The history, use and gynaecological aspects of menstrual containment devices

1. History and need

The subject of menstruation is replete with folklore and superstition. In ancient and primitive medicine, menstruation was connected with the lunar cycles and the full moon was a libido symbol. Passages of Bible, in Leviticus, are concerned with the prohibition of intercourse and ritual uncleanliness during menstruation.

Contrary to the Biblical injunction, medical opinion of today hold that, except for aesthetic reasons, there is no objection to sexual intercourse during menstruation unless the flow is excessive in amount. Menstruation is no longer an excuse for curtailing work, pleasure or other activities.1

Means of menstrual protection have evolved over hundreds of years.

The ancient Egyptians fashioned disposable tampons from softened papyrus. The Greek physician Hippocrates, writing in the fifth century B.C., described another type of tampon which was made of lint wrapped around lightweight wood. Elsewhere, women improvised from the materials at hand: in Rome, it was wool; in Japan, paper; in Indonesia, vegetable fibres, in Equatorial Africa, rolls of grass.2

The common means of menstrual protection was a home-made sanitary napkin. In some instances, old sheets or pillowcases were torn into strips. These napkins were washed and used again and again.1 Pads went from reusable rags to disposable cotton worn attached to a belt, from bulky rectangular sponge-like things to ultra-thins with wings. The first disposable pads (‘‘Lister’s Towels—for Ladies Use’’) were manufactured around 1896. But their use was limited by the societal constraints that prevented significant advertising. Kotex pads, introduced in the 1920s, finally crept through advertising barriers to make disposable pads become widely available. The last generation was self-stick pads.

In the United States, the first menstrual cup was patented in 1867, but was obviously not commercially viable. The first usable commercial cup was patented by Leona Chalmers in 1937. This bell-shaped prototype has been used with little variation in more than 12 brands of reusable menstrual cups available today. 

The Food and Drug Administration (FDA) has classified menstrual products as Class I or II medical devices based on the level of regulatory control necessary to assure the safety and effectiveness of the device.3

 

Class I 

General control: Baseline requirements of food, drugs and cosmetics; It includes unscented menstrual pad.

 

Class II

General control and Special control; It includes scented or scented-deodorised menstrual pad, scented or scented-deodorised menstrual tampon, unscented menstrual tampon, and menstrual cup.4

 

2. What is in a name: sanitary towel, tampon 

Sanitary towel (UK), sanitary napkin (US), sanitary pad (Australia): The Cambridge dictionary defines sanitary towel as a piece of soft, material worn by a woman to absorb blood during her period (blood flow each month).

Tampon: The Oxford dictionary defines the tampon as (1) a plug of soft material inserted into the vagina to absorb menstrual blood. (2) Medicine: a plug of material used to stop a wound or block an opening in the body and absorb blood or secretions.

In mid 19th century, it originated from French, nasalised variant of tampon ‘plug, stopper’, ultimately of Germanic origin and related to tap.

 

3. Main types in the UK

A large variety of means of menstrual protection are available in the UK: sanitary pad, napkin, panty liners, tampon and menstrual cups. Among the available menstrual cups, Mooncup was developed in the UK and launched in 2002.5

In 2010, Stewart, K. et al determined the frequency of leakage and changing the Mooncup along with acceptability of the Mooncup by asking question to participant women. Mooncup leaked 0.5 times less frequently and required to be changed 2.8 times less frequently than regular sanitary protection. This study concluded that the Mooncup is acceptable for most women, but could not be used for the objective measurement of menstrual blood loss because of the leakage that did occur.6

 

4. User characteristics

The choice of means of menstrual protection seems dependant on a number of user’s characteristics: favourable maternal attitude, friends’ use of particular products, regional difference, ethnicity and climates.

