Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis

Handling and positioning of menstrual cup

Cup not clear (Divacup or softcup) Event April, 2012; vaginal wound due to use of menstrual cup, needing treatment from physician for vaginal bleeding Complete medical records were not available for evaluation FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Softcup (cervical) Reported April, 2012; long-term customer of softcup product claimed vaginal scarring due to use Medical director did not find anything in medical records provided by customer related to vaginal health FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Softcup (cervical) FDA database case report: “…cup wore through the vaginal wall, damaging an artery that required surgical repair” Event could not be confirmed; no medical records were available North et al (2011) 13 North B

Oldham M Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection.

Divacup (vaginal) Event March, 2017; extreme pain on removal (first use), individual stopped using the cup Self-report; no medical report available FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Softcup (cervical) Event February, 2017; pain in lower pelvis and rectum and nausea about 1 h after insertion, no longer present approximately 30 min after removal Self-report; no medical evaluation available; individual stopped use after trying twice (possibly vascular compression) FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Gynaeseal (cervical) One (1%) of 73 Self-report by participant Cattanach et al (1991) 39 Cattanach JF A diaphragm tampon applied to an ovulation method in a birth control system.

Menses cup (vaginal) One (2%) of 51 Cervical smear was normal Cheng et al (1995) 41 Cheng M

NR, vaginal cup Allergy: one (1%) of 150; and rash: two (1%) of 150 · · Kakani et al (2017) 48 Kakani CR

Bhatt JK Study of adaptability and efficacy of menstrual cup in managing menstrual health and hygiene.

Softcup (cervical) FDA database: two case reports NR North et al (2011) 13 North B

Mooncup (vaginal) Event 2010: silicone allergy in one individual Surgery was needed for vaginal repair; manufacturer noted that silicone allergy is very rare FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Difficulty with removal requiring professional assistance

Gynaeseal (cervical) One (5%) of 22 · · Gleeson et al (1993) 46 Gleeson N

Bonnar J Menstrual blood loss measurement with gynaeseal.

Softcup (cervical) FDA database: three case reports reported by North 2011; one event in 2018 · · North et al (2011), 13 North B

Oldham M Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection. 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Softcup (cervical) Reported complaints to company 2003–08: 42 individuals underwent physician-assisted removal Other complaints reported to company included poor fit (n=102), leakage (n=168), messy (n=98) North et al (2011) 13 North B

Mooncup (vaginal) Case report: menstrual cup lodged on cervix, difficult to remove, requiring assistance Moderate cervical inflammation after retrieval Day et al (2012) 63 Day S A retained menstrual cup.

Divacup (vaginal) Event April, 2015: one case report required an emergency room visit for removal · · FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Reproductive tract observations with use of menstrual cup

Softcup (cervical) Baseline: four (1%) of 393; cycle 1: eight (2%) of 365; cycle 2: six (2%) of 326; cycle 3: five (2%) of 305 Vulva-vaginal inspection at baseline and monthly for 3 months; no p values reported North et al (2011) 13 North B

Softcup (cervical) Zero of 44 Vulva-vaginal inspection at baseline and monthly for 3 months North et al (2011) 13 North B

Tassette (vaginal) Zero of 12 Vaginal inspection after 3 months Pena et al (1962) 52 Pena EF Menstrual protection. Advantages of the menstrual cup.

Tassette (vaginal) Zero of 50 Vaginal inspection done; timing of inspections not clear Karnaky et al (1962) 70 Karnaky KJ Internal menstrual protection with the rubber menstrual cup.

Softcup (cervical) Baseline: 23 (6%) of 390; cycle 1: ten (3%) of 345; cycle 2: six (2%) of 326; cycle 3: four (1%) of 300 Inspection of cervix; no p values reported for differences North et al (2011) 13 North B

Softcup (cervical) Abnormal cervical smear test: baseline: one (<1%) of 406; cycle 1: one (<1%) of 368; cycle 2: two (1%) of 329; cycle 3: zero of 308 Abnormal cervical smear test results were exclusion criteria at admission, and a reason for discontinuation of the study; no p values reported for differences North et al (2011) 13 North B

Condition of vaginal and cervical epithelium

Softcup (cervical) 44 women examined at baseline, 37 at 2–3 months, and 25 at 5–6 months “The Softcup caused no alteration or disruption in vaginal or cervical epithelium, as assessed by colposcopy and cervical cytology” North et al (2011) 13 North B

Vaginal flora and infections with use of menstrual cup

Tassette (vaginal) Zero of 50 No abnormalities, vaginal areas where menstrual cup was placed were more acid Karnaky et al (1962) 70 Karnaky KJ Internal menstrual protection with the rubber menstrual cup.

