(Toledo News Now) - For Toledo native Evelynn McCulloch Owens, her family had grown big enough. She and her husband decided to make the decision to move forward with a type of permanent birth control called Essure.
Evelynn was implanted with the device in January of 2011. It wasn't long after that her life changed. She was dealing with painful symptoms nearly everyday.
She says," I was getting very depressed. It was affecting my ability to be a good mom and a good wife."
Her symptoms ranged from extreme pelvic and muscle pain to fatigue. She needed a nap just to make it through the day.
Evelynn starting doing more research on Essure and says she was shocked to find out how many women were in a similar situation.
She says, "I found thousands of other women going through the same thing I was going through. I felt such a relief from finding these ladies, but I was appalled at the amount of women having these problems."
Evelynn suffered for nearly three years. She finally met with a doctor who agreed that taking out Essure was her best option. On November 8, 2013, she made the decision to get the coils removed and undergo a hysterectomy.
Since having the coils removed, Evelynn says, she's literally gotten her life back and feels amazing.
She says she hopes her story can help other women going through the same thing.
WHAT IS ESSURE?
Essure is a set of coils placed in the fallopian tubes. It's supposed to work with your body to form a natural barrier that permanently prevents pregnancy.
Many doctors believe it's safe and a better alternative to having your tubes tied.
Dr. Terry Gibbs, a Promedica Physician, says he performs anywhere from 50 to 100 of the procedures a year. He says his patients have been pleased, but says, like anything there is always a risk.
Dr. Gibbs says, "I would tell you that there is a very low complication rate to it and It's like anything, nothing is 100-percent perfect."
But Dr. Gibbs says he is aware of the controversy. One issue that has raised a red flag for some, is what Essure is made of... titanium and nickel.
Gibbs say, "Some people talked about a reaction if you have a bad allergy to nickel. Some people say that you will itch and have some reaction from it. The company really doesn't say that they've had a lot of complications with people having severe reactions to it."
FDA WEIGHS IN
The US Food and Drug Administration has acknowledged complaints. On it's website it says there are reports that describe symptoms "not included in the labeling." Some of those include; fatigue, depression, and weight gain.
From November 4th, 2002, through October 25th, 2013, the FDA received 943 reports of adverse events related to Essure. The most frequently reported adverse events were pain.
To read more about what the FDA says about Essure click here.
ERIN BROCKOVICH TAKES ON ESSURE
Well known consumer advocate Erin Brockovich is now getting behind the cause and be a voice for women. She has taken her campaign against Essure on national television. Back in October, she spoke on NBC's 'The Doctors' about the hundreds of women who have contacted her to share their personal and painful stories about Essure.
Brokovich has set up an Essure website dedicatied to spreading the word about the potential dangers. On it, there is a petition to further the message. So far, more than 6,000 women have signed.
To view Erin Brokovich's Essure website or to sign the petition click here: http://www.essureprocedure.net/
BAYER RESPONDS
WTOL 11 reached out to Bayer, the company who makes Essure.
A representative responded with this statement:
"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, regardless of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effectiveness. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control... No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians."
To view a video statement from Edio Zampaglione, MD, FACOG, US Medical Affairs, Bayer HealthCare click here.
