Multifunctional patch for use during laser procedures: Optimization and feasibility testing.

OBJECTIVE: The objective of this study was to develop a patch that can be placed on the skin during laser hair removal and similar procedures, that serves to reduce the laser-induced plume, provides a ready indicator to the laser surgeon of where pulses have been applied, and cools the skin. METHODS: A two-layer patch composed of a cooling hydrogel layer and an indicator layer was optimized and tested ex vivo. The hydrogel was composed of gelatin and glycerin. The concentration of each hydrogel component was optimized to determine the minimum gelatin concentration at which the gel can be handled without breakage and the minimum glycerin concentration that allows for storage at -20°C without crystallization. This is the temperature of a conventional freezer; application of the cooling layer to the skin would help prevent epidermal injury. The indicator layer was composed of a plastic transparency sheet with small dots of black ink particles printed onto its surface. Transparency sheets were printed from templates created in Adobe Photoshop in which dots are at a specified density; additionally, Photoshop's opacity function was used to vary the opacity of the dots themselves. Performance was tested using a 755 nm alexandrite laser used clinically for hair removal by measuring light transmission through the patch and observing the sheet's ability to indicate the location of laser exposures. The transmittance of patch components across a broad spectrum was also measured using a microplate reader. Several adhesives, including a two-part epoxy, silicone rubber, and cyanoacrylate, were tested for their ability to adhere to the hydrogel and indicator layers. Assembled patches composed of the hydrogel layer, indicator layer, and adhesive were tested ex vivo for their ability to mitigate the laser hair removal plume by measuring airborne particulate matter during simulated laser hair removal. RESULTS: A minimum gelatin concentration of 5% was found to enable easy handling of the hydrogel. A mixture composed of 60% water and 40% glycerin by volume consistently allowed storage at -20°C without crystallization. For the indicator layer, ink particle density of 50% and opacity of 5% provided a readily apparent indicator function following laser exposure. Transmission through the sheet measured during alexandrite laser exposures was 90% and was not different than transmission through the sheet alone without ink particles. A cyanoacrylate glue was found to adhere to the hydrogel and indicator layers, while the other adhesives proved inadequate. Measurements using a microplate reader confirmed that the reflection from the transparency sheet itself was the primary contributor to energy loss. In experiments exposing hair clippings to the laser with and without the patch, the patch allowed an increase of 5000 particles/cc relative to baseline particles in the environmental air, while the absence of the patch allowed an increase of 150,000 particles/cc relative to baseline, indicating that the patch decreased particle debris in the plume by 97%. CONCLUSIONS: A two-layer patch composed of hydrogel and plastic indicator layer with cyanoacrylate adhesive can be stored in a conventional freezer without crystallization, then placed over an area of skin to be treated for laser hair removal. The patch clearly indicates the pattern and sites of laser exposure, while blocking almost all (97%) of particles in the laser-induced plume. Future work will include safety validation and in vivo testing of efficacy, as these were not undertaken in this study.

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.

Social Media in Aesthetic Dermatology: Analysis of the Users Behind the Top Filler Posts.

BACKGROUND: Within the aesthetic realm, the influence of social media is quite prominent, with a growing percentage of patients using this technology to seek out health care recommendations and education. OBJECTIVE: To ascertain the most accurate representation of what our patients may encounter on social media, we sought to characterize the top posts on the most popular visually-based social media platform (Instagram). MATERIALS AND METHODS: We queried Instagram with variations of hashtags related to filler to determine which hashtags had the greatest number of posts associated with them. We then reviewed the top 100 posts associated with the top 9 hashtags, making note of whether the poster was a physician or nonphysician and whether an off-label procedure was performed or discussed. RESULTS: Most (85.6%) of the 900 reviewed posts were written by nonphysicians, and most (84.6%) of the posts focused on off-label procedures were posted by nonphysicians. Among the physician posters, the most common specialties were Plastic Surgery and Family Medicine, followed by Dermatology. CONCLUSION: At a time when patients are increasingly turning to social media for health care recommendations and education, most "top" content related to soft tissue augmentation is being provided by nonphysicians, many of whom are performing off-label procedures.

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.

Litigation Arising From Minimally Invasive Cosmetic Procedures: A Review of the Literature.

