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1.
PLoS One ; 17(1): e0262295, 2022.
Article in English | MEDLINE | ID: mdl-34982805

ABSTRACT

BACKGROUND: Adolescent girls face several challenges relating to menstruation and its proper management. Lack of adequate sanitary products, inadequate water supply, and privacy for changing sanitary pads continue to leave adolescent girls with limited options for safe and proper menstrual hygiene in many low-income settings, including Ethiopia. These situations are also compounded by societal myths, stigmas surrounding menstruation, and discriminatory social norms. This systematic review and meta-analysis aimed to estimate the pooled proportion of safe menstrual hygiene management among adolescent girls in Ethiopia using the available studies. METHODS: We searched PubMed, Google Scholar, African Journal Online (AJOL), Hinari, Science Direct, ProQuest, Direct of Open Access Journals, POPLINE, and Cochrane Library database inception to May 31, 2021. Studies reporting the proportion of menstrual hygiene management among adolescent girls in Ethiopia were considered. The Cochrane Q test statistics and I2 tests were used to assess the heterogeneity of the included studies. Since the included studies revealed considerable heterogeneity, a random effect meta-analysis model was used to estimate the pooled proportion of menstrual hygiene management (MHM). RESULTS: Of 1,045 identified articles, 22 studies were eligible for analysis (n = 12,330 participants). The pooled proportion (PP) of safe MHM in Ethiopia was 52.69% (95%CI: 44.16, 61.22). The use of commercial menstrual absorbents was common 64.63% (95%CI: 55.32, 73.93, I2 99.2%) followed by homemade cloth 53.03% (95%CI: 22.29, 83.77, I2 99.2%). Disposal of absorbent material into the latrine was the most common practice in Ethiopia 62.18% (95%CI: 52.87, 71.49, I2 98.7%). One in four girls reported missing one or more school days during menstruation (PP: 32.03%, 95%CI: 22.65%, 41.40%, I2 98.2%). CONCLUSION: This study revealed that only half of the adolescent girls in Ethiopia had safe MHM practices. To ensure that girls in Ethiopia can manage menstruation hygienically and with dignity, strong gender-specific water, sanitation, and hygiene (WASH) facilities along with strong awareness creation activities at every level are needed.


Subject(s)
Health Knowledge, Attitudes, Practice , Hygiene/standards , Menstrual Hygiene Products/standards , Menstruation , Patient Education as Topic/methods , Sanitation/standards , Adolescent , Ethiopia , Female , Humans , Rural Population
2.
Midwifery ; 92: 102858, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33157498

ABSTRACT

OBJECTIVE: To investigate the effect of copper impregnated sanitary towels on the infection rate following vaginal delivery (VD). DESIGN: Single center double blind randomized controlled trial. PARTICIPANTS: Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD. INTERVENTIONS: All women were randomized to receive either a copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group). MAIN OUTCOME MEASURES: The primary study outcome was the incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire. Secondary outcomes were length of hospital stay and risk factors of infection. RESULTS: 450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group. Follow-up rate was 98.2%. A total of 102 women (23.1%) developed an infection within 30 days following VD, 19 in the study group (8.6%) and 83 (37.4%) in the control group (P = <0.001, absolute risk reduction (ARR) of 28.8%). The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = <0.001 and 4.6% vs. 31.5%, P = <0.001 respectively) with an ARR of 22.5% and 27.0% respectively. Multivariable analysis reported Asian ethnicity and prolonged rupture of membranes as significant risk factors; for the development of infection (OR 1.91, P = 0.03 and OR = 1.97, P = 0.04 respectively). CONCLUSIONS: This is the first study to demonstrate a significant reduction in infection rate following VD with the use of copper impregnated sanitary towels.


