In 2002