BACKGROUND: Minimally invasive cosmetic procedures are on the rise. To meet this rising demand, increasing numbers of physicians and nonphysicians are performing these procedures. Understanding malpractice trends and reasons for litigation in cosmetic medicine is important to establish safeguards for patient care and minimize liability. OBJECTIVE: Perform a comprehensive review of the literature on litigation associated with minimally invasive cosmetic procedures and discuss strategies to avoid facing a lawsuit. MATERIALS AND METHODS: The authors searched PubMed databases using a variety of keywords to identify studies of lawsuits arising from minimally invasive cosmetic procedures through December 2020. RESULTS: A total of 12 studies of litigation meeting inclusion criteria were identified: botulinum toxin (1), soft tissue fillers (3), lasers (5), body contouring/liposuction (1), chemical peels/dermabrasion (1), and sclerotherapy (1). Principle factors associated with litigation included negligence, lack of informed consent, vicarious liability for action of delegates, lack of communication, poor cosmetic result, failure to inform of risks, inappropriate treatment or dose, and failure to recognize or treat injury. CONCLUSION: Understanding malpractice trends and reasons for litigation in minimally invasive cosmetic procedures can strengthen the patient-provider relationship, establish safeguards for patient care, and may minimize future risk of a lawsuit.

Gaseous and Particulate Content of Laser Tattoo Removal Plume.

BACKGROUND: There is increasing awareness of the potential hazards of surgical plumes. The plume associated with laser tattoo removal remains uncharacterized. OBJECTIVE: To determine the gaseous, particulate, and microbiological content of the laser tattoo removal plume. MATERIALS AND METHODS: Air sampling was performed during laser tattoo removal from pig skin and from patients. Measurement of metals, volatile organic compounds (VOCs), carbon monoxide (CO), hydrogen sulfide (HS), and ultrafine particulates (UPs) as well as bacterial 16S ribosomal DNA sequencing were performed. RESULTS: Metals were identified in the plume from both pig and human skin. Volatile organic compounds were found at similar levels within and outside the treatment room. Several bacterial phyla were detected in the treatment room, but not outside. High levels of UPs were measured throughout the treatment room during tattoo removal from pig skin. Ultrafine particulates were detected at low levels in the room periphery during tattoo removal from human skin, but at higher levels in the immediate treatment zone. HS and CO were not detected. CONCLUSION: Metals, VOCs, HS, and CO were found at levels below applicable occupational exposure limits. The presence of bacteria is of uncertain significance, but may be hazardous. High levels of UPs require further investigation.

Aesthetic Office Disaster Preparedness and Response Plan.

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.

The Evolving Story of Laser Therapeutics for Basal Cell Carcinoma.

BACKGROUND: The increasing burden from basal cell carcinoma (BCC) has stimulated the development of alternative treatments for these tumors. OBJECTIVE: This review focuses on upcoming laser treatments for BCC and highlights the limitations of these therapies. METHODS: A PUBMED search was conducted for articles on laser therapy of BCC. Key studies involving lasers to treat BCC were reviewed. Novel approaches to BCC are also described. RESULTS: Vascular-specific laser therapy has increasingly been studied as an addition in the therapeutic armamentarium of BCC. Although these studies demonstrate efficacy for nonaggressive BCC, optimization of this technique is ongoing to minimize scarring. A more targeted approach to the treatment of BCC, such as immunized photothermal therapy or laser-assisted chemotherapeutic delivery, may result in less scarring, while maintaining efficacy similar to that of lasers targeting tumor vasculature. CONCLUSION: Vascular-specific laser therapies show promise in treating low-risk BCC; however, scarring is not an uncommon adverse event. Although only animal studies have been performed to date, laser-activated gold nanoparticle therapy and laser-assisted drug delivery of vismodegib are potential therapies that theoretically confer a more selective approach. Laser modalities demonstrate promise in the treatment of nonaggressive BCC, although long-term studies have yet to be published.

Analysis of U.S. Food and Drug Administration Data on Soft-Tissue Filler Complications.

BACKGROUND: With the rising popularity of dermal fillers, the number of complications associated with fillers has increased. OBJECTIVE: To identify and review reports of adverse events involving cosmetic injectable soft-tissue fillers from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from June 1993 to August 2014. MATERIALS AND METHODS: The authors conducted a search of adverse events within the U.S. Food and Drug Administration database that involved injectable dermal fillers for soft-tissue augmentation from June 1993 to August 2014. Search terms included generic and trade names of commercially available soft-tissue fillers. RESULTS: Three thousand seven hundred eighty-two complications involving dermal fillers were identified in the MAUDE database. Forty-four percent of complications implicated hyaluronic acid fillers, 40% involved poly-L-lactic acid fillers, 15% complications included calcium hydroxylapatite fillers, and <1% complications arose from polymethylmethacrylate fillers. Common adverse events included lumps, infection, allergic reaction, ischemia, and swelling. Rare events included trigger of autoimmune reactions, visual disturbances, and stroke. CONCLUSION: Although complications with dermal fillers are infrequent in comparison with the growing number of filler procedures being performed in the United States every year, this study underscores the importance of appropriate skill and training when administering dermal fillers. Physicians using injectable dermal fillers should be trained to recognize potential complications and know how to appropriately manage them.

