Safety research

Studies of male circumcision show that the procedure is safest when it is performed in a clinical setting by well-trained providers who have the necessary equipment and supplies. When circumcision is provided in non-medical or ill-equipped settings, however, post-surgery complications are common and may be severe.

Early infant male circumcision

Adult and adolescent male circumcision

Safety of devices

Resources

Early infant male circumcision

Infant male circumcision tends to be safer than adult circumcision because it does not require suturing to stop the bleeding and close the wound. Complications of infant male circumcisions performed in medical settings are rare and usually minor and treatable, particularly during the first month of life (neonatal period). Common complications include pain, bleeding, and swelling.

In a global review of 16 prospective studies of neonatal and infant male circumcision from 12 countries, only two studies reported serious complications, and the median frequency of any complications was 1.5 percent. However, the frequency of reported complications varied widely among studies (from 1 percent to 16 percent), pointing to the need for comprehensive, ongoing training programmes for both medically trained and non-medically trained providers.1,2

More evidence on the safety of early infant male circumcision (EIMC) is emerging as programmes in eastern and southern Africa begin to expand access to the procedure. An analysis of data on 1,239 infant male circumcisions performed at five government health facilities in Nyanza, Kenya, found that the rate of complications (2.7 percent) was comparable to those reported in resource-rich countries. Infants circumcised at age one month or older were more likely to experience complications, suggesting that the first month of life is the optimal time for infant male circumcision.3 Complication rates were also low in a randomised controlled trial of EIMC in rural Uganda: 2.4 percent for procedures performed by clinical officers and 1.6 percent for those performed by registered nurse midwives.4

The male circumcisions in the Kenya and Uganda studies were performed with the Mogen clamp device. A study in Botswana found low rates of complications with both the Mogen clamp and Plastibell, but in two cases the Plastibell device (which is supposed to fall off eight to 10 days after the procedure) had to be removed by study staff. The authors concluded that the Mogen clamp might be a better option in settings where emergency medical care is not available.5 The results of a trial of the AccuCirc device in Zimbabwe suggest that it is comparable in safety to the Mogen clamp; assessments of the safety, acceptability, and feasibility of AccuCirc-assisted infant male circumcision are ongoing.6

Circumcision of adult and adolescent males

The main complications of circumcision in adults and adolescents include delayed healing, infection, and bleeding. Studies have shown that circumcision of adult and adolescent males can be provided safely in low-resource settings when it is performed by providers who have the proper training, equipment, and supplies.

The rates of surgery-related complications observed in the three randomised controlled trials of male circumcision for HIV prevention were 1.7 percent in Kenya, 3.8 percent in South Africa, and 3.5 percent in Uganda. (The differences among these rates can most likely be explained by different definitions of complications related to the procedure and the methods used for detecting and reporting them.) 7-9

Low rates of complications have been reported in VMMC programmes in the priority countries in eastern and southern Africa.10 Among clients returning for post-operative follow-up visits in programmes supported by the US Centers for Disease Control and Prevention, for example, the complication rate was 0.8 percent in 2012 (based on reports from six countries), down from 1.7 percent in 2010 (in three countries). However, more than 40 percent of the 614,478 clients did not return for a follow-up visit.11 Whether men who are lost to follow-up have higher or lower rates of complications is unknown. One study in Kenya found that the rate of complications was almost twice as high among men who returned for a follow-up visit compared to those who did not.12

Severe complications and deaths are rare in VMMC programmes. Through early 2015, about 9 million men had been circumcised and 10 deaths after VMMC had been reported. Six of those deaths were likely related to tetanus.13 These reports led to recognition that many adolescent boys and men are not adequately protected against tetanus through immunisation and to efforts to strengthen national surveillance systems, ensure rapid investigation of VMMC-related complications, and implement the tetanus mitigation strategies recommended by WHO, including providing tetanus vaccinations along with, or prior to, VMMC services.14,15

