Activist Erin Brockovich leading the fight against Essure birth control, wants FDA rules changed
11:53 PM, Oct 24, 2013
12:29 PM, Oct 25, 2013
(WXYZ) Some women across the country believe a permanent birth control device implanted in their bodies is making them sick.
But a 7 Action News Investigation found there's little they can do about it.
These women have had problems including severe pain, perforated organs, and in some cases, they've had to have full hysterectomies. They say it's all because of a tiny device that's supposed to prevent pregnancy. According to federal law, their only recourse is to make a complaint to the FDA.
But a name you'll recognize is hoping to change that.
"We are not getting the full story. I don't even believe the doctors are getting the full story. They take an oath to protect life, not to ruin it and to destroy it," said Darlene Taylor.
Taylor is one of hundreds of women who have resorted to Facebook to describe problems related to a birth control device called Essure.
"I used to be a very active mom, playing football and such with my kids. I can't even laugh at their jokes or sneeze without feeling it stab me. When it stabs me I can bleed for up to 30 days, sometimes longer and I often wonder how I'm still alive, bleeding so much," Taylor told 7 Action News Investigator Heather Catallo.
This 43-year-old mother from Detroit says one of the metal coils implanted in her fallopian tubes migrated, and it's now lodged in part of her abdomen, causing severe pain.
Essure is marketed as being a safer and easier form of permanent birth control, compared to tubal ligation.
A 7 Action News Investigation found that complaints like Taylor's are similar to more than 800 adverse event reports that have been made to the Food and Drug Administration.
The complaints range from the device lodging in organs, to pregnancy, to women having to undergo hysterectomies to remove the device.
"I was just astounded at what I was reading and even more angered that there was just going be no recourse for these women," said consumer advocate Erin Brockovich (the same one from the movie) who has taken up the cause.
Due to a law passed in the 1970's, medical devices like Essure that go through pre-market testing and are approved by the FDA are exempt from lawsuits. It's called "preemption."
"I don't know what else it takes for us to look at a group of women - thousands of them - that are having a problem that maybe something is wrong," said Brockovich.
So, Brockovich set up another way for the women to tell their stories on
this website .
She also started a petition to get lawmakers to reconsider the preemption rules.
"You have to look at the numbers of women in front of you, all presenting with the same type of symptoms, from excess bleeding to hysterectomies to getting pregnant," said Brockovich.
The FDA approved Essure after two years of clinical trials, but Brockovich says it was 'fast-tracked.'
"Women are being harmed, somewhere we're not being informed appropriately or truthfully… If you think there's a problem, get it off the market until you fix it," said Brockovich.
Women like Darlene Taylor and Katrina Stock, who are speaking out against Essure, could not agree more.
"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.
A spokeswoman for Bayer, which now owns Essure, told us the device is safe. Bayer bought Conceptus (the original manufacturer of Essure) in June.
In a written statement, Bayer spokeswoman Rosemarie Yancosek told us:
"At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause."
The company also feels that the problems reported reflect a small percentage of the more than 750 thousand women who have received the device worldwide.
In July of 2011, Conceptus (original manufacturer of Essure) petitioned the FDA to have its stronger contraindication removed and was successful.
Click here to see the press release Conceptus sent out, announcing the removal of the warning that women should be skin-tested for nickel allergies.
If you have a story for 7 Action News Investigator Heather Catallo call 248-827-4473 or email: email@example.com
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