Rep. Mike Fitzpatrick (R-PA) just launched the “Faces of E-Free series, focused on sharing the stories of those harmed by Bayer’s “permanent” birth control device, Essure. This ongoing series highlights the dangers of and damages caused by this defective product. Rep. Fitzpatrick is the author of the bipartisan E-Free Act [H.R. 3920].
Rep. Mike Fitzpatrick (R-PA) just launched the “Faces of E-Free series, focused on sharing the stories of those harmed by Bayer’s “permanent” birth control device, Essure. This ongoing series highlights the dangers of and damages caused by this defective product. Rep. Fitzpatrick is the author of the bipartisan E-Free Act [H.R. 3920], which would force the FDA to remove Essure from the market as well as strip Bayer of the pre-emption status it now has which prevents those injured from suing. Angie Firmalino of the Essure Problems Facebook group, a grassroots movement of over 25,000 women, is the first in the Faces of E-Free series.
Essure has caused tens of thousands of serious injuries since its approval by the FDA on November 4, 2002. The injuries range from “extreme pelvic and abdominal pain, migraines, autoimmune reactions, loss of teeth and hair, the metal coil breaking and migrating throughout the body, and the coil cutting into the uterus and other organs in the abdominal cavity.”
The product has also caused the deaths of four women and five unborn children (that we know of).
Rep. Fitzpatrick is an outspoken advocate on issues of medical device safety. He has also gone head-to-head with the FDA over the agency’s approval of power morcellators, a medical instrument proven to spread undetected cancer in women. He also spearheaded a bipartisan letter, which got the Government Accountability Office to begin investigating both the morcellator and the approval process used to get it on the market.
The transcript of Rep. Fitzpatrick’s first Faces of E-Free is below.
“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 metal coil that is designed to be inserted in 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 gotten pregnant, this device has killed the unborn child.
Yet, despite its failings, this device remains on the market with the full support of the Food and Drug Administration and the industry.
In 2009, three months after the birth of Angie and her husband’s last child, she underwent the Essure procedure. While her procedure itself was extremely painful, the pain didn’t stop when she went home as she began having side effects immediately after.
For almost two years, Angie suffered from 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 two years of pains 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 became embedded in the wall of her uterus. Meanwhile, the left coil was almost completely expelled, but twisted and curled. 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 could this happen.
Searching online for answers, she found little information or comfort.
It took Angie weeks after identifying the problem to find a doctor that 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 — 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. 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 with my 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 4, 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 she found. It was a place to tell her story and to see if others had been impacted the same way she had.
Mr. Speaker, in the years since, this online community has surged to more than 24,000 members. Sadly, Angie now knows 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 towards one common goal: To remove this dangerous device from the market so no more women are harmed.
I am proud to rise today as a voice for these women. To tell this Chamber that their stories are real. Their pain is real. Their fight is real.
If the manufacturer or the regulatory agency tasked with oversight won’t act then we as the Representatives of the thousands of harmed women must.
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 in 2002.
Mr. Speaker, the E-Free Act can halt this tragedy and I urge my colleagues to join in this fight — because stories like Angie’s are too important to ignore.”