In 2016, WHO updated those recommendations after convening a technical consultation to review the 15 cases of tetanus and ten tetanus-related deaths (among more than 12 million men circumcised) that had been reported by August 2016.16,17 The new recommendations call for different risk mitigation measures by circumcision method and reemphasise the need for adequate vaccination and wound care practices.18

Most of the information about the safety of adult male circumcision is from studies among HIV-negative adults. One study in Rakai, Uganda, found that the safety of the procedure was comparable among 2,326 HIV-negative men and 420 HIV-positive men, with rates of moderate or severe complications of about 3 percent in both groups. The results also suggest that the wound from a circumcision heals slightly slower in men who are infected with HIV compared to HIV-negative men.9 However, a study in Kenya found no statistically significant difference in time to complete healing by HIV status.19

Only one randomised trial, conducted in Uganda, has examined whether male circumcision affects HIV transmission to women. The findings suggest that the female partner of an HIV-positive man may be at increased risk of acquiring HIV if the couple resumes having sex before his circumcision wound has healed.20 Separate studies in Kenya and Uganda detected HIV shedding from circumcision wounds (which may increase the risk of HIV transmission) among HIV-positive men who reported that they were not on antiretroviral therapy (ART).21,22

In both studies, HIV shedding surged after the procedure, but declined to pre-circumcision levels or lower within six weeks. Researchers concluded that their results reinforce the need to promote sexual abstinence during the healing period and consistent condom use thereafter.21,22 The Uganda study, which included more men who reported receiving ART (183, versus 41 in the Kenya study), found that having a lower HIV viral load in the blood was associated with decreased frequency and quantity of HIV shedding from circumcision wounds. The authors called for research on providing ART to HIV-positive men before circumcision.22

Safety of devices

Studies have been conducted to assess devices that could make performing adult circumcision quicker and easier (for example, to avoid the need for sutures). Based on the results to date, the World Health Organization has released recommendations on the use of two of these devices.23

In August 2016, technical experts convened by WHO concluded that the epidemiological evidence about tetanus cases and deaths after VMMC — a rare but serious complication — indicates a higher risk of tetanus following circumcision with an elastic collar compression device compared with other circumcision methods that remove the foreskin at the time of the procedure. They recommended that male circumcision with a device that is removed along with the foreskin several days after it is applied should be performed only if the client is adequately protected against tetanus by immunisations.18 To date, WHO has prequalified one such device, the elastic collar compression device called PrePex.

References

  1. Joint United Nations Programme on HIV/AIDS. Neonatal and Child Male Circumcision: A Global Review. Geneva: UNDP, 2010.

  2. Weiss HA, Halperin D, Bailey RC, et al. Complications of circumcision in male neonates, infants and children: a systematic review. BMC Urol 2010;10(2). doi: 10.1186/1471-2490-10-2.

  3. Young MR, Bailey RC, Odoyo-June E, et al. Safety of over twelve hundred infant male circumcisions using the Mogen Clamp in Kenya. PLoS One 2012;7(10):e47395.doi: 10.1371/journal.pone.0047395.

  4. Kankaka EN, Murungi T, Kigozi G, et al. Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda. BJU Int 2017;119(1):164-70. doi:10.1111/bju.13589.

  5. Planck RM, Ndubuka NO, Wirth KE, et al. A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana. J Acquir Immune Defic Syndr 2013;62(5):e131-37.

  6. Mahvu W, Larke N, Hatzold K, et al. Implementation and operational research: a randomized noninferiority trial of AccuCirc device versus Mogen clamp for early infant male circumcision in Zimbabwe. J Acquir Immune Defic Syndr 2015;69(5):e156-e163.doi: 10.1097/QAI.0b013e318285d449.

  7. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomized controlled trial. Lancet 2007;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.

  8. Auvert B, Taljaard D, Lagarde E, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 trial. PLoS Med 2005;2(11):e298. doi: 10.137/journal.pmed.0020298.

