The concept of “to be or not to be,” circumcised that is, is both ageless and fraught with emotional, religious, psychological, medical, and moral issues. All sides have argued both for and against circumcision with a high degree of emotion and ill-conceived prejudice.
Finally, several reliable medical studies have shown that circumcising adult heterosexual men is one of the most effective therapies against HIV and AIDS. These studies pointed out that by merely circumcising these men, the chance of infection decreases by 60 percent or more. Circumcision is believed to protect heterosexual men because the foreskin has a type of cell that attracts the virus and literally delivers it to the immune system—which HIV attacks.
With these findings in mind, the World Health Organization (WHO) has focused on the devastating HIV and AIDS problems in Africa and has been desperately searching for a method of performing assembly-line circumcisions. The need for mass circumcisions has now become obvious in South Africa, particularly in the province of KwaZulu-Natal, which has South Africa’s highest AIDS rate. Zulu’s King Goodwill Zwelithini has ordered that all Zulu men be circumcised, reversing 200 years of tradition.
To meet the goal of circumcising 20 million African men by 2015, a quick-fix circumcision must be found. To date, only about 600,000 have been “clipped.” African countries are critically short of surgeons, even a skilled surgeon takes about 15 minutes to perform a circumcision, and as far as I know, there is no “Mohels Without Borders.” All humor aside, with these obstacles in mind, WHO and the Bill & Melinda Gates Foundation have been looking for a ring device that could be used by a trained nurse to perform assembly-line circumcisions.
Several weeks ago, the Food and Drug Administration approved such a device called PrePex, invented in 2009 by four Israelis after they heard an appeal for doctors to perform mass circumcisions in Africa. The initial safety studies indicate that PrePex is faster, less painful, and more bloodless than any of its current rivals. The technology—a rubber band—is extremely simple and nonthreatening. PrePex uses a ringlike device that is slipped inside the band and placed around the penis to block blood flow to the foreskin. After about a week, the dead foreskin falls off or can be clipped off. A spokesman from PrePex compared the process to the stump of an umbilical cord shriveling up and dropping off a few days after it is clamped. The procedure uses a topical anesthetic cream and is free of any bleeding. The device can be put in place and removed by a nurse after about three days of training.
WHO is also examining the Shang Ring, a plastic device consisting of two rings that was developed in China. However, this method requires cutting off the excess foreskin beyond the clamp. The circumciser (nurse or physician) 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. Although faster than a surgical circumcision, the Shang Ring is not fast enough for the purpose of circumcising millions of men.
Preliminary studies from Rwanda’s health ministry noted that the PrePex device had been used to circumcise nearly 600 men and that only two men experienced moderate complications. One complication was fixed with a single suture, and one man required a new ring and rubber band in a slightly different spot. This complication rate of 0.34 percent is about one-tenth the typical complication rate of surgical circumcision.
Utilizing the PrePex system in Rwanda, two-nurse teams could perform the procedure in about three minutes. The best surgical assembly lines—a practice being pioneered in Africa with American taxpayer support—can complete the circumcision in about seven minutes per patient, but only by getting six nurses and a surgeon into a tight team.
Theoretically, three two-nurse teams could circumcise about 400 men a day, rather than the 60-80 a busy surgical team now circumcises in Africa. Furthermore, the surgeon involved could be doing something more surgically relevant.
According to Dr. Jason Reed, an epidemiologist in the global AIDS division of the Centers for Disease Control and Prevention, most American AIDS dollars for circumcisions go toward an operating room with lights and an instrument sterilizer. Instead of circumcisions, these hospitals are more likely to use the operating room for other procedures without regard to HIV and AIDS prevention.
In addition to the ease of application and effectiveness, the PrePex device does not require any anesthesia, a benefit that provides a real advantage. On a 10-point pain scale, the men reported an average of only about 1 when the ring was placed and only 3 when it was removed.
Rwanda is currently training about 150 two-nurse teams. Rwanda may serve as a role model for the rest of Africa because the country’s health-care system is well organized, government corruption scandals are rare, and health care is heavily supported by donor funds.
There are a number of other clamp devices on the market, including the Tara Klamp, manufactured in Malaysia since the 1990s; Ali’s Klamp, a Turkish device currently being tested in Kenya; and the SmartKlamp device, approved by the Food and Drug Administration in 2004. But the PrePex device clearly seems to have an edge over the others and may offer a revolutionary breakthrough to assembly-line circumcisions and AIDS prevention involving tens of millions of men worldwide.
Dudley S. Danoff, MD, FACS is the attending urologic surgeon and founder/president of the Cedars-Sinai Medical Center Tower Urology Group in Los Angeles, California. He is the author of Penis Power: The Ultimate Guide To Male Sexual Health (Del Monaco Press, 2011) and Superpotency (Warner Books).
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