Good Afternoon,
My
name is Amanda Dykeman. I am one of the original administrators who run and
manage the Essure Problems Facebook group. We have over 24,000 members and are growing
daily. I am Vice President of our newly formed non-profit organization ASHES,
and I am also a victim of Essure. I was
implanted with Essure in 2010 and developed an allergic reaction so severe it
caused me to undergo a hysterectomy at age 31.
Angie Firmalino, who I am very proud to
call my friend, started the Essure Problems group in 2011. Angie suffered life-altering injuries, which
required several surgeries due to her Essure coils migrating and embedding into her uterus. Angie started the group to warn friends and family members about
Essure. Slowly but steadily, the group has grown, as thousands of women with
similar horrific stories, has joined to share how Essure has injured them and
altered their lives. As our numbers grew and our research intensified, we
realized that many things regarding this device and its approval by the FDA,
was very, very wrong. Additional administrators were added to manage the
growing number of women members, and thus the grassroots movement to advocate
about the dangers of Essure began.
As I stand here before you today, this
very minute there are 13 women across the country, just from our group, undergoing
major surgery in hopes of restoring their health and reversing the pain and
agony brought on by Essure.We have over 3,000 of these procedures documented to
date, and thousands of women who need surgery but cannot afford it or cannot
find a physician to properly remove the Essure devices. Some say we are the
minority, but I would like to know where and when in America have we
accepted the sacrifice of a ‘minority’ of unsuspecting women simply for the
sake of choice and convenience in birth control? At what point do our severe injuries and surgeries
begin to count? Is it at 10,000 injured
women? 15,000? 25,000? We are
women. We are all important. We are NOT sacrificial!
We have been repeatedly lied to. We
were told that once the devices were confirmed to be in place that we would
never have to worry about unplanned pregnancy again. That was a lie. We were
told that because Essure does not contain hormones that there would be no side
effects. That was a lie. And we were told that Essure is a safe non-surgical
procedure. Also a lie. These and multiple
other lies have led to debilitating, catastrophic, life altering side effects
that have not only destroyed our lives, but also the lives of those who love
and depend on us.
After years of inaction by the FDA, we
are standing before Congress today asking for help. Diverse women from all
different backgrounds, beliefs, and political affiliations have been harmed.
This campaign is not about choice, and it’s not about being anti birth control. This
movement concerns the tens of thousands of women around the world being
avoidably harmed by a dangerous and defective medical device, yet the
manufacturer remains shielded by its PMA status, a status we believe was
fraudulently obtained.
The E-Free Act is designed to revoke
Essure’s pre-market approval status. This is an important step that would restore
our civil rights, which have been stripped away by the FDA’s expedited approval of this
dangerous device. It will allow those harmed by Essure to seek compensation for
further medical treatment so desperately needed, and which is currently
unavailable to them. The device has irreparably harmed thousands of women and
families; yet the manufacturer bears zero liability or responsibility to any of
us. They have no incentive to remove it from the market as they profit greatly
from the sales without the fear of any liability or accountability to the
victims. The manufacturer can act with impunity and it does. Because of this, Essure’s Conditional Premarket Approval should
be INVALIDATED and REVOKED!
Therefore, we are urging all members of
congress, regardless of their political affiliations, to please do what is
right by women and support the E-Free Act. We are real. We could be your
mother, your sister, your daughter, or someone else that you love, and we
deserve to live out the rest of our lives in the best health we could possibly
regain after having it stripped away by corporate greed and lies.
Thank you!