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 them 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.