Complications With Noninvasive Fat and Cellulite Reduction Devices: A Cross-sectional Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND AND OBJECTIVE: The US FDA mandates that manufacturers and device operators disclose medical device reports (MDRs) to monitor suspected injuries and device malfunctions by submitting information to the Manufacturer and User Facility Device Experience (MAUDE) database. Given the rapid growth in the noninvasive fat and cellulite reduction market, it is essential that physicians be aware of associated adverse events. STUDY DESIGN/MATERIALS AND METHODS: Using the MAUDE electronic database on the FDA website, the authors performed a comprehensive search of reported complications of noninvasive fat reduction and cellulite reduction devices from January 1, 2014 to January 1, 2020 at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Medical device reports that likely represented medical adverse events from device use were included. RESULTS: The search yielded 165 MDRs, a majority submitted by patients. There were 68 MDRs reported on cryolipolysis (41.2%), 34 MDRs reported on 1,060-nm laser lipolysis (20.6%), 19 MDRs reported on high-intensity focused ultrasound (11.5%), 17 MDRs reported on vacuum-assisted subcision (10.3%), 10 MDRs reported on 1,440-nm laser-assisted subcision (6.1%), 8 MDRs reported on monopolar radiofrequency (4.8%), 6 MDRs reported on focused ultrasound (3.6%), and 4 MDRs reported for a combination infrared light, bipolar radiofrequency energy, massage, and gentle suction treatment (2.4%). CONCLUSION: It can be safely presumed that most physicians do not regularly report adverse events to the FDA; however, the MAUDE database remains the largest global repository of adverse events reported for noninvasive body contouring devices, an area that has grown tremendously over the last few years. Some MDRs may be unrelated and/or unsubstantiated, and MDRs for any given device must be correlated to the total number of procedures performed. Nevertheless, the MAUDE database allows a glimpse into potential adverse events that can occur. The authors hope that physician awareness of this database and the adverse events it reports will help improve patient safety.

Causes of Injury and Litigation in Cutaneous Laser Surgery: An Update From 2012 to 2020.

OBJECTIVE: To identify common causes of injury and liability claims related to cutaneous laser surgery from 2012 to 2020. MATERIALS AND METHODS: Search of online national legal database of public legal documents regarding cutaneous laser surgery litigation. RESULTS: From 2012 to 2020, 69 cases of liability claims due to a cutaneous laser surgery device were identified. Of these, 49 (71%) involved a nonphysician operator (NPO); 12 incidents (17%) involved non-core physician operators performing the procedure; 6 cases (9%) involved a plastic surgeon operator; and 2 cases (3%) involved a dermatologist operator. Laser hair removal was most litigated (44 cases, 64%), followed by laser skin rejuvenation (20 cases, 30%). Thirty-six of 69 cases had a discernible outcome, 53% (n = 19) rendered judgements in favor of the plaintiff, with a mean indemnity payment of $320,975 (range, $1,665-$1.5 million). CONCLUSION: Previous work evaluating trends in laser surgery litigation from 1985 to 2012 identified increasing injury and legal action when performed by NPOs. Data from this study are consistent with these previous findings. Both studies demonstrate that NPOs account for most cases of legal action with an increasing proportion of cases being performed by NPOs. In this study, unsupervised NPOs comprise nearly three-quarters of laser surgery lawsuits, but the data may underestimate the frequency of injury and litigation caused by unsupervised NPOs.

Treatment of benign pigmented lesions using a novel Dermal Cooling System.

Benign pigmented lesions are among the most common dermatologic diagnoses that patients seek treatments for. Treatment modalities range from cryotherapy to light and laser-based technologies. These treatments have been shown to be effective, yet may lead to dyschromia or significant downtime. Therefore, we report the first clinical experience with a novel Dermal Cooling System that provides localized and controlled freezing to benign pigmented lesions. Twenty patients seeking treatment for benign pigmented lesions were treated with the Dermal Cooling System at the laser and cosmetic dermatology clinic at the University of California, San Diego. Photographs were captured at baseline and follow-up visits. Two blinded investigators reviewed and graded the photographs. Most patients experienced improvement after 1 month following the first treatment. Macular or slightly raised lesions responded best. Treatment side effects were transient, lasted a maximum of 3 days, and included erythema, swelling, itching, and darkening. There was no observed long-term dyschromia. The novel Dermal Cooling System shows promise in the treatment of flat to slightly raised benign pigmented lesions with little-to-no downtime. Further clinical experience is necessary to continue to optimize treatment parameters. Lasers Surg. Med. 51:59-61, 2019. © 2018 Wiley Periodicals, Inc.

