An Israeli firm behind the only nonsurgical medical male circumcision is remodeling its device over tetanus risk concerns. This follows confirmation by the World Health Organisation WHO that there was a higher risk of tetanus in circumcision performed with the elastic collar compression device compared to other circumcision methods that remove the foreskin at the time of the procedure.
PrePex Medical Male Circumcision Device. It had been hailed by many because it is nonsurgical, pain-free and did not require sterile environment.
An Israeli firm behind the only nonsurgical medical male circumcision is remodeling its device over tetanus risk concerns.
Circ MedTech has now developed a device which enables the foreskin to be removed after thirty minutes.
This follows confirmation by the World Health Organisation (WHO) that there was a higher risk of tetanus in circumcision performed with the elastic collar compression device compared to other circumcision methods that remove the foreskin at the time of the procedure.
Prepex device manufactured by Circ MedTech, an Israeli social enterprise company, has been used in Uganda and 13 other African countries in voluntary medical circumcision (VMMC).
The device which was prequalified by WHO in 2013 uses an elastic band to cut off the blood supply to the foreskin until it dies or gets removed after seven days.
PrePex had attracted demand because one didn't need anesthesia and surgery to be circumcised. One did not need a sterile setting to perform circumcision using it.
It was hoped that the device would help to reduce the spread of HIV in Africa because being circumcised reduces a heterosexual man's risk of becoming infected by 60 per cent.
Some of those who were circumcised using the device in Uganda and other countries contracted tetanus disease transmitted by bacteria through broken skin.
The deaths in Uganda due to tetanus in males circumcised under medical male circumcision forced the Ministry Health to introduce mandatory tetanus vaccination of those seeking to be circumcised.
The World Health Organization's (WHO) Technical Working Group on Innovations in Male Circumcision (TAG) last year unanimously noted that there was a higher risk of tetanus following circumcision with the elastic collar compression device compared with other circumcision methods that remove the foreskin at the time of the procedure.
The technical working group recommended that male circumcision with a device that is removed along with the foreskin several days after it is applied should be performed only if the client is adequately protected against tetanus by immunization.
Now Circ MedTech says in line with the WHO recommendation, it is introducing PrePex Day-Zero Foreskin Removal Procedure (D0FRP).
Circ MedTech Ltd Chief Executive Officer, Eddy Horowitz, in a statement says the improved PrePex procedure has been designed to facilitate use of the device with equal Tetanus mitigation to that of Surgical Circumcision.
The improved technique according to Horowitz enables removal of the foreskin shortly after the device placement while conserving the known and accepted advantages of the PrePex device, including no injected anesthesia, no recovery time, creating of incremental demand for Medical Circumcision.
With the improved device, the fore skin is removed after thirty minutes as opposed to seven days for PrePex TM.
A large field study of the D0FRP change is currently at its end phase with more than 600 subjects in two different settings in Zambia. Horowitz says the study will be completed soon, and the results will be submitted to the WHO Technical Working Group on Innovations in Male Circumcision (TAG) team for its review planned later in May.
WHO and UNAIDS prioritized 14 eastern and southern African countries with high HIV and low male circumcision prevalence for a voluntary medical male circumcision (VMMC) scale-up in 2017.