Tampon users were significantly more likely than pad users to have mothers and friends, but not sisters, who had a favourable attitude toward tampon use. The best predictors of tampon use in a multivariate model were a favourable maternal attitude (odds ratio (OR), 5.3; 95% confidence interval (CI), 2.4, 12.1) and friends’ use of tampons (OR 7.9; 95% CI 3.5, 18.1).7

Brooks-Gunn et al surveyed 619 adolescent girls regarding the relation of tampon use to reports of symptoms, attitudes, and family beliefs about menstruation. Napkin use decreased and tampon use increased from elementary to senior high school. Tampons were used by 23% of the 5th and 6th grade girls and 75% of the 11th and 12th grade girls. The majority of adolescents learned how to use tampons from their mothers, although the source of explanation varied by age. Tampon users were less self-conscious about themselves and more comfortable talking about menstruation. A positive family atmosphere was reported by girls who learned how to use tampons from their mothers rather from others.8

Regional differences in usage practices depend on culture, economics, and climate, which may influence on user’s skin compatibility. Evidence for ethnic differences in skin irritant susceptibility is not compelling. Dark skin may be less susceptible to certain irritants than fair skin. Ambient conditions such as high temperature and humidity increase the skin temperature and skin surface moisture under sanitary pads by small but measurable amounts, causing no discernible skin irritation; vapour-permeable pad backings reduce these effects. Cold dry conditions, which can irritate exposed skin, may not affect vulvar skin to the same degree due to its elevated hydration and occlusion. 

To address the practical significance of these variables, results of prospective clinical trials of sanitary pads performed by industry and academic scientists in North America (Indiana), Mexico, Western Europe (Munich, Athens; Goteborg, Sweden; Eastern Europe (Kiev) and Africa (Abuja, Nigeria) were reviewed. Despite the diverse range of conditions, no significant adverse skin effects were observed with modern pads compared to traditional pad designs. Study participants generally preferred modern pads for performance and comfort.9

 

5. Common complications 

 

Forgotten tampons

Many women have inserted a new tampon, while forgetting to remove the old one. More often, the woman simply forgets to take the last one out at the end of the period. Others have genital intercourse with a tampon in. 

 

Cup 

Popular use of these cups may be limited by several factors:

• Insertion can be difficult. 

• Once inserted, it may still need to be oriented properly in the vaginal canal. 

• Users find it distasteful and messy to handle menstrual fluid during device removal and washing.

• Concerns about ‘‘virginity’’ may limit use among inexperienced women

 

Menstrual Pad

The annoyances of the menstrual pad are quite well known:

• Chafing

• The dampness, warmth and soiling of the cloth

• The to-and-fro motion provides a potential means of spreading infection from one habitus to another; namely the rectum, vagina and urethra.

• The straps and buckles are annoying, and the bulge is visible through diaphanous clothing. The menstrual pad is a serious handicap to actresses, dancers, acrobats and athletes due to visible through scanty clothing.

• Contact dermatitis has been reported

 

There were surveys and studies comparing commercially available sanitary pads with a nonwoven unique surface sheet and pads with a perforated film, on the cutaneous and sensory effects. No significant difference from baseline was found in the vulvar skin surface pH or in the number of total bacteria for either product. The majority of subjects were highly satisfied with both types, but they especially preferred the sanitary pad with a nonwoven unique surface top sheet.10, 11

 

6. Uncommon complications 

Toxic shock syndrome (TSS), a rare but potentially fatal disease caused by a bacterial toxin, has also been associated with tampon use. Although the exact connection remains unclear, use of high-absorbency tampons produced with rayon and leaving tampons in for an extended period of time seem to increase the risk of TSS. The disease was first described among teenage girls in 1978. The TSS epidemic reached a peak in 1980 with a total of 813 cases, including 38 deaths, reported to the Center for Disease Control and Prevention (CDC).12

Vostral, SL examined factors leading to the identification of Toxic Shock Syndrome with the bacteria Staphylococcus aureus in 1978 and the specific role of Rely tampons in generating a technologically rooted health crisis.13 Among women using tampons, cases were more likely to have used Rely brand tampons when compared with controls.14

In 1980, the FDA began requiring all tampon packages to include package inserts educating women about the risk of TSS and how to prevent it. In 1982, the FDA required that all tampon labels advise women to use the lowest absorbency needed to control their flow and include TSS warning signs. In 1990, standardised absorbency labelling was introduced so that absorbency terms (e.g. regular, super, etc.) are consistent across brands.12, 15 The manufacturers advised not to use a tampon for more than eight hours. 

