Feminine Tampons

 Background

Feminine tampons are nonwoven textile structures used to temporarily stop the flow of blood and shed tissue, due to menstruation, from exiting the vagina. Feminine tampons have two separate parts:

Image 1: Feminine Tampon

the nonwoven tampon that absorbs menstrual flow and the applicator used to insert it into the vagina. The absorbent core of tampons are typically made using cotton and/or rayon due to their ability to absorb liquids effectively. This absorbent core is covered in a thin nonwoven fabric that is typically made of rayon and polyester or polyethylene and polypropylene. The applicator can be made of cardboard or plastic with pigments for color [1].  Cardboard materials are less expensive, but plastic applicators tend to allow more comfort in application.

There are many manufacturers and producers of feminine hygiene products worldwide. Feminine hygiene is a category of products that encompases a large range of diversified product offerings from sanitary napkins, to pantyliners, to tampons.  Some manufacturers of feminine tampons in the United States are First Quality Hygienic, Kimberly-Clark Corporation, Maxim Hygiene Products, Natracare LLC, Playtex Products, and Procter and Gamble. Some of these corporations, like Maxim Hygiene Products and Natracare LLC,  are relatively small and can produce specialty items like organic or 100% cotton tampons. Other companies, like Playtex, Kimberly-Clark, and Procter and Gamble, are very large and produce a wide range of products in many different product categories [2]. Each of these manufactures sells their products either directly to a store using a recognizable brand name, or to another corporation that will brand the products according to their own specifications and sell them to stores.

Surface modifications and treatments for feminine tampons must be closely studied prior to use in the body. Because the tampon is inserted into the vagina, substances cannot go through typical elimination processes. Chemicals on tampons are absorbed by the vaginal mucosa and have the ability to pass directly into the bloodstream. Many feminine tampons are fragranced. According to research done by Ami Zota at George Washington University, fragranced tampons can “raise a woman’s exposure to phthalates, a class of suspected endocrine disrupters some research has linked to developmental issues like lower IQs and higher rates of asthma.” [3]. Historically, dioxins in tampons caused many problems in feminine health. Dioxins are highly toxic chemicals that are a byproduct of the bleaching process involved in the manufacture of tampons. Although the amount of these chemicals has decreased over time, cumulative exposure to dioxins can increase the woman’s chance for complications such as Toxic Shock Syndrome [3].  Although rare, Toxic Shock Syndrome is a life-threatening complication of certain types of bacterial infections.  For more information on TSS and its causes, read the Contra-indications section further down on this webpage. 

Condition for Use and Epidemiology

• Menstruation occurs when a woman’s uterus sheds its lining.  Menstrual blood sheds from the uterus and travels through the cervix where it is passed out of the body through the vagina.  This occurs cyclically with the average period lasting 3 to 5 days with about 28 days in between.  The menstrual cycle provides the body with important hormones and prepares the body for pregnancy each month [4].
• A woman’s first period usually begins when she is between 12 and 15 years old, but it can start as early as age 8 [12]. Menstruation stops during pregnancy and after menopause. Menopause typically occurs between 45 and 55 years of age [13]. There are approximately 91 million women in the United States that are between the ages of 10 and 54 according to the 2015 US census [14]. Although it is possible for all 91 million of these women to be menstruating, not all will be able to because of infertility issues and other complications.
• The main symptom of menstruation is the shedding of uterine lining and extra blood through the vagina. This comes with other symptoms that are classified as Premenstrual Syndrome (PMS). PMS typically occurs one to two weeks prior to the start of a woman’s period.  Symptoms commonly classified as PMS are acne, feeling tired, headaches, appetite changes, anxiety and more.  These symptoms present themselves differently for different women[5].
• The biological environment is the female reproductive system, with the main surrounding component being the cervix. The cervix is a cylindrical tissue that connects the vagina and uterus. The cervix is a cylindrical tissue that connects the vagina and uterus. The cervix is mostly made of fibromuscular tissue and there are two main parts: the ectocervix and the endocervix. The ectocervix is the middle of the cylindrical shape. The endocervix is a tunnel through the cervix that goes from the external os (opening in the center of the ectocervix) to the uterus. There is an overlapping border between these two parts called the transformation zone. The surrounding blood is also tissue that the tampon comes into contact with. Along with the tissue components, the cervix is comprised of mucus that changes consistency during the menstrual cycle to prevent or promote pregnancy [6].

