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09 July 2010

Tara clamp call rejected

The Southern African distributors of the Tara KLamp circumcision device have rejected a call for it to be put on hold until safety concerns have been addressed.

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The Southern African distributors of the Tara KLamp circumcision device have rejected a call for it to be put on hold until safety concerns have been addressed.

The call was made on Thursday in a joint statement by the Treatment Action Campaign and the Southern African HIV Clinicians Society.

Tony Lawrence, spokesman for distributors Carpe Diem Enterprises, said however that the statement contained numerous allegations about the clamp which were "totally inaccurate, unjustified and unfounded".

These would require some time to respond to in detail, with input from the manufacturers, he said.

"We are determined to correct the views of all the parties concerned, as the experiences of our medical doctors across the country can attest to the efficacy and ease of use of the [clamp]."

He promised a full response later.

Aggressive marketing

TAC and the doctors said the device was being aggressively marketed in several southern African countries, including South Africa.

They said they encouraged voluntary male circumcision as a way of reducing the risk of heterosexual men contracting HIV and the human papilloma virus.

Adverse events

However, a controlled trial of the Tara KLamp at Orange Farm, in Gauteng, had found a high rate of "adverse events".

Men circumcised using the clamp had, in the trial, also reported worse pain than men circumcised using the forceps-guided method of medical circumcision.

That trial was stopped early due to the unacceptably high rate of adverse events, and the researchers had "strongly" cautioned against using the clamp on young adults.

The clamp was attached to the foreskin, and after about a week the device, along with the foreskin, usually fell off. But in some cases the device did not fall off, forcing the patient to have it removed surgically.

"Safety must be proven before any new medical intervention is implemented," TAC and the doctors said.

"Currently, the balance of evidence shows that the [clamp] is unsafe for use on adolescents and adults," they said.

"The [clamp] must be withdrawn from sale and distribution for adolescent and adult circumcision throughout sub-Saharan Africa until the device's safety concerns are addressed." - (Sapa, July 2010)

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