Monday, February 4, 2013

KENYA, ZAMBIA: Dangerous circumcision clamp being used

January 30, 2013

Dangerous circumcision clamp still in use in Africa

by Hugh Young

While the Mogen circumcision clamp is no longer manufactured in the USA, the Mogen company having been driven out of business by legal action, Mogen clamps are still being tested in Africa with a view to circumcising babies to reduce HIV-acquisition. No study has shown infant circumcision has any effect on HIV acquisition.

In 2010, a Florida family won $10.8 million in damages from the Mogen company, after the glans (head) of their son's penis was partially cut off in a Mogen clamp. This followed another successful claim for $7.5 million. As a result the Mogen Company went out of business.

Now, two studies from Africa, involving Mogen clamps have been published, suggesting they should be used on babies there.

J Acquir Immune Defic Syndr. 2013 Jan 1;62(1):e1-6. doi: 10.1097/QAI.0b013e318275741b.
A controlled trial of three methods for neonatal circumcision in lusaka, zambia.
Bowa K, Li MS, Mugisa B, Waters E, Linyama DM, Chi BH, Stringer JS, Stringer EM.

Neonatal male circumcision (NMC) is not routinely practiced in Zambia, but it is a promising long-term HIV prevention strategy. We studied the feasibility and safety of three different NMC methods.
We enrolled healthy newborns in a controlled trial of the Mogen, Gomco, and Plastibell devices. Doctors, nurses, and clinical officers were trained to perform Mogen, Gomco, and Plastibell techniques. Each provider performed at least 10 circumcisions using each device. Neonates were reviewed at 1 and 6 weeks after circumcision for adverse events.
Between October 2009 and March 2011, 17 providers (5 physicians, 9 nurse midwives, and 3 clinical officers) without previous NMC experience were trained, and 640 circumcisions were performed. The median infant birth weight was 3.2 kg (interquartile range: 2.9-3.5 kg), and median age at the time of procedure was 11 days (interquartile range: 7-18 days); 149 babies (23.3%) were exposed to HIV. The overall adverse event rate was 4.9% (n = 31/630), and the moderate-severe adverse event rate was 4.1% (n = 26/630). Rates did not significantly differ by method. Most providers (65%) preferred Mogen clamp over Gomco and Plastibell.
Doctors, nurses, and clinical officers can be trained to safely provide NMC in a programmatic setting. The 3 studied techniques had comparable safety profiles. Mogen clamp was the preferred device for most providers.

That is, one baby in 24 suffered a moderate-to-severe adverse event, and one baby in 20 any adverse event.

PLoS One. 2012;7(10):e47395. doi: 10.1371/journal.pone.0047395. Epub 2012 Oct 17
Safety [or danger] of over twelve hundred infant male circumcisions using the Mogen clamp in Kenya.
Young MR, Bailey RC, Odoyo-June E, Irwin TE, Obiero W, Ongong'a DO, Badia JA, Agot K, Nordstrom SK.

Several 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.
AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged 2 months [or less] and weighing 2.5 kg [or more] 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.
A 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.
IMC 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.

The Adverse Event frequency of 2.7% reported here is an order of magnitude greater than that reported by the AAP. Any claim the AAP makes of "the benefits exceeding the risks" is diluted by this. The AE rate is also higher than that of 1.7% reported by Weiss, Larke, Halperin and Schenker.

They report a [parental?] dissatisfaction rate of 4% and less than 1 in 10 of those would not circumcise their son again.

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