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1.
BJOG ; 131(5): 655-664, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37743685

ABSTRACT

BACKGROUND: From menarche until menopause, the average menstruator will use over 11 000 tampons or sanitary pads. Vaginal and vulvar tissue is highly permeable, and chemicals are absorbed without undergoing first-pass metabolism. OBJECTIVES: To conduct a review of the literature to determine exposure to environmental chemicals in menstrual products. SEARCH STRATEGY: This review identified 15 papers over the past 10 years. SELECTION CRITERIA: Papers that measured chemicals in menstrual products and that measured human biomarkers of chemical exposure were included. Papers had to also be available in English. DATA COLLECTION AND ANALYSIS: Reviewers assessed the articles and data provided. Multiple chemical groups were found. MAIN RESULTS: Phthalates, volatile organic compounds, parabens, environmental phenols, fragrance chemicals, dioxins and dioxin-like compounds were detected in menstrual products. Research gaps were identified, including the lack of studies on newer products such as menstrual underwear and cups/discs. In addition to measuring chemicals in these products, future research should focus on clarifying the exposure per menstrual cycle to these chemicals to understand how menorrhagia and cycle length influence exposure from menstrual products. CONCLUSION: Menstrual products contained measurable levels of a range of endocrine disrupting chemicals including phthalates, phenols and parabens. This reflects a potentially important route of exposure to chemicals that can impact women's reproductive health.


Subject(s)
Menstrual Hygiene Products , Phthalic Acids , Humans , Female , Menstrual Hygiene Products/adverse effects , Parabens/adverse effects , Reproduction , Phenols
2.
Mol Ecol ; 32(10): 2592-2601, 2023 05.
Article in English | MEDLINE | ID: mdl-36057782

ABSTRACT

The vaginal ecosystem is a key component of women's health. It also represents an ideal system for ecologists to investigate the consequence of perturbations on species diversity and emerging properties between organizational levels. Here, we study how exposure to different types of menstrual products is linked to microbial, immunological, demographic, and behavioural measurements in a cohort of young adult women who reported using more often tampons (n = 107) or menstrual cups (n = 31). We first found that cup users were older and smoked less than tampon users. When analysing health indicators, we detected potential associations between cups use reporting and fungal genital infection. A multivariate analysis confirmed that in our cohort, reporting using cups over tampons was associated with the higher odds ratio to report a fungal genital infection diagnosis by a medical doctor within the last 3 months. We did not detect significant differences between groups in terms of their bacterial vaginal microbiota composition and found marginal differences in the level of expression of 20 cytokines. However, a multivariate analysis of these biological data identified some level of clustering based on the menstrual product type preferred (cups or tampons). These results suggest that exposure to different types of menstrual products could influence menstrual health. Larger studies and studies with a more powered setting are needed to assess the robustness of these associations and identify causal mechanisms.


Subject(s)
Menstrual Hygiene Products , Microbiota , Young Adult , Female , Humans , Menstrual Hygiene Products/adverse effects , Menstrual Hygiene Products/microbiology , Vagina/microbiology , Bacteria/genetics , Microbiota/genetics
3.
Int J Mol Sci ; 24(18)2023 Sep 15.
Article in English | MEDLINE | ID: mdl-37762424

ABSTRACT

Many women report embarrassment as the cause for their avoidance of routine gynaecological screening appointments. Methods of self-collection of bio samples would perhaps encourage women to participate in routine screening programs. The vaginal microbiome plays a key role in women's health and reproductive function. Microbial disturbances can result in the loss of lactobacillus dominance, also known as dysbiosis, associated with an increased risk of contracting sexually transmitted infections (STIs), pregnancy complications and infertility. Our primary aim was to determine if vaginal microbiome screening results are comparable between two methods for self-collected sample acquisition: tampons and lower vaginal swabs (LVSs). Secondary aims included the assessment of the effect of pre-analytic storage on the data (to streamline processing), the prevalence of dysbiosis and the acceptability of the tampons to the participants. Statistical analysis revealed no significant difference in the microbiome data, from tampons versus LVSs or fresh versus frozen samples. The prevalence of dysbiosis in this population of healthy volunteers was 42.9%. The questionnaire data revealed that 52.4% of volunteers use tampons every period, and the majority of volunteers rated the tampons as 5 on a 1-5 Likert scale regarding their perceived comfort using tampons. All (100%) of volunteers were happy to provide a tampon as a sample for testing. The findings from this study show that tampons and LVSs were comparable when analysing the vaginal microbiome, with potential superiority of the tampon with regard to patient acceptability. Self-collection of vaginal secretions for gynaecological screening using tampons warrants further research as this could change the screening landscape, ensuring wider participation and increasing efficacy.


