My name is Angie Firmalino, I am a wife, a daughter, a sister, a friend, but most importantly, a mother. In 2009, after my last child was born, I had a sterilization procedure done called Essure, and since then, my life has never been the same. I am making these videos to raise awareness about the dangers of this procedure, to educate women, men, doctors, nurses, and the media. Essure was approved by the FDA in 2002 after the manufacturer fast tracked the process for PMA. PMA means pre-market approval. It is a process a company has to go through to receive this status for their drug or device from the FDA. This status provides the company with preemption, a law protecting them from ever being sued by any patient that could be harmed by their device. The FDA claims that this PMA process is a rigorous and thorough review of all clinical studies and trials performed by the manufacturer and presented before an advisory panel and the FDA. I am here to present to you exactly what those trials were, and how this company was granted their status. I have some clips from that PMA meeting that took place on July 22, 2002. I have received permission from the video company who recorded the meeting, to share these clips publicly. Members of my Facebook group Essure Problems pitched in to help pay for the DVD and copyright, and I want to acknowledge and thank those who contributed.
Let me first review what this device is and its purpose. The Essure procedure is the first hysteroscopically delivered permanent birth control device. The Essure device is comprised of two coils. An inner stainless steel coil wrapped with a loose weave of PET fibers. The outer coil is nitinol, a nickel titanium alloy, a shape memory alloy, that expands to anchor itself into the Fallopian tube. As it expands, it causes trauma to the Fallopian tube, which elicits the body's initial reaction to that trauma. The PET fibers then cause acute and then chronic inflammation to start the process of scar tissue, or fibrosis, to form and grow, thus blocking the Fallopian tube. The chronic inflammatory response is continuous. At about three months after the procedure, the patient must undergo an HSG test. This is a test where the doctor fills the uterine cavity with a dye while using an X-ray. The dye is pushed into the cavity with pressure that most women find quite uncomfortable, to see whether the tubes have successfully occluded, or closed. This X-ray is also supposed to be used to check placement of the coils. Ideal placement is considered to be about 3-8 turns of the outer coil trailing into the uterus from the Fallopian tube. If properly placed and occluded, the woman is told she can now rely on this form of sterilization for the remainder of her life. The manufacturer claims Essure is greater than 99% effective at preventing pregnancy.
At the time of this PMA presentation, the manufacturer, Conceptus, presented clinical trial information pertaining to 281 women who were relying on Essure for 18 months, 149 women relying on Essure for 24 months, and 5 women who were relying on it for 36 months. So the majority of their information was based on a few hundred women for about a year. The advisory panel did express some concerns regarding this time frame and low number of trial participants.
The meeting lasted about 3 hours.
In the end, they voted for approval with conditions. Conditional PMA. The conditions set forth are as follows.....
The doctor training post approval study was terminated early.