First meta-analysis finds menstrual cups safe with similar or lower leakage

Organisation: Position: Deadline Date: Location:

MenstrualThe first systematic review and meta-analysis of the international use of menstrual cups, including 43 studies and data from 3,300 women and girls, suggests they are safe and result in similar, or lower, leakage than disposable pads or tampons. Four studies within the review (293 participants) compared leakage between different sanitary products, and found that levels were similar between menstrual cups and pads and tampons, while one found that leakage was significantly less.

Globally, menstruation can affect girls’ schooling and women’s experience of work, increase their disposition to urogenital infections if they use poor quality sanitary products, and even make both women and girls a target of sexual violence or coercion when they don’t have the funds to buy them. There are an increasing number of initiatives in both high- and low-income countries to combat ‘period poverty’, so it is essential that policy makers know which sanitary products to include in menstrual health programmes and puberty education materials.

“Despite the fact that 1.9bn women globally are of menstruating age – spending on average 65 days a year dealing with menstrual blood flow, few good quality studies exist that compare sanitary products,” says senior author Professor Penelope Phillips-Howard from the Liverpool School of Tropical Medicine, UK. “We aimed to address this by summarising current knowledge about leakage, safety, and acceptability of menstrual cups, comparing them to other products where possible.”

The study combines data from medical studies and grey literature – such as conference abstracts, reports and theses – for which participants reported their experiences of menstrual cups or their willingness to use them. The authors selected 43 studies involving 3,319 participants in both low- and middle-income countries (LMICs) (15 studies) and high-income countries (28 studies). They also compiled global information on the availability and costs of menstrual cups, conducted preliminary estimates on waste savings, and examined puberty education materials to assess the extent to which menstrual cups are referred to as an option.

The authors note that the quality of the studies included was low, and call for more, quality research in this area, and note that further studies are needed on cost-effectiveness and environmental effects between different menstrual products. In the review, some of the information was taken from reports not published in peer-reviewed journals and the focus of some studies was to evaluate other topics. Some data were from older studies, when reporting requirements were less stringent, or with menstrual cups that are no longer available. Most of the studies depended on self-reporting, which might have overestimated use of the menstrual cup.

Menstrual cups collect blood flow, rather than absorbing it as with pads and tampons. Like tampons, they are inserted into the vagina, before being emptied every 4-12 hours. There are currently two types: a vaginal cup which is generally bell-shaped, and a cervical cup which is placed around the cervix high in the vagina like a diaphragm for contraception. The materials used to make them are medical grade silicone, rubber, latex or elastomer and can last up to 10 years.

The current review identifies the products usually used in LMICs, which include cloths, cotton wool, tissue paper and other pieces of material, as well as disposable pads. Leakage and chaffing are a common concern.

Four studies in the review, involving 293 participants, made direct comparisons of leakage between menstrual cups and disposable pads or tampons. Leakage was similar in three studies and significantly less among menstrual cups for one study. In some studies, leaking was associated with abnormally heavy bleeding, unusual anatomy of the uterus, need of a larger cup size, incorrect placement of the cup, and the cup becoming full.

There was no increased risk of infection associated with using menstrual cups among European, North American, and African women and girls. There were five reported cases of toxic shock syndrome following their use, but the overall number of menstrual cup users is unknown, so it is not possible to make comparisons of the risk of toxic shock syndrome between menstrual cups and other products. In four studies involving a total of 507 women, use of the menstrual cup showed no adverse effects on vaginal flora. In studies that examined the vagina and cervix during follow-up, no tissue damage was identified from use of a menstrual cup.

Difficulty in removing cups, requiring professional assistance, was reported twice for vaginal cups and 47 times for cervical cups. Some women use them in combination with intrauterine devices and, in 13 cases, removing the cup was associated with an IUD becoming dislodged. They suggest that the combination of an IUD and use of a menstrual cup might need further study. The authors identified five women who reported pain, three who reported vaginal wounds, six who reported an allergy or rash and nine who reported urinary tract complaints.

Results from 13 of the studies suggest that around 70% of women wanted to continue using menstrual cups once they were familiar with how to do so. Interview-based studies revealed that practice, peer support and training are key to participants finding them successful. In six qualitative studies, participants suggested that adopting the menstrual cup required a familiarisation phase over several menstrual cycles. The authors note that information and follow-up on correct use might need to form a part of menstrual health programmes.

The review suggests that awareness of menstrual cups as an option is low. Three studies in high-income countries found that only 11-33% of women are aware of them. Among 69 websites containing educational materials on puberty in 27 countries, 77% mentioned disposable pads and 65% mentioned tampons, while only 30% mentioned menstrual cups and 22% mentioned reusable pads.

