[Congressional Record Volume 161, Number 178 (Wednesday, December 9, 2015)]
[House]
[Pages H9087-H9088]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     REMOVE ESSURE FROM THE MARKET

  The SPEAKER pro tempore. The Chair recognizes the gentleman from 
Pennsylvania (Mr. Fitzpatrick) for 5 minutes.
  Mr. 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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