SOUTH AFRICA: Millions spent on risky circumcision clamps

Politics Web
Marvh 13, 2013

KwZulu Natal government has spent R48.5M [$US5.3M] on risky clamps

NATIONAL ASSEMBLY

FOR ORAL REPLY QUESTION NO. 51

...

Mrs C Dudley (ACDP) to ask the Minister of Health:

(1) Why is the Tara Klamp still being used at hospitals despite reports that a clinical trial has shown it to be unsafe;

(2) what (a) is the Government paying per Tara Klamp and (b) amount has the Government spent on Tara Klamps to date;

(3) has the Tara Klamp been put out to tender?

...

REPLY:

(1) ... The World Health Organisation (WHO)'s Department of Reproductive Health & Research (RHR) hosted a consultation ... The group concluded that while rates of adverse events and device related incidents were of primary focus "it was agreed that they did not necessarily exclude the Tara Klamp device from further assessment in an adult African population, nor imply that similarly high complication rates would be see in younger men or adolescents".

(2) (a) The cost per unit item for the TK is R222.30 [$US 24.81] VAT inclusive depending on the rand/dollar exchange rate.

(b) -->The KwaZulu/Natal Department of Health has spent R48,544,916.75 [$US 5,368,736.66] from April 2010 to date on the purchase of the TK device.
(3) ... The Department procured the device from the sole distributor for Africa,...
Issued by Parliament, April 8 2013

DURBAN: Call for enquiry into TaraKLamp

iol
August 23, 2012

Call for circumcision device probe

By Nosihle Shelembe
Durban - The Treatment Action Campaign has asked the Public Protector to investigate the procurement and ongoing use of a device used to perform medical male circumcisions in KwaZulu-Natal.

...

“The TK [Tara KLamp] is a dangerous device. It has specifically not been approved by the World Health Organisation because it failed in the only clinical trial conducted to test its safety,” [TAC provincial chairman Patrick] Mdletshe said.

The TK is a plastic device which is clamped over the foreskin of a man’s penis for seven to 10 days until the foreskin falls off. Sometimes, the device has to be surgically removed.

The TAC said the TK was used only in KwaZulu-Natal, as all the other provinces had rejected it.
Using TK cost R120 more per circumcision than the standard surgical method, Mdletshe said.

A man who did not want to be named, and who was circumcised using the TK, said that before the procedure, his penis had not been measured when it was in an erect state.

“At about 3am in the morning, when I get my erection, it becomes very painful as my penis size increases,” he said.

...

“In January 2012, we received a draft document outlining the research carried out. However the methodology of this research was so poor it provided no evidential value regarding the safety of the TK,” Mdletshe said.

Trials of the TK on adults in Orange Farm showed that it was unsafe.

The trials revealed that there was a 32 percent infection rate using the TK compared to the zero percent when using the forceps guided method (FGM), which was the standard surgical method.

The complication rate when using the TK was 37 percent compared to three percent using the FGM.
According to the TAC, no tender had been published for the procurement of the TK.

“The TK was purchased from a supplier with links to government, rather than a competitor offering a low price,” Mdletshe said.

...