Preliminary evidence on the cost and waste savings associated with using menstrual cups suggests that over 10 years, a single menstrual cup could cost much less than pads or tampons. The authors identified 199 brands of cup being available in 99 countries, with a wide range of prices from $ 0.72 to $46.72. A cup could cost roughly 5% or 7% of the cost of using 12 pads (on average $ 0.31 each) or tampons (on average $ 0.21 each) per period. Plastic waste might also be reduced. Over 10 years, a cup is estimated to create 0.4% of the plastic waste generated by single-use pads or 6% of that produced by using tampons. The authors note that the cost and waste estimates are only illustrative, and do not account for the combined use of menstrual products, inflation, or production costs.

Given the limited number of reports on the use of menstrual cups, the authors also caution that other potential issues cannot be excluded, including use of menstrual cups in combination with IUDs. Further international research will be needed to provide more information on acceptability, to monitor adverse events, to assess best practice to shorten the familiarisation phase, and to more reliably assess cost-effectiveness and environmental effects.

Writing in a linked comment, Dr Julie Hennegan from the Johns Hopkins Bloomberg School of Public Health, says: “For consumers purchasing menstrual products, the results highlight cups as a safe and cost-effective option. Critically, findings indicate that menstrual education resources are not providing a comprehensive overview of products to support informed choices. Authors found that awareness of menstrual cups was low, and that only 30% of websites with educational materials on menarche included information about menstrual cups.”

Background: Girls and women need effective, safe, and affordable menstrual products. Single-use products are regularly selected by agencies for resource-poor settings; the menstrual cup is a less known alternative. We reviewed international studies on menstrual cup leakage, acceptability, and safety and explored menstrual cup availability to inform programmes.
Methods: In this systematic review and meta-analysis, we searched PubMed, Cochrane Library, Web of Science, Popline, Cinahl, Global Health database, Emerald, Google Scholar,, and WorldWideScience from database inception to May 14, 2019, for quantitative or qualitative studies published in English on experiences and leakage associated with menstrual cups, and adverse event reports. We also screened the Manufacturer and User Facility Device Experience database from the US Food and Drug Administration for events related to menstrual cups. To be eligible for inclusion, the material needed to have information on leakage, acceptability, or safety of menstrual cups. The main outcome of interest was menstrual blood leakage when using a menstrual cup. Safety outcomes of interest included serious adverse events; vaginal abrasions and effects on vaginal microflora; effects on the reproductive, digestive, or urinary tract; and safety in poor sanitary conditions. Findings were tabulated or combined by use of forest plots (random-effects meta-analysis). We also did preliminary estimates on costs and environmental savings potentially associated with cups. This systematic review is registered on PROSPERO, number CRD42016047845.
Findings: Of 436 records identified, 43 studies were eligible for analysis (3319 participants). Most studies reported on vaginal cups (27 [63%] vaginal cups, five [12%] cervical cups, and 11 [25%] mixed types of cups or unknown) and 15 were from low-income and middle-income countries. 22 studies were included in qualitative or quantitative syntheses, of which only three were of moderate-to-high quality. Four studies made a direct comparison between menstrual cups and usual products for the main outcome of leakage and reported leakage was similar or lower for menstrual cups than for disposable pads or tampons (n=293). In all qualitative studies, the adoption of the menstrual cup required a familiarisation phase over several menstrual cycles and peer support improved uptake (two studies in developing countries). In 13 studies, 73% (pooled estimate: n=1144; 95% CI 59–84, I2=96%) of participants wished to continue use of the menstrual cup at study completion. Use of the menstrual cup showed no adverse effects on the vaginal flora (four studies, 507 women). We identified five women who reported severe pain or vaginal wounds, six reports of allergies or rashes, nine of urinary tract complaints (three with hydronephrosis), and five of toxic shock syndrome after use of the menstrual cup. Dislodgement of an intrauterine device was reported in 13 women who used the menstrual cup (eight in case reports, and five in one study) between 1 week and 13 months of insertion of the intrauterine device. Professional assistance to aid removal of menstrual cup was reported among 47 cervical cup users and two vaginal cup users. We identified 199 brands of menstrual cup, and availability in 99 countries with prices ranging US$0·72–46·72 (median $23·3, 145 brands).
Interpretation: Our review indicates that menstrual cups are a safe option for menstruation management and are being used internationally. Good quality studies in this field are needed. Further studies are needed on cost-effectiveness and environmental effect comparing different menstrual products.

Anna Maria van Eijk, Garazi Zulaika, Madeline Lenchner, Linda Mason, Muthusamy Sivakami, Elizabeth Nyothach, Holger Unger, Kayla Laserson

The Lancet material
The Lancet Public Health abstract
The Lancet Public Health comment

Receive Medical Brief's free weekly e-newsletter

Related Posts

Thank you for subscribing to MedicalBrief

MedicalBrief is Africa’s premier medical news and research weekly newsletter. MedicalBrief is published every Thursday and delivered free of charge by email to over 33 000 health professionals.

Please consider completing the form below. The information you supply is optional and will only be used to compile a demographic profile of our subscribers. Your personal details will never be shared with a third party.

Thank you for taking the time to complete the form.