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Since 1994, Conceptus has conducted significant research and
development in the laboratory and clinical testing of its micro-insert
technology. The following summarizes the clinical testing of micro-inserts,
performed under strict guidelines, in four separate clinical studies involving
more than 900 women in Australia, Europe, the United States and Mexico.
Short-Term Safety & Feasibility
Two studies were conducted in more than 200 patients to understand the
short-term (less than 6 months) safety and feasibility of Essure.
In the first study, early designs of micro-inserts were tested to ensure that
they could be safely placed in patients. These women agreed to allow placement
of the micro-insert just before surgical removal of the uterus for medical
purposes, so they never relied on the inserts for birth control. From this
study we obtained preliminary evidence that we could safely place micro-inserts
in fallopian tubes with our delivery system.
In the second study, women agreed to allow placement of micro-inserts up to 12
weeks before hysterectomy (surgical removal of the uterus for medical
purposes), so they never relied on the inserts for birth control. From this
study we obtained evidence that micro-inserts could be safely placed in awake
patients, and women could safely 'wear' micro-inserts for up to 12 weeks. The
fallopian tubes containing micro-inserts were then examined under a microscope
by leading researchers. This study found that the biological response to the
micro-inserts was consistent with the response seen in other medical procedures
such as, blood vessel grafts, heart valve replacement, and devices used to
block brain aneurysms, where the same materials are used.
The preliminary results of this study were published in Fertility and
Sterility, in November, 2001.
The findings from these two studies supported additional clinical testing of
the long-term safety and effectiveness of the micro-inserts.
Safety and Effectiveness
The safety and effectiveness of Essure has been tested in more than 650 women
in two clinical trials - the Phase II Study and the Privotal Trial. The
combined data from these clinical trials support a first year effectiveness
rate of greater than 99%. We continue to follow these women and will
periodically report our future findings.
Results from the Australian site in the Phase II Study were recently published
in The Australian and New Zealand Journal of Obstetrics and Gynaecology, 2001.
The safety and effectiveness of a new hysteroscopic method for permanent birth
control: results of the first Essure clinical study
Data from the Pivotal Trial showed that women recovered quickly after the
procedure, and that their comfort with Essure was very high:
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92% of patients returned to work in one day or less after the procedure,
excluding the day of the procedure
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96% of women rated their comfort with the procedure as "good" to
"excellent" within one week of the procedure
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99% of women who had Essure for six months or more rated their comfort as
"good" to "excellent".
As with any medical procedure, there are risks and possible complications with
Essure. In the Pivotal Trial there was a 2.5% rate of adverse events, which
prevented women from relying on Essure for birth control and 6% of women
relying on Essure had more than one placement procedure. To learn more about
risks and possible complications with Essure, click
here.
For information on Essure and other birth control options,
click here.
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Talk to a registered nurse to get more
information about Essure. Call 1 800 785 336. |
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| Find an Essure trained gynaecologist who is right for you, or
find a knowledgeable general practitioner who can give you a referral. |
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