Tuesday, April 29, 2014
FiDA highlight
Good morning, I’ve prepared something
I’d like to read to you. I’ll first speak in English, and then I’m prepared to
give the same statement in German if necessary. I have also prepared some
questions for the members of the Board.
A few years ago, I had a Bayer device
implanted inside me. I chose this device, a birth control device, because it
was approved by the United States Food and Drug Administration. This was device
was also advertised as safe and effective. The biggest mistake of my life was
choosing this device. It would change me, leaving me with permanent reminders
of the day I almost died. The physical and emotional scars will never go away.
My name is Michelle Garcia and I live
in Miami, Florida. I am an Essure victim, an Essure survivor and a voice to
thousands. I stand before you with a simple, yet powerful message. Essure is dangerous and Essure
does not belong on the market.
Essure is a form of birth control which is intended
to be the non-surgical alternative to a tubal ligation. In April of
2013, Bayer announced the acquisition of a company called Conceptus. During the
time they were in existence, Conceptus was never profitable. When Bayer
acquired Conceptus, you also acquired Essure. Seven studies following less than six hundred women with
Essure were published. The data from these studies was presented when
Essure was approved for use in the United States. The same data is also used to
support claims the device is safe and effective.
My story goes like this . . . A broken Essure coil pierced my
fallopian tube, resulting in internal bleeding and hemorrhaging. Fortunately, while in the
emergency room, the bleeding stopped but not before I lost a significant amount
of blood and coming close to needing a blood transfusion. I could be dead; I
should be dead. As terrified as I was and as frightening as my experience is,
there are countless women with stories far worse than mine. For every story we
do know, there are thousands more still unreported.
In 2011, a mom named Angie Firmalino,
started a group called Essure
Problems to warn her friends about the effects this device had on her
body. I found the group in May of 2012 when there were only 30 members. Today, worldwide, we are more
than 7,000 women strong, 10 times more than the size of your studies.
Gabriela
Avina is a health care professional with a Master’s degree in
Women’s Health Nursing. She was involved in the clinical trials professionally
and became a clinical trial participant in October of 2000. In 2002, she
presented to the United States Food and Drug Administration as a clinical trial
patient. Gabriela went on to become a spokesperson for Essure, and she toured the United States
promoting Essure. Little did she know, the device was slowly destroying her
health.
Earlier
this year, Gabriella made a second presentation to the United States Food and
Drug Administration. During this presentation, she stated that she was wrong
when she supported this device 12 years ago. In her own words,
she said, “Lives of women have been changed by a device that was not adequately
monitored during clinical trials, by physicians who were not adequately trained
and by a company that has
not adequately listened to their patients.”
So how safe and effective is your
device? 3% of the ladies in our group is either currently pregnant or has been
pregnant. 2% of the pregnancies ended in death of the child with 55% of our ladies suffering
miscarriages. That is a big difference from your published success rate
of 99%. The March of Dimes reports the expected rate for miscarriages is ten to
fifteen percent.
We prepared a survey so we could
collect more specific information from the ladies in our group. The responses
support the urgent need to have this device immediately removed from the
market. Almost 40% reported issues related to Essure almost immediately after
placement with 32% reporting that their coils are no longer properly placed. After successful placement and
confirmation of occlusion, the coils may move.
Ectopic
pregnancy, which has an expected occurrence rate of 2%, occurred in
14% of our pregnancies. 48%
indicated they have experienced three or more miscarriages. For a device
that’s effective, 15% of the respondents reported they did not achieve
successful tubal occlusion. That 85% failure rate is a significant difference
from the success rate reported during the clinical trials.
Almost
1,000 women, over 16% of our membership, women as young as 22 years old, have
had major surgeries, usually a hysterectomy to remove the coils. In many instances, one surgery isn’t enough to repair all the
damage. Many have endured multiple surgical procedures costing significant
amounts of money. These multiple surgeries are usually to find errant coils
which have ended up outside the fallopian tube. Essure may be the non-surgical
alternative to a tubal ligation, but it is NOT going to keep someone out of the
operating room.