Subject(s)
Copper/pharmacology , Episiotomy/instrumentation , Menstrual Hygiene Products/standards , Perineum/surgery , Surgical Wound Infection/prevention & control , Adolescent , Adult , Anti-Infective Agents, Local/pharmacology , Anti-Infective Agents, Local/therapeutic use , Copper/therapeutic use , Double-Blind Method , Episiotomy/adverse effects , Episiotomy/methods , Female , Hospitals, University/organization & administration , Hospitals, University/statistics & numerical data , Humans , Menstrual Hygiene Products/statistics & numerical data , Perineum/abnormalities , Pregnancy , Surgical Wound Infection/drug therapy
3.
Eur J Clin Microbiol Infect Dis ; 39(1): 31-38, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31853743

ABSTRACT

Tampons are associated with toxic shock syndrome (mTSS). One reason for this association is oxygen introduction within tampons into the anaerobic vagina. Oxygen is required for Staphylococcus aureus to produce TSS toxin-1 (TSST-1). There have been changes in use of medical devices to control menstrual flow, including increased use of menstrual discs and cups. These devices composed of solid, flexible materials do not absorb menstrual fluid and thus do not trap oxygen. This study evaluates tampons and non-absorbent devices for effect on S. aureus and TSST-1 production. There are three in vitro tests to evaluate devices for effect on TSST-1 production: (1) stationary flask, (2) shake flask, and (3) tampon sac. In this study, 100% rayon and 100% cotton tampons with three absorbencies, contraceptive diaphragms, and menstrual discs and cups were tested for effect on S. aureus growth and TSST-1 production. Product composition did not affect bacterial growth or TSST-1 production. Tampons showed no effect on S. aureus growth compared with no-tampon controls, but tampons showed enhanced TSST-1 production as a function of trapped oxygen in stationary cultures and tampon sacs but not in shake flasks. The non-absorbent devices showed no enhanced S. aureus growth or TSST-1 production compared with no-device controls. These studies are consistent with the association of tampons with mTSS as a function of absorbency, but they suggest the occasional association of mTSS with non-absorbent devices may be coincidental as opposed to co-causative.


Subject(s)
Bacterial Toxins/analysis , Contraceptive Devices, Female/standards , Enterotoxins/analysis , Menstrual Hygiene Products/standards , Staphylococcus aureus/growth & development , Superantigens/analysis , Vagina/microbiology , Cellulose , Cotton Fiber , Female , Humans , Oxygen/metabolism , Shock, Septic , Staphylococcal Infections/microbiology , Staphylococcus aureus/metabolism
4.
PLoS One ; 14(8): e0220114, 2019.
Article in English | MEDLINE | ID: mdl-31369595

ABSTRACT

There has been growing recognition of menstrual hygiene management (MHM) as a significant public health issue. However, research has predominately focused on the experiences of adolescent girls in school settings. The purpose of this research is to examine detailed accounts of menstruation for women in rural Odisha, India at various life stages with a view toward improving international monitoring of MHM. Focus group discussions and in-depth interviews were conducted to understand women's experiences of menstruation across four life stages (unmarried women, recently married women, married women, and older women). Thematic analysis was used to identify menstruation-related challenges and needs. We found women voiced needs that aligned with those captured by the WHO/UNICEF Joint Monitoring Programme for Water Supply, Sanitation and Hygiene (JMP) definition for MHM: access to clean materials, privacy for changing materials, soap and water for bathing, and disposal facilities for materials. However, we also found women require materials that are not only clean but comfortable and reliable; soap and water for more than bathing; privacy for the full spectrum of menstruation-related practices, not just when changing; and disposal facilities that are private and safe, not just accessible. Additionally, we identified needs that extend beyond the existing definition: pain management, social support, and an enabling sociocultural environment. Overall, women representing all life stages discussed menstruation challenges, including bathing, pain, and washing, drying, and storing cloth materials. Cloth management challenges were most acute for unmarried and recently married women, who were concerned that practices could reveal their menstrual status and harm their reputations, thus informing their preference for disposable materials, if attainable. We propose a revised definition of adequate MHM for this population that more comprehensively captures their needs. This definition may also prove useful for other populations, future research, creating measures of assessment, and guiding interventions and program priorities.


