ShangRing: WHO approval of second nonsurgical circumcision device sets stage for accelerated access to HIV prevention measure

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Latest device approved for use on adolescents, broadening scope of low-cost intervention

Call it “VMMC,” for voluntary medical male circumcision, or the current, and more concise “MC” for medical circumcision, by any name, removing men’s foreskins has been proven to lower their risks of acquiring HIV through vaginal sexual intercourse by as much as 60 percent. The benefits of the one-time intervention are multiple too, having also been found to lower transmission of herpes  — a virus that in turn increases risks of HIV infection —  and human papillomavirus  — a virus that is a major cause of cervical cancer.

ShangRinglabeledNow, with the World Health Organization’s green light for a nonsurgical circumcision device designed by an engineer in China, there is one more way to remove a foreskin. The first new circumcision device in two years to receive WHO prequalification  (and the second one ever) the ShangRing differs from both surgical foreskin removal and the previously approved PrePex device, in ways that those who laid the groundwork for getting the device cleared for use in HIV prevention programs in Africa say could lower the costs and broaden the reach of the intervention.

Source: World Health Organization

Source: World Health Organization

Cutting the time, skills, and the stitches required for conventional surgical circumcision, the development of devices that can be used by nurses and clinical officers has been seen as important to making circumcision widely available and safe in low-resource settings where physicians are in short supply. The previously approved PrePex device, which came with the added advantage of not requiring injected local anesthetic, however, was not okayed for use on adolescents, a significant population of those seeking medical circumcision in those environments. The ShangRing, in turn, which does require an injected local anesthetic, is the first device to be approved by WHO for both adult men and boys aged 13 to 17. To see how the ShangRing works, see this video from the Cornell Brady Urology Studio, Department of Urology, Weill Cornell Medical College.

The device already was in use in China in 2007, when work began to get it approved for use in Africa. A medical intervention intended for prevention, rather than treatment of an illness always must stand up to the highest level of scrutiny to ensure it doesn’t cause harm, noted Dr. Philip Li, who directed the video, is a Weill Cornell urology and reproductive health research professor and a principal investigator for studies evaluating the device. “I don’t think in history any procedure has been evaluated more,” he added.

With funding from the Bill & Melinda Gates Foundation, and support from Weill Cornell as well as the nonprofits FHI360 and EngenderHealth, that encompassed acceptability and safety studies including ones comparing the device to conventional surgery in Kenya, Zambia and Uganda over the course of seven years. They found the ring safe, and preferred to surgery by men among whom, also, “satisfaction with cosmetic appearance of their circumcized penis was very high.”

No studies have compared it directly to PrePex, but one comparison is available; Shang Jianzhong, inventor of the ring and board chairman of Wuhu Snnda Medical Treatment Appliance Technology, has agreed to provide rings to 14 of the countries with the highest burdens and lowest resources to confront HIV for $10, and with sufficient sales volume, a projected price of $7 per device. Prequalified in 2013, PrePex started at about $20 per device and recently dropped to $12.

WHO prequalification does not replace individual countries’ regulatory authority process, but, indicating compliance with international standards tends to speed them up, and makes the device eligible for procurement by programs that include the US. President’s Emergency Plan for AIDS Relief.

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