Clinical safety in use of a layered-fiber tampon
2001; Lippincott Williams & Wilkins; Volume: 97; Issue: 5 Linguagem: Inglês
10.1016/s0029-7844(01)01174-7
ISSN1873-233X
Autores Tópico(s)Pelvic floor disorders treatments
ResumoObjective: To confirm the safety of layered-fiber (TAMPAX) tampons compared with blended-fiber control tampons. Methods: Potential product-related irritation (determined by colposcopic examination and subject diary data); prevalence and count of E coli, yeast, group B streptococci, and S aureus (obtained by vaginal swab cultures); vaginal pH; and vaginal discharge were assessed monthly in a 4-month double-blind, randomized, crossover clinical safety-in-use study. Results: Eighty-two women completed the study. There were no meaningful differences between groups using the layered- and blended-fiber tampons 1) in prevalence and mean count of any microorganism; 2) for incidence or severity of erythema, laceration, or ulceration of the cervix, vagina, or vestibule; or 3) in mean vaginal pH and vaginal discharge (color and consistency) assessments. The few statistically significant differences were deemed not biologically relevant or were sporadic and formed no consistent pattern. There were similar, low incidences of menstrual and vaginal symptoms during tampon use and in the weeks after using either the layered-fiber or control tampons. Subjects reported little discomfort upon tampon insertion, wear, or removal. Conclusion: These results support the conclusion that the safety of a layered-fiber tampon is equivalent to that of blended-fiber tampons.
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