Summary 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, Science.gov, 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, I 2=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. Funding UK Medical Research Council, Department for International Development, and Wellcome Trust.