Genitogluteal porokeratosis in an HIV-positive man: a case report and review of the literature on genital porokeratosis.

Genitogluteal porokeratosis is a disorder of keratinization that may present in men in their fourth decade of life. We describe a 52-year-old human immunodeficiency virus (HIV)-positive man with history of anal squamous cell carcinoma who developed verrucous lesions on the buttocks and genitals. The buttock lesions presented shortly after radiotherapy for anal carcinoma a decade prior, whereas the genital lesions presented three months prior in areas treated with injectable medication for erectile dysfunction. Skin biopsy revealed a cornoid lamella, leading to the diagnosis of genitogluteal porokeratosis. The buttock lesions were treated with shave excision and the genital lesions were treated with topical agents. Using the PubMed database, a literature search was performed with combinations of the following key words: acuminata, condyloma, cornoid lamella, genital, genitogluteal, HIV, penile, porokeratosis, verrucous, vulvar. The generated papers and their references were reviewed. To the best of our knowledge, we present the first reported case of genitogluteal porokeratosis in an HIV-positive man. Notably, these lesions developed in sites of prior radiation or injection. This condition should be included in the differential diagnosis of chronic lesions of the genitals and buttocks in patients with HIV and/or history of radiation treatment and/or trauma to the genitogluteal region.

Continuity of care in dermatology residency programs in the United States.

PURPOSE: As established by the AccreditationCouncil for Graduate Medical Education (ACGME),dermatology residents in the United States must participate in continuity clinic. This requirement may be achieved through multiple means, allowing for program variation. To better assess continuity clinic's role in resident learning, more data on this component of graduate medical education is needed. METHODS: An anonymous online survey was distributed via the American Board of Dermatology list serv to all U.S. dermatology residents. Continuity clinic organization, setting, frequency, and patient and preceptor characteristics were assessed; resident satisfaction and learning were compared. RESULTS: Of 231 responses, 7.8% reported continuity clinic daily, 77.1% weekly, 9.1% every other week, 3.0%monthly, 0.4% once every several months, and 2.2%only during certain blocks. Of the clinics reported,80.1% were "resident-run with attending" and 11.3%were attending-run. The rest were "resident-run with no attending" (0.9%), both resident and attending run(3.0%), or "other" (4.8%). Trainees in resident-run clinics (with attendings) reported greater continuity of care than those in attending-run clinics (p<0.001).Residents reported better teaching with attending presence during patient encounters than when attendings were present only if concerns were raised(p<0.01).

Treatment of Merkel cell carcinoma of the head and neck: a systematic review.

BACKGROUND: Merkel cell carcinoma (MCC) is a rare and aggressive neurocutaneous malignancy that frequently arises in sun-exposed areas of the head and neck. Standard therapy focuses on wide local excision (WLE) with adjuvant locoregional radiotherapy. However, treatment is often complicated by concerns for cosmesis and for preservation of the head and neck neurovasculature. OBJECTIVE: To explore treatment-related outcomes of the head and neck MCC. METHODS: A MEDLINE and Google Scholar search was performed for studies focusing on the head and neck MCC treatment. RESULTS: The search terms produced 100 articles. Seventeen studies met eligibility/screening criteria, yielding 868 patients. Three of the 6 relevant studies found a significant difference in disease-free survival (DFS) between surgery and surgery plus adjuvant radiation. Two studies found no difference in DFS or overall survival (OS) in patients receiving chemotherapy. Two studies found no difference in DFS between radiotherapy and surgery with adjuvant radiation. No difference in OS was found between WLE and Mohs surgery. CONCLUSION: In an uncomplicated head and neck MCC, treatment with surgery and adjuvant radiotherapy is effective in increasing survival and reducing recurrence. Radiotherapy alone may be appropriate for inoperable regions. Primary chemotherapy seems to have a limited role; however, few studies explored this treatment modality.

