Doctors who spoke anonymously to Health-e, expressed concern about the department’s use of the Tara Klamp (TK), a disposable device designed to stay on the penis for around seven days until it falls off with the foreskin.
A small trial of young men in Orange Farm found that those circumcised with the Malaysian-developed TK were far more likely to report bleeding and swelling than those circumcised with forceps.
The trial involved 69 men, 35 of whom were circumcised with the TK and 34 with forceps, and was published in the SA Medical Journal in March 2009.
Almost 40 percent of those circumcised with the TK reported ‘adverse effects’ including infection, delayed wound healing, swelling and problems with penis appearance while only three percent of those circumcised with forceps reported any problems.
This prompted lead researcher Dr Emmanual Lagarde and colleagues to conclude: ‘Given the high rate of adverse events in this study and the low number of available studies, we strongly caution against the use of the TK for young adults, and we recommend careful evaluation of the procedure when performed on children.’
The World Health Organisation (WHO) has advised caution when using any devices to circumcise men.
‘Currently, WHO does not recommend any devices for circumcision among adult or young men,’ according to the organisation’s circumcision guidelines.
‘WHO encourages further research on promising devices to assess their safety, effectiveness and acceptability. The surgical approaches used in the randomized controlled trials (the forceps-guided and sleeve resection methods) have been shown to be safe, effective and acceptable.’
After a significant delay in responding to queries, during which time the province’s first ‘circumcision weekend’ was held, departmental spokesperson Chris Maxon said that while the WHO ‘provides guidance to member countries’, countries ‘may use their discretion to utilise methods that might not be approved by the WHO but are beneficial to their communities’.
‘It is not the fact that WHO does not approve the Tara clamp but the fact is they do not have enough data on the use of the device at a mass scale, which is what KZN will provide at a later stage,’ said Maxon
‘The use of the Tara clamp in KZN will be used under strict protocols which will include training and supervision by the surgeon that has been identified by the province.’
However, Dr Francois Venter, head of the SA HIV Clinicians Society said: ‘Good local and published data suggests that the Tara Klamp is more dangerous than WHO recommended methods. We have precious few HIV prevention interventions available to us. I do not understand why KZN would be using this device, when we have safer alternatives, especially where unsafe circumcision has been roundly condemned by the national Department of Health.’
Currently, the device is being sold wholesale for R99 and Health-e was unable to confirm rumours that the Malaysian company planned to open a manufacturing plant in the province.
The province has embarked on a mass male circumcision drive as circumcised men have a far lower chance of getting HIV than uncircumcised men.