Outcomes of long-pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma: A retrospective review.

BACKGROUND AND OBJECTIVE: Recent prospective trials have supported treatment of nonfacial BCC with long-pulsed 1064 nm Nd:YAG laser based on short-term histologic clearance rates. Studies have yet to identify the long-term clinical clearance rates of this specific laser therapy for BCC. STUDY DESIGN/MATERIAL AND METHODS: This is a retrospective review of BCC treated with long-pulsed 1064 nm Nd:YAG laser, which have been clinically monitored for at least 6 months, to assess for recurrence and cosmetic outcomes of the treated area. RESULTS: 16 BCC lesions (11 subjects) treated with 1064 nm Nd:YAG laser were enrolled. Our analysis revealed 100% clearance rate in all subjects (16 of 16 BCC) treated with long-pulsed Nd:YAG laser based on mean follow-up of 9 months (range 6-15 months). Minimal scarring and no long-term adverse events were noted. CONCLUSIONS: This study supports the use of 1064 nm Nd:YAG laser as a therapeutic modality for BCC based on the absence of clinical recurrence upon a mean follow-up of 9 months. As studies progress, we are beginning to observe a potential role for laser as an alternative to patients who refuse surgery, have multiple co-morbidities, or decline non-surgical therapies. Laser treatment with 1064 nm Nd:YAG is an evolving, promising story that we continue to investigate to optimize parameters. Lasers Surg. Med. 51:34-39, 2019. © 2018 Wiley Periodicals, Inc.

Lasers and energy-based devices marketed for vaginal rejuvenation: A cross-sectional analysis of the MAUDE database.

INTRODUCTION: The FDA issued a statement on July 30, 2018, expressing concern over the marketing of lasers and energy-based devices to promote "vaginal rejuvenation." The FDA stated that there is insufficient data to recommend this modality for optimization of sexual function and alleviation of genitourinary syndrome of menopause (GSM)-related symptoms in postmenopausal or postpartum women. This analysis aims to characterize the mandatory and voluntary reports concerning laser and energy-based procedures marketed for vaginal rejuvenation. METHODS: Cross-sectional analysis of the FDA database, Manufacturer and User Facility Device Experience (MAUDE), for events related to laser and energy-based devices for vaginal rejuvenation. RESULTS: Between October 2015 and January 2019, 45 distinct events describing 46 patients were recorded and reviewed. The most commonly reported adverse event related to the procedure was pain (vulvar, bladder, urethral, or unspecified) (n = 19). The majority of patients sought medical care for their injuries, which included evaluation by urgent care, urology, gynecology, neurology, gastroenterology, pelvic floor therapy, primary care providers, and the device operator. Thirty-three patients indicated chronicity of their injury, which included long-term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, aggravation of lichen sclerosis, and disfigurement. CONCLUSIONS: A variety of adverse events associated with the use of laser and energy-based devices for "vaginal rejuvenation" was reported to the MAUDE database. Although the circumstances surrounding these events were unclear, these reports signify the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices for optimization of sexual function and treatment of GSM-related symptoms. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Lidocaine-induced potentiation of thermal damage in skin and carcinoma cells.