Image 2: Diagram of the Female Reproductive System

Application

Tampons are commonly used and are implanted into the body by the user. Before inserting a tampon, the woman should wash her hands with soap and water. There should be a string hanging out the back end of the applicator. She should gently pull on the strings to make sure they are firmly attached. It is best to insert the tampon from a seated position where muscles are relaxed. She should gently insert the front end of the tampon applicator (NOT the side with strings) into the vagina until her fingers touch the skin. She should push on the back end of the tampon applicator (the side with strings) to insert the tampon into the body [4]. The tampon should be removed and changed every 4 to 8 hours. To remove the tampon, the woman should wash her hands first. Then, she should get into a seated position where her muscles are most relaxed. After, she should use two fingers to grip the string on the back of the tampon that is inserted.  She should gently pull the string until the tampon has been removed completely from the body. The tampon should then be discarded.

Alternatives 

Menstrual Cup 

Image 3: Menstrual Cup

The menstrual cup is an alternative interior protection device to the tampon.   It acts as a catch basin which is inserted in the upper vagina and seals off the blood flow during the menstrual cycle.  It is a safe, sanitary, and comfortable method for women to continue with daily activities during their period.  

The menstrual cups is produced with bacteria resistant rubber and should be immersed in a weak solution of chlorine bleach after each use.  It is inserted and should rest well below the anterior and posterior vagina, leaving a gap between the cervix and the circumference of the cup itself.

The menstrual cup is made of soft, flexible plastic to ensure that the wearer is never conscious of its presence.  It is designed to retain its proper position.  The double molded, concave rim of the cup measures at approximately 1 ¾ inches receives a fold of the vagina to secure it in place.  Below the lower, smaller rim there are tiny perforations which allow oxygen to escape to prevent cramps and to release the vacuum when the cup is removed.  The receptacle is 2 in deep and can hold up to one fluid ounce of fluid. The average flow during a menstrual cycle is 10 to 35 ml of blood loss.

The cup can be inserted by folding it over lengthwise twice, lubricating, and inserting.  Once inside it will pop open and adjust to a correct position.  For removal, the withdrawal tip drawn downward, angled toward the rectum to remove the vacuum and ensure a comfort during removal [15].

The table below outlines some of the advantages and disadvantages to using a menstrual cup in comparison to a tampon [19]:

Advantages	Disadvantages
Economical ($30 yearly vs monthly purchases of tampons/pads) Can be used for up to five more hours than a tampon Decreases the chance of getting Toxic Shock Syndrome Does not expose the vagina to harmful chemicals Odor free	Messy removal They don’t always fit and determining the correct size can be difficult Require maintenance to remove because they are reusable- they must be cleaned properly before reinserted

Sanitary Napkins (Pad)

Image 4: Sanitary Napkin

The sanitary pad is the most widely used method for menstrual management and has been dated back as far as ancient Rome. It is a low risk, disposable medical textile and does not require insertion in the body for use.  

In ancient times, these devices were made from wool to absorb fluids during women’s menstrual cycles.  In parts of Africa, rolls of grass were used while in Hawaiian women used ferns.  Most sanitary pads today are made from bleached rayon, cellulose made from wood pulp, cotton and plastic.  However, each brand of tampons manufactured differently.  

All pads utilize an adhesive layer on the underside of the device and an extended front and back to assist in maintaining its position during use.  Sanitary napkins are all treated with fragrances and antibacterial finish to help in preventing infections.  The video below outlines the process for making a sanitary napkin [16].

The table below outlines some of the advantages and disadvantages to using a menstrual cup in comparison to a tampon [20]:

Advantages	Disadvantages
Pose fewer health risk than tampons Can be worn with a lighter flow Can be worn overnight External product Allows you to better monitor flow Do not increase menstrual cramps	Disposable pads have been said to be uncomfortable Can cause bad odor Disposable pads risk infection Can create more waste Can show through clothing Makes it harder to participate in physical activities

Product Examples

Playtex

Image 5: Playtex No Slip Grip Tampon

Playtex, renowned as the #1 athletic tampon company, offers many different option for the active female[7].  The Sport Compact tampon showcased above, is the smallest discreetly sized compact tampon the company offers. With FlexFit fibers that are interlocked to trap leaks, it is very effective in reducing leakage, an issue commonly voiced by those interviewed on their experience with this product.  This product also features easy application, with a Pull & Click into place applicator, as well as an Expandable plunger.  Though this product is designed for the active kind, it can be used in any setting for any female. These athletic tampons are designed to move comfortably with the body, and stay in place during strenuous exercise. This is possible through the FlexFit technology, which is designed to move as the body moves.

