Essure birth control: Woman dies, report filed with FDA on Essure coils
11:08 PM, Oct 24, 2013
11:12 PM, Oct 24, 2013
Thousands of women are sharing devastating stories about how they say they're suffering side effects from a permanent birth control called Essure. Now there's a new warning about Essure: a report of a death has been filed with the U. S. Food and Drug Administration
"It's the worst thing that I've ever done to myself," said Katrina Stock, a 31-year-old mother of two from Mt. Pleasant.
Katrina Stock and several other women who came forward to 7 Action News Investigator Heather Catallo say that when decided they didn't want any more children, they chose to get Essure birth control because they were told it was cheaper, faster, and less invasive than getting their tubes tied.
Without surgery, metal coils are placed inside the fallopian tubes -- blocking conception.
But now after years of painful side effects they say were caused by this FDA-approved medical device, their "easy route" turned into a nightmare.
"I'm only 31 years old. I have two beautiful children… At this age, I should not be feeling like this when I was completely healthy before I got the Essure springs," said Stock.
Thousands of these women have taken to social media to speak out about the life-changing side-effects they've experienced since getting Essure -- most of them related to an allergy to nickel, which is a component of the coils.
Women describe extreme bloating, skin rashes and headaches. X-rays show the coils perforated the fallopian tubes, and reports describe coils breaking or misfiring in dozens of women.
More than 838 reports of these types of adverse events with Essure were also filed with the Food and Drug Administration.
Now the 7 Action News investigators found a new report detailing a woman's death also filed as an adverse event involving Essure.
A physician describes a patient who had the Essure coils implanted this year, going to the 'emergency room with abdominal pain.' That's where doctors found her 'cervix, fallopian tubes and uterus were necrotic' -- her organs were dying. On August 26 th, the 'patient went into renal failure ... [and] passed away.
We reached out to Bayer, which recently purchased the manufacturer of Essure. They provided 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."
There is a manufacturer narrative on the report stating, "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.
We also asked the FDA about this death. They told us that device manufacturers must submit a report to them when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury.
But, according to the FDA, submission of such a report is not an admission that the product actually did cause or contribute to the event.