Subject(s)
Health Knowledge, Attitudes, Practice , Hygiene/standards , Menstrual Hygiene Products/standards , Menstruation/psychology , Sanitation/standards , Social Support , Water Supply/methods , Adolescent , Adult , Aged , Female , Focus Groups , Humans , Hygiene/education , India , Menstrual Hygiene Products/supply & distribution , Middle Aged , Rural Population , Young Adult
5.
J Prev Med Hyg ; 59(3): E226-E229, 2018 Sep.
Article in English | MEDLINE | ID: mdl-30397679

ABSTRACT

INTRODUCTION: Sanitary tampons have been in existence for over 60 years. Their use may present certain health risks, potentially associated with an abnormal change of microbial flora in the vagina (e.g., toxic shock syndrome). Tampon production and marketing are regulated differently in different countries. In Australia, Canada and the USA, tampons are classified as Class-II medical devices and their marketing requires pre-clinical and clinical studies, including microbiological trials. In Europe, tampons are considered consumer products and safety-related data are provided only if the manufacturer deems them to be useful. Sterility of these products is not requested by law; thus they may represent a potential vehicle for microorganisms. Due to the lack of data on microbial characteristics of tampons, an analytical investigation was carried out to characterize and quantify the microbial flora present on sealed tampons of various brands present on the market in Italy. METHODS: Traditional cultural methods were used to characterize and quantify bacteria and fungi. Identification of colonies was performed with biochemical techniques. RESULTS: Results showed low microbial concentrations in 93% of the positive samples. A rare presence of opportunistic pathogens was detected and a few samples (6%) were characterized by bacterial species of human origin. CONCLUSIONS: In the light of these data, the examined tampons were found to have good hygienic quality. Nevertheless, to minimize the microbial risks linked to the use of these products, strict hygienic rules during their production and manipulation have to be adopted.


Subject(s)
Hygiene , Menstrual Hygiene Products/standards , Vagina/microbiology , Female , Humans , Italy
7.
Regul Toxicol Pharmacol ; 70(1): 357-62, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25078889

ABSTRACT

A risk assessment study of dioxins in sanitary napkins produced in Japan was performed. The daily estimated exposure volume to dioxins was compared with the tolerable daily intake (TDI). The concentrations of dioxins such as polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), and dioxin-like polychlorinated biphenyls (DL-PCBs) in seven sanitary napkins were measured using gas chromatography and mass spectroscopy analytical methods. Among the seven napkins, a range of 0.0044-0.076pg TEQ/g dioxins was measured. Daily estimated exposure volume from sanitary napkins was calculated as follows: (dioxin volumes in a sanitary napkin (0.0044-0.076pg TEQ/g)×pulp weight in a sanitary napkin (11.2g)×used napkin numbers/d (7.5)×the number of days/month that women use sanitary napkins (7)×skin absorption rate (0.03)×used years (40))/(average body weight of women (50kg)×the number of days in the month (30)×life years (86)). Daily exposure volumes were estimated to be 0.000024-0.00042pg TEQ/kg/d. For hazard assessment, we used 0.7pg TEQ/kg/d which was the lowest level of TDI among TDI values reported by international agencies. When the daily exposure volume was compared with the TDI, the former was approximately 1666-29,166 times less than the latter. This fact indicated that the risk of exposure to dioxins from sanitary napkins produced in Japan was negligible.


Subject(s)
Benzofurans/analysis , Menstrual Hygiene Products/standards , Polychlorinated Biphenyls/analysis , Polychlorinated Dibenzodioxins/analogs & derivatives , Dibenzofurans, Polychlorinated , Female , Gas Chromatography-Mass Spectrometry/methods , Humans , Japan , No-Observed-Adverse-Effect Level , Polychlorinated Dibenzodioxins/analysis , Risk Assessment/methods
8.
Fertil Steril ; 101(2): 515-22, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24331833

ABSTRACT

OBJECTIVE: To validate the menstrual pictogram (superabsorbent polymer-c version) for Always Ultra-slim feminine towels containing superabsorbent polymers. DESIGN: Prospective, multicenter, evaluator-blinded study. SETTING: Three gynecology research clinics in the United Kingdom. PATIENT(S): Women with self-perceived light, normal, or heavy menstrual periods who had not previously used a graphical method to assess their menstrual loss. INTERVENTION(S): One hundred twenty-two women were asked to complete the menstrual pictogram throughout two menstrual periods and collect their feminine towels for measurements of menstrual blood loss (MBL) by the alkaline hematin method and total menstrual fluid loss (MFL) by fluid weight. MAIN OUTCOME MEASURE(S): Agreement of menstrual pictogram MBL and MFL scores with alkaline hematin and towel weight, respectively. The percentage blood fraction was determined at various volumes of menstrual discharge. RESULT(S): Alkaline hematin and fluid weight were highly correlated (r = .97). However, the percentage blood fraction progressively increased with total MFL and MBL score. After correction for this incremental rise in blood fraction, the menstrual pictogram gave a sensitivity of 82% and a specificity of 92% for a diagnosis of heavy menstrual bleeding. CONCLUSION(S): The menstrual pictogram (superabsorbent polymer-c version) provides a simple means of measuring MBL in the clinical setting.