Softcup (cervical) Mean pH at baseline: 4·6 (n=400); cycle 1: 4·6 (n=368); cycle 2: 4·6 (n=329); cycle 3: 4·5 (n=308) No p values reported North et al (2011) 13 North B

Softcup (cervical) Number with clue cells: baseline n=6; cycle 1 n=6; cycle 2 n=2; cycle 3 n=4 Sample sizes and p values were not reported North et al (2011) 13 North B

Softcup (cervical) “…before, during, and after use of the cup, vaginal Lactobacillus (normal vaginal flora) was maintained at normal levels.” Data in figure 3 in publication cannot be extracted; no significant changes according to authors North et al (2011) 13 North B

Softcup (cervical) No significant changes from baseline-cycle 3 according to authors Data in figure 3 in publication cannot be extracted North et al (2011) 13 North B

Softcup (cervical) No significant changes from baseline to cycle 3 according to authors Data in figure 3 in publication cannot be extracted North et al (2011) 13 North B

Mooncup (vaginal) Study end survey: cup 21 (15%) of 144; pads 40 (20%) of 202, and usual practice (control) 32 (21%) of 156; cup vs control p=0·11 and cup vs pads p=0·13; among girls enrolled for ≥9 months: cup 13 (13%) of 101, pads 29 (20%) of 143, usual practice 20 (19%) of 104; cup vs control p=0·07, and cup vs pads p=0·018 Cluster randomised trial of schools; median follow-up 11 months (range 3–15) Phillips-Howard et al (2016) 5 Phillips-Howard PA

et al. Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya.

Softcup (cervical) Number with candidiasis: baseline n=6; cycle 1 n=6; cycle 2 n=3; cycle 3 n=6 Sample sizes not reported; according to authors, yeast decreased significantly from month 1 to 2 North et al (2011) 13 North B

Ruby cup (vaginal) Zero of 18 participants had vaginal candidiasis at follow-up (3–5 months) NA Tellier et al (2012) 56 Tellier M

Gad M Assessing acceptability and hygienic safety of menstrual cups as a menstrual management method for vulnerable young women in Uganda Red Cross Society's Life Planning Skills Project.

Tassette (vaginal) Candida albicans decreased with the use of the cup NR Karnaky et al (1962) 70 Karnaky KJ Internal menstrual protection with the rubber menstrual cup.

Mooncup (vaginal) Study end survey: cup 11 (8%) of 143, pads 19 (10%) of 200, usual practice (control) 13 (9%) of 156; cup vs control p=0·87, and cup vs pads p=0·68 Cluster randomised trial of schools; median follow-up 11 months (range 3–15) Phillips-Howard et al (2016) 5 Phillips-Howard PA

Softcup (cervical) No differences between baseline and cycle 1 to cycle 3 Data in figure 3 in publication cannot be extracted; no significant changes according to authors North et al (2011) 13 North B

Softcup (cervical) Increase in Enterococcus from cycle 2 to cycle 3 (p=0·03) “… this increased frequency persisted for 3 months after discontinuing use of the cup, suggesting that factors or behavior other than cup use may have influenced colonization”; data in figure 3 in publication cannot be extracted North et al (2011) 13 North B

Mooncup (vaginal) Nine (53%) of 17 if used cup for <6 months; four (22%) of 18 if used for ≥6 months (p=0·12); association between E coli with heavy periods: 61·5% of girls reporting heavy periods had E coli on cups, compared with 22·7% of those stating they did not have heavy periods (p=0·022, no numbers presented) Cluster randomised trial of schools; median follow-up 11 months (range 3–15) Juma et al (2017) 29 Juma J

et al. Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study.

