A picture of Representative Michael G. Fitzpatrick
Michael F.
Republican PA 8

About Rep. Michael
  • Remove Essure from the Market

    by Representative Michael G. Fitzpatrick

    Posted on 2015-12-09

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    FITZPATRICK. Mr. Speaker, I rise today to tell the story of Angie Firmalino of Tannersville, New York, one of the tens of thousands of women harmed by the permanent sterilization device, Essure.

    Essure is a nickel-based coil that is designed to be inserted into the fallopian tube and cause tissue scarring, leading to blockage of the tube. However, tens of thousands of women have complained of terrible side effects and excruciating pain. Women have died. And when the device has failed and women have become pregnant, this device has killed their unborn child. Yet, despite its failings, this device remains on the market with the full support of the Food and Drug Administration and industry.

    In 2009, 3 months after the birth of Angie and her husband's last child, she underwent the Essure procedure. While the procedure itself was extremely painful, the pain didn't stop when she went home, as she began having side effects immediately thereafter.

    For almost 2 years, Angie suffered from a sharp, stabbing pain in her lower left side, back pain, heavy and constant bleeding, joint pains, fevers, fatigue, and depression. Her doctor reassured her that it was just her body recovering from the pregnancy, C-section, and Essure procedure, and that she would eventually get back to her old self. That did not happen.

    In 2011, after nearly 2 years of pain and complications, Angie's doctor ordered an ultrasound to try to determine a cause. What was discovered was shocking. An Essure coil had dislodged itself from her right fallopian tube and had become embedded in the wall of her uterus. Meanwhile, the left coil was almost completely expelled, but twisted and coiled. These were the causes of her pain.

    Overwhelmed and alone, Angie tried to comprehend the situation. She was never told that the coils could expel, migrate, or embed in other organs. She wondered how this could happen. Searching online for answers, she found little information and little comfort.

    It took Angie weeks after identifying the problem to find a doctor she felt comfortable with for the removal surgery. With no information available about Essure removal, Angie located a doctor who seemed to know what they were doing and seemed to have a plan for the device's removal. Unfortunately, during the procedure, the Essure coils broke as they were removed, sending metal fragments, like shrapnel, further into her body.

    In the years since, Angie has undergone four surgeries directly resulting from Essure, and eventually lost her fallopian tubes, uterus, cervix, and one ovary. And as her joints mysteriously began deteriorating, she has undergone an additional three surgeries on her joints.

    Today, after a hysterectomy and surgery after surgery, Angie still lives with daily, chronic pain, joint issues, and debilitating headaches. And while some of her pain may be gone, the emotional scars have stayed with her.

    At the age of 43, the mother of four, Angie says she is still not, nor will she ever be, her old self. But as a result of all this pain and suffering, she was able to do something pretty incredible: Angie started a Facebook group called the Essure Problems Group--something to fill the void that she found. It was a [[Page H9088]] place to tell her story and to see if others had been impacted the same way that she had.

    Mr. Speaker, in the years since, this online community has surged to more than 24,000 members. Sadly, Angie now knows that she was not alone. Every day, this group connects women living through their own Essure nightmares; and every day, Angie is brought to tears at seeing the stories, many so similar to her own, of thousands of women around the country. Together with her Essure sisters, they now work toward one common goal: to remove this dangerous device from the market so that no more women are harmed.

    I am proud to rise today as a voice for these women, to tell the Chamber that their stories are real, their pain is real, their fight is real. If the manufacturer or the regulatory industry tasked with oversight won't act, then we, as representatives of the thousands of harmed women, must act.

    That is why I rise in support of the E-Free Act, a one-page bill to remove Essure from the market by forcing the Food and Drug Administration to revoke the pre-market approval that let this product into the public back in 2002.

    Mr. Speaker, the E-Free Act can halt this tragedy. I urge my colleagues to join this fight because stories like Angie's are too important to ignore.


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