Natracare

Image 6: Natracare Organic Tampons

During interviews with college-aged female students, many pointed out the fact that they feel more could be done to make tampons more environmentally friendly, at a low cost. Though it is not cheap compared to other mainstream products, the Natracare Organic Cotton tampons provide an environmentally healthy alternative for the green minded. These products are 100% cotton, chlorine free, biodegradable and compostable[8]. They also feature a standard cardboard applicator, though few have voiced concern over the comfort issue associated with cardboard. Natracare also offers a product without an applicator, which requires manual insertion. The brand markets the fact that typical plastic applicators from mainstream companies contribute heavily to marine pollution. By using the cardboard applicator, Natracare avoids this issue, keeping females and animal populations healthy worldwide.

Indications and Contra-indications

Indications for use: Menstruation is a natural biological process and is not “treatable.” However, the symptoms can be controlled. Vaginal tampons are used to plug the cervix in order to absorb the menstrual flow to temporarily prohibit the shed uterine lining from exiting the vagina [7]. Their compact design allows the woman to be more comfortable in her activities throughout the day.

Contra-indications: According to most recent data from the Center for Disease Control and Prevention, from 1979 to 1996, 5,296 TSS cases were reported. Of those reported cases, 93% were reported among women [18].  Although rare, Toxic Shock Syndrome is a life-threatening complication of certain types of bacterial infections. Many times, TSS results from toxins produced by Staphylococcus aureus (staph) bacteria, but the condition may also be caused by toxins produced by group A streptococcus (strep) bacteria. Historically, TSS has been associated with the use of superabsorbent tampons.  TTS can occur in menstruating women when they leave in a tampon for longer than eight hours. Now, manufacturers of tampons sold in the United States are no longer allowed to use materials or designs that were originally associated with TSS. The FDA also requires manufacturers to use standard measurements and labeling for absorbency in order that the correct information is printed on each tampon box [8]. To prevent TSS, it is important to read these labels and use the lowest absorbency available in coordination to the heaviness of the menstrual flow. The woman should also change her tampon at least every four to eight hours, and it is recommended that she alternate between tampons and sanitary napkins. Another potential cause for TSS and/or the need for a hospital visit is the tampon getting “lost” in the vagina. This occurs when the string cannot be retrieved or breaks while the tampon is still inside the woman. In order to prevent this, it is advised that the woman gently pull on the strings of the tampon while it is in the applicator prior to insertion to test for defects. 

Advantages and Deficiencies

Advantages

• Tampons are designed to absorb menstrual flow, before it has a chance to leave the body.
• In nearly all tampons currently on the market, withdrawal strings are present to help facilitate the comfortable removal of the feminine tampon.
• Many tampons on the market are small and portable, making them very convenient.
• Many tampons offer resealable wraps, making them easily disposable.
• Tampon companies typically offer multiple levels of absorbency as needed based on the personal case.
• Tampons come in various “sizes” and applications.  The sizes include regular which holds 4-6g of blood, super holds 6-9g, and super plus holds 9-12g.  There is also a junior size which is smaller than regular in actual size/shape but holds the same.

