My name is Angie Firmalino. I have no financial conflict of interest with Bayer or Essure. What you are viewing, are images and posts from women suffering from Essure. I was implanted with Essure in 2009, three months after the birth of my son, Elijah. I started the Essure Problems Facebook group in 2011, after finding out my coils expelled and were embedded in my uterus. After the ultrasound that revealed this, I felt very betrayed and misled, not only by my doctor, but by the manufacturer. I honestly had no idea that these devices could expel from our fallopian tubes and perforate organs, or embed in other areas of the body. That is just not made clear to patients AT ALL. Even though I now know that migration and perforation are currently listed adverse events, the reality of what that means, and what one faces when this happens, is ruthlessly downplayed.
After creating the group to warn my female friends and family members, many women that I did not know started joining, and posting similar stories of their problems with essure. After more than 4 ½ years now and approaching 21,000 members in the group, I have probably read a quarter of a million posts. Day after day, month after month, year after year. Posts from women in debilitating pain, women suffering, having no one who will believe them that Essure may be the cause, let alone help them. If this were men, complaining of pain, bleeding, or sexual dysfunction after having a medical device implanted in their testicles, no doctor would question the cause, or hesitate to remove the implant. It’s just not the same for women. I only have time to share a very small fraction of what we see in our group on a daily basis, but I will do my best to represent these women who have put their faith in me to come here today.
The clinical trial information that Conceptus, now Bayer, presented to the FDA in 2002, is not what is happening in the real world. There is no one in this room who has more experience with what is going on in the real word with Essure problems, than me and my team of administrators, and the women who have lived through this nightmare. I’m not here to tell my story today, I’m here to tell the story of those 21,000 women. There will, no doubt, be women here today to tell you how happy they are with their essure procedure. We understand and expect that. I just hope THEY can understand that because of the life altering damage this device CAN do to some, we believe it is not fair to sacrifice one more women, one more mother, just for birth control.
We’ve watched mothers have to bury their babies, after essure coils perforated the infant’s amniotic sac. We’ve had to mourn the loss of women in our group. We’ve seen suicides, and we’ve seen death during or after Essure related surgery. We watch surgery after surgery every single day in our group, and the complications that come with them. We’ve seen coils in the spine, in the colon, in the kidney, in the cervix. Husbands walking out on families because we can no longer have sex due to excruciating pain. We’ve watched mothers cry in despair because they cannot take care of their children anymore, we watch women lose their careers, all because of problems from Essure. There are patterns of auto immune diseases, cancers, pelvic adhesive disorder, PID, and other recurrent infections that will JUST not go away. These side effects are extreme. This is not just “period type cramping. “ The allergies some are experiencing are not just “simple dermatitis”. These are life altering side effects that stop you from functioning as a person.
At the time essure was presented to the FDA for approval in 2002, there were 281 women who had been followed for 18 months, 149 women for 24 months, and 5 who had relied on Essure for 36 months. One of those five women is in our group, and so are 17 other of the clinical trial participants. They are finding us, one by one. Looking for answers to their failing health, and looking for help. You will hear (or have heard) from three trial participants today.
At the last FDA meeting that we had regarding essure I invited every single person in that room to please join our group and see the reality of what is going on out here in the world. Not one has made that effort.
Epidemico recently wrote and published a paper, An Analysis of Adverse Event Reporting for the Essure Device in the US. Working with our admin team, and our FB group, we jointly educated women on how to file an event report using the medwatcher app. They recently presented their findings at a conference in Boston. The Epidemico employees who had to read and enter the Essure reports, told our admins, that they were absolutely horrified at what they were reading every day. You see, once you spend a few weeks or even days, watching what is going on out here, you cannot help but wonder why this device is still on the market. This is not a life saving device. This is just birth control. There are safer and more effective options out there, like tubal ligation and vasectomy.
While we understand the desire of the population council, and the world health organization, and the decades of research and trials, to try and find a way to sterilize women, in an office setting, we are here to tell you, Essure is not the answer.
I did not sign up to be a test subject nor did I sign up to be in chronic pain for the rest of my life. None of us did.
The fate of Essure ultimately lies in the hands of the panel members and the FDA today. Bayer has no intention of issuing a recall or stopping any of this. They just invested millions in a new manufacturing plant in Costa Rica for essure, and they just got approval from the FDA to replace the follow up HSG with transvaginal ultrasound. One of the women from that clinical study, just gave birth. She got pregnant after her confirmed ultrasound. Even though her clinical trial paperwork said that she would be compensated a whopping $800 if she became pregnant, she has yet to see that money. You see, not only do we have trial participants from the original studies, we have them from a slew of post market studies as well, and just like in the case of Conceptus, Bayer seems to cut ties with anyone who has a problem with their device in a trial. It’s time to take a good hard look at that. It’s time to put people before profits. Either the FDA acts in the best interest of the people. Or they don’t.
It is unlawful and inhumane to sacrifice a group of unsuspecting women for the benefit of the majority. Especially over birth control.
Our Lives Matter