Subject(s)
Absorbent Pads/standards , Audiovisual Aids/standards , Menstrual Hygiene Products/standards , Menstruation/physiology , Polymers/chemistry , Polymers/standards , Adolescent , Adult , Female , Humans , Middle Aged , Prospective Studies , Single-Blind Method , Young Adult
9.
Ginekol Pol ; 83(8): 633-8, 2012 Aug.
Article in Polish | MEDLINE | ID: mdl-23342891

ABSTRACT

The group of experts representing the Polish Gynecologic Society has issued this Statement based on the review of available literature on the potential benefits of the use of ellen probiotic tampon. It has been firmly proven that during menstrual bleeding the vaginal flora undergoes profound changes prodisposing to both bacterial and fungal infections. Safety of menstrual tampons has been studied for over 60 years. According to the current state of knowledge, the use of tampons does not lead to any clinically significant change in the vaginal flora. The link between tampon use and Toxic Shock Syndrome (TTS) was revealed in 1978 after introduction of superabsorbent tampons to the United States market. Following the replacement of carboxymethylcellulose and polyester based tampons by the new generation of cotton based tampons, cases of tampon connected TSS are extremely rare in the US. The proper use of modern tampons is considered to be safe. Ellen tampon features dioxin and chlorine free natural fibres treated with the acidic acid producing probiotic Lacto Naturel (LN), which contains a combination of patented benevolent bacteria that can strengthen women's defense against vaginal infections. Both in vivo and in vitro studied have shown that ellen probiotic tampons are able to succesfully colonize vagina with the LN probiotic bacteria which then coexist with endogenous Lactobacilli present in the patients vaginal ecosystem. The ellen probiotic tampon constitutes an innovative solution of the vaginal probiotic application during menses. The use of this product is aimed to maintain natural vaginal flora as well as its pH during menstrual bleeding. According to the available clinical data, the potential benefits of the probiotic tampon use include: prevention of the vaginal/vulval discomfort as a result of frequent swimming poll use, maintaning of the therapeutic effect of antibacterial/antifungal vaginal treatment and prevention of the recurrent infections, prevention of iatrogenic vaginal flora imbalance after an antibiotic treatment.


Subject(s)
Menstrual Hygiene Products/standards , Probiotics/administration & dosage , Vagina/microbiology , Vaginal Diseases/prevention & control , Female , Gynecology/standards , Humans , Menstrual Hygiene Products/microbiology , National Health Programs/standards , Poland , Pregnancy , Quality Assurance, Health Care/standards , Shock, Septic/prevention & control , Societies, Medical/standards
10.
Fertil Steril ; 94(7): 2742-6, 2010 Dec.
Article in English | MEDLINE | ID: mdl-20447631

ABSTRACT

OBJECTIVE: To validate the alkaline hematin technique for measurement of menstrual blood loss using ultra-thin sanitary towels that contain superabsorbent polymer granules as the absorptive agent. DESIGN: Laboratory study using simulated menstrual fluid (SMF) and Always Ultra Normal, Long, and Night "with wings" sanitary towels. SETTING: Keele Menstrual Disorders Laboratory. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Recovery of blood, linearity, and interassay variation over a range of SMF volumes applied to towels. Because of the variable percentage of blood in menstrual fluid, blood recovery was assessed from SMF constituted as 10%, 25%, 50%, and 100% blood. The lower limit of reliable detection and the effect of storing soiled towels for up to 4 weeks at 15°C-20°C, 4°C, and -20°C before analysis were determined. RESULT(S): Ninety percent recovery was reproducibly achieved up to 30 mL applied volume at all tested SMF compositions, except at low volume or high dilution equivalent to <2 mL whole blood. Samples could be stored for 3 weeks at all tested temperatures without loss of recovery. The technique was suitable for processing towels individually or in batches. CONCLUSION(S): The alkaline hematin technique is a suitable and validated method for measuring menstrual blood loss from Always Ultra sanitary towels that contain superabsorbent polymers.


