Retrospective Analysis of US Litigations Involving Dermatologists From 2011 to 2022.

BACKGROUND: Physician malpractice lawsuits are climbing, and the reasons underlying litigation against dermatologists are unclear. OBJECTIVE: To determine the reasons patients pursue litigation against dermatologists or dermatology practices. MATERIALS AND METHODS: A retrospective analysis of all state and federal cases between 2011 and 2022 was performed after a query using "Dermatology" and "dermatologist" as search terms on 2 national legal data repositories. RESULTS: The authors identified a total of 48 (37 state and 11 federal) lawsuits in which a practicing dermatologist or dermatology group practice was the defendant. The most common reason for litigation was unexpected harm (26 cases, 54.2%), followed by diagnostic error (e.g. incorrect or delayed diagnoses) (16 cases, 33.3%). Six cases resulted from the dermatologist failing to communicate important information, such as medication side effects or obtaining informed consent. Male dermatologists were sued at a rate 3.1 times higher than female dermatologists. CONCLUSION: Although lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed diagnoses and ensure critical information is shared with patients to safeguard against easily avoidable litigation.

Nonablative Fractional Laser Treatment Is Associated With a Decreased Risk of Subsequent Facial Keratinocyte Carcinoma Development.

BACKGROUND: Keratinocyte carcinoma (KC) is the most common type of nonmelanoma skin cancer. Currently, prophylactic treatment options are limited. Nonablative fractional lasers (NAFL) have received the Food and Drug Administration approval for the treatment of actinic damage; however, their role in KC prophylaxis is not known. OBJECTIVE: The aim of this study is to determine whether NAFL treatment is associated with a decrease in subsequent facial KC development. MATERIALS AND METHODS: A retrospective cohort study of patients with a history of facial KC treated at the Massachusetts General Hospital Dermatology Laser and Cosmetic Center between 2005 and 2021 was conducted. RESULTS: Forty-three NAFL-treated patients with a history of facial KC and 52 matched control subjects were included in the study. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in control subjects (RR 0.52, p = .049). Control subjects developed new facial KC significantly sooner than NAFL-treated patients (p = .033). When controlling for age, gender, and skin type, control subjects were more likely to develop new facial KC than NAFL-treated patients (hazard ratio 2.65, p = .0169). CONCLUSION: NAFL treatment was associated with a decreased risk of subsequent facial KC development and may have a benefit for KC prophylaxis.

FDA MAUDE database reported adverse events on noninvasive body contouring, cellulite treatment, and muscle stimulation from 2015 to 2021.

OBJECTIVE: Noninvasive cosmetic procedures have continued to gain popularity, owing to their short, in-office treatments combined with little to no downtime. These procedures are also highly accessible, even offered at medical spas by nonphysician operators. The coronavirus disease 2019 (COVID-19) pandemic also saw heightened interest in all cosmetic procedures, presumably as social distancing and stay-at-home orders allotted time and space for postop recovery. As the market for these procedures expand, a thorough understanding of potential adverse events is critical for providers to better counsel their patients on risks and expectations when obtaining informed consent. MATERIALS AND METHODS: We employed the Food and Drug Administration (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm), which compiles medical device reports (MDRs) for suspected injuries from device use or malfunction, submitted by manufactures and operators. We focused our query on three main categories: noninvasive body contouring, cellulite treatments, and muscle stimulation therapies that utilize electromagnetic energy. The query was performed in February 2022 using a comprehensive list of product names and manufacturers. RESULTS: The initial search yielded 827 MDRs, which were individually reviewed for duplicate reports or insufficient data. Ultimately, 723 MDRs were analyzed (660 for noninvasive body contouring, 55 for cellulite treatment, and 8 for muscle stimulation). Paradoxical hyperplasia accounted for the majority of MDRs for noninvasive body contouring, while burns and scars were most common for muscle stimulation and cellulite treatments, respectively. Of the 7-year span we surveyed, 2021 accounted for 515 of the 723 total assessed MDRs (71.2%), the majority of which were from cryolipolysis procedures. CONCLUSION: The MAUDE database remains an essential tool to monitor potential adverse events of medical devices, including those utilized for noninvasive, cosmetic procedures. Insight from the MAUDE database can be clinically translated when discussing treatment options with patients, helping to optimize patient safety and satisfaction.

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.

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.

The Cutaneous Procedures Adverse Events Reporting (CAPER) Registry.

The CAPER Registry is a voluntary, national safety reporting program that gathers patients' adverse events encountered during dermatologic procedures. This registry is intended as an aid for practitioners, patients, industry, and government regulators, and aims to facilitate safety monitoring for the specialty by identifying resource, process, education, and other systemic gaps associated with adverse events, as well as any potential risk factors for adverse events. CAPER will provide new or corroborating information to help dermatologists improve clinical practices, improve safety and effectiveness, and treat and prevent adverse events. The data generated will also help industry partners and regulatory bodies prevent adverse events from going unnoticed.

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.

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.

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.

Predicting Negative Outcomes of Cryolipolysis in Patients With and Without Raynaud Disease.

BACKGROUND: Cryolipolysis is an effective means of noninvasive fat reduction. There are numerous relative contraindications to cryolipolysis including scars, hernias, and cold-related disorders such as Raynaud disease, because cryolipolysis has a theoretical risk of exacerbating these conditions. OBJECTIVE: To examine predictors of negative outcomes of cryolipolysis, especially as it pertains to safety of cryolipolysis in patients with Raynaud disease. MATERIALS AND METHODS: A retrospective review of patients who received consultation for cryolipolysis was conducted and analyzed. RESULTS: Patients with Raynaud disease did not experience any exacerbations of their underlying condition after cryolipolysis. Side effects in all patients, regardless of medical history, were mild, temporary, and not associated with any predisposing factors. CONCLUSION: Cryolipolysis seems to be safe in patients with mild-moderate Raynaud disease.

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.