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CanWest News Service , February
24, 2005
Birth control
for men promising
Author : Bruce Ward
OTTAWA - It's called an IVD, and by the end of
the decade it may be to male birth control
what the iPod is to music geeks.
The Intra Vas Device has the potential to bring
about a societal shift by transferring the
responsibility for birth control from women
to men.
The IVD -- the world's first implantable male
contraceptive -- is being billed as a reversible
alternative to permanent vasectomy and is anticipated
to provide contraceptive effectiveness comparable
to the IUD and the birth control pill.
The IVD works something like a vasectomy, only
better, explains Dr. Neil Pollock, Vancouver's
top vasectomy surgeon and a partner in Shepherd
Medical, the U.S. company that owns the patents
for the IVD.
"The big bonus that we are anticipating
this device will have is the reversibility.
Whereas with vasectomy, it's a complex three
to four-hour microsurgery, expensive, and with
limited success rates."
The IVD -- a 2.5-centimetre hollow silicone plug
-- is implanted into the vas deferens tubes
to block the flow of sperm from the testicles
to the penis.
Implanting the IVD involves accessing the vas
deferens tubes, much like a vasectomy. But
rather than cutting and cauterizing the tubes,
which permanently damages them, only a small
opening is made in each tube. The tubes are
then capped with silicone plugs. The seven-minute
procedure is carried out under local anesthetic
in a doctor's office.
The IVD can later be removed in a procedure similar
to its insertion, thereby re-establishing sperm
flow.
Although men are a tough sell when it comes to
contraceptives, the device could revolutionize
the multibillion- dollar birth control industry.
Shepherd Medical has been given a $1.4-million
grant from the U.S. National Institutes of
Health for clinical trials on humans. The clinical
study is expected to begin this year, pending
Food and Drug Administration (FDA) investigational
device exemption approval.
"This study is going to see us leave the
device in 90 men in two centres in Seattle,
and then we're going to follow these men for
18 months. We're going to assess the contraceptive
efficacy, how the device works. We're going
to compare side-effects to vasectomy and test
the device for side-effects and complications.
And that's going to be under FDA approved conditions."
The Seattle trials are "a big step forward"
for the IVD, added Dr. Pollock. "We're
hoping that this data might be strong enough
for consideration for approval in Europe. And
then we might need another study for approval
in the U.S. and Canada. So our timeline is
to have approval in Europe, and then the U.S.
and Canada by the end of the decade."
Men are known to be wusses about pain, and squeamish
when it to comes to their reproductive bits.
Which is why Dr. Pollock has developed no-needle,
no-scalpel vasectomy procedures at his five
clinics.
To allay their anxieties, guys get to listen
to their own CDs during the vasectomy procedure,
and they can even leave their shoes and socks
on.
But that's the vasectomy. To implant an IVD,
the surgeon makes a tiny hole in the scrotal
sac using an inserter tool. In diagrams, this
tool looks something like a miniature K-Tel
Fishin' Magician. Then the IVD is implanted
through the opening into the tubes. Silicone
caps are then plugged into each tube, blocking
the sperm.
So far, the IVD has successfully completed two
separate primate studies and preliminary human
trials.
"We're hoping human studies about reversibility
of IVDs will support what the primate studies
supported," said Dr. Pollock.
"The device was fully reversible in primates.
So if that's the case, basically you've got
a reversible implant contraceptive device that
would be great as an option for guys in a relationship
who have no kids, or who are in between kids,
or who are finished with their families."
But every prospective user will have to decide
whether the IVD is right for him.
"It's a matter of each person or couple
weighing out every contraceptive option --
the side-effects and profile -- and how it
fits in with their priorities and lifestyle
choices."
<< CanWest News Service -- 2/24/05 >>
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