Legal analysis of South Korean cosmetic filler litigations for safer medical practices.

Cosmetic filler injections have gained popularity in recent years, but the rise in complications has led to an increase in legal disputes. This study analyzes civil court rulings related to cosmetic filler injection lawsuits in South Korea from 2007 to 2023. A retrospective case analysis was performed using a systematic database search, and a mixed-methods approach was employed for data analysis. The study examined 27 cases, revealing a high rate of liability findings against medical practitioners. Skin necrosis and blindness were the most common complications, and intravascular filler injection was recognized as negligence. Violation of informed consent was found in most cases, with mean compensation awards of ￦193,019,107 KRW ($142,831 USD) for first instance cases and ￦81,845,052 KRW ($60,564 USD) for second instance cases. The findings emphasize the importance of practitioner awareness, adherence to precautionary measures, and proactive prevention and management of complications. Collaboration among stakeholders is crucial for developing strategies that prioritize patient safety and minimize legal disputes in the aesthetic medicine industry. This study provides valuable insights for enhancing medical practices and safeguarding patient well-being in the field of cosmetic filler injections.

Epidemiological case-control study on contact sensitisation in female foot care specialists with occupational contact dermatitis: Patch test data of the Information Network of Departments of Dermatology (IVDK), 2008 to 2022.

BACKGROUND: Mainly women work as foot care specialists (FCS). They are at risk to develop occupational dermatitis (OD). OBJECTIVES: The objective of this study is to describe the contact sensitisation pattern of female FCS with OD. METHODS: In a retrospective study, patch test and clinical data collected by the Network of Departments of Dermatology (IVDK) from 2008 to 2022 were analysed. Data of 116 female FCS with OD were compared with data of 13 930 female patients with OD working in other professions and 78 612 female patients without OD. RESULTS: Hand dermatitis (93.1%) was significantly more common and face dermatitis (0.9%) significantly less common in female FCS with OD compared to other female patients with or without OD. Frequent suspected allergen sources were disinfectants, gloves, leave-on and nail cosmetics. Occlusion and wetness were important co-factors. The most common diagnoses were irritant contact dermatitis (26.7%) and allergic contact dermatitis (21.6%). No sensitisation to any of the baseline series allergens was significantly more frequent in female FCS with OD than in the two control groups. However, sensitisations to allergens which FCS are abundantly exposed to, including fragrances, preservatives, rubber ingredients and disinfectants, were most common. CONCLUSIONS: FCS should be aware of the OD risk and prevention should be promoted.

Are "clean" products safe for children? An analysis of contact allergens in "clean" children's products from a popular retailer.

BACKGROUND: Considering consumer trends toward the use of "clean" personal care products and increasing recognition of childhood allergic contact dermatitis, we sought to characterize the allergen profile of such children's products. METHODS: Ingredients of baby washes/shampoos, bubble baths, and moisturizers identified using the "Clean Baby" filter on Target®'s online marketplace were analyzed for relevant pediatric contact allergens. RESULTS: Product compositions declared fragrance in 82% of products, Compositae in 46%, cocamidopropyl betaine in 45%, glucosides in 37%, propylene glycol in 12%, lanolin in 1%, and no allergens in 9%-methylisothiazolinone and formaldehyde were not found. CONCLUSION: Children are greatly impacted by atopic dermatitis and skin barrier dysfunction, which underscores a need for greater public awareness of sensitizing and irritating ingredients, particularly regarding pediatric personal care products.

Clinical Safety Profile of TrichoConcept™, a Line of Cosmetic Vehicles for Personalized Treatment of Alopecia.

Alopecia is a chronic dermatological disorder that affects patients worldwide, with a significant impact on quality of life, self-esteem, and psychological wellbeing. However, commercially available options for alopecia treatment are still limited. Considering that topical formulations have a long-term use therapeutic profile, the safety of their ingredients should be closely evaluated to avoid potentially irritant substances. Alternative active ingredients with different mechanisms of action, as well as adequate vehicles, might increase patients' adherence leading to better clinical outcomes. The purpose of this study was to examine the irritation, skin sensitization, photoallergy, and phototoxicity potential of a line of ready-to-use vehicles for producing topical therapies for alopecia treatments, TrichoConcept™. Subjects were selected and randomly assigned to compare the patch test with the study products or to the control solution (sterile 0.9% NaCl solution). No clinical signs of irritation, sensitization, photoallergy or phototoxicity were reported. From the results of this study, it is suggested that the investigated products can be considered safe under the evaluated conditions, and the claims "dermatologically tested", "clinically tested", and "nonirritant" can be supported.

