Tested and safe? Court battle over circumcision device

The roll-out of a new surgical device to make circumcisions easier has been delayed. Photo: Wikimedia user Rickyblax (CC BY-SA 4.0)

• A national tender for circumcision devices is being challenged in court by Unicirc, which says the chosen device is untested and unsafe.

• The company argues that its own device is safer, quicker, and already widely used, while the device chosen by the government, made by CircumQ, is not backed up by published research or World Health Organisation approval.
• Unicirc wants the tender process to start over.

A tender for a circumcision device, set to be used in all provincial health care centres and the military, is under legal scrutiny amid claims that the device is untested and unsafe.

Unicirc Pty Ltd has filed papers in the Pretoria High Court seeking to review and set aside the award of the tender to CircumQ RF Pty Ltd amid claims that the CircumQ device is “vastly inferior” compared to its own and others.

In his founding affidavit, Dr Cyril Norman Parker said that the application was “in the public interest” to ensure only safe and proven surgical devices are used in circumcision procedures.

“There is no publicly available information even to suggest that CircumQ’s device is such a device,” he said.

Parker – who has extensive circumcision experience – and his wife, Elizabeth Pillgrab-Parker, co-founded and continue to work in two primary health care centres they established in Mitchells Plain and Sea Point in the Western Cape under the auspices of Simunye Health Care.

Parker says he has worked in the area of male circumcision for 30 years, in particular as an HIV prevention strategy.

They are also the co-directors of Unicirc, which has the licence to distribute and sell a single-use circumcision device for safe and cost effective circumcision. The device “has significant capacity for scaling up circumcision procedures”, Parker said.

Unicirc bid for the tender for the supply of a surgical aid to be used at the nine departments of health and the Department of Defence.

Parker said he and his wife set up the Simunye health care centres when HIV prevalence was high.

“The conclusive results of three landmark clinical trials gave cause for optimism that circumcision could reduce female to male transmission of HIV by between 50 and 60%,” he said.

In terms of a policy decision taken by the National Department of Health, circumcision services were offered to all males aged ten and above.

“Our role, as service providers, is to ensure that we provide that service safety. In so far as ten to 14-year-olds, this means the strict use of device-based methods that avoid the need for sutures which brings complication rates down to less than 1.5%.”

He said he had performed over 3,000 circumcisions across all age groups using multiple techniques.

“What is absolutely clear is that in order to provide services to everyone in need, a surgical-only approach has to be abandoned in favour of a device approach. But not all devices are the same.

“We conceptualised the development of a new circumcision device to improve safety, efficiency and accessibility.”

He said the Unicirc device, which is manufactured overseas, allowed for a complete circumcision in one visit, performed by a single health care provider, using a local anaesthetic and without any sutures.

The whole procedure is completed in about ten to 12 minutes and with proper training, it can also be performed by nurses.

“It has now been used for more than ten years by a range of different health care providers. More than 7,500 procedures have been performed in all ages in both public and private health care sectors. No severe adverse events have been reported and excellent cosmetic results have been achieved.

“It has resulted in the doubling of the number of circumcisions that can be performed safely in a day, a significant reduction in complications and increased client satisfaction,” Parker said.

When the World Health Organisation (WHO) published its (device) guidelines in 2020, only the Unicirc device came close to meeting the requirements. The manufacturer had now started the process of securing WHO pre-qualification. (WHO pre-qualified devices have to meet strict standards of quality, safety and efficacy.)

The device had also been tested in medical trials.

In contrast, Parker said, very little was known publicly about the CircumQ device.

“I am not aware of any peer-reviewed publications that consider its use. It has not been reviewed in any of the WHO literature I have perused or in any systematic review of circumcision devices that I have read. This is in contrast to the Unicirc device as well as other products.

“While I have come across two studies, I have not been able to find out anything about this research and I have not seen any evidence to suggest that it is close to being prequalified or even evaluated by WHO.”

Parker said however, he had studied its design, read training material and spoken to various experts and researchers and health care workers who had used that device and later attended training on the Unicirc device.

“It is vastly inferior. Sutures are required, increasing healing time and requiring a follow up visit. It increases patient discomfort and the risk of infection, the procedure takes longer and it’s more difficult to scale up because it requires two operators,” he said.

“But it’s not just a question of which device is better. There is simply no scientific data supporting the use of it.

“In the absence of that, it would be highly irresponsible to recommend its use, especially in the vulnerable ten to 14 age group. It places young boys at unnecessary risk of potentially irreparable harm and undermines the circumcision programme as a whole.”

He said while the tender was awarded in August 2023, “the public health system was far from ready to implement it”.

This was apparent from a letter from National Treasury, dated March 2025, in which it was stated that because of delays in training, service providers were allowed to continue using the conventional dorsal slit surgical method.

Parker submitted that the tender should be reviewed and set aside, and a new bidding process should start afresh.

Unicirc has called on the Treasury to provide a record of its decision-making process after which it may file a further affidavit. This will be provided by 30 May.

So far only the Treasury respondents have filed notices of opposition and they have yet to file affidavits.

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