The
“lucky” ladies have coils expel into their uterus. For some women, doctors have
retrieved coils from the vicinity of their liver, kidney, chest cavity,
abdominal cavity and the lining of their stomach. One woman had an Essure coil
migrate into her colon. She was required to have a colon
resection due to the buildup of scar tissue. Her intestines also fused to her
rectum. Despite this, Essure continues to be labeled and marketed as a form of
birth control that is SAFE.
For the 84% of our group who have not
been able to get the coils removed due to a lack of financial resources or the
inability to find a surgeon willing to remove them, they suffer from the same
debilitating side effects which led the other ladies in our group to the
operating room.
Many
of these women can attribute their issues to an allergic reaction to nickel,
and an Essure coil is over 50% nickel. Nickel is a common allergen and a
contraindication was included when the device was first marketed. The contraindication was removed from the label in 2011. The
CEO of Conceptus explained the purpose of the new label was to further strengthen our competitive
advantage and leadership in the permanent birth control market. In the
same press release, he states that Conceptus will be aggressively marketing
this change to the members of the OB/GYN community who won’t use our product
“primarily because of potential nickel allergy in patients.” The motivation for
this change was not based on patient safety but on the manufacturer’s financial
interest. They did such a great job with their aggressive marketing that 82% of
the respondents to our survey were not asked about any metal sensitivities. And the change in label led some
doctors to believe that nickel had been completely removed from the product.
Women
suffering from an allergic reaction live with constant pain, irritation and
inflammation.
Women
without a nickel allergy are also suffering with similar intense side effects
which rob us of our health and a quality of life. We suffer with severe pelvic
plain, headaches, joint pain and deterioration, chronic inflammation, extreme
fatigue, severe bloating, skin conditions, irregular bleeding and many other
side efforts. The side effects of Essure affect everyone in a family, not just
the patient. Children grow up with a mom who is not healthy — who can’t lift
and hug her child. Couples are robbed of their ability to have an intimate
relationship because the act of making love is far too painful. Women post
messages in our group contemplating suicide because of the pain caused by
Essure. They are just so sick that being dead just seems like a better
alternative. All of this for birth control; just birth control.
I leave you with two final stories.
The first is a baby named Julius. He was conceived because, as with so many,
Essure failed. Julius’ mom
went into premature labor when an Essure coil perforated her amniotic sack
causing her water to break. Julius was born alive, and his under-developed
lungs couldn’t sustain him. Julius died on the day he was born, an innocent
victim of a device you continue to say is safe and effective.
We learned about the women in the
last story when an adverse event report was filed with the "United States
Food and Drug Administration". While we don’t know her name, we know she
was someone’s wife, mother and daughter. She had Essure and went to the
emergency room complaining of abdominal pain. An exam found that her
reproductive system, specifically her cervix, fallopian tubes and uterus were necrotic.
In layman’s term, her organs were dead. She went into renal failure and did not
recover. Her cause of death is listed as necrosis and toxic shock syndrome. The
question of what caused her organs to die resulting in her death can’t be
answered based on a report; however, it’s a coincidence that can’t be ignored.
Julius and the women in report number
are dead. Will you still say this device is safe and effective?
On behalf of the 7,000 women who trust me to be their
voice, and the women we have yet to hear from, we ask you, pull Essure from the
market. I thank you for the opportunity to speak before you. Please do the
right thing. Remove Essure from the market.
The Mom vs. Melinda Gates
This blog isn't only about me or Melinda Gates, its
much bigger, its about a battle against the FDA and a defective birth control
device called Essure. The Gates Foundation dispenses this product as part of
their global contraceptive initiaive.
I'm a mom from Miami, Florida. This blog tells the story how I went from
victim, to advocate to activist for women's birth control and against the FDA
and a dangerous birth control device called Essure.
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