Occurrence of alkyl glucosides in rinse-off cosmetics marketed as hypoallergenic or for sensitive skin.

Rinse-off cosmetic products, primarily shampoos, are frequently implicated in the onset of allergic contact dermatitis (ACD) caused by alkyl glucosides (AGs). AGs are increasingly popular surfactants and known contact allergens. Glucoside-induced ACD was most frequently observed with shampoos and skin-cleansing products in both consumer and occupational settings. Thereby, studies have shown that atopic individuals are the most susceptible to ACD. Also, several investigations have indicated that individuals with sensitive skin might be more prone to skin allergies. This is why the presence of AGs was investigated in shampoos and body cleansers marketed as hypoallergenic or for sensitive skin. For this purpose, the website of Amazon.com was surveyed. Four groups of cosmetics were obtained by using the following keywords: "hypoallergenic shampoo for adults," "sensitive skin shampoo for adults," "hypoallergenic body cleanser for adults," and "sensitive skin body cleanser for adults." The first 30 best-selling cosmetics in each group were investigated for the presence of AGs, by analyzing the product information pages. The results showed that as much as 56.7% of hypoallergenic shampoos contained AGs, as ingredients, whereas the percentage was somewhat lower for other product categories. Even though decyl and lauryl glucoside were nearly ubiquitously used AGs in cosmetics over the past decade, the most commonly present AG in our analysis was coco-glucoside. The results of this study indicated a necessity to include coco-glucoside in the baseline series of patch testing allergens. Industry, regulators, and healthcare providers should be made aware of the frequent presence of AGs in rinse-off cosmetic products marketed as hypoallergenic or for sensitive skin to ensure the safety and well-being of consumers and patients.

Market analysis of the presence of endocrine disrupting chemicals in cosmetic products intended for oncological patients and other vulnerable groups.

There is growing concern about the presence of endocrine disrupting chemicals (EDCs) in cosmetics. We aimed to identify the main cosmetic ingredients with suspected endocrine-disrupting properties, and analyse their presence in current marketed products. Particular attention was given to products intended for susceptible (due to physiological status) and vulnerable (due to specific pathologies) groups with a view to informing cosmetologists and related health professionals of the scientific basis and current status of any concerns. Suspected EDCs used as cosmetic ingredients, included in lists published by regulatory agencies, were documented and investigated by weight of evidence analysis based on endocrine-related toxicity studies. In total, 49 suspected EDCs were identified from a sample of over a thousand cosmetic products marketed in the European Union. Suspected EDCs were found in approximately one third of products, with a similar frequency in products intended for susceptible and vulnerable groups. Avobenzone (CAS number:70356-09-1), octisalate (CAS number: 118-60-5), and butylated hydroxytoluene (CAS number: 128-37-0) were mostly commonly identified. The presence of EDCs was particularly high for sun care cosmetic products. Our results highlight potentially significant exposure through cosmetics to substances currently studied by regulatory institutions as suspected endocrine disrupters. EDCs are not yet universally regulated, and informing health professionals and educating the population as a precaution are options to reduce individual exposure levels, especially in vulnerable and susceptible groups. Special recommendations are needed for products intended for oncological patients.

Questionnaire-Based Study of 392 Women in Abbottabad, Pakistan, to Evaluate the Types of Cosmetic Products Purchased Between December 2018 and March 2019 and Their Associated Adverse Events.

BACKGROUND Cosmetics are applied topically to enhance appearance and are commonly used by women of all ages. Cosmetics contain many chemical agents, but the incidence of adverse reactions is low, possibly due to underreporting. This questionnaire-based study included 392 women to evaluate information on the types of cosmetics purchased between December 2018 and March 2019, their use by the women surveyed, and their associated adverse events. MATERIAL AND METHODS A cross-sectional study was conducted among 392 women in Abbottabad, Pakistan, using a pre-structured and validated questionnaire to evaluate information on the types of cosmetics, their use, and their associated adverse events. Part 1 of the study collected information about demographics. Part 2 contained a total of 11 items, and collected the frequency of use of cosmetic on skin and hair care products. Part 3 consisted of 4 items and collected information about problems encountered due to the use of cosmetics. RESULTS In the winter season, 47.7% (n=187) of women preferred chemical-based cosmetic products, while 30.9% (n=121) preferred Ayurvedic products. Among commonly used cosmetic products, 26.9% (n=106) of women used foundations. The most frequently used skin care product was face wash 39.5% (n=155). The most prevalent adverse events related to cosmetics were pimples (19.9%, n=78), redness (17.6%, n=69), and eye discomfort (15.8%, n=62). Furthermore, 51.3% (n=201) strongly agreed that cosmetics aid in getting a whiter complexion. CONCLUSIONS The survey concluded that most women preferred cosmetics with a chemical base, which are associated with rashes, redness, and acne. It is important to encourage cosmetovigilance and awareness campaigns among cosmetic product sellers and users.

Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation.

INTRODUCTION: Medical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound-specific restrictions when used in MDs. OBJECTIVE: This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009. METHOD: Sixty-nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods to identify and quantify occurring preservatives and fragrances. RESULTS: Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave-on cosmetics. CONCLUSION: Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.

Contact allergy in Swedish professional ice hockey players.

BACKGROUND: Professional ice hockey players may contract irritant and allergic contact dermatitis. AIMS: To investigate the presence of contact allergy (CA) in professional ice hockey players in Sweden. METHODS: Ten teams from the two top leagues were assessed for potential occupational exposure to sensitizers. Exactly 107 players were patch tested with an extended baseline series and a working series, in total 74 test preparations. The CA rates were compared between the ice hockey players and controls from the general population and dermatitis patients. RESULTS: One out of 4 players had at least one contact allergy. The most common sensitizers were Amerchol L 101, nickel and oxidized limonene. CA was as common in the ice hockey players as in dermatitis patients and significantly more common than in the general population. Fragrances and combined sensitizers in cosmetic products (fragrances + preservatives + emulsifier) were significantly more common in ice hockey players compared with the general population. CONCLUSION: The possible relationship between CA to fragrances and cosmetic products on the one hand and the presence of dermatitis on the other should be explored further.

An Observational Study on Cosmetics Use-related Adverse Effects: Cosmetovigilance Need of the Day.

INTRODUCTION: The pursuit of aesthetic attractiveness and increased awareness have contributed significantly to the growth of the cosmetic industry. However, it is crucial to recognize that even the minimal use of cosmetics may have harmful consequences for both the overall well-being and the broader community, an issue that has yet to be adequately recognized or addressed. OBJECTIVE: This study is aimed at providing insights into the usage pattern of consumer behavior regarding skin care products and to assess the prevalence and determinants of cosmetic-related adverse events among the general populace. MATERIALS AND METHODS: A community-based cross-sectional study was carried out for four months in a satellite city of the National Capital Region (NCR) of India. The data from 435 respondents was collected using a self-administered questionnaire and analyzed using frequencies and percentages. RESULTS: Among 435 participants, 32.9% experienced one or more adverse effects owing to the use of skincare products; the prevalence was higher in females (36.3%). Hair loss, allergies, and dry skin were the most frequently reported adverse effects. The majority of the adverse reactions were reported with soap (21%), followed by shampoo (17%). The gender-wise difference between adverse effects of skin care products was found to be statistically significant. CONCLUSION: To improve the system's efficiency, a comprehensive review of the current regulatory protocols for cosmetics is crucial. Additionally, it is essential to widely disseminate information on Cosmetovigilance and promote the reporting of any adverse effects of cosmetics within the community; this is the demand of the present time.

Nail cosmetology.

Nail cosmetics is enjoying growing success due to recent technological advances. Manicures can be responsible for mechanical, infectious or allergic adverse effects. Nail cosmetics (e.g., nail varnishes, acrylic false nails, light-curing gels, and adhesive false nails) incorporate substances that harden after solvent evaporation or after polymerization. Allergic reactions can occur, remotely with conventional varnishes and locally with polymerizing substances. Artificial nails incur a risk of carrying infectious agents which can cause serious infection, and should not be used by caregivers. Recently, there has been a worrisome increase in the frequency of acrylate allergy, due to the appearance of home kits and lack of information in the general public. The infectious, allergic and toxic risks incurred by consumers and professionals regarding manicure or pedicure treatments and the application of nail cosmetics are the subject of recommendations and monitoring measures.

Increasing non-cosmetic exposure and sensitization to isothiazolinones require action for prevention: Review.

