Circumcision clamp slammed

In a joint statement released yesterday the Southern African HIV Clinicians Society and the Treatment Action Campaign said although they supported the implementation of a country-wide voluntary male medical circumcision (VMMC) programme, they had concerns about the Tara KLamp (Subs: CORRECT).

They doctors and activists said they were deeply concerned that a Malaysian company, Taramedic Corporation, and its South African partner, Carpe Diem Enterprises, were aggressively marketing a circumcision device called the Tara KLamp (TK) to several sub-Saharan African countries, including South Africa, Lesotho, Kenya, Botswana and Zimbabwe.

A randomised controlled trial in adolescents and adults found a very high rate of adverse events and much greater pain associated with this device compared to the standard forceps-guided circumcision technique.

‘€œThe TK must be withdrawn from sale and distribution for adolescent and adult circumcision throughout sub-Saharan Africa until the device’s safety concerns are addressed,’€ the statement said.

The TK is a circumcision device that is clamped onto the foreskin with the purpose of necrotising it. After approximately seven days the device, along with the foreskin, usually falls off. In some cases the device does not fall off forcing the patient to have the TK removed surgically.

The Orange Farm clinical trial showed that Voluntary Medical Male Circumcision can reduce a heterosexual male’€™s risk of contracting HIV by 60%. In 2005 the Orange Farm researchers performed a randomised controlled trial to see if the TK could be used as an alternative method of circumcision. 35 men were circumcised with the TK and 34 with the standard forceps-guided technique that was used during the original trial.

Adverse events from use of the TK were far higher: 37% compared to 3.4% for the forceps-guided method. This was a statistically significant result. Men circumcised using the TK also reported worse pain than men circumcised using the forceps-guided method. Furthermore, the device saw 97 men refused to participate in the trial, 94 of them giving the reason that they did not wish to use the TK.

The TK trial was stopped early due to the unacceptably high rate of adverse events. The researchers concluded, ‘€œGiven the high rates 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.’€

Carpe Diem Enterprises is the distributor of the TK in South Africa. The statement accused the company of disregarding the safety concerns raised in the Orange Farm study. The device’s website states, ‘€œThis invention enables circumcisions to be performed not only safely and easily but also —– for the first time in surgical history —– enables circumcisions to be performed just as aseptically, at home, on the roadsides or out there in the bush, as in an operating theater. ‘€

The device is marketed as a faster method of performing circumcisions, as it can be carried out in less than 10 minutes. However, this is not much faster than the medical forceps-guided method of circumcision and does not outweigh safety concerns. It also does not take into account the additional time needed to surgically remove the device from some patients.

The TK is also more expensive than the forceps-guided method of circumcision. The Treatment Action Campaign said that according to discussions with the manufacturer, the TK is being sold to general practitioners for R160 excluding VAT. However the device only slightly reduces the number of surgical instruments needed in a circumcision. ‘€œConsequently we estimate that using the TK adds significant cost, even without considering the extremely large additional cost that would be incurred from hospitalisations due to increased adverse events,’€ the statement said.

‘€œThe attitude of the company towards critical research of its device is exemplified by Dr. G. Singh, the inventor of the TK, who made the following threat in an email exchange with one of the authors of the Orange Farm study, ‘€˜All it needs is a simple withdrawal of your manuscript and gracefully accept the reality. I am even not asking for an apology, for I am a very forgiving man….. but there is a limit!’€™,’€ the TAC statement revealed.

The statement claimed that the TK has also been used throughout the region as a part of the evangelical mission of the marketers of the device, Tony Lawrence and Magda Van Der Walt. A book promoting the device and the work of Tony Lawrence states the following:

‘€œTwice per year… young male initiates in South Africa alone take an important step toward manhood by undergoing circumcision during a time of initiation ‘€¦ But what should be a glorious occasion for these teenagers often turns out to be a nightmare. One out of five boys end up with their genitals partially or fully amputated…. The Seize the Day foundation is rescuing these children in a holistic way. Among other things, Tony Lawrence and the seize the day volunteer distribute a pack to each initiate. (The pack contains a TK and a bible) … The solution is to circumcise and evangelize.’€2

‘€œThe TK is being aggressively marketed and, at times, with an inappropriate religious agenda. The marketers of the device make unsubstantiated claims and disregard safety concerns. They have threatened researchers who published data critical of the TK. The TK must be withdrawn from use throughout sub-Saharan Africa for adults and adolescents until its safety concerns are addressed’€ the statement said.

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