  9. Kigozi G, Gray RH, Wawer MJ, et al. The safety of adult male circumcision in HIV-infected and uninfected men in Rakai, Uganda. PLoS Med 2008;5(6):e116. doi: 10.1371/journal.pmed.0050116.

  10. Tobian AAR, Adam T, Reed JB, et al. Voluntary medical male circumcision in resource-constrained settings (Abstract only). Nat Rev Urol 2015;12(12):661-70. doi: 10.1038/nrurol.2015.253.

  11. Voluntary medical male circumcision — southern and eastern Africa, 2010–2012. MMWR Morb Mortal Wkly Rep 2014;62(47):953-7.

  12. Herman-Roloff A, Bailey RC, Agot K. Factors associated with the safety of voluntary medical male circumcision in Nyanza province, Kenya. Bull World Health Organ 2012;90(10):773-81. doi: 10.2471/BLT.12.106112.

  13. Grund JM, Toledo C, Davis SM, et al. Notes from the field: tetanus cases after voluntary medical male circumcision for HIV prevention — eastern and southern Africa, 2012–2015. MMWR Morb Mortal Wkly Rep 2016;65(2):36-7. doi: 10.15585/mmwr.mm6502a5.

  14. World Health Organization. WHO Technical Advisory Group on Innovations in Male Circumcision, Meeting Report, 30 September – 2 October 2014. Geneva: WHO, 2015.

  15. World Health Organization. WHO Informal Consultation on Tetanus and Voluntary Medical Male Circumcision: Meeting Report, 9–10 March 2015. Geneva: WHO, 2015.

  16. Dalal S, Samuelson J, Reed J, et al. Tetanus disease and deaths in men reveal need for vaccination. Bull World Health Organ 2016;94(8):613-21.

  17. World Health Organization. WHO Technical Consultation Update to the WHO March 2015 Report: Informal Consultation on Tetanus and Voluntary Medical Male Circumcision. Geneva: WHO, 2016.

  18. World Health Organization. Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation. Report of the WHO Technical Advisory Group on Innovations in Male Circumcision — Consultative Review of Additional Information, 12 August 2016. Geneva: WHO, 2016.

  19. Rogers JH, Odoyo-June E, Jaoko W, et al. Time to complete wound healing in HIV-positive and HIV-negative men following medical male circumcision in Kisumu, Kenya: a prospective cohort study. PLoS One 2013;8(4):e61725. doi: 10.1371/journal.pone.0061725.

  20. Wawer MJ. Makumbi F, Kigozi G, et al. Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial. Lancet 2009;374(9685):229-37. doi: 10.1016/S0140-6736(09)60998-3.

  21. Odoyo-June E, Rogers JH, Jaoko W, et al. Changes in plasma viral load and penile viral shedding after circumcision among HIV-positive men in Kisumu, Kenya. J Acquir Immune Defic Syndr 2013;64(5):511-17. doi: 10.1097/QAI.0b013e3182a7ef05.

  22. Tobian AA, Kigozi G, Manucci J, et al. HIV shedding from male circumcision wounds in HIV-infected men: a prospective cohort study. PLoS Med 2015;12(4):ee1001820. doi: 10.1371/journal.pmed.1001820.

  23. World Health Organization. Guideline on the Use of Adult Male Circumcision Devices for HIV Prevention. Geneva: WHO, 2013.

Resources

 
thumbnail_WER_tetanus_vaccine_recommendations

WHO’s updated guidance on tetanus vaccines addresses the provision of "catch-up" booster doses to those who have not yet received the full series, including the adolescent and adult clients of VMMC programmes

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Wound Healing After VMMC

Developed by a committee and led by the US Centers for Disease Control and Prevention, which incorporated inputs from the WHO Technical Advisory Group on Innovations in MC, this document provides a definition of clinical wound healing after voluntary medical male circumcision.

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WHO Technical Advisory Group on Innovations - Evaluation of Two Devices

The WHO Technical Advisory Group on Innovations in Male Circumcision met in January 2013 to review the clinical performance of two male circumcision devices, PrePex and the ShangRing.

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