Frequent use of methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) and MI in cosmetic products has been the main cause of widespread sensitization and allergic contact dermatitis to these preservatives (biocides). Their use in non-cosmetic products is also an important source of sensitization. Less is known about sensitization rates and use of benzisothiazolinone (BIT), octylisothiazolinone (OIT), and dichlorooctylisothiazolinone (DCOIT), which have never been permitted in cosmetic products in Europe. BIT and OIT have occasionally been routinely patch-tested. These preservatives are often used together in chemical products and articles. In this study, we review the occurrence of contact allergy to MI, BIT, OIT, and DCOIT over time, based on concomitant patch testing in large studies, and case reports. We review EU legislations, and we discuss the role of industry, regulators, and dermatology in prevention of sensitization and protection of health. The frequency of contact allergy to MI, BIT, and OIT has increased. The frequency of contact allergy to DCOIT is not known because it has seldom been patch-tested. Label information on isothiazolinones in chemical products and articles, irrespective of concentration, is required for assessment of relevance, information to patients, and avoidance of exposure and allergic contact dermatitis.

Contact allergens responsible for eyelid dermatitis in adults.

Allergic contact dermatitis has been established as the most frequent cause of eyelid dermatitis, but it is often misdiagnosed. The purpose of this study was to evaluate the characteristics of patients with eyelid dermatitis who were referred for patch testing. The patients were divided into three subgroups in this retrospective study: patients with only eyelid involvement, patients with involvement of eyelids and other areas, and patients without eyelid involvement. Data was collected on diagnoses, medical history, personal care products and make-up use, occupational dermatitis, and positive allergens. An independent t-test, one-way ANOVA, and chi-squared test were used to analyze the data. A total of 427 patients who referred for patch tests were included in the study. Of these, 139 patients had eyelid dermatitis. Allergic contact dermatitis (ACD) was the most common diagnosis in all three groups referred for patch tests. Use of shaving cream and hair conditioner was significantly higher in patients with only eyelid involvement and nickel sulfate was the most common allergen among them. Patch testing is the gold standard tool in the evaluation of eyelid contact dermatitis, and it is a necessity in the treatment of eyelid dermatitis, for the accurate identification of responsible allergens.

Contact allergy caused by acrylates in nail cosmetics: A pilot study from Greece.

BACKGROUND: The growing popularity of nail techniques based on acrylates has led to a higher frequency of sensitization in both nail technicians and users. OBJECTIVES: The study aimed to assess cases of allergic contact dermatitis (ACD) caused by acrylates in individuals with occupational or non-occupational exposure to nail techniques. METHODS: A preliminary study was conducted on 30 patients with ACD caused by acrylates in nail techniques, who were patch tested from September 2022 to March 2023 at the First Department of Dermatology and Venereology of Andreas Syggros Hospital, Athens, Greece. RESULTS: Thirty female patients with ACD to acrylates were documented (15 users and 15 nail technicians and users). The most common allergens were: 2-hydroxyethyl methacrylate (HEMA), 2-hydroxypropyl methacrylate (HPMA) and ethyleneglycol dimethacrylate (EGDMA), which tested positive in all 30 patients (100.0%). Twenty patients (66.7%) had been exposed to dental procedures involving acrylates, before the onset of ACD. Nail technicians exhibited extensive skin lesions, 40.0% experienced ACD within the first year of work and 13.3% during their professional practice. Three of them (20.0%) had to discontinue their work. CONCLUSION: Acrylates have been identified as potent allergens, necessitating the implementation of safety measures for the use of these chemicals in nail techniques.

Contact allergy to acrylate-containing nail cosmetics: A retrospective 8-year study.

BACKGROUND: Over the last 10 years, allergic contact dermatitis (ACD) from acrylate-containing nail cosmetics (acrylic nails, gel nails, gel nail polish) has been reported repeatedly. OBJECTIVES: To investigate the frequency and clinical features of ACD in nail cosmetics in a university hospital in Amsterdam, The Netherlands. PATIENTS AND METHODS: A retrospective study in patients diagnosed with ACD from acrylate-containing nail cosmetics at the Amsterdam University Medical Centers between January 2015 and August 2023. RESULTS: Sixty-seven patients, all women, were diagnosed with ACD from nail cosmetics, representing 1.6% of all individuals and 2.3% of all women patch tested in this period. Sixty-five of sixty-seven (97%) subjects had a positive patch test to 2-hydroxyethyl methacrylate (HEMA). Forty-nine patients (73%) were consumers and 18 (27%) were professional nail stylists. The sites most frequently affected with dermatitis were the fingers (79%), hands (40%) and the head and/or neck. Avoidance of contact with acrylate-containing products resulted in complete clearing of dermatitis in 80% of patients. CONCLUSIONS: ACD from acrylate-containing nail cosmetics is frequent in women patch tested in Amsterdam. Nearly all were identified by a positive patch test to 2-hydroxyethyl methacrylate in the (meth)acrylate series or the European baseline series.