Doctors are concerned that the government is using a circumcision device, the Tara KLamp, that has not been approved by the World Health Organisation.
The most ambitious medical male circumcision project in South African history was launched by the KwaZulu-Natal health department in April, but doctors are concerned that the government is using a circumcision device, the Tara KLamp, that has not been approved by the World Health Organisation.
The department is targeting 2,5?million uncircumcised men in the province.
Medical male circumcision has been identified as a way to limit the spread of HIV, after clinical trials in Kenya and Uganda in 2003, and South Africa in 2005, established that HIV infection rates decreased by 60% among circumcised men.
Male circumcision among the Zulu people was stopped by King Shaka in the 19th century, because the initiation of young men disrupted the nation’s military requirements. But in December last year current monarch King Goodwill Zwelithini called for it to be reinstated because of its health benefits and asked for government support in conducting the circumcisions medically.
KwaZulu-Natal authorities decided to use the Tara KLamp, a Malaysian-manufactured plastic circumcision device, in the ambitious campaign.
The device made headlines last month when Deputy President Kgalema Motlanthe introduced and explained it in Parliament, to the amused surprise of MPs.
The Tara KLamp makes circumcisions quicker and easier by cutting off blood supply to the foreskin during surgery. It remains on the penis for a week, allowing the wound to heal.
Proponents claim it is possible to do 10 circumcisions with the Tara KLamp in the time it would normally take to do one using other methods.
But two medical researchers who spoke to the Mail & Guardian raised concerns about the lack of medical research on the Tara KLamp in relation to adult circumcisions.
They also pointed out that it is not a WHO-approved device.
Adrian Puren, deputy director of virology at the National Institute for Communicable Diseases, was the co-principal investigator in a randomised sub-trial conducted in Orange Farm, south of Johannesburg, in 2004 to compare the safety of the Tara KLamp technique with the conventional forceps-guided method.
The sub-trial is the only such medical research to have been conducted in South Africa among young adult males. An article on the trial, published last year in the South African Medical Journal, found “compelling evidence that strongly cautions against use of the TK [Tara KLamp] method on young adults”.
The article says that 37% of participants in the Tara KLamp sample experienced complications, as opposed to 3,4% in the forceps-guided sample.
Complication rates for male circumcisions are typically in the 2% to 10% range, the article says. Nineteen participants were circumcised using the Tara KLamp, before the study was stopped due to the high complication rates.
Speaking to the Mail & Guardian last week, Puren conceded that the 2004 study consisted of a “relatively small sample” but said that “in the absence of options with lower complication rates than the forceps-guided method, we recommend that one should keep to established, scientifically proved circumcision methods”.
Dirk Taljaard was the principal supervisor for the 2004 Orange Farm study. He is chief executive of the Centre for HIV/Aids Prevention Studies, which oversees Bophelo Pele, a medical male circumcision project in Orange Farm.
“The issue is really that the [Tara] KLamp is not a WHO-approved device. Until such time as there is enough evidence, WHO will not endorse any method or device. Funders are following WHO guidelines in this regard and will provide funding only to be used for WHO-approved surgery techniques,” Taljaard said. As a result, Bophelo Pele—an international donor-funded project—does not use the Tara KLamp.
The M&G has seen a draft WHO statement on male circumcision devices, summarising the main points of a consultative meeting held last year. The statement confirms that “[c]urrently, WHO does not recommend any devices for circumcision among adult or young men”. Only three surgical procedures—the forceps-guided, dorsal slit and sleeve resection methods—are recommended for adults.
“Manufacturers all make claims about what their products can do. WHO approval is there to protect government health departments against unverified marketing claims. It [WHO approval] is the world standard of what should be done,” Taljaard said.
This week the M&G presented Puren and Taljaard’s concerns about the Tara KLamp to both the KwaZulu-Natal health department and Carpe Diem Enterprises, the distributor of Tara KLamps in Southern Africa.
KwaZulu-Natal’s health minister, Sibongiseni Dhlomo, responded that “we are aware of the [2004 Orange Farm] report and we are proceeding very cautiously [with the Tara KLamp]”.
He said both the Tara KLamp and forceps-guided procedures will be available to patients: “We will not force them to use one method or another. We will show and explain both and they can choose.”
But, from a health economics perspective, Dhlomo’s preference is clear: “The Tara KLamp is more cost-effective. Whereas surgical methods can be administered only by a doctor and require three or four subsequent visits to a clinic for replacement bandages and check-ups, the Tara KLamp method can be done by a male nurse and needs only one further check-up. This reduces patients’ bus fares back and forth, sick-leave days, and so on.”
The department’s medical male circumcision budget for the 2010-11 financial year is R76,21?million and it will target 186 703 adult males.
Dhlomo travelled to Malaysia two weeks ago to learn more about the Tara KLamp and to request the help of Malaysian doctors to train provincial health staff. He said “all circumcisions in KwaZulu-Natal will be conducted under the strict supervision of a urologist”.
“As with anything medical, I cannot guarantee that Tara KLamp users won’t experience any complications. But we have seen good results in a short space of time,” Dhlomo said.
Carpe Diem Enterprises partner Tony Lawrence told the M&G that he hoped the Tara KLamp “would become a brand name that is synonymous with circumcision”.
Lawrence is advising the KwaZulu-Natal health department on how to use the Tara KLamp, although the department has procured its devices directly from the Malaysian manufacturer, via Intratrek Properties. According to Lawrence, Tara KLamps retail at R160 each, excluding VAT.
“South Africa faces a major backlog in circumcising men as part of its prevention of HIV-transmission strategy. The issue is how to roll these programmes out, without impacting on medical service delivery in other areas, or overstretching the country’s medical health system,” he said.
Lawrence said that the Tara KLamp has “undergone minor improvements” last year and that “in two years [distributing the device in South Africa, we] only had two complaints”, which he attributed to “lack of training and patient unreliability”.
“It is not for us to prove the Tara KLamp works—we know it does. Now the important thing is to get it out there to help in preventing HIV transmission,” he said.