Mooncup (vaginal) Study end survey: cup three (2%) of 144, pads three (2%) of 201, usual practice (control) seven (5%) of 154; cup vs control p=0·20, and cup vs pads p=0·63 Cluster randomised trial of schools; median follow-up 11 months (range 3–15) Phillips-Howard et al (2016) 5 Phillips-Howard PA

Softcup (cervical) Zero cases at baseline, and cycles 1 to 3 Sample sizes not reported North et al (2011) 13 North B

Mooncup (vaginal) Study end survey: cup two (1%) of 143, pads five (3%) of 200, usual practice (control) seven (5%) of 154; cup vs control p=0·12, and cup vs pads p=0·36 Cluster randomised trial of schools; median follow-up 11 months (range 3–15) Phillips-Howard et al (2016) 5 Phillips-Howard PA

Ruby cup (vaginal) Zero of 18 at baseline, and at 3–5 months of follow-up NA Tellier et al (2012) 56 Tellier M

Mooncup (vaginal) Study end survey: cup one (1%) of 144, pads one (1%) of 201, usual practice (control) one (1%) of 154; cup vs control p=0·96, and cup vs pads p=0·81 Cluster randomised trial of schools; median follow-up 11 months (range 3–15) Phillips-Howard et al (2016) 5 Phillips-Howard PA

Softcup (cervical) No significant changes in cycles 1–3 compared with baseline Data in figure 3 of publication cannot be extracted North et al (2011) 13 North B

Mooncup (vaginal) Among menstrual cup users: four (11%) of 38 in first month of intervention, 13 (9%) of 139 after first month; p=0·83 (median follow-up 4 months, range 2–11 for this substudy); prevalence was 21 (11%) of 197 in sanitary pads group, and 16 (11%) of 153 in usual practice group Cluster randomised trial in schools; median follow-up 11 months (range 3–15); samples from vaginal swab (self-swabbing) Juma et al (2017) 29 Juma J

be'Cup (vaginal) Silicone cup: potentially more S aureus after incubation for 8 h with shaking in a plastic bag with S aureus in one of two cups used, but not when no shaking In-vitro study Nonfoux et al (2018) 73 Nonfoux L

et al. Impact of currently marketed tampons and menstrual cups on Staphylococcus aureus growth and TSST-1 production in vitro.

Me Luna (vaginal) Thermoplastic isomer cup: no more S aureus after incubation for 8 h with shaking in plastic sac, and not when no shaking In-vitro study Nonfoux et al (2018) 73 Nonfoux L

Mooncup (vaginal) 49 schoolgirls with vaginal S aureus had second swab: ten yielded S aureus, two had TSST-1, both in sanitary pad group; the cases were asymptomatic Cluster randomised trial in schools; median follow-up 11 months (range 3–15); sample from vaginal swab (self-swabbing) Juma et al (2017) 29 Juma J

NR No TSST-1 in supernatant of S aureus cultivated for 24 h (incubated aerobically in a still growth environment) in the presence of elastic polymer menstrual cup (n=16 menstrual cups) In-vitro study Tierno et al (1989) 71 Tierno Jr, PM

Hanna BA Ecology of toxic shock syndrome: amplification of toxic shock syndrome toxin 1 by materials of medical interest.

Tassaway (vaginal) S aureus MN8 produced no TSST-1 when grown in the presence of Tassaway (elastomeric polymer, n=6), washed or unwashed, no shaking, incubation overnight In-vitro study Tierno at al (1994) 72 Tierno PM

Hanna BA Propensity of tampons and barrier contraceptives to amplify Staphylococcus aureus Toxic shock syndrome toxin-I.

be'Cup (vaginal) Silicone cup: potentially more TSST-1 production after incubation for 8 h with shaking in plastic bag with S aureus compared with control, but not when not shaken or with pieces of cup In-vitro study Nonfoux et al (2018) 73 Nonfoux L

Me Luna (vaginal) Thermoplastic isomer cup: potentially more TSST-1 production after incubation for 8 h with shaking in plastic bag with S aureus compared with control, but not when not shaken or with pieces of cup In-vitro study Nonfoux et al (2018) 73 Nonfoux L

Mooncup (vaginal) Zero of 192 in trial in Kenya “Safety monitoring components comprised routine nurse-based screening, population-based monitoring (school and community) and clinical evaluation of infection with laboratory confirmation” Juma et al (2017) 29 Juma J

Softcup (cervical) Two case reports in the FDA database Both unconfirmed cases of TSS North et al (2011) 13 North B

Divacup (vaginal) One case report: blood cultures and urine culture negative, no culture of the menstrual cup was done Woman had history of Hashimoto's thyroiditis and chronic menorrhagia Mitchell et al (2015) 66 Mitchell MA

Hosseini-Moghaddam SM A confirmed case of toxic shock syndrome associated with the use of a menstrual cup.

