09 Jul 2010
CAPE TOWN — 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 yesterday in a joint statement by the Treatment Action Campaign and the Southern African HIV Clinicians’ Society.
Tony Lawrence, spokesperson for distributors Carpe Diem Enterprises, said, however, that the statement contains numerous allegations about the clamp which are “totally inaccurate, unjustified and unfounded”.
“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.
TAC and the doctors said they encourage voluntary male circumcision as a way of reducing the risk of heterosexual men contracting HIV and the human papilloma virus.
In a controlled trial of the Tara KLamp at Orange Farm in Gauteng, circumcised men using the clamp reported worse pain than men 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 have “strongly” cautioned against using the clamp on young adults.
The clamp is attached to the foreskin, and after about a week the device, along with the foreskin, usually falls off. But in some cases the device does not fall off, forcing the patient to have it removed surgically.
“Currently, the balance of evidence shows that the [clamp] is unsafe for use on adolescents and adults,” TAC and the doctors 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“The [clamp] must be withdrawn from sale and distribution for adolescent and adult circumcision throughout sub-Saharan Africa, until the device’s safety concerns are addressed.”