Subject(s)
Absorbent Pads , Hemin/chemistry , Menstrual Hygiene Products , Menstruation/physiology , Polymers/pharmacology , Absorbent Pads/standards , Adsorption , Blood/metabolism , Blood Physiological Phenomena/drug effects , Calibration , Drug Stability , Female , Humans , Hydrogen-Ion Concentration , Linear Models , Menstrual Hygiene Products/standards , Menstruation/blood , Polymers/chemistry , Polymers/pharmacokinetics , Time Factors , Uterine Hemorrhage/pathology
11.
J Womens Health (Larchmt) ; 19(2): 273-8, 2010 Feb.
Article in English | MEDLINE | ID: mdl-20109120

ABSTRACT

BACKGROUND: Menstrual tampons are available in a range of absorbencies to allow women to use the product most appropriate to their needs. This study assessed the safety of an ultra absorbency (15 g to 18 g) tampon compared with a currently marketed super-plus absorbency (12 g to 15 g) tampon as a control. METHODS: Healthy women age 18-45 years (n = 95) were enrolled in this single-blind, crossover study. Subjects used, in random order, the experimental tampon during one menstrual cycle and the control tampon during the other. Subjects were also randomly assigned to receive either vaginal microbial assessments for determination of the presence and density of Staphylococcus aureus (n = 35) or colposcopic examinations for assessment of changes in the vaginal mucosa (n = 60). Data on comfort and acceptability of the tampons were collected by using diaries and questionnaires completed by the subjects in both groups. RESULTS: Twenty-eight women in the microbial assessment group and 43 in the colposcopic examination group completed the study; these subjects made up the primary analysis population. No differences in isolation frequency or cell density of S. aureus or in vaginal mucosal changes were observed with the experimental tampon in comparison with the control tampon. No reported adverse events were attributed to the experimental tampon. Both tampons received positive comfort ratings. CONCLUSIONS: Based upon microbial assessments, colposcopic examinations, adverse events, and subject reporting of comfort, the ultra absorbency tampon is similar in safety profile to the currently marketed super plus absorbency tampon.


Subject(s)
Consumer Product Safety , Menstrual Hygiene Products/standards , Adult , Colposcopy , Cross-Over Studies , Female , Humans , Menstrual Cycle/physiology , Menstrual Hygiene Products/adverse effects , Menstrual Hygiene Products/classification , Middle Aged , Mucous Membrane/microbiology , Personal Satisfaction , Single-Blind Method , Staphylococcus aureus/isolation & purification , Surveys and Questionnaires , Vagina/microbiology , Young Adult
15.
Contraception ; 79(6): 463-8, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19442783

ABSTRACT

BACKGROUND: Managing menses is a challenge for women in developing countries. Duet is a cervical barrier being developed for contraception and STI prevention. We explored the hypothetical acceptability of using Duet as a menstrual cup, among Zimbabwean women. STUDY DESIGN: A survey and focus group discussions (FGD) were conducted with 43 women aged 18-45 years to gain information about their menstrual practices and attitudes regarding the use of Duet for menstrual protection. RESULTS: All 43 women reported that if Duet were available, they would "definitely" try it, and that it was "very important" that Duet is low cost and easy to clean; 86% reported that using it would make a difference in their lives. FGD findings highlighted unhygienic practices due to the lack of affordable options for menstrual management and a genuine interest in Duet, including its potential use for multiple purposes (contraception, disease prevention and menstrual protection). CONCLUSIONS: Accessing affordable and hygienic menstrual protection was a problem for these Zimbabwean women. Duet appeared acceptable and it would be feasible to conduct a user-acceptability study of Duet as a menstrual cup in Zimbabwe.