Deficiencies

• From personal interviews, it was found that many women are concerned about the environmental aspect of the disposal of tampons. Many times, tampons use plastic applicators which are not biodegradable or recyclable. In developing nations, these plastic applicators can not be disposed of in a sanitary matter as well as they can be in developed nations.
• Many women reported that the string can be very annoying and uncomfortable, especially when wearing in a bathing suit.
• Many women also report that tampons simply aren’t easy to use, having to be replaced every few hours. Women run the risk of toxic shock syndrome if they do not replace the tampons in a timely manner.
• A few stated that the applicators are difficult to use, and many often times don’t use the applicator, instead manually inserting  the tampon.
• Many also stated that traditional cardboard applicators can cause extreme discomfort, forcing them to use the plastic alternative that is often more expensive. When the average female runs through a box of tampons during one cycle, these costs can add up.
• Because tampons must be replaced every few hours, many women find themselves spending an exorbitant amount of money in order to buy the brands that are the most comfortable and suitable for them, even though these may carry a higher price tag.
• Gloria Srita; An inventor of reusable tampons, highlights the potential harms tampons can cause, claiming: “Women are starting to understand they don’t really want to put toxic products up their vaginas at the receptive to whatever poisons you are putting in there”.
• Many women state that it is believed that bleached rayon, a product commonly used in tampons, can cause cancer[7].
• Many tampons fail to prevent leakage. A patent on a new design for tampons states:  “However, some tampons, regardless of their rated capability to absorb and hold fluid, fail to prevent leakage before the tampon reaches its rated absorbent capacity, allowing the menstrual fluid to bypass the tampon along vaginal walls. This problem has been known as a premature leakage.”[11]
• Though there are many factors that can contribute to premature leakage, the shape of the tampon plays a large role in this phenomenon. The shape of the tampon must be such that it intercepts the flow of fluid through the vaginal canal. It is difficult to design a tampon that can account for the many folds and convolutions of the vagina.[12]
• “Yet a further factor is the residual menses which accumulates on the withdrawal end of a tampon during the withdrawal process and which exits the vagina at the onset of the tampon removal. Therefore, even if a tampon is shaped to prevent leakage in use, it has been found that leakage may still occur upon tampon absorbent withdrawal.”[13]
• In conclusion, “There remains a need for a tampon and tampon absorbent product that prevents leakage of body fluid soon after being inserted into a woman’s vagina, provides efficient utilization of the entire absorbent structure during use, without the necessary use of blocking agents or extraneous chemistry, or physical structures, and which also provides for comfort to a user throughout various daily activities.”[13]

Studies

In vitro 

Patent US7166085B2 describes a test method for testing both the tampon and the applicator. In this patent, “tampon” refers to any type of absorbent structure that can be inserted into the human vagina for the absorption of blood. An “Applicator” is referred to as a device that is part of a tampon-and-applicator system used to insert the tampon into a vagina. A typical applicator includes two tubes. The larger tube contains the tampon and the smaller tube has a purpose of pushing the tampon out from the larger tube and into the vagina. The invention includes an in vitro testing device that resembles an in vivo test environment. The test is meant to be tested using an applicator to insert the tampon to reflect the user inserting the tampon during the tampon inserting procedure. The in vitro testing device includes vagina-representative elements inside transparent walls that enable the test operator to view and photograph the test. The purpose of this test is to simulate tampon insertion to stop blood flow during the menstrual cycle. The test recognizes that the reason most tampons fail is due to premature leakage and the test displays a target positioning in the vagina to reduce leakage. [14]

FDA Regulations

• Design and Dimensions
  • FDA recommends that an engineering drawing of the feminine tampon is included along with dimensions and materials.
  • FDA also recommends that you provide a cross-sectional drawing to illustrate the design and dimensions of the tampon, both compressed and uncompressed.
• Absorbancy Range
  • FDA recommends that you provide specifications, including tolerances for the weight of the pledget (in grams), for each absorbency range of tampon in your submission.
• Component Materials (including Addatives)
  • For all component materials present in a tampon, applicator, or pad, we recommend that you provide:
    • detailed chemical identity and quantity (in µg per tampon or pad) for all components, and any additives or finishing (e.g., anti-wicking) agents,
    • chemical identity of each component of any fragrance or deodorants
    • references to any Device Master Files⁶ for component materials, whenever possible.
• Performance Characteristics
  • Tampons must be labeled in accordance with 21 CFR 801.430. To determine the absorbency of menstrual tampons, you must use the “Syngyna testing” method as specified in 21 CFR 801.430(f)(2). We recommend you provide a summary of this testing in your submission for each absorbency level you plan to market.
  • FDA recommends that tampons be free of 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)/2,3,7,8-tetrachlorofuran dioxin (TCDF) and any pesticide and herbicide residues.
  • FDA also recommends that you demonstrate the performance characteristics for the following features of tampons:
    • string strength
    • fiber shedding
    • tampon integrity
• Preclinical Toxicology
  • For tampons and pads, we recommend that you conduct biocompatibility testing as described in the FDA guidance
• Preclinical Microbiology
  • For tampon materials, we recommend that you demonstrate that the tampon, in its final manufactured form, does not:
    • enhance the growth of Staphylococcus aureus
    • increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
    • alter the growth of normal vaginal microflora [17].

Current Business Strategy

The current business strategy involving marketing, fabrication, evaluation, and distribution is listed below. The current methods are satisfactory, as competition between many brands has helped progress the industry. One of the biggest things that could improve in the feminine market is the reduction of price, through government subsidiaries or the absolution of taxes on feminine products. Many people in the general public view feminine products as human necessities to cope with a natural process, and feel that the price women pay for feminine goods is excessive and should be drastically reduced to make feminine goods affordable to all.

