Tuesday, October 08, 2013

Essure birth control: Woman dies, doctor files report with the FDA . By Lauren Gilger and Maria Tomasch

Since 2004, almost 850 women and doctors have filed Adverse Event Reports with the Food and Drug Administration (FDA) about Essure birth control.

They detail extreme symptoms – from women experiencing excess bleeding, rashes and bloating to women who were forced to have their reproductive organs removed.

Now, the ABC15 Investigators found a new Adverse Event Report filed with the FDA just weeks ago regarding Essure. It details a woman’s death after she was admitted to the hospital for abdominal pain. She had the Essure coils implanted this year, but it has not been determined what caused her death.


Amanda Holt saw a lot of positives when she decided to get Essure as a permanent form of birth control.

“I have three children. I work at lightning speed. And when someone told me that I can go in and get this procedure done and then go back to work that afternoon or the next morning, I’m like, ‘Absolutely! Sign me up!’” she said.

For Katie Reader, Essure sounded like a great idea. “I wanted the latest and greatest,” she said.

They say they were told that Essure would be cheaper, faster and less invasive than getting their tubes tied.

During the Essure procedure, small metal coils are implanted inside the fallopian tubes to block conception.

But now, after years of painful side-effects, many women like Holt and Reader say Essure has turned into a nightmare.

Thousands of women like them have taken to social media. There are private and public Facebook groups dedicated to issues with Essure where thousands of women are sharing their experiences. The posts show woman after woman, many with the exact same symptoms, telling nightmare scenarios after getting the Essure coils implanted.

Most of the comments and photos detail side effects from an allergy to nickel, which is a component of the coils. Originally, women were advised to test for that allergy before getting Essure, but the manufacturer asked the FDA to remove that requirement a few years ago.

Women in the Facebook group describe extreme bloating, skin rashes and headaches. X-rays show the coils perforated the fallopian tubes of some women. And there are photos of broken coils after they were removed.

When the FDA approved Essure in 2002, it gave the device preemption status. That means a women who is injured by it can't sue the manufacturer.


In an Adverse Event Report filed with the FDA on September 19, 2013, a physician describes a patient who had the Essure coils implanted this year going to the “emergency room with abdominal pain.” There, a different doctor “performed a pelvic exam [and] found the patient’s cervix, fallopian tubes and uterus were necrotic.”

The report goes on to describe the patient as testing positive for a type of strep infection. Then, the “patient went into renal failure and dic, and patient passed away,” the report said.

The doctor “believes the cause of death was related to necrotizing group a streptococcus infection (streptococcal toxic shock syndrome),” the report said.

The ABC15 Investigators contacted the FDA for a comment on this story, but they did not provide a response.

Bayer, the current manufacturer of Essure, provided ABC15 with this statement:

Although we do not comment on individual adverse events, we do take all adverse events seriously, and they are reported to the US FDA as required.

This is also a Manufacturer Narrative on the Adverse Event Report. It states, “The medical opinion of the attending physician was that the cause of death was not directly related to the essure inserts or procedure.”

Bayer would not elaborate on this explanation or confirm that they provided it to the FDA.

You can see the full report here . 

Read more: http://www.abc15.com/dpp/money/consumer/alerts/Essure-birth-control-Woman-dies-doctor-files-report-with-the-FDA-on-Essure-coils?#ixzz2h6ULpbxp

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