Essure Problems 

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The Faces of E-Free

Fitzpatrick Launches ‘Faces of E-Free’ Series on Women Harmed by Essure

In the first of what will be an ongoing series, Congressman Mike Fitzpatrick (PA-8) addressed the House on the dangers of, and damage done by, the medical device Essure by highlighting the personal story of one of the more than 25,000 women negatively impacted by the device.

Fitzpatrick is the author of the bipartisan E-Free Act [H.R. 3920] which would require the Food and Drug Administration (FDA) to remove the permanent sterilization device produced by Bayer from the market.




Angie Firmalino — Tannersville, NY (12/9/15)



“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.”



Kathryn Fredrickson — Maryland (12/10/15)

“Mr. Speaker, I rise to tell the story of Kathryn Fredrickson of Maryland, one of the tens of thousands of women harmed by the permanent sterilization device, Essure.
Essure was recommended as the “optimal birth control solution” for Kathryn despite a pre-existing autoimmune condition and known nickel allergy. After the procedure, she felt sever pain, extreme bleeding, vomiting, and rashes caused by the nickel based devise. After three weeks of pain and discomfort, Kathryn paid $7,000 out of pocket to remove the device. One coil was found in her uterus. She lost 2 months of work and of her life. Kat’s health has never been the same.
I rise as a voice for the Essure Sisters. To tell this Chamber that their stories are real. Their pain is real. Their fight is real.
Mr. Speaker, my bill, the E-Free Act can halt this tragedy by removing this dangerous device from the market. Too many women have been harmed.
And I urge my colleagues to join in this fight — because stories like Kat are too important to ignore.”

Lisa Conti — Pennsylvania

“Mr. Speaker, I rise to tell the story of ­Lisa Conti one of the tens of thousands of women harmed by the permanent sterilization device, Essure.
In 2010, ten months after the birth of her son, Lisa underwent the Essure procedure. Her doctor said it was a safe, non-surgical procedure with no down time — the perfect option for a single mother. Unfortunately, like so many others, following the failure of the device Lisa now lives with chronic pain, multiple surgeries and depression. What was supposed to be a simple procedure has cost her jobs, time with her children and years of her life.
I rise as a voice for the Essure Sisters. To tell this Chamber that their stories are real. Their pain is real. Their fight is real.
Mr. Speaker, my bill, the E-Free Act can halt this tragedy by removing this dangerous device from the market. Too many women have been harmed.
I urge my colleagues to join in this fight — because stories like Lisa’s are too important to ignore.”

Since it was approved by the FDA on November 4, 2002, the agency has received over 5,000 formal complaints related to the device. Tens of thousands of women have reported symptoms including 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 deaths of four women and five unborn children have been attributed to the use of Essure.

Fitzpatrick is an outspoken advocate for medical device safety and has previously pushed back against the FDA’s approval process for power morcellators which have been proven to spread undetected cancer in women. After receiving a bipartisan letter led by Fitzpatrick, the Government Accountability Office is in the process of investigating the device and its approval process.


Deaths reported to Medwatcher related to Essure

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=2700733

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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=4784158

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=4899748

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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=5147868