Marketing

The target consumer for tampons is females who have begun their menstruation cycle. The average age this occurs is at age twelve. Menstruation cycles typically cease at the onset of Menopause, which can typically occur anywhere from the mid 30’s to mid 50’s. Therefore, advertisements should be targeted towards females from age 12 to 55. Different types of tampons appeal to different age groups, for instance a small portable tampon would be better suited to advertise towards younger female consumers. The more expensive, premium tampon brands are targeted towards those with more disposable income. The media for these advertisements is often via Television commercials, magazine advertisements in feminine magazines, and in store advertisements at local pharmacies.

Fabrication

Fabrication begins by the processing of cotton and the creation of rayon. Many companies use cotton only, or a blend of the two fibers. Both fibers are highly absorbent, ideal for the absorption of menstrual blood. Because Rayon comes from Wood Pulp, it must be purified, which typically involves bleaching. This process can release harmful toxins, thus special attention must be paid to monitor the byproducts of this process, to ensure no harm can be caused to the user. It is ideal to use hydrogen peroxide instead of chlorine to bleach the rayon, because this process has been certified by the FDA to be non-toxic. Applicators are typically made of plastic or cardboard, and incorporate pigments to add color.

Evaluation

In vitro testing is a method commonly used for testing tampons and applicators. The vitro receptacle is a sleeve with a tampon-deflecting zone, which resembles the in vivo vaginal channel. This is designed to simulate inserting a tampon to stop the flow of blood. Because many tampons fail due to premature leakage, it is important to test the flow of leakage.

Distribution

The most common means of sale for tampons are in supermarkets, big box stores, pharmacies, gas stations, and convenience stores such as airports.  The distribution channels typically follow those of other masculine and feminine care goods, as they are often sold by the same corporations that produce other hygienic products. At convenience stores such as airports and gas stations, the price of tampons is often inflated to account for the convenience factor.

References

[1] Procter & Gamble, “What’s in a Tampax Tampon?”  vol. 2017, 2017.

[2] Nonwovens Industry, “Feminine Hygiene Manufacturers Directory,”  vol. 2017, November 16,. 2012.

[3] M. Heid, “The Truth About Your Tampons,”  vol. 2017, July 27,. 2016.

[4] Anonymous “Menstruation and the menstrual cycle,”  vol. 2017, January 4,. 2017.

[5] Anonymous “Premenstrual Syndrome,”  vol. 2017, December 23,. 2014.

[6] Anonymous “The Cervix: Human Anatomy,”  vol. 2017, 2014.

[7] E. Martin, Oxford Concise Medical Dictionary, Oxford University Press, 2016, .

[8] Anonymous “Toxic shock syndrome,”  vol. 2017, May 08,. 2014.

[9] Playtex, “Playtex® Sport® Compact Tampons,”  .

[10] Anonymous “Natracare Organic Tampons,”  .

[11] Anonymous “Apparatus for in vitro testing of tampon-and-applicator systems,”  23 Jan. 2007.

[12] Anonymous “Kimberly-Clark Worldwide, Inc.; Patent Issued for Absorbent Tampon for Feminine Hygiene,”  Women’s Health Weekly; Atlanta, pp. 5025, Sep 25,. 2014.

[13] Anonymous “Patents; Researchers Submit Patent Application, “Tampon Absorbent”, for Approval,”  Politics & Government Week; Atlanta, pp. 8365, Nov 29,. 2012.

[14] T.W.I. Osborn and D.L. Gann, “Apparatus for In Vitro Testing of Tampon-and-Applicator Systems,”  Apr 6,. 2010.

[15] E. PEÑA, “Menstrual Protection: Advantages of the Menstrual Cup,” Obstetrics & Gynecology, vol. 19, pp. 684-687, May. 1962.

[16] Sabrina, “The History of the Sanitary Pad,” Femme Focus, Jun 24,. 2013.

[17] Anonymous “Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s),” July 27,. 2005.

[18] Hajjeh RA, Reingold AL, Weil A, Shutt K, Schuchat A, Perkins BA, et al. Toxic Shock Syndrome in the United States: Surveillance Update, 1979–1996. Emerg Infect Dis. 1999;5(6):807-810. https://dx.doi.org/10.3201/eid0506.990611

[19] T. Janelle, “The Advantages and Disadvantages of Menstrual Cups,” Aug 03,. 2016.

[20] StayHealthWise, “Sanitary Pads v Tampons,” Jan 21,. 2014.