OBJECTIVE: Lidocaine acts as a local anesthetic by blocking transmembrane sodium channel permeability, but also induces the synthesis of heat shock proteins and sensitizes cells to hyperthermia. A previous study reported two cases of deep focal skin ulceration at points corresponding to depot local lidocaine injection sites after treatment with non-ablative fractional resurfacing and it was hypothesized that lidocaine had focally sensitized keratinocytes to the thermal damage of laser treatment. The objective of this study was to investigate whether lidocaine potentiates hyperthermia damage to both normal and cancerous skin cells using an in vitro model. METHODS: Normal skin cell lines (fibroblasts, keratinocytes), skin cancer cell lines (melanoma, basal cell carcinoma), and a mucosal cancer cell line (cervical carcinoma) were exposed to various concentrations of lidocaine (0-0.3%) with or without hyperthermia (37°C, 42°C). RESULTS: Compared to normal skin cells, we demonstrate that cancer cell lines show significantly increased cell toxicity when a moderate temperature (42°C) and low lidocaine concentrations (0.1-0.2%) are combined. The toxicity directly correlates with a higher percentage of cells in S-phase (28-57%) in the cancer cell lines compared to normal skin cell lines (13-19%; R-square 0.6752). CONCLUSION: These results suggest that lidocaine potentiates thermal sensitivity of cell cycle active skin cells. The direct correlation between cell toxicity and S-phase cells could be harnessed to selectively treat skin and mucosal cancer cells while sparing the surrounding normal tissue. Additional research pre-clinically and clinically using several different heat sources (e.g., lasers, ultrasound, etc.) and lidocaine concentrations is needed to confirm and optimize these results. Lidocaine-enhanced hyperthermia may provide a non-invasive, alterative treatment option for highly proliferating, superficial skin, and mucosal lesions such as cancer or warts. Lasers Surg. Med. 51:88-94, 2019. © 2018 Wiley Periodicals, Inc.

Laws and regulations of laser operation in the United States.

The laws and regulations governing laser operation in the United States are vague, complex, and vary state-to-state. The objective of this study is to present an overview of the laws and regulations of laser operation in each of the 50 states. We performed an extensive online search of the law in each of the 50 states by examining multiple state cosmetology boards, state legislative boards, state nursing boards, and state medical boards. Laser regulations are best divided into three categories: delegation, supervision, and operation. Our findings demonstrate the complicated nature of the regulations covering this issue and identify a lack of regulation in numerous states. Lasers Surg. Med. 50:272-279, 2018. © 2018 Wiley Periodicals, Inc.

An expanded study of long-pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma.

BACKGROUND AND OBJECTIVE: Basal cell carcinoma (BCC) is an indolent form of skin cancer that is rarely life threatening, but can cause significant cosmetic and functional morbidity. Surgical treatments often result in disfiguring scars, while topical therapies frequently result in recurrence. The need for a more effective nonsurgical alternative has led to the investigation of laser treatment of BCC. We have previously conducted a pilot study which showed 100% histologic clearance at high fluences. Treatments were well tolerated with no significant adverse events. The objective of this larger study was to confirm preliminary results that the 1064 nm Nd:YAG laser is a safe and effective method for treating non-facial BCC. DESIGN: This is an IRB-approved, prospective, multi-center study evaluating the safety and efficacy of the 1064 nm Nd:YAG laser for the treatment of BCC on the trunk and extremities. Thirty-three subjects seeking treatment for biopsy-proven BCC that did not meet the criteria for Mohs surgery were recruited. Subjects on current anticoagulation therapy, or with a history of immunosuppression were excluded. Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC. Standardized photographs and adverse assessments were taken at the baseline visit, immediately after laser treatment and on the day of excision. RESULTS: Thirty-one subjects completed the study. BCC tumors had a 90% (28 of 31 BCC tumors) histologic clearance rate after one treatment with the long-pulsed 1064 nm Nd:YAG laser. Treatments were generally well tolerated without any anesthesia. Immediate side effects included edema and erythema. At 1-month follow-up, some patients had residual crusting. No significant adverse events occurred. CONCLUSION: The 1064 nm long-pulsed Nd:YAG laser is an alternative for treating non-facial BCC for those that are poor surgical candidates. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.

Immediate skin responses to laser and light treatments: Warning endpoints: How to avoid side effects.

Lasers are versatile, commonly used treatment tools in dermatology. While it is tempting to follow manufacturer's guidelines or other "recipes" for laser treatment, this approach alone can be a recipe for disaster. Specific and immediate skin responses or endpoints exist and are clinically useful because they correlate with underlying mechanisms that are either desirable (ie, therapeutic), undesirable (ie, warning signs of injury or side effects), or incidental. The observation of clinical endpoints is a safe and reliable guide for appropriate treatment. This article presents the warning endpoints during specific dermatologic laser treatments, and the accompanying article presents the therapeutic endpoints, their underlying mechanisms, and the utility of these endpoints.

Immediate skin responses to laser and light treatments: Therapeutic endpoints: How to obtain efficacy.

Clinical endpoints are immediate or early tissue reactions that occur during laser treatment. They can guide the laser surgeon in delivering safe and effective laser treatment. Some endpoints act as warning signs of injury to the skin; others can indicate a therapeutic response. The first article in this series reviewed undesirable and warning endpoints, and this article focuses on desirable and therapeutic endpoints and their underlying mechanisms in laser surgery. We will also review treatments without clinical endpoints.