Safety of over Twelve Hundred Infant Male Circumcisions Using the Mogen Clamp in Kenya

Abstract

BackgroundSeveral sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya.MethodsAE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤2 months and weighing ≥2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors.FindingsA total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR = 1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed.ConclusionIMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life.

Determinants of morbidity associated with infant male circumcision: community‐level population‐based study in rural Ghana

“…The risk of morbidity doubled for circumcisions performed after 20 days of life. Similar findings were reported in a recent systematic review and studies from Kenya, Pakistan and the USA . The risk of morbidity in younger infants may be lower due to the simpler nature of the procedure during this period and faster healing .…”

Single-Arm Evaluation of the AccuCirc Device for Early Infant Male Circumcision in Botswana

“…There are rare but serious potential complications associated with all three devices currently on the WHO prequalified list of EIMC devices: 1) use of the Mogen clamp can result in partial or total amputation of the glans penis or removal of too little foreskin [10, 13, 16–18]; 2) migration of the Plastibell can result in necrosis of the glans and other injuries, and risk is increased if the incorrect size “bell” is utilized [10, 14, 19, 20], and 3) mismatching the sizes of the separate pieces of the Gomco clamp can result in laceration of the glans penis [10, 16]. Sequelae of these rare adverse outcomes may be worse in settings with limited resources for treating such complications.…”

HIV Prevention in Clinical Care Settings

“…226 Despite the recommendations, efforts to promote male circumcision in priority countries have had mixed results, likely due to limited health care resources and cultural attitudes toward circumcision. The need to simplify the procedure in resource-limited settings has led to development of medical devices that require minimal or no surgery, introduction of new, more efficient procedures that increase productivity by task shifting, use of diathermy 227,228 for hemostasis, and use of prepackaged surgical instruments. In some countries, demand from men has been low, and changes in the delivery system alone will not achieve the levels targeted.…”