In 1997, there were only five confirmed menstrual-related TSS cases and no deaths. The possible reason for this reported decrease is because tampon manufacturers have removed three of the four synthetic ingredients (polyester, carboxymethyl cellulose, and polyacrylate rayon) once commonly used in tampons to enhance absorbency. However, highly absorbent viscose rayon is still used.

The removal of the synthetic fibres by manufacturers was due in part to independent research that showed tampons containing synthetic additives increase production of the TSS toxin, and that all-cotton tampons do not. According to Tierno, this suggests that all-cotton tampons are safer than rayon and rayon-blend tampons. Considering that a 1994 study found that up to 99 percent of menstruating women diagnosed with TSS were using tampons, and that not enough is known about potential health risks associated with tampon additives, it is clear that more accurate information is needed regarding the hazards of tampons.

 

Other uncommon possible risks

The Environmental Protection Agency has concluded that dioxin is probably human carcinogen and risk factor for non-carcinogenic effects that could suppress the immune system, increase the risk of pelvic inflammatory disease and reduce fertility. Some studies have produced conflicting information between dioxin exposure and increased risks for endometriosis.

Tampons are usually made of cotton and rayon. Rayon is a synthetic fibre made from wood pulp. During the chlorine bleaching process, a toxic by-product known as dioxin is created. Very small amounts of dioxin are in the rayon fibre. Even if all dioxin in tampons were absorbed into the body, exposure to dioxin would still be many times less than dioxin typically consumed in food. However, effects of dioxin are cumulative and can be measured 20 to 30 years after exposure. That is particularly troubling because tampons are used by up to 70 percent of menstruating women in the U.S., and it has been estimated that the average woman may use as many as 16,800 tampons in her lifetime. 

 

Sponge

Sea sponges are technically no longer allowed to be sold as menstrual products. In late 1980, menstrual sponges sold commercially were examined by a University of Iowa laboratory and found to contain sand, grit, bacteria, and various other contaminants. Other studies have found chemical pollutants and fungi in sponges sold for menstrual use. Therefore, it is potentially dangerous. The Centers for Disease Control have documented at least one case of Toxic Shock Syndrome associated with the use of a sea sponge.16, 17

The FDA said that sea sponges labelled as “menstrual sponges,” “hygienic sponges,” or “sanitary sponges,” intended for use as menstrual tampons, are regarded as significant risk devices requiring premarket approval.17

 

7. Implications of new developments: absorbency, ‘anti-bacterial’ brands, anti-odour brands

 

Tampon absorbency

Menstrual tampons are available in a range of absorbencies to allow women to use the product most appropriate to their needs. 

 

Tampons absorbency ratings

 

 

Hochwalt, A E and et al 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. This study concluded that 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.18 No differences were found between cases with TTS and controls in the absorbency of tampon products used.14

 

Anti-odour brand

Women feel dirty and ashamed of their bodies although menstruation is not dirty and a healthy vagina smells like a vagina. 

There have been a load of scented sanitary products on the market. Commercial tampons and pads are associated with general risks along with the chemicals and bleach used to unnecessarily bleach products, but now fragranced to make our vaginas smell like flowers. It is important for manufacturers to explore carefully the safety of perfumes and preservatives. 

 

Anti-bacterial brand

There were some tampons with antibacterial and antimycotic effects, by a formula maintaining physiological level of vaginal pH.19

 

8. The tampon as a ‘sampling /diagnostic tool’

There were studies to evaluate acceptability of self-collected tampon samples for screening of sexually transmitted infections (gonococcus, chlamydia, Herpes and human papilloma virus) and cervical smear. It found to have a variable effectiveness. One of the factors is women’s perceptions of the examination, discomfort; inconvenience, embarrassment, and shame have all been shown to be barriers to screening. Although the self-administered tampon Thin Prep method is a poor detector of cervical abnormalities compared to Papanicolou smear, it is highly acceptable to women.20-24 

 

9. The tampon as a ‘drug delivery device’

Drug impregnated vaginal tampons were studied to manage dysmenorrhoea and to deliver antimicrobial drugs.

