Correlation of behaviors with microbiological changes in vaginal flora.
(1/43)
Bacterial vaginosis (BV) is characterized by dramatic changes in the vaginal ecosystem. Women without evidence of vaginal infection may exhibit transient changes in their flora. We prospectively followed up women by using diaries and self-obtained vaginal smears to correlate behaviors with changes in flora. The majority of women (38/51, 78%) had significant, although transient, changes. Behaviors associated with unstable flora were a history of BV, a greater number of partners, and more frequent episodes of receptive oral sex. Only the latter remained significantly associated in the multivariate analysis. Variables that were associated with day-to-day variability in the flora included use of vaginal medication, menses, greater number of partners, spermicide use, more frequent vaginal intercourse, and less frequent use of condoms. Only a minority of women (11/51, 22%) maintained a "normal" lactobacillus-predominant flora. Factors associated with instability of the flora are similar to those epidemiologically associated with BV. (+info)
Toxic shock syndrome in the United States: surveillance update, 1979 1996.
(2/43)
Menstrual toxic shock syndrome (TSS) emerged as a public health threat to women of reproductive age in 1979 80. We reviewed surveillance data for the period 1979 to 1996, when 5,296 cases were reported, and discuss changes in the epidemiologic features of TSS. (+info)
Medical devices; labeling for menstrual tampon for the "ultra" absorbency. Food and Drug Administration, HHS. Final rule.
(3/43)
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". (+info)
Site-specific prevalence and cell densities of selected microbes in the lower reproductive tract of menstruating tampon users.
(4/43)
OBJECTIVE: To assess differences in prevalence and cell densities of enterococci, Gram negative enterics (GNEs), yeast and Staphylococcus aureus among four genital sites and to examine whether the presence of organisms at one site affected the presence of organisms at other sites. METHODS: Swab samples from the perineum, below and above the hymen, and the posterior fornix obtained from 52 tampon users on menstrual cycle day 3 were analyzed for site-specific prevalence and cell densities of microorganisms. RESULTS: Enterococci and GNEs were the most prevalent study organisms at all sites and decreased in prevalence from the perineum to the posterior fornix. Cell densities similarly decreased from below the hymen to the posterior fornix. Yeast were detected at the hymen only; S. aureus frequency was similarly low at all sites. Yeast and S. aureus site-specific cell densities were similar. The above- and below-hymen sites were similar in prevalence and cell density of organisms. An above-chance association existed between the presence of any study organism below the hymen and above the hymen and was strongest for GNEs. CONCLUSIONS: The pattern of genital colonization with enterococci and GNEs reflects their likely gastrointestinal source. The absence of significant differences in the prevalence and cell densities of study microflora above and below the hymen combined with an above-chance association of the presence of microorganisms at these regions suggests that the regions above and below the hymen are not different with respect to the presence of the organisms evaluated in this study. (+info)
Detection of Staphylococcus aureus biofilm on tampons and menses components.
(5/43)
Culturing has detected vaginal Staphylococcus aureus in 10%-20% of women. Because growth mode can affect virulence expression, this study examined S. aureus-biofilm occurrence in 44 paired-tampon and vaginal-wash-specimens from 18 prescreened women, using fluorescent in situ hybridization (FISH). All 44 specimens were also analyzed for S. aureus by standard culturing on mannitol salt agar, which produced positive results for 15 of the 44 specimens. FISH detected S. aureus cells in all 44 specimens, and S. aureus biofilm was observed in 37 of the 44 specimens. Independent confirmation of the presence of S. aureus in specimens from all 18 women was also obtained by amplification, via polymerase chain reaction, of an S. aureus-specific nuclease gene. The results of this study demonstrate that S. aureus biofilm can form on tampons and menses components in vivo. Additionally, the prevalence of vaginal S. aureus carriage may be more prevalent than what is currently demonstrated by standard culturing techniques. (+info)
Clinical safety-in-use study of a new tampon design.
(6/43)
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. (+info)
Factors affecting the detection rate of human papillomavirus.
(7/43)
BACKGROUND: Maximizing the accuracy of human papillomavirus (HPV) detection from a single sample is important for clinical and research purposes. The purpose of this study was to determine whether cyclic hormonal variation, recent sexual intercourse, interval between samplings, and the technique used to sample affect the detection of HPV. METHODS: This study was a prospective, longitudinal, randomized controlled trial. Three techniques for self-sampling (2 consecutive synthetic polyester fiber [Dacron] swabs, a single Dacron swab, and a tampon) were repeated at 3 different sampling times during a period of 4 to 6 weeks in addition to 1 clinician-directed sampling of the ectocervix and endocervix at the first sampling time. All self-samplings were taken in a proscribed randomized order. Women (aged 18 to 68 years) attending a colposcopy clinic for abnormal cytology or abnormal cervical appearance participated in the study. The outcome measure was the detection of HPV by polymerase chain reaction amplification. RESULTS: The 103 participants provided 1,189 cervicovaginal samplings. Logistic regression indicated that intercourse within 48 hours of sampling did not result in a greater detection of high-risk or any HPV type (odds ratio [OR] = 1.05, 95% confidence interval [CI], 0.65-1.69; OR = 1.08, 95% CI, 0.73-1.60, respectively). Among those women who have regular menstrual cycles, there was no cyclic effect on HPV detection for high-risk and any HPV types. Time from previous sampling did not affect HPV detection. Among the self-sampling techniques, using a single self-swab and the tampon resulted in the detection of HPV between 10% and 35% less often than using 2 consecutive swabs (P < .025). Self-sampling with 2 swabs was not significantly different from clinician sampling for detecting high-risk HPV types (OR for self-sampling = 0.87 (95% CI, 0.66-1.13)). CONCLUSIONS: HPV detection is not dependent on menstrual cycle timings, the recency of intercourse, or the time between samplings, but it is dependent on the sampling technique. (+info)
Medical devices; labeling for menstrual tampons; ranges of absorbency, change from "junior" to "light." Final rule.
(8/43)
The Food and Drug Administration (FDA) is issuing a final rule that amends its menstrual tampon labeling regulation to change the current term for tampons that absorb 6 grams (g) and under of fluid. A tampon with absorbency of 6 g or less is currently required to be labeled as "junior". FDA is changing the term "junior" to "light". The term "junior" implies that the tampon is only for younger or teenage women when, in fact, it may be appropriate for women of any age with light menstrual flow. FDA encourages women to use the lowest absorbency tampon appropriate for their flow to help minimize the risk of Toxic Shock Syndrome (TSS). At present, FDA requires standardized terms to be used for the labeling of a menstrual tampon to indicate its particular absorbency. This rule enables women to compare the absorbency of one brand and style of tampons 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. (+info)