalls. REFERENCES 1. Tierney EP, Hanke CW. Recent trends in cosmetic and surgical procedure volumes in dermatologic surgery. Dermatol Surg. 2009;35:1324-1333. 2. Ahn CS, Davis SA, Dabade TS, Williford PM, Feldman SR. Cosmetic procedures performed in the United States: a 16-year analysis. Dermatol Surg. 2013;39:1351-1359. 3. American Society for Aesthetic Plastic Surgery. Statistics. Available from: http://www.surgery.org/media/statistics. Accessed November 16, 2014. 4. Korman JB, Jalian HR, Avram MM. Analysis of botulinum toxin products and litigation in the United States. Dermatol Surg. 2013;39:1587-1591. 5. Vartanian AJ, Dayan SH. Complications of botulinum toxin A use in facial rejuvenation. Facial Plast Surg Clin North Am. 2005;13:1-10. 6. Carruthers JA, Lowe NJ, Menter MA, et al. A multicenter,double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002; 46:840-849. 7. Matarasso SL, Matarasso A. Treatment guidelines for botulinum toxin type A for the periocular region and partial upper lip ptosis following injections to the lateral canthal rhytids. Plast Reconstr Surg. 2001;108:208-214. 8. Brin MF, Boodhoo TI, Pogoda JM, et al. Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. J Am Acad Dermatol. 2009;61:961-970. 9. Rubin MG, Dover JS, Glogau RG, Goldberg DJ, Goldman MP, Schlessinger J. The efficacy and safety of a new US botulinum toxin type A in the retreatment of glabellar lines following open-label treatment. J Drugs Dermatol. 2009;8: 439-444. 10. Kane MAC, Brandt F, Rohric RJ, et al. Evaluation of variable-dose treatment with a new US botulinum toxin type A (Dysport) for correction of moderate to severe glabellar lines: results from a phase 3, randomized, double-blind, placebo-controlled study. Plast Reconstr Surg. 2009;124:1619-1629.
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