Subject(s)
Menstrual Hygiene Products/standards , Menstruation , Adolescent , Adult , Developing Countries , Feasibility Studies , Female , Humans , Middle Aged , Young Adult , Zimbabwe
16.
J Womens Health (Larchmt) ; 14(4): 311-5, 2005 May.
Article in English | MEDLINE | ID: mdl-15916504

ABSTRACT

BACKGROUND: Human exposure to dioxins and furans through diet and other sources has been of concern for many years. One specific concern, related to exposure in women's health, is the possible link to endometriosis. Although there are differences in opinion about this link, the concern from the public is real. Congressional interest has prompted investigations to determine the amounts of dioxins and furans present in feminine hygiene products available within the United States. METHODS: Tampon samples were analyzed via Gas Chromatography/High Resolution Mass Spectrometry (GC/HRMS) using a Micromass AutoSpec Ultima high resolution mass spectrometer at 10,000 mass resolution. As data were confirmed and quantified using direct isotope dilution, only the 17 2,3,7,8-chlorine-containing dioxin and furan concentrations were calculated from these analyses. RESULTS: A total toxic equivalence (TEQ), using the World Health Organization's toxic equivalency factor (TEF) values, was calculated for each sample. The calculated TEQs for samples were not statistically different from those of the calculated TEQs using the average limit of detection (LOD) values. CONCLUSIONS: Data show results similar to those reported by DeVito and Schecter (Environ Health Perspect 2002;110:23) in that most of the dioxins and furans were below the detection limit or estimated detection limits (EDLs).


Subject(s)
Dioxins/analysis , Environmental Exposure , Environmental Pollutants/analysis , Furans/analysis , Menstrual Hygiene Products/standards , Women's Health , Female , Gas Chromatography-Mass Spectrometry , Humans , Reference Values , Risk Assessment , Risk Factors , United States
17.
Infect Dis Obstet Gynecol ; 11(2): 89-99, 2003.
Article in English | MEDLINE | ID: mdl-14627214

ABSTRACT

OBJECTIVE: To confirm the safety of a new experimental Tampax tampon and applicator compared with that of a currently marketed Tampax tampon and applicator using comprehensive gynecological and microbiological assessments. METHODS: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms (yeast, Escherichia coli, Staphylococcus aureus and group B streptococci) obtained by vaginal swab cultures after normal menstrual use in the experimental and control groups. RESULTS: In total, 110 women completed the study. There were no significant differences between the groups that used either the experimental or control tampon with regard to prevalence or mean cell density for the selected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion or ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments. There were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal, and a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon. There was a more favorable overall product rating for the experimental tampon (p = 0.003). CONCLUSIONS: This approach provides a combination of gynecological, microbiological and self-reported (diary recall) methodologies in order to assess tampon safety during use more thoroughly than has previously been reported, and it supports a comparable safety profile for the experimental tampon and a currently marketed tampon.


Subject(s)
Menstrual Hygiene Products , Vagina/chemistry , Vagina/microbiology , Adolescent , Adult , Colposcopy , Cross-Over Studies , Female , Humans , Hydrogen-Ion Concentration , Menstrual Hygiene Products/adverse effects , Menstrual Hygiene Products/standards , Mental Recall , Middle Aged , Safety , Single-Blind Method , Vagina/pathology , Vaginal Discharge/etiology
18.
Fed Regist ; 65(202): 62282-5, 2000 Oct 18.
Article in English | MEDLINE | ID: mdl-11503680

ABSTRACT

The Food and Drug Administration (FDA) is issuing a final rule that amends its menstrual tampon labeling regulation to add the term "ultra" absorbency for tampons that absorb 15 to 18 grams (g) of fluid with the syngyna test. At present, FDA requires standardized terms to be used for the labeling of a menstrual tampon to indicate its particular absorbency. This rule enables consumers to compare the absorbency of one brand and style of tampon with the absorbency of other brands and styles. FDA is issuing this final rule under the Federal Food, Drug, and Cosmetic Act (the act) to ensure that labeling of menstrual tampons is not misleading. Elsewhere in this issue of the Federal Register, FDA is proposing to change the standardized menstrual tampon term "junior" to "light".


Subject(s)
Menstrual Hygiene Products , Menstruation , Product Labeling , Female , Humans , Menstrual Hygiene Products/classification , Menstrual Hygiene Products/standards , Product Labeling/legislation & jurisprudence , United States , United States Food and Drug Administration
19.
Contraception ; 44(6): 607-21, 1991 Dec.
Article in English | MEDLINE | ID: mdl-1773618

