AIDS Prevention Inspires Ways to Make Circumcisions Easier
The day of the assembly-line circumcision is drawing closer.
Now that three studies have shown that circumcising adult heterosexual men is one of the most effective “vaccines” against AIDS - reducing the chances of infection by 60 percent or more - public health experts are struggling to find ways to make the process faster, cheaper and safer.
The goal is to circumcise 20 million African men by 2015, but only about 600,000 have had the operation thus far. Even a skilled surgeon takes about 15 minutes, most African countries are desperately short of surgeons, and there is no Mohels Without Borders.
So donors are pinning their hopes on several devices now being tested to speed things up.
Dr. Stefano Bertozzi, director of H.I.V. for the Bill and Melinda Gates Foundation, said it had its eyes on two, named PrePex and the Shang Ring, and was supporting efforts by the World Health Organization to evaluate them.
Circumcision is believe to protect heterosexual men because the foreskin has many Langerhans cells, which pick up viruses and “present” them to the immune system - which H.I.V. attacks.
PrePex, invented in 2009 by four Israelis after one of them, a urologist, heard an appeal for doctors to do circumcisions in Africa, was approved by the Food and Drug Administration three weeks ago. The W.H.O. will make a decision on it soon, said Mitchell Warren, an AIDS-prevention expert who closely follows the process.
From the initial safety studies done so far, PrePex is clearly faster, less painful and more bloodless than any of its current rivals. And it relies on the simplest and least-threatening technology - a rubber band.
The band compresses the foreskin against a plastic ring slipped inside it; the foreskin dies within hours for lack of blood and, after a week, falls off or can be clipped off “like a fingernail,” said Tzameret Fuerst, the company’s chief executive officer, who compared the process to the stump of an umbilical cord’s shriveling up and dropping off a few days after it is clamped.
It is done with topical anesthetic cream, and there is usually no bleeding. And PrePex can be put in place and removed by nurses with about three days’ training.
No anesthesia. No blood. No sutures. No sterile settings.
In 2007, the World Health Organization and UNAIDS proved that circumcised men reduce their risk of HIV Infection by approximately 60% in high risk areas such as Sub-Saharan Africa.
The Circ MedTech team developed the patent pending PrePex device to achieve rapid scale-up of male circumcision (MC) in resource limited settings, prevalent in Sub-Saharan Africa. PrePex is the first known device to facilitate non-surgical medical adult MC that can claim all of the following: No injected anesthesia. No blood. No sutures. No sterile settings.
The guiding principle of the company is to offer safe, simple, scalable and cost effective adult male circumcision programs that can be implemented by minimally skilled healthcare workers. Learn more about the device Features & Benefits.
The PrePex device is FDA cleared and certified CE Mark Class IIa and is manufactured using USP Class VI biocompatible elastomeric materials compliant to ISO_13485 Medical Devices (Quality Management systems) and FDA, 21 CFR177. 2600. Circ MedTech is ISO 13485 certified.
The rings come in five sizes, A through E, Ms. Fuerst said, “and you won’t believe how high-tech the rubber band is.” Each size must apply just enough pressure to cut off blood flow without being tight enough to cause pain.
The W.H.O., Mr. Warren said, is also evaluating the Shang Ring, a plastic two-ring clamp developed in China to treat conditions in which the foreskin becomes so tight that it cuts off urination.
However, it requires cutting off the excess foreskin beyond the clamp, which means the circumciser must inject anesthetics directly into the penis and groin, wait for them to take effect, create a sterile surgical field and be trained in minor surgery.
“The Shang is not as fast, but it’s faster than full-fledged surgery,” Mr. Warren said. “And it hasn’t submitted as much safety data.”
In a safety study presented at an AIDS conference last month, scientists from Rwanda’s health ministry said they had used PrePex to circumcise 590 men. Only two had “moderate” complications; one was fixed with a single suture, and one required a new band in a different spot.