A Pain-Reliever Eluting Tampon (the Tampain) was designed for two main components:  a generic tampon base that absorbs menstrual fluid and a drug eluting capsule that relieves cramps, bloating, and headaches. The absorbent tampon base falls under the medium absorbency range of 9-12 grams-fluid and is made from 100% cotton. The drug-eluting capsule is held on the top of the tampon by a small flexible plastic cup. The drug capsule is a PVA hydrogel that is doped with 650mg of aspirin, to relieve cramping and headaches.14

Joanis CL evaluated the concept a non-woven textile material (modified tampon) for vaginal drug delivery. The study was nested within a Phase I randomised safety trial of delivering yeast medications and STI/HIV preventives used intra-vaginally.25

In 1982, Chien YW et al studied the technical feasibility of utilising tampons as a drug delivery system for prolonged intravaginal drug administrations (metronidazole) was studied. But the result was not published.26

In 1979, Dame, W R. et al reported a study on a short term two and a half day treatment with miconazole medicated tampons (five tampons), which showed a success rate of 92.5%. The fast relief of symptoms like discharge, itching and burning is an improvement of the medicated tampon treatment.27

 

10. Unorthodox use of tampon

Treatment of vaginal yeast infection: it is a popular method and a little unorthodox is to dip a tampon into the yogurt and insert into the vaginal area for several minutes.

News reports from Phoenix suggest that teenagers are getting high by utilising tampons which are soaked in vodka first before inserted in their vaginas. This method appears to be very effective due to the fact that the alcohol gets absorbed directly and quickly into the blood stream without any barrier or stomach acid to mitigate its effects. A Super Tampon can hold the equivalent of a shot of vodka.

 

Conclusion

A large variety of means of menstrual protection are available in the UK and worldwide. The choice of means of menstrual protection seems depend on a number of user’s characteristics, culture, economics, and climate. 

The manufacturers should determine the safety of their product, the presence of dioxin, synthetic fibres, and other additives in tampons and related products pose any health risks to women. There is no research to support the absolute safety of the product. 

This area is not touched by health professionals and doctors to provide correctly information to the patients about the safety of these products. Therefore, this area is needed to explore and included in medical literature especially in the chapter for management of menstrual disorders and menorrhagia.

In the past, drug impregnated vaginal tampon were studied to manage dysmenorrhoea and to deliver antimicrobial drugs, although the results were not clear. The medicated tampon can provide sustained released action of drug to vagina, which is absorbed into systemic circulation. This route of drug administration should be explored as it can be effective for local and systemic treatment purposes. It will be beneficial for women who need a sustained release local treatment e.g. recurrent vaginal candidiasis, or who find other routes of drug administration are not possible.

