Menstrual cup is a device increasingly becoming popular in managing menses across the globe. van Eijk et al., 2019 published a systematic review and meta-analysis study on menstrual cup for use, leakage, acceptability, safety and availability in the Lancet. This article collated the available menstrual cup data and also summarised the adverse effects reported from menstrual cup use. Safety monitor research foundation (SMRF) (www.safetymonitor.org) an NGO empowering consumers to choose products based on health and safety of ingredients attempts to discuss the existing state of regulation regarding menstrual cups, the potential impact and the recommendations for a policy.

Courtesy SochGreen®

Menstrual cup – Ecofriendly

Food and Drug Administration (FDA, US) defines a menstrual cup as a receptacle placed in the vagina to collect menstrual flow. Menstrual cups appeal to women in terms of freedom, eco friendliness and being pocket friendly in the long run. These three features make this product standout among the otheravailable options to manage menstruation.

Risk assessment policies – Inconsistent

Regulations on menstrual cups vary from country to country. This means each country has different requirements to assess the potential risk of the product. The table below shows the regulatory controls in countries to assess risk or mitigate potential risks from menstrual cup use.

Table 1: Regulatory control in different countries

Data requirements and controls

Country

 

Performance standards Classified as Medical device Post market surveillance Device registration Special labelling requirements
United States Yes Yes Yes Yes Yes
Europe Yes No Yes No No
Australia Yes Yes Yes No Yes
India* Not available Not available Not available Not available Not available

*Currently menstrual cup is not regulated.

Concerns

Regulatory controls are present in many countries (Tab1), however, official epidemiological data on the number of users and their experiences reported are limited to none. Thevan Eijk et al., 2019 systemic review clearly showed a lack and need for good qualitative and quantitative data.  van Eijk et al., 2019 concluded that adverse effects were not common among users. It’s important to monitor whether such a trend continues with increasing cup adoption. Based on the existing literature, menstrual cup concerns can be classified into two categories namely the silicone material concerns and the adverse events reported due to cup use.

Material concerns – Chemicals

Menstrual cups are composed of thermoplastic elastomer or medical-grade silicone.  Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6)are key monomers used for producing silicone polymers which have been recently restricted by European Chemical Agency (ECHA) for their effects on environment. It is technically not possible to produce silicone polymers with ‘zero content of D4, D5 and D6’ using conventional production techniques, although the residual impurities are highly dependent on the manufacturing procedures and conditions. It may be noted that the ECHA has classified D4 as “suspected of damaging fertility”. Given that menstrual cup has a prolonged contact with vaginal mucosa, concentration of D4 in the final product and its potential risk on the body needs to be investigated.

Swedish Chemical Agency (2018) surveyed and studied the hazardous chemical substances present in feminine hygiene products. Chemicals present in 8 different brands of cups from the Swedish market were assessed. Eight hazardous chemicals were identified, of which seven chemicals were beyond the reporting limit. It was noted that cups made out of TPE did not contain or had low concentration of chemicals. The study could not assess the health risks associated with 3 chemicals (D7, D8 and D9) which were present at a maximum concentration of 0.08 percent weight by weight due to data limitations.

The Danish Consumer Council THINK Chemicals in cooperation with the Austrian Consumer organization (2018) tested 7 different brands of menstrual cups and reported the presence of endocrine disrupting phthalate (1cup), Poly aromatic hydrocarbons (PAH) or carcinogenic nitroamines (3 cups), naphthalene (1 cup), allergy causing latex proteins (2 cups) and non- intentionally added substances (TPE made cup), although, the concentration of these problematic chemicals was low. However, the study also observed the presence of volatile organic compounds. The identity and the potential effects of these volatile substances are unknown. It was noted that the concentration of these compounds were much higher compared to other silicone based products such as pacifiers and food containers.  This study concludes that consumers should follow manufacturers’ use instructions before first time use such as placing it in hot water as part of sanitizing the cup routine to avoid exposure to volatile compounds.

With the list of materials and ingredients declared by the manufacturer, scientific assessments can be done on the health risks of menstrual cups. For example, SMRF has verified two cups as part of voluntary safety verification program.  Soch and Evercup were assessed for material composition and manufacturing practices based on the information/documentation provided by the manufacturers.  Please visit http://safetymonitor.org/verified-products/for more details.

The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) appointed committee of experts (CES) for assessing the safety of hygiene products (2018). The CES opined that there was insufficient information on the composition of menstrual cup materials and recommended to carry out material characterisation for cups. The opinion report also recommended increase in surveillance for cups.

Adverse effects

van Eijk et al., 2019 compiled the adverse effects/ events reported in journals till date. Effects include vaginal wound, pain and irritation, pelvic pain, allergy, urinary incontinence, IUD displacements, endometriosis, TSS and hydronephrosis. The paper concludes that these effects are uncommon. It may be noted there is no data on the number of cup users or presence of quality user data. Therefore, it is important to monitor that these effects continue to be uncommon among cup users.