Acitretin for the management of generalized cutaneous lichen planus.

BACKGROUND: Lichen planus is an inflammatory disease that affects the skin, the oral mucosa, or both. Generalized cutaneous lichen planus may pose a therapeutic challenge for clinicians if the condition persists or flares after topical or systemic corticosteroid therapy. PURPOSE: Acitretin, a systemic retinoid, can be considered a potential second-line treatment for patients with generalized cutaneous lichen planus. Herein, we describe a postmenopausal woman with generalized cutaneous lichen planus who was successfully treated with acitretin. METHODS: A 58-year-old woman presented with generalized cutaneous lichen planus involving her upper and lower extremities as well as her lower back. After failing corticosteroid therapy, she was started on acitretin 20 mg/day, which was later increased to 30 mg/day. To review the literature on the use of acitretin in cutaneous lichen planus, we used the PubMed search engine and searched for the terms "acitretin" and "cutaneous lichen planus." RESULTS: Our patient had complete resolution of pruritus within one week of initiating acitretin 20 mg/day. After an increase in dose to 30 mg/day, the cutaneous lesions completely resolved over a 3-month period. There was no recurrence of disease as acitretin was tapered and discontinued. CONCLUSION: Generalized cutaneous lichen planus may pose a therapeutic challenge for the symptomatic relief of skin lesions. Topical and systemic corticosteroids are first-line treatments. In patients who fail corticosteroids, relapse after corticosteroid therapy, or have contraindications to corticosteroids, acitretin may be considered a potential second-line therapy.

Nonsurgical jawline rejuvenation using injectable fillers.

BACKGROUND: A well-defined jawline is a critical component in the perception of facial attractiveness in both men and women. Dermal fillers offer a nonsurgical, temporary method of correcting mild-to-moderate mandibular bone resorption. AIMS: The authors discuss pertinent aspects of anatomy, pathophysiology of aging, patient evaluation, gender considerations, injection technique, and complications in jawline augmentation using injectable fillers. METHODS: A brief review of the literature surrounding jawline augmentation using injectable fillers in both men and women, as well as the authors' experience in this area, is provided. RESULTS: Nonsurgical jawline augmentation using injectable fillers can be performed effectively and safely with adequate background knowledge of the regional anatomy and appropriate patient selection. The authors discuss both injection techniques in the published literature and their own approach. Potential complications are also reviewed. CONCLUSION: Jawline rejuvenation is a key component to global facial aesthetic rejuvenation. Therefore, it is important for physicians to understand how to safely and effectively perform nonsurgical jawline rejuvenation using injectable fillers.

Poland's syndrome: a concise review of the clinical features highlighting associated dermatologic manifestations.

Poland's syndrome is a rare congenital condition characterized by absence of the pectoralis major muscle and a wide spectrum of associated ipsilateral chest wall and upper extremity anomalies. Associated dermatologic anomalies classically include pectoral and axillary alopecia, anhidrosis due to the absence of sweat glands, and deficiency in subcutaneous fat. Functional limitations are minimal, and thus surgical correction is primarily indicated for aesthetic purposes. Chest wall reconstruction typically involves transposition of a latissimus dorsi myocutaneous flap with or without a temporary subcutaneous tissue expander prior to surgical reconstruction. Using the PubMed database, a literature review was done on Poland's syndrome. We summarize the key features of Poland's syndrome, including the epidemiology, clinical presentation, pathogenesis, and management, and highlight the dermatologic associations reported in the literature.

Race and competing mortality in advanced head and neck cancer.