References

  1. Rebecca Liswood. Use of a safe and sanitary menstrual cup, Internal Menstrual Protection: Obstetrics and Gynaecology; May 1959; Vol. 13, No. 5: 539-43. 
  2. Sarah Kowalski. Welcome This New Day, For Womanhood, Tampons in American History, December 1999
  3. Device classification [www.fda.gov] 
  4. Guidance for Industry and FDA Staff. Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s): www.fda.gov: Document issued on July 27, 2005. 
  5. www.mooncup.co.uk
  6. Stewart, K. Greer, R. Powell, M. Women’s experience of using the Mooncup; Journal of Obstetrics & Gynaecology 2010: 30(3):285-7.
  7. Emans SJ, Woods ER, Allred EN, Grace E. Hymenal findings in adolescent women: impact of tampon use and consensual sexual activity. The Journal of Paediatrics 1994 Jul; 125(1):153-60.
  8. Brooks-Gunn, J. Ruble, D N. Psychological correlates of tampon use in adolescents: Annals of Internal Medicine. 1982 June; 96(6 Pt. 2):962-5.
  9. Farage, Miranda. Elsner, Peter. Maibach, Howard. Influence of usage practices, ethnicity and climate on the skin compatibility of sanitary pads [Review]: Archives of Gynaecology & Obstetrics 2007 Jun; 275(6):415-27.
  10. Fujimura, Tsutomu. Sato, Noriko. Takagi, Yutaka. Ohuchi, Atsushi. Kawasaki, Hironori. Kitahara, Takashi. Takema, Yoshinori. Rizer, Ronald L. An investigator blinded cross-over study to characterize the cutaneous effects and suitability of modern sanitary pads for menstrual protection for women residing in the USA: Cutaneous & Ocular Toxicology 2011 Sep; 30(3):205-11.
  11. Xuemin, Wang. Sato, Noriko. Chao, Yuan. Na, Liu. Fujimura, Tsutomu. Takagi, Yutaka. Nojiri, Hirosh. Kitahara, Takashi. Takema, Yoshinori. Cutaneous and sensory effects of two types of sanitary pads with different surfaces in the Shanghai, Chinese population: Cutaneous & Ocular Toxicology 2011 Sep; 30(3):212-6.
  12. Susan Dudley, PhD, Salwa Nassar, BA, Emily Hartman, BA. Tampon Safety. National Research Center for Women & Families; Revised July 2009
  13. Vostral, Sharra L. Rely and Toxic Shock Syndrome: a technological health crisis [Review]: Yale Journal of Biology & Medicine 2011 Dec; 84(4):447-59.
  14. Schlech, W F 3rd. Shands, K N. Reingold, A L. Dan, B B. Schmid, G P. Hargrett, N T. Hightower, A. Herwaldt, L A. Neill, M A. Band, J D. Bennett, J V. Risk factors for development of toxic shock syndrome; Association with a tampon brand: JAMA 1982 Aug; 248(7):835-9.
  15. 100 years of Protecting and Promoting women’s Health 1906-2006. FDA Centennial 2006; p7
  16. Menstrual cycles and sea sponges [www.johnrobbins.info]
  17. CPG Sec. 345.300 Menstrual Sponges; Inspections, Compliance, Enforcement, and Criminal Investigations; FDA; U.S Department of Health & Human Services 
  18. Hochwalt, Anne E. Jones, Michaelle B. Meyer, Sandy J. Clinical safety assessment of an ultra absorbency menstrual tampon: Journal of Women’s Health 2010 Feb; 19(2):273-8.
  19. Fras Zemljic, Lidija. But, Igor. Stana-Kleinschek, Karin. Ribitsch, Volker. Zabret, Andrej. Tampon which contains pH regulating, antibacterial, and antimycotic active formulation and the procedure of its production: World Intellectual Property Organization; 13 Dec 2007; WO/2007/142609   
  20. Kimmitt, P T. Tabrizi, S N. Crosatti, M. Garland, S M. Schober, P C. Raja Kumar, K. Chapman, C A. Pilot study of the utility and acceptability of tampon sampling for the diagnosis of Neisseria gonorrhoea and Chlamydia trachomatis infections by duplex real time polymerase chain reaction in United Kingdom sex workers: International Journal of STD & AIDS 2010 Apr; 21(4):279-82.
  21. Smith, B L. Cummings, M C. Benes, S. McCormack. Evaluation of vaginal tampons for collection of specimens for detection of Chlamydial infection: Sexually Transmitted Diseases 1996 Mar-Apr; 23(2):127-30.
  22. 22 Ekwo, E E. Myers, M G. Tampon culture for quantitation of cervicovaginal herpes simplex virus: Journal of Medical Virology 1978; 2(1):1-5.
  23. Michael A Bidus, Christopher M. Zahn, G. Larry Maxwell, Mildred Rodriguez, John C. Elkas and G. Scott Rose. Clinical Obstetrics and Gynaecology; Lippincott Williams & Wilkins 2005; 48 (1), 127–132. 
  24. Budge, Mardi. Halford, Jenny. Haran, Mano. Mein, Jacki. Wright, Gordon. Comparison of a self-administered tampon Thin Prep test with conventional pap smears for cervical cytology: Australian & New Zealand Journal of Obstetrics & Gynaecology 2005 Jun; 45(3):215-9. 
  25. Kari Cooper, Robert Dulabon, Sean Moran, Nina O’Connell. The Tampain; A Pain-Reliever Eluting Tampon: University of Pittsburgh USA; April 22, 2008.
  26. Y. W. Chien1, J. Oppermann2, B. Nicolova2, H. J. Lambert. Medicated tampons: Intravaginal sustained administration of metronidazole and in vitro-in vivo relationships: Journal of Pharmaceutical Sciences 1982 July; 71(7):767–771.
  27. Dame, W R. Fegeler, W. Experiences with an antimycotic tampon in the treatment of saccharomycetic vaginal infection; German: Fortschritte der Medizin; 1979 May; 97(19):923-5.



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