Mooncup (vaginal) Event February, 2012: TSS 2 days after using of first and new Mooncup resulting in 9 days of inpatient hospital stay; vaginal swab positive for S aureus Had an IUD, Mooncup was not sent for bacteriological testing FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Divacup (vaginal) Event February, 2015: TSS from Streptococcus resulting in 5 days of i-patient hospital stay; culture of cup isolated group A and B streptococcus Woman had used Divacup for menstrual period, which started 3 days before illness; menstrual cup was in for 18 h on admission to hospital FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Ruby cup (vaginal) Baseline: four (13%) of 31; at follow-up (after 3–5 months) three (17%) of 18; p=0·65, McNemar test One participant with a UTI at enrolment and follow-up had her cup stolen and used toilet paper in vagina as a tampon Tellier et al (2012) 56 Tellier M

Gynaeseal (cervical) One (1%) of 73 had transient dysuria “The woman who developed dysuria did not seek treatment and the problem subsided within 24–48 hours” Cattanach et al (1991) 39 Cattanach JF A diaphragm tampon applied to an ovulation method in a birth control system.

Softcup (cervical) Urine analysis done; detailed results not reported “Monthly monitoring of gynecological health via urinalysis, pelvic examination with visual evaluation of tissues, vaginal pH, and microscopic wet mount showed no adverse effects of cup use” North et al (2011) 13 North B

Softcup (cervical) Event August, 2014: UTI confirmed by urine cultures twice after use of softcup Medical records were not available for evaluation FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Tassette (vaginal) “The amount of bacterial contamination was greatest with the pad, next with the tampon and least with the rubber cup” No data provided; study reported to make cultures from vaginal wall samples and to examine fresh and stained smears for C albicans, Trichomonas vaginalis, Haemophilus vaginalis, and for predominance of Gram-positive or Gram-negative cocci, small rods or long-rod bacilli (Doederlein bacilli) Karnaky et al (1962) 70 Karnaky KJ Internal menstrual protection with the rubber menstrual cup.

Softcup (cervical) FDA database: one case report Vaginal infection not further specified; could not be confirmed at follow-up North et al (2011) 13 North B

Butterfly cup (vaginal) “…none of the women sought treatment for a pelvic infection. There was no onset or worsening of dysmenorrhoea in 83%, dyspaurenia in 94%, pelvic pain in 92% and vaginal discharge in 92% of the participants during the 12 months of cup use”; n=52 NA Madziyire et al (2018) 49 Madziyire MG

Madziwa CF Menstrual cups as a menstrual management method for low socioeconomic status women and girls in Zimbabwe: a pilot study. , 50 Madziyire MG

Madziwa CF The safety of menstrual cups in women of low socio-economic status in Zimbabwe: pilot study.

Gynaeseal “There was no increased pathogenicity detected in vaginal flora. There was a trend towards smaller numbers of potentially pathogenic bacteria for 4 of the women, and the remaining woman showed no change. None of the women developed any significant medical problems” Vaginal swabs before and after use, five women, median follow-up 14 months (range 3–22) Cattanach et al (1989) 69 Cattanach J A new type of sanitary tampon, (Gynaeseal) that can also be used as an alternative diaphragm has been developed.

Mooncup (vaginal) Study end survey: menstrual cup six (4%) of 144, pads nine (5%) of 202, and usual practices (control) 12 (8%) of 156; cup vs control p=0·11, and cup vs pads p=0·87; when follow-up was ≥9 months: cup four (40%) of 101, pads seven (5%) of 143, and usual practice 11 (11%) of 104; cup vs control p=0·004, and cup vs pads p=0·60 Presence of either C trachomatis, T vaginalis or N gonorrhoea; cluster randomised trial of schools in Kenya; median follow-up 11 months (range 3–15) * The decrease in STIs in the trial in Kenya in the groups in which either menstrual cups or sanitary pads were provided is thought to be an indirect effect because of the decrease in risky sexual behaviour to obtain money to buy pads. Phillips-Howard et al (2016) 5 Phillips-Howard PA

