
Conceptus
Inc.
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The Essure microinsert has a stainless steel
inner coil, a nitinol superelastic outer coil,
and polyethelene fibers. The device expands from
0.8 mm to between 1.5 and 2 mm when placed in
the fallopian tubes.
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Until recently, U.S. women seeking permanent methods
of birth control had no other choice but to have a
tubal ligation. Eleven million women aged 15 to 44 — 25%
of this population — have undergone this surgical
procedure,1 making it the most common form of contraception
among U.S. women, according to the national Centers
for Disease Control and Prevention.
Tubal ligation is also the most common form of birth
control in the world.2 Every year, more
than 700,000 women in the U.S. undergo the procedure.
Tubal ligation
is effective immediately in preventing pregnancy and
can be done using local, general, or spinal anesthesia.
Although it has an effectiveness rate higher than
99%, it is an invasive surgical procedure with risks
inherent to surgery and the use of anesthesia. And
it is expensive for patients, costing an average of
$1,200 to $2,500.3
This cost, however, is covered by Medicaid and some
private health insurance policies.
The two most common procedures for performing a tubal
ligation are the lap aroscopic procedure and the minilaparotomy.
In the laparoscopic procedure, a laparoscope is inserted
through a small incision near the navel to allow visualization
of the fallopian tubes. Either an instrument is inserted
through the laparoscope or another incision is made
in the abdomen, through which the fallopian tubes are
surgically closed.4
When tubal ligations are performed immediately after
childbirth, as is most often the case, the procedure
used is the minilaparotomy. In this procedure, only
one incision is made in the patient’s abdomen,
just above the pubic bone, to access the fallopian
tubes.
More women complain of pain and cramping for a few
days following a minilaparotomy than those who undergo
the laparoscopic procedure.5 But either procedure can
be done on an outpatient basis, and most women go home
the same day the surgery is performed.4
Less invasive
In November 2002, the U.S. Food and
Drug Administration approved a new method of permanent
birth control
that requires no incisions. The EssureAE method,
developed by Conceptus, Inc., is a form of transcervical
sterilization.6 Essure is the first and only FDA-approved
transcervical sterilization method available to
women in the U.S.
Transcervical sterilization differs from traditional
tubal ligation in that it is an incision-free procedure
in which a catheterlike instrument is guided through
the cervix and uterus and then into the fallopian tubes
(facing page, top illustration). The Essure method
uses a small-diameter trans cervical access cath eter
to place a mi cro insert (a soft, springlike coil made
of polyester fibers and nickel titanium alloy) in each
fallopian tube.
The microinsert has a stain less steel inner coil,
a nitinol superelastic coil, and polyethylene fibers
that are 0.8 mm long in a tightly wound configuration.
Once in place, the outer coil expands to between 1.5
mm and 2 mm to anchor the microinsert (facing page,
center image). Then tissue grows in and around it,
blocking the fallopian tube7,8 (facing page,
bottom illustration.)
In clinical studies of women who had un dergone the
Essure method, both fallopian tubes had closed in 96.5%
of the women within three months and in 100% of the
women within six months of the procedure.9
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