Apart from the above list of effects, SMRF gathered information on adverse event by directly talking to users (7) and also from the following sources such as social media (Campaign whatsapp groups, Instagram and facebook). Some of the effects some users faced led them to abandon the use of cup. These include urinary infection, gastric issues including bloating, cervix inflammation, endocervical polyp, back pain, changes in the ovulation pattern and increase in prolapse severity. Although these are user experiences rather than direct cause-and-effect studies, they underline the importance of doing a more thorough study.

Policy recommendations

Given the above, the following recommendations are suggested.

Regulators/ policy makers

  • Performance standards of menstrual cups should include the identification and estimation of chemical residues and unintentionally present residues in the final product.
  • Menstrual cup is a prolonged contact internal device used by women during their birthing years and therefore it is important to categorise a menstrual cup as a medical device. To know more about the advantages of menstrual cup being classified as a medical device, please read our earlier article https://safetymonitor.org/menstrual-cup-the-need-and-the-benefits-of-regulation/.
  • Investing in monitoring and collecting epidemiological studies/ data on user experience can identify any concerns at an early stage.
  • Health risks of all hazardous chemical residues used in menstrual cups need to be assessed.

Manufacturers

  • Manufacturers should develop a full spectrum vision were they assess and record the quality right from raw materials sourcing to end user experience.
  • Menstrual cup industry can initiate more measures to avoid unpleasant experience in users which will also ensure the sustainability of the product in the market. Table 2 represents some of the measures that manufacturers can take to limit potential risks.

 Table 2: Adverse effects reported and mitigation measures

Risks Mitigation measures
Vaginal wound

Clinical studies – Biocompatibility testing,

Design performance testing

Vaginal pain

Design performance testing,

Labelling information –

Use instructions/ warnings

Pelvic pain

Design performance testing,

Labelling information –

Use instructions/ warnings

Vaginal or cervix irritation

Clinical studies – Biocompatibility testing

Labelling information –

Use instructions / warnings

Allergy and rash

Clinical studies – Biocompatibility testing

Labelling information -Warnings

Abnormalities of cervix or vulva or vaginal wall

Clinical studies – Biocompatibility testing

 

Changes in vaginal flora and infections

Labelling information –

Use instructions/ warnings

Urinary incontinence

Labelling information –

Use instructions/ warnings

Displacement of IUD

Labelling information –

Warnings

 

  • Manufacturers can be forthcoming in sharing data with regulators and public.
  • Menstrual cup serves as areceptacle placed in the vagina to collect menstrual flow, therefore design plays a role in terms of users comfort. It’s important that manufacturers maintain a design history.

Consumers:

Consumers can take the following measures to reduce any unfavourable experience with cup use.

  • Before starting: Make a checklist of your body behaviour and your experience with your present menstrual management product. Eg. Irritation, pimples, 28 or 30 day cycles, ovulation pain, nausea etc.
  • Purchasing cup: Look for a cup that comes with certifications for its materials, biocompatibility and manufacturing quality. Read and follow care instructions and warnings that comes along with the product.
  • During use: Compare the checklist and if unfavourable changes are observed, consult a doctor. Please make observations every 6 months to understand any long term changes.
SMRF is in the process of collecting user’s experience with cups. We request consumers to write to us on your experiences or any other concerns to contactus@safetymonitor.org.

SMRF’s Conclusions:

Menstrual cup, though an eco-friendlier option for women, has a number of data gaps. Therefore, it is important to focus on data collection for material composition, manufacturing practices and user experience to ensure the safety and sustainability of the product. There are no specific regulations governing the composition, manufacture or use of menstrual cups in India. Studies showed that material composition and manufacturing practices can influence the presence of concerning by-products or chemicals in the final product. With growing Indian cup manufacturers, imported menstrual cup brands and users, absence of standards and monitoring is a concern. SMRF recommends the Bureau of Indian Standards to frame standards at the earliest in order to ensure safety of Indian menstruators. It may be noted that a large number of imported brands are also available in the Indian market which are not monitored or regulated.

If the recommendations given earlier were reviewed and adopted, SMRF believes that we can look forward to safer use of menstrual cups while also enjoying the ecological and economic benefits they bring.

Bibliography

  1. van Eijk, A.M., Zulaika, G., Lenchner, M., Mason, L., Sivakami, M., Nyothach, E., Unger, H., Laserson, K., and Phillips-Howard, P. A. (2019). Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Health, S2468-2667(19), 30111-2. doi : http://dx.doi.org/10.1016/
  2. Swedish Chemical Agency (KEMI). (2018). Survey of hazardous chemical substances in feminine hygiene products – A study within the government assignment on mapping hazardous chemical substances 2017–2020. Article number: 361 308.
  3. Danish Consumer Council THINK Chemicals. (2018). Tests : Menstrual cup. https://kemi.taenk.dk/bliv-groennere/test-menstrual-cups.
  4. French Agency for Food, Environmental and Occupational Health & Safety (ANSES). (2018). Opinion on the safety of feminine hygiene products. ANSES Opinion.Request No. 2016-SA-0108.