Mooncup (vaginal) Study end survey: cup 31 (22%) of 144, pads 58 (29%) of 202, and usual practice (control) 42 (27%) of 156; cup vs control p=0·36, and cup vs pads p=0·19 Presence of either B vaginosis or C albicans; cluster randomised trial of schools in Kenya; median follow-up 11 months (range 3–15) Phillips-Howard et al (2016) 5 Phillips-Howard PA

Femcap (first model of femmycycle, vaginal) FDA database: one case report; event July, 2014; pelvic pain and urinary incontinence when wearing and removing menstrual cup; urine sample negative for infection Self-report; stopped using menstrual cup FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

Displacement of IUD when using menstrual cup

NR IUD expulsion 6–8 weeks after insertion: menstrual cup five (4%) of 135, tampon 11 (2%) of 469, pads: seven (4%) of 169; cup vs tampon p=0·57, and cup vs pads: p=0·92 Retrospective cohort; expulsion of an IUD occurs in approximately one in 20 women and is most common in the first 3 months after insertion; expulsion commonly occurs during menstruation; some recommend not to use internal sanitary protection for 3–6 weeks after insertion because of an increased infection risk Wiebe et al (2012) 57 Wiebe ER

Trouton KJ Does using tampons or menstrual cups increase early IUD expulsion rates?.

Mooncup (vaginal) FDA database: one case report; event July, 2012; potential IUD dislodgment after Mooncup removal; patient had an ectopic pregnancy and needed surgery Patient felt pain after removal of Mooncup and had the position of the IUD checked at a health centre where it was declared in position; 2 months later she was found to be pregnant FDA database 14 US Food and Drug Administration Manufacturer and user facility device experience database (MAUDE).

NR Case series of seven women with IUD expulsion when removing menstrual cup; expulsion occurred 1 week to 13 months after insertion of IUD and was recurrent in two women; of seven women, two choose to use different contraception; the five others had their IUD re-inserted Two women opted for cutting the wires of the IUD close to the cervix to avoid the problem; authors also stress importance of releasing vacuum of menstrual cup before removal Seale et al (2019) 64 Seale R

Coleman-Minahan K Unintentional IUD expulsion with concomitant menstrual cup use: a case series.

Endometriosis because of menstrual backflow via use of menstrual cup

Tassette (vaginal) Position of cup confirmed with X-ray imaging “Hence the free space available in the upper vagina plus the capacity of the cup itself are ample to accommodate several times the amount of blood passed in a complete menstrual cycle” Pena et al (1962) 52 Pena EF Menstrual protection. Advantages of the menstrual cup.

Tassette (vaginal) No evidence for backflow “Thin watery solutions could not be introduced under high pressures during the menstrual flow in 6 multiparous women” Karnaky et al (1962) 70 Karnaky KJ Internal menstrual protection with the rubber menstrual cup.

Keeper (vaginal) Case report: dysmenorrhoea 2 years after start of menstrual cup use (10 years ago tubal ligation); laparoscopy showed adenomyosis and endometriosis, treated with laser; patient stopped use of menstrual cup; pain decreased after surgery; 2 years of follow-up “The observations in our patient suggest that it may be useful to inquire about use of these devices in women with pelvic pain or endometriosis”; petition for revoking of market approval to US FDA rejected because of lack of evidence 74 The Museum of Menstruation and Women's Health Do menstrual cups cause endometriosis?. Spechler et al (2003) 68 Spechler S

Stratton P The Keeper, a menstrual collection device, as a potential cause of endometriosis and adenomyosis.

NR Case report: severe colicky flank pain; CT scan showed menstrual cup was slightly dislocated, pressing into left ureter “The extraction of the menstrual cup resulted in resolution of hydronephrosis and associated symptoms” Adedokun et al (2017) 60 Adedokun BO 43 - Hydronephrosis associated with the use of menstrual cup.

NR Case report: 3 h of back pain on the right side; low-dose unenhanced CT scan showed entrapment of left vaginal wall and part of interolateral bladder wall; improperly positioned menstrual cup Symptoms and swelling disappeared after removal of menstrual cup, confirmed by another CT scan; patient had used a menstrual cup for a long time with no previous problems, and continued use of cup; no problems at follow-up after several weeks Stolz et al (2019) 62 Stolz A

Nicodème Paulin E An improperly positioned menstrual cup complicated by hydronephrosis: a case report.