The New York Times - January 30, 2012
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
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
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
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.
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
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.
According to Dr. Jason Reed, an epidemiologist in the global AIDS
division of the Centers for Disease Control and Prevention, 2 of
590, or 0.34 percent, is a tenth the typical complication rate of
None of the men became infected.
On the 10-point pain scale, they reported on average only about 1
when the ring was placed and only 3 when it was removed (about
the same level of pain caused by erections during the week they
By the end of the study, the two-nurse teams could do a procedure
in three minutes.
By contrast, Dr. Reed said, the best surgical "assembly lines" --
a practice being pioneered in Africa with American taxpayer
support -- can get down to seven minutes per patient, but only by
getting six nurses and a surgeon into a tight harmony.
In theory, he said, breaking that into three two-nurse PrePex
teams could mean circumcising around 400 men a day, rather than
the 60 to 80 a busy team now does. And the surgeon could go do
something more important.
In fact, Dr. Reed said, American AIDS dollars for circumcisions
often go toward an operating room with lights and an instrument
sterilizer. Instead of circumcisions, hospitals are more likely
to use it for procedures like saving women in obstructed labor.
"Which is understandable -- of course that takes precedence," he
said. "But then the circumcisions don't get done."
Robert C. Bailey, an epidemiologist at the University of Illinois
at Chicago who helped design Kenya's circumcision efforts,
opposes timesaving devices because training nurses in minor
surgery has other benefits, he said. A trained nurse could close
a wound or take out an appendix, for example. And the
time-consuming parts of the process are counseling and H.I.V.
testing, Dr. Bailey said, so "doing it in five minutes instead of
20 is trivial."
But he conceded, "If PrePex really doesn't require anesthesia,
that's truly an advance."
Rwanda is training 150 two-nurse teams; it is a small country,
but it serves as a bellwether for Africa because its health care
system is well organized, government corruption scandals are
rare, and it is heavily supported by donor funds.
Other, rival devices are not far along in safety testing or are
The Tara KLamp, manufactured in Malaysia since the 1990s, has
created controversy in South Africa. It is a hinged plastic
bracket the size of a small drinking cup. A plastic tube goes
over the head of the penis, and the foreskin is pulled up it and
painfully crushed by the bracket. Then the whole contraption must
be worn at least five days. A 2005 clinical trial in South Africa
was stopped early after the device caused far more injuries and
infections than surgery did.
The national health ministry has banned it in most of South
Africa, but it is still used heavily in KwaZulu-Natal Province,
which has the country's highest AIDS rate and where the Zulu
king, Goodwill Zwelithini, reversing 200 years of tradition,
ordered that all Zulu men circumcised.
The W.H.O. knows about the stopped trial and is not considering
the KLamp, Mr. Warren said.
Dr. Reed said he had heard that another device, Ali's Klamp, was
being tested in Kenya under protocols that seemed to match W.H.O.
requirements. According to Circlist.com, a circumcision
information Web site, it is a Turkish device dating to 2007, and
works on principles similar to those of the Tara KLamp and
another device, the SmartKlamp, approved by the F.D.A. in 2004.
PrePex was cleared by the F.D.A. because it was judged
"substantially equivalent" to the SmartKlamp, Ms. Fuerst said.
Proving equivalence in safety to an approved device is the
fastest way to get approval, she said, although the technology is
PrePex's ultimate cost is still being negotiated with donor
agencies and foundations, Ms. Fuerst said, but may end up in the
$15-to-$20 range, about the same as a surgical circumcision kit.