ABSTRACT

Gynaeseal is a re-usable diaphragm tampon made from latex which forms a unique cervico-vaginal seal and isolates menstrual loss. In a prospective study involving 80 women, Gynaeseal was offered in combination with the Billings Ovulation Method in an advised birth control system. This system included: use of the diaphragm tampon during the menstruation-fertile phase interphase; periodic abstinence during the overtly fertile phase of the cycle; and if extreme reliability was required, for a further 2 days after the Billings method 'rules' allow resumption of intercourse. The diaphragm tampon successfully complemented the Billings Ovulation Method with 44 women (60.4%) assessing the GOM System as being as good, or better than, currently available reversible methods. It functioned effectively as a tampon with 50% (31 women) stating that they used the product as a contraceptive. One woman claimed an unplanned pregnancy. No significant medical complications were recorded. The product has major advantages as a tampon: it is easily and accurately inserted because of the efficient applicator; it isolated menstrual loss within a collection chamber; it protects the cervix; and it facilitates sexual activity. Based on a minimum effective diameter (62mm), the diaphragm tampon does not interfere with the normal physiology of the vagina. There appeared to be no significant distortion of normal adult pelvic anatomy, and properly placed, no sensation of the diaphragm tampon's presence. Regarding insertion of the diaphragm tampon using the spiral-curved applicator: 31 women (42.5%) had little or no difficulty; 29 (39.7%) moderate difficulty; 13 (17.8%) experienced serious difficulty; and 7 (8.7%) were unable to use the product.


PIP: Gynaeseal is a reusable diaphragm tampon made from latex which forms a unique cervicovaginal seal and isolates menstrual loss. In a prospective study involving 80 women. Gynaeseal was offered in combination with the Billings Ovulation Method in an advised birth control system. This system included use of the diaphragm tampon during menstruation-fertile phase interphase; periodic abstinence during the overtly fertile phase of the cycle; and if extreme reliability was required, for a further 2 days after the Billings method "rules" allow resumption of intercourse. The diaphragm tampon successfully complemented the Billings Ovulation Method with 44 women (60.4%) assessing the GOM system as being as good, or better than, currently available reversible methods. It functioned effectively as a tampon with 50% (31 women) stating that the product was superior to fiber tampons. 33 women (45.3%) stated that they used the product as a contraceptive. One woman experienced an unplanned pregnancy. No significant complications were recorded. The product has major advantages as a tampon--it is easily and accurately inserted with its efficient applicator; it isolates menstrual loss within a collection chamber; it protects the cervix; and it facilitates sexual activity. Based on a minimum effective diameter (62 mm), the diaphragm tampon does not interfere with the normal physiology of normal adult pelvic anatomy, and properly positioned, no sensation of the diaphragm tampon using the spiral-curved applicator, 31 women (942.5%) had little or no difficulty; 29 (39.7%) moderate difficulty; 13 (17.8%) experienced serious difficulty; and 7 (8.7%) were unable to use the product.


Subject(s)
Family Planning Services/methods , Intrauterine Devices/standards , Menstrual Hygiene Products/standards , Ovulation , Adolescent , Adult , Cohort Studies , Female , Humans , Ovulation Detection/methods , Prospective Studies , Surveys and Questionnaires , Time Factors
20.
Epidemiol Rev ; 13: 99-112, 1991.
Article in English | MEDLINE | ID: mdl-1662639

ABSTRACT

There has been a substantial reduction in the incidence of toxic shock syndrome in the 10 years since the association between tampons and toxic shock syndrome was first recognized. The decreased incidence is real, and not the result of decreased reporting to the passive surveillance system. The decreased incidence of menstrual toxic shock syndrome can primarily be explained by changes in the absorbency and composition of tampons available to the consumer. The reduction in the occurrence of menstrual toxic shock syndrome can be attributed to the withdrawal of Rely brand, which consisted of a unique composition, and subsequently to the lowering of absorbency of all brands of tampons. The conclusions of the early studies of toxic shock syndrome pointed the way to prompt public health interventions and resulted in the prevention of substantial morbidity.


Subject(s)
Bacterial Toxins , Menstrual Hygiene Products/adverse effects , Menstruation , Shock, Septic/epidemiology , Staphylococcal Infections/complications , Superantigens , Case-Control Studies , Centers for Disease Control and Prevention, U.S. , Enterotoxins/metabolism , Female , Humans , Menstrual Hygiene Products/standards , Risk Factors , Shock, Septic/metabolism , Shock, Septic/microbiology , Shock, Septic/prevention & control , Staphylococcus aureus/metabolism , United States
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