Subject(s)
Menstrual Hygiene Products , Sexually Transmitted Diseases , Pregnancy , Female , Humans , Menstrual Hygiene Products/adverse effects , Dysbiosis/etiology , Vagina , Sexually Transmitted Diseases/diagnosis , Women's Health
4.
Regul Toxicol Pharmacol ; 135: 105260, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36067853

ABSTRACT

Allergic contact dermatitis (ACD) often associated with the topical use of perfumed products, remains one of the most common chronic skin disorders in Western countries. Since labelling of scented menstrual hygiene products (MHPs) is not mandatory, women might be unknowingly exposed to allergens. Given that vaginal mucosae lack the vital barrier function of the skin, skin allergens can easily penetrate and become systemically available and hence women may experience adverse effects in the anogenital region. The aim of this study was therefore to investigate whether women using scented MHPs are at risk of sensitization and hence developing ACD. Hereto, a Quantitative Risk Assessment (QRA) is performed on four well-known skin sensitizing chemicals (α-isomethyl ionone, benzyl salicylate, hexyl cinnamaldehyde and heliotropine) that were previously found leaching from five different scented MHPs including tampons and sanitary pads. The amounts of heliotropine, leached by one of the investigated tampons, exceeded acceptable exposure levels determined with the QRA and could induce sensitization. In addition, although no sensitization is expected for the other three compounds, an allergenic reaction might be provoked in women who are already sensitized. Labelling of allergens on scented MHPs would therefore help consumers to prevent adverse effects linked to ACD.


Subject(s)
Allergens , Dermatitis, Allergic Contact , Allergens/adverse effects , Dermatitis, Allergic Contact/prevention & control , Female , Humans , Hygiene , Menstrual Hygiene Products/adverse effects , Menstruation , Risk Assessment
5.
Clin Microbiol Rev ; 33(3)2020 06 17.
Article in English | MEDLINE | ID: mdl-32461307

ABSTRACT

In the 1980s, menstrual toxic shock syndrome (mTSS) became a household topic, particularly among mothers and their daughters. The research performed at the time, and for the first time, exposed the American public as well as the biomedical community, in a major way, to understanding disease progression and investigation. Those studies led to the identification of the cause, Staphylococcus aureus and the pyrogenic toxin superantigen TSS toxin 1 (TSST-1), and many of the risk factors, for example, tampon use. Those studies in turn led to TSS warning labels on the outside and inside of tampon boxes and, as important, uniform standards worldwide of tampon absorbency labeling. This review addresses our understanding of the development and conclusions related to mTSS and risk factors. We leave the final message that even though mTSS is not commonly in the news today, cases continue to occur. Additionally, S. aureus strains cycle in human populations in roughly 10-year intervals, possibly dependent on immune status. TSST-1-producing S. aureus bacteria appear to be reemerging, suggesting that physician awareness of this emergence and mTSS history should be heightened.


Subject(s)
Bacterial Toxins/toxicity , Enterotoxins/toxicity , Menstrual Hygiene Products/adverse effects , Shock, Septic/epidemiology , Shock, Septic/microbiology , Staphylococcal Infections/microbiology , Superantigens/toxicity , Female , Humans , Menstruation , Risk Factors , Staphylococcus aureus/pathogenicity
6.
J Obstet Gynaecol ; 41(2): 275-278, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32500774

