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.
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.
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.
- Manufacturers
can be forthcoming in sharing data with regulators and public.
- Menstrual
cup serves as a receptacle 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
- 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/
- 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.
- Danish
Consumer Council THINK Chemicals. (2018). Tests : Menstrual cup. https://kemi.taenk.dk/bliv-groennere/test-menstrual-cups.
- 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.