OBJECTIVES: Black patients with head and neck cancer (HNC) have poorer survival and disease control compared to non-black patients, but disparities in death from non-cancer causes (i.e., competing mortality) are less well-studied. MATERIALS AND METHODS: We conducted an analysis of 538 patients (169 black, 369 non-black) with stage III-IV HNC treated on one of six multi-institutional protocols between 1993 and 2004 involving multi-agent chemoradiotherapy with or without surgery. Competing mortality was defined as death due to intercurrent comorbid disease, treatment-related morbidity, or unknown cause in the absence of disease recurrence, progression, or second malignancy. Cox proportional hazards and competing risks regression were used to estimate the effect of black race on competing mortality. RESULTS: Black race was associated with increased rates of comorbidity, smoking, heavy alcohol use, advanced tumor stage, and poorer performance status (p<.001 for all). Compared to non-black patients, black HNC patients had a higher 5 year cumulative incidence of disease progression (31.4%; 95% CI, 24.4-38.5% vs 23.4%; 95% CI, 19.1-28.1%) and competing mortality (28.1%; 95% CI, 21.2-35.3% vs 14.5%; 95% CI, 11.0-18.5%). When adjusting for age, male sex, body mass index, distance traveled, smoking and alcohol use, performance status, comorbidity, and tumor stage, the black race was associated with death from comorbid disease (Cox hazard ratio 2.13; 95% CI, 1.06-4.28, p=0.033). CONCLUSIONS: Black patients with advanced HNC are at increased risk of both disease progression and death from competing non-cancer mortality, particularly death from comorbid disease. Improved strategies to manage comorbid disease may increase the benefit of treatment intensification in black patients.

MicroRNA-21 targets the vitamin D-dependent antimicrobial pathway in leprosy.

Leprosy provides a model to investigate mechanisms of immune regulation in humans, given that the disease forms a spectrum of clinical presentations that correlate with host immune responses. Here we identified 13 miRNAs that were differentially expressed in the lesions of subjects with progressive lepromatous (L-lep) versus the self-limited tuberculoid (T-lep) disease. Bioinformatic analysis revealed a significant enrichment of L-lep-specific miRNAs that preferentially target key immune genes downregulated in L-lep versus T-lep lesions. The most differentially expressed miRNA in L-lep lesions, hsa-mir-21, was upregulated in Mycobacterium leprae-infected monocytes. By directly downregulating Toll-like receptor 2/1 heterodimer (TLR2/1)-induced CYP27B1 and IL1B expression as well as indirectly upregulating interleukin-10 (IL-10), hsa-mir-21 inhibited expression of the genes encoding two vitamin D-dependent antimicrobial peptides, CAMP and DEFB4A. Conversely, knockdown of hsa-mir-21 in M. leprae-infected monocytes enhanced expression of CAMP and DEFB4A and restored TLR2/1-mediated antimicrobial activity against M. leprae. Therefore, the ability of M. leprae to upregulate hsa-mir-21 targets multiple genes associated with the immunologically localized disease form, providing an effective mechanism to escape from the vitamin D-dependent antimicrobial pathway.

Convergence of IL-1beta and VDR activation pathways in human TLR2/1-induced antimicrobial responses.

Antimicrobial effector mechanisms are central to the function of the innate immune response in host defense against microbial pathogens. In humans, activation of Toll-like receptor 2/1 (TLR2/1) on monocytes induces a vitamin D dependent antimicrobial activity against intracellular mycobacteria. Here, we report that TLR activation of monocytes triggers induction of the defensin beta 4 gene (DEFB4), requiring convergence of the IL-1beta and vitamin D receptor (VDR) pathways. TLR2/1 activation triggered IL-1beta activity, involving the upregulation of both IL-1beta and IL-1 receptor, and downregulation of the IL-1 receptor antagonist. TLR2/1L induction of IL-1beta was required for upregulation of DEFB4, but not cathelicidin, whereas VDR activation was required for expression of both antimicrobial genes. The differential requirements for induction of DEFB4 and cathelicidin were reflected by differences in their respective promoter regions; the DEFB4 promoter had one vitamin D response element (VDRE) and two NF-kappaB sites, whereas the cathelicidin promoter had three VDREs and no NF-kappaB sites. Transfection of NF-kappaB into primary monocytes synergized with 1,25D3 in the induction of DEFB4 expression. Knockdown of either DEFB4 or cathelicidin in primary monocytes resulted in the loss of TLR2/1-mediated antimicrobial activity against intracellular mycobacteria. Therefore, these data identify a novel mechanism of host defense requiring the induction of IL-1beta in synergy with vitamin D activation, for the TLR-induced antimicrobial pathway against an intracellular pathogen.