ABSTRACT

The widespread use of tampons carries a risk of tampon loss due to imperfect use. We performed a retrospective study including all women attending the emergency room (ER) with the complaint of tampon loss during 2011-2018. Overall, 72 women presented to the ER with a complaint of tampon loss. In 25% (18/72), a lost tampon was found on physical examination. The lost tampon was found in a higher rate among adolescents as compared to older women (4 (80%) vs. 14 (21%), 15.1, p = .01). Time from tampon loss to referral for evaluation was shorter among adolescents as compared to older women (7 ± 3 vs. 21 ± 21 h, p = .007). In most adolescents with a complaint of a lost tampon - it was eventually found on pelvic examination, as opposed to older women, in whom a finding was present in only one-fifth of cases. This highlights the importance of thorough examination of adolescents presenting due to tampon loss. The study protocol was approved by the Sheba Medical Center review board (March 15, 2018), 6345-19-SMC.IMPACT STATEMENTWhat is already known on this subject? Very little is known regarding the distinguished phenomena of tampon loss among adult females.What do the results of this study add? In most adolescents referred due to tampon loss - a tampon was found on pelvic examination, as opposed to older women.What are the implications of these findings for future clinical practice and/or further research? In most adolescents referred due to tampon loss - a tampon will be found on pelvic examination, as opposed to older women, in whom a finding is present in only one-fifth of cases. This highlights the importance of thorough examination of adolescents presenting with a loss of tampon.


Subject(s)
Adolescent Health/statistics & numerical data , Equipment Failure/statistics & numerical data , Foreign Bodies , Gynecological Examination , Menstrual Hygiene Products/adverse effects , Adolescent , Adult , Age Factors , Female , Foreign Bodies/diagnosis , Foreign Bodies/etiology , Foreign Bodies/prevention & control , Gynecological Examination/methods , Gynecological Examination/statistics & numerical data , Health Education/methods , Humans , Israel/epidemiology , Menstruation , Retrospective Studies , Risk Factors , Risk Reduction Behavior , Vaginal Diseases/therapy
7.
Contact Dermatitis ; 82(5): 279-282, 2020 May.
Article in English | MEDLINE | ID: mdl-31951286

ABSTRACT

BACKGROUND: Allergenic fragrances are present in a wide range of products but they are not regulated in all industries to the same extent. In Europe, absorbent hygiene products (AHPs) are only covered by the general product safety directive and therefore fragrances can be used freely, whereas in cosmetics and toys the use of these ingredients is regulated. METHOD: An analytical method was developed to evaluate the presence of 24 sensitizing fragrances in AHPs. This method allows simultaneous identification and quantification and was validated using the total error approach with an acceptance value of ±15%. RESULTS: The validated method was applied to evaluate 10 scented AHPs consisting of four tampons, three panty liners, and three sanitary pads. Eight allergenic fragrances were identified in these products and five products contained at least one allergen above 10 µg/g. CONCLUSION: The presence of these allergens is not communicated to the consumer. This is, however, a strict requirement in other industries (eg, cosmetics, toys) to ensure adequate consumer protection. Knowing that the exposed area is more susceptible to allergens and irritants, the presence of these allergens should be disclosed.


Subject(s)
Allergens/analysis , Dermatitis, Allergic Contact/etiology , Menstrual Hygiene Products/adverse effects , Odorants/analysis , Chromatography, Gas , Mass Spectrometry
8.
Pediatr Emerg Care ; 36(3): e163-e165, 2020 Mar.
Article in English | MEDLINE | ID: mdl-29040243

ABSTRACT

BACKGROUND: Toxic shock syndrome (TSS) is an acute, severe, toxin-mediated disease, characterized by fever, hypotension, and multiorgan system involvement. Toxic shock syndrome has made headlines because of its high associated morbidity and mortality rate in previously healthy young females. Incidence peaked in the early 1980s owing to increased usage of ultra-absorbent tampons. After improved patient education and tampon labeling, the incidence of menstrual TSS has declined. CASE: A previously healthy 14-year-old girl presented to an urgent care center with a 2-day history of fever, erythematous maculopapular rash, vomiting, diarrhea, and malaise. She was found to be tachycardic and hypotensive. Investigations revealed thrombocytopenia, an elevated white count and lactate, and acute kidney injury, consistent with septic shock. Recent tampon usage with menstruation was reported, and a pelvic examination revealed purulent vaginal discharge. The patient was transferred to a pediatric intensive care unit for antibiotic and vasopressor therapy. Vaginal swabs later tested positive for Staphylococcus aureus and TSS toxin-1. CONCLUSIONS: Although the incidence of TSS has decreased in recent years, it is crucial that clinicians rapidly recognize and treat this life-threatening condition. Emergency physicians should always have a high index of suspicion for TSS in young females presenting without another obvious cause of shock. A pelvic examination should always be completed in these cases.


