KZN govt still using Tara KLamp for medical circumcisions - TAC
Treatment Action Campaign |
23 August 2012
Organisation lodges a complaint with Public Protector over use of dangerous device
KZN Government continues to roll out an expensive and dangerous circumcision device: TAC lodges a complaint with the Public Protector against KZN MEC for health and KZN DoH
The Treatment Action Campaign (TAC) has lodged a complaint with the Public Protector against the KwaZulu-Natal (KZN) Member of the Executive Council (MEC) for health and the KZN Department of Health (DoH). The complaint asks the Public Protector to investigate the procurement and ongoing use of the Tara KLamp (TK) to perform medical circumcisions on adolescent and adult men in KZN. The TK is a plastic device that is clamped over the foreskin of a man's penis for 7 to 10 days until the foreskin dies and falls off (sometimes it has to be surgically removed).
The TK 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.
The TK is also more expensive to use than the standard surgical circumcision methods.
TAC has been asking the KZN government to halt the use of the TK since we first learned of its use in early 2010. We have also asked the National Department of Health to intervene. Our efforts have been in vain and we have therefore been left with no choice except to lodge a complaint with the Public Protector.
Our complaint is supported by the South African Medical Association and the Southern African HIV Clinicians Society.
That the KZN government continues to roll out the TK against the advice of the country's foremost medical practitioners and scientists is arrogant and irresponsible. It raises our suspicion that all is not above board with the procurement of this device.
In medicine, it is a fundamental ethical principle not to implement an intervention unless it has been tested and shown to be safe. The only clinical trial of the TK in adults, which was carried out in Orange Farm, Gauteng, showed that it is very unsafe. Attached is a table comparing the side effects of the Tara KLamp to the control arm in the clinical trial. Because of the high rates of adverse events, the trial was suspended early and the researchers cautioned against the use of the TK in young adult men.
Following numerous complaints by TAC, we were informed by the KZN government that it would carry out its own research on the TK. TAC sent a letter to the KZN government requesting the details of this research, but we never received a response. In January 2012, we received a draft document outlining the research that was carried out. However, the methodology of this research was so poor that it provided no evidential value regarding the safety of the TK. Several of the researchers involved in this study were so appalled by its quality that they distanced themselves from the study. Critically, the study did not have ethical clearance.
Since 2010, TAC has received picture and video evidence of TK injuries and spoken to men who have experienced adverse events as a result of the device.
As well as our safety concerns, our complaint to the Public Protector asks questions about the procurement of the TK. The KZN government is paying more to perform circumcisions using the TK than it would cost to use a standard surgical method. Using the TK costs approximately R120 more per circumcision and this does not include the additional costs due to the high rates of adverse events caused by the TK. A cost comparison of the two methods is attached.
No tender was published for the procurement of the TK and the TK was purchased from a supplier with links to the government, rather than a competitor company offering a lower price. We have therefore requested that the Public Protector investigate the procurement of the device.
On 18 September 2011 the Zulu edition of the Sunday Times newspaper reported that the local supplier of the TK, Ibrahim Yusuf, gave King Goodwill Zwelithini a car worth R1 million.
There are numerous unanswered questions about the TK. We are deeply suspicious of the officials in the KZN government who have driven its use.
We are also concerned about the haphazard and chaotic way in which the KZN government is implementing circumcision. Circumcision camps are being organised in which community service doctors are carrying out circumcisions without supervision. We have supported the rollout of circumcision since the publication of clinical trials showing its massive effect on reducing HIV incidence. We supported voluntary medical male circumcision when former president, Thabo Mbeki, and the late health minister, Manto Tshabalala-Msimang, failed to support it. But we cannot support chaos and a disorganised approach that endangers patients.
One of the reasons the KZN government has managed to persist with the TK and its chaotic circumcision programme is that the National Department of Health, despite our requests, has failed to publish circumcision guidelines. It is negligent and unacceptable that two years into the circumcision rollout we still do not have guidelines. We have met with the Minister of Health to alert him to our concerns.
TAC's complaint was sent to the Public Protector on 2 August and we have received an acknowledgement of receipt. The deponent in the complaint is Patrick Mdletshe, the elected provincial Chairperson of TAC KZN.
Table 1. Comparison of adverse events: Tara KLamp vs forceps guided method
Tara KLamp (%)
Forceps Guided (%)
Delayed wound healing
Problems with penis appearance
Participants more likely to report bleeding
Injury to the penis
Table 2. Comparison of cost: Tara KLamp vs forceps guided method
Surgical circumcision kit
Pain relief (paracetamol, paracodeine)
Local anaesthesia (7.5mm lignocaine, 2.5mm bupivacaine)
Doctor's time (at R300/hour)
Background documents and timeline for Tara KLamp complaint:
November 2010 - TAC representatives and men who had experienced adverse events from the TK met with Premier Mkhize and representatives of the KZN government. Premier Mkhize informed TAC that KZN would carry out its own research on the use of the TK