Subject(s)
Menstrual Hygiene Products/adverse effects , Menstruation , Shock, Septic/diagnosis , Adolescent , Anti-Bacterial Agents/therapeutic use , Bacterial Toxins , Enterotoxins , Female , Humans , Shock, Septic/drug therapy , Staphylococcal Infections/drug therapy , Staphylococcus aureus , Superantigens
9.
Eur J Contracept Reprod Health Care ; 24(5): 368-372, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31335218

ABSTRACT

Purpose: To gather preliminary data about menstrual hygiene product use and associated risk of intrauterine device (IUD) expulsion. Materials and methods: We conducted an Internet-based survey using the Amazon Mechanical Turk (MTurk) platform and Researchmatch.org. Eligible participants were women at least 18 years old and self-identified as current or previous IUD users. Results: Of 902 survey responses, 71% reported current or previous IUD use and 19.7% reported menstrual cup use. IUD users were significantly more likely than non-IUD users to use a menstrual cup or tampons. Among all IUD users, 56 individuals reported experiencing at least one expulsion (8.8%). We found a positive association between concurrent menstrual cup use and IUD expulsion (OR: 2.75, 95% CI: 1.40-5.42, p = .002), but no association with concurrent tampon or pad use. Of concurrent IUD and cup users who experienced an expulsion, one reported it occurring 'while using a menstrual cup', with others reporting the expulsion during other events. Conclusions: Menstrual cup use may be higher than previously reported, particularly in IUD users. Concurrent menstrual cup use may increase the risk of IUD expulsion. Prospective research is necessary to fully explore the relationship between menstrual hygiene product use and IUD expulsions.


Subject(s)
Intrauterine Device Expulsion/etiology , Intrauterine Devices/statistics & numerical data , Menstrual Hygiene Products/adverse effects , Menstrual Hygiene Products/statistics & numerical data , Adolescent , Adult , Female , Humans , Intrauterine Devices/adverse effects , Risk Factors , Self Report , United States , Young Adult
10.
Ann Dermatol Venereol ; 146(4): 287-291, 2019 Apr.
Article in French | MEDLINE | ID: mdl-30691878

ABSTRACT

BACKGROUND: Toxic shock syndrome (TSS) was first described by Todd in 1978. The relevant Lancet publication reported 7 cases of children with fever, exanthema, hypotension and diarrhoea associated with multiple organ failure. An association between TSS and use of hyper-absorbent tampons in menstruating women was discovered in the 1980s. Following the market withdrawal of such tampons, TSS virtually disappeared. Herein we report a new case of TSS in a 15-year-old girl. PATIENTS AND METHODS: A 15-year-old patient was admitted to intensive care for severe sepsis and impaired consciousness associated with diffuse abdominal pain. Dermatological examination revealed diffuse macular exanthema. Laboratory tests showed hepatic cytolysis (ASAT 101 U/L, ALAT 167 U/L, total bilirubin 68µmol/L) and an inflammatory syndrome. Lumbar puncture and blood cultures were sterile while thoraco-abdomino-pelvic and brain scans were normal. The patient was menstruating and had been using a tampon over the previous 24hours. Vaginal sampling and tampon culture revealed TSST-1 toxin-producing S. aureus. Management consisted of intensive care measures and treatment with amoxicillin-clavulanic acid and clindamycin for 10 days. CONCLUSION: In case of septic shock associated with diffuse macular exanthema a diagnosis of TSS must be envisaged, particularly in menstruating women.


Subject(s)
Erythema/etiology , Fever of Unknown Origin/etiology , Shock, Septic/diagnosis , Shock/etiology , Abdominal Pain/etiology , Adolescent , Amoxicillin-Potassium Clavulanate Combination/therapeutic use , Bacterial Toxins/analysis , Clindamycin/therapeutic use , Critical Care , Diagnosis, Differential , Drug Therapy, Combination , Enterotoxins/analysis , Female , Humans , Menstrual Hygiene Products/adverse effects , Shock, Septic/therapy , Staphylococcus aureus/pathogenicity , Superantigens/analysis
11.
Reprod Health ; 13(1): 143, 2016 Dec 07.
Article in English | MEDLINE | ID: mdl-27923379

ABSTRACT

BACKGROUND: Governments, multinational organisations, and charities have commenced the distribution of sanitary products to address current deficits in girls' menstrual management. The few effectiveness studies conducted have focused on health and education outcomes but have failed to provide quantitative assessment of girls' preferences, experiences of absorbents, and comfort. Objectives of the study were, first, to quantitatively describe girls' experiences with, and ratings of reliability and acceptability of different menstrual absorbents. Second, to compare ratings of freely-provided reusable pads (AFRIpads) to other existing methods of menstrual management. Finally, to assess differences in self-reported freedom of activity during menses according to menstrual absorbent. METHODS: Cross-sectional, secondary analysis of data from the final survey of a controlled trial of reusable sanitary padand puberty education provision was undertaken. Participants were 205 menstruating schoolgirls from eight schools in rural Uganda. 72 girls who reported using the intervention-provided reusable pads were compared to those using existing improvised methods (predominately new or old cloth). RESULTS: Schoolgirls using reusable pads provided significantly higher ratings of perceived absorbent reliability across activities, less difficulties changing absorbents, and less disgust with cleaning absorbents. There were no significant differences in reports of outside garment soiling (OR 1.00 95%CI 0.51-1.99), or odour (0.84 95%CI 0.40-1.74) during the last menstrual period. When girls were asked if menstruation caused them to miss daily activities there were no differences between those using reusable pads and those using other existing methods. However, when asked about activities avoided during menstruation, those using reusable pads participated less in physical sports, working in the field, fetching water, and cooking. CONCLUSIONS: Reusable pads were rated favourably. This translated into some benefits for self-reported involvement in daily activities, although reports of actual soiling and missing activities due to menstruation did not differ. More research is needed comparing the impact of menstrual absorbents on girls' daily activities, and validating outcome measures for menstrual management research.


Subject(s)
Health Knowledge, Attitudes, Practice , Menstrual Hygiene Products , Menstruation , Rural Health , Activities of Daily Living , Adolescent , Adult , Child , Consumer Behavior , Cross-Sectional Studies , Culturally Competent Care/ethnology , Equipment Reuse , Female , Follow-Up Studies , Health Knowledge, Attitudes, Practice/ethnology , Humans , Hygiene/education , Materials Testing , Menstrual Hygiene Products/adverse effects , Menstruation/ethnology , Patient Education as Topic , Rural Health/ethnology , Self Report , Uganda , Young Adult
12.
Regul Toxicol Pharmacol ; 73(1): 419-24, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26255105

ABSTRACT

Sanitary pads for menstrual hygiene have a layered design consisting of a fluid permeable surface (topsheet), an absorbent core, and an impermeable backing with adhesive. Most sanitary pads employ cellulose-based cores. This describes the safety evaluation of a menstrual pad with an emollient-treated topsheet and a novel polymeric foam core. A quantitative risk assessment was performed, which included: (1) toxicological evaluation of the raw material components; (2) quantitative exposure assessments of pad constituents, accounting for the fluid handling properties of the product and pertinent conditions of use; and (3) risk characterization for exposure to raw materials (e.g., potential for skin irritation, contact sensitization, or systemic effects, if relevant) and to the physical article itself (potential effects on skin friction, etc.). No significant risk of adverse effects was found. Five years of post-market surveillance substantiates that the product is well-tolerated (1 health complaint reported per 2 million products shipped to market) and surpasses women's expectations for menstrual protection and overall comfort and dryness. This report illustrates how the classical risk assessment paradigm, informed by the impact of product design, functionality and pertinent use conditions, allowed the systematic safety evaluation of a personal hygiene product with a novel, non-cellulosic absorbent foam core technology.


Subject(s)
Menstrual Hygiene Products/adverse effects , Polymers/adverse effects , Female , Friction , Humans , Risk , Safety , Skin/drug effects
15.
Clin Med (Lond) ; 14(3): 316-8, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24889583

ABSTRACT

Toxic shock syndrome (TSS) represents a fascinating example of immune activation caused by infection resulting in a dramatic and challenging clinical syndrome. TSS is commonly associated with tampon use and still causes significant morbidity and mortality in young healthy women. A misconception is that TSS presents with a skin rash and only occurs in women and children; however, it can occur in males and can present without skin changes. TSS presents initially as a febrile illness and within a few hours can progress to severe hypotension and multiple organ failure (MOF). Staphylococcus aureus and group A beta haemolytic streptococcus (GABHS) can secrete toxins from a small or hidden focus of infection and hence blood culture and sensitivity (C+S) tests can be negative, thereby making diagnosing this condition challenging. Clindamycin is superior to penicillin in the treatment of this condition and significantly decreases the mortality rate in TSS. However, there is also an important role for intravenous immunoglobulins (IVIG). Early intensive care unit (ICU) as well as surgical team involvement (in selected cases) is required to avoid mortality which may approach 70%.


Subject(s)
Shock, Septic/diagnosis , Staphylococcal Infections/diagnosis , Staphylococcus aureus/isolation & purification , Anti-Bacterial Agents/therapeutic use , Female , Humans , Menstrual Hygiene Products/adverse effects , Middle Aged , Shock, Septic/drug therapy , Staphylococcal Infections/drug therapy
16.
Obstet Gynecol ; 144(1): e1-e3, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38772038

ABSTRACT

BACKGROUND: Vesicovaginal fistula (VVF) is an uncommon cause of urinary incontinence (UI). Iatrogenic etiologies, especially abdominal hysterectomy, are most common; however, a minority of VVFs are caused by retained foreign bodies. Objects associated with VVF include intrauterine devices, gauze, pessaries, bottle caps, and sexual aids, but retained tampons or other menstrual products have not been commonly reported. CASE: We present the case of a 53-year-old woman, gravida 0, with no prior pelvic surgery, with 2 months of intermittent UI and hematuria. Although initial diagnostic test results were negative, cystoscopy and vaginoscopy eventually confirmed the diagnosis of VVF associated with a retained foreign body. In the operating room, all debris was removed using vaginoscopy, and the VVF was repaired using a modified Latzko technique. At the patient's 9-week follow-up appointment, she was found to have complete healing of the VVF and resolution of associated symptoms. CONCLUSION: This is a case of VVF secondary to a retained tampon fragment. In addition to this uncommon etiology, our patient's presenting symptoms were atypical, leading to a delay in diagnosis and treatment for which vaginoscopy was critical.


Subject(s)
Foreign Bodies , Vesicovaginal Fistula , Humans , Female , Vesicovaginal Fistula/etiology , Vesicovaginal Fistula/surgery , Vesicovaginal Fistula/diagnosis , Middle Aged , Foreign Bodies/complications , Foreign Bodies/surgery , Tampons, Surgical/adverse effects , Urinary Incontinence/etiology , Urinary Incontinence/surgery , Menstrual Hygiene Products/adverse effects
17.
Australas J Dermatol ; 54(4): 283-6, 2013 Nov.
Article in English | MEDLINE | ID: mdl-22897229

ABSTRACT

Menstrual toxic shock syndrome (MTSS) is a rare and potentially life-threatening illness. We present a case of recurrent MTSS initially associated with tampon use that continued to recur when tampons were discontinued, which was successfully treated with rifampicin and clindamycin.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Carrier State/drug therapy , Menstrual Hygiene Products , Shock, Septic/drug therapy , Staphylococcal Infections/drug therapy , Adolescent , Carrier State/microbiology , Clindamycin/therapeutic use , Female , Humans , Menstrual Hygiene Products/adverse effects , Recurrence , Rifampin/therapeutic use , Shock, Septic/microbiology , Staphylococcus aureus
18.
Arch Gynecol Obstet ; 287(3): 435-9, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23179806

ABSTRACT

INTRODUCTION: Colposcopic inspection of the vagina is a routine component of the safety assessment of intravaginal products. However, colposcopic findings occur frequently in healthy women, raising questions about their relevance to intravaginal product safety. Practical disadvantages limit the utility of colposcopy for evaluating menstrual tampons, among them the presence of background microtrauma, the inability to assess effects during menstruation, and, importantly, the question of whether post hoc assessments are sufficiently sensitive to detect small inflammatory changes. The Behind-The-Knee (BTK) test is an alternative for evaluating inflammatory and tissue dryness effects of physical articles by their repeated application to the popliteal fossa under an elastic bandage. It enables concurrent parallel comparisons of experimental and control articles over time and substantially increases the sensitivity of detecting small changes in tissue inflammation. MATERIAL AND METHODS: With the protocol, uncompressed experimental and control tampons yielded comparable relative and absolute erythema scores (after overnight recovery) as did colposcopic assessment of the lower genital tract 3-48 h after menstrual use. Scoring erythema in the BTK test immediately after product removal increased the level of visually discernible inflammation sixfold. In a study of commercial menstrual pads, subclinical inflammation visualized with cross-polarized light correlated with the frequency of subjective reports of discomfort during the test and discriminated the relative tolerability of the two products determined by market surveillance, providing added confidence in the predictive value of the test. CONCLUSION: We believe the BTK test can be a valuable alternative to colposcopy for assessing inflammation and dryness associated with menstrual tampons.


Subject(s)
Dermatitis/etiology , Erythema/etiology , Menstrual Hygiene Products/adverse effects , Skin Irritancy Tests/methods , Colposcopy , Female , Humans , Knee , Vagina
20.
Cutan Ocul Toxicol ; 31(3): 198-203, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22141375

ABSTRACT

CONTEXT: Apertured polyethylene films (AF) have been used as a surface for sanitary pads for decades because they are compatible with the skin and keep the pad surface drier. A modified film (AF-plus) with improved fluid handling and a smoother, suppler texture has been developed. We hypothesized that these changes would improve both performance and skin compatibility. However, distinguishing the skin effects of materials that are inherently mild is a challenge. OBJECTIVES: (i) To compare the skin irritation potential of pads with AF-plus modified film relative to the standard AF film and (ii) to assess the potential for the AF-plus film to induce delayed contact hypersensitivity. MATERIALS AND METHODS: Pads bearing the AF-plus film were compared to pads with the standard AF film in a behind-the-knee (BTK) test, which assesses the combination of chemical irritation and frictional effects of materials applied to the popliteal fossa under a semi-occlusive bandage. Erythema on the skin surface was scored with the naked eye and subsurface tissue erythema was visualized and scored using cross-polarized illumination. Skin dryness was scored with the naked eye only. One-sided statistical evaluations were performed to test the hypothesis of AF-plus film superiority. The potential of the AF-plus film to induce delayed contact hypersensitivity was assessed by a human repeat insult patch test (HRIPT). RESULTS: Pads with the AF-plus surface were significantly milder to skin in the BTK test, producing lower levels of both surface and subsurface tissue erythema. Moreover, subjects with preexisting erythema on the skin surface at study start developed comparatively less erythema over the course of the study overall with the AF-plus pad compared to the AF pad. No significant difference in skin dryness was observed between product groups. The AF-plus pad showed no evidence of inducing delayed contact hypersensitivity. CONCLUSIONS: The AF-plus pad was superior to the AF pad in terms of skin mildness as discerned by objectively scored surface and subsurface tissue erythema. In subjects with preexisting erythema, the AF-plus pad appeared to contribute less to the further development of inflammation under the test conditions. Given the compositional similarities in the two films, the results could point to more limited contribution of the AF-plus film to skin friction, one of the factors simulated by the BTK test protocol.


Subject(s)
Equipment Design , Menstrual Hygiene Products/adverse effects , Adult , Double-Blind Method , Erythema/chemically induced , Female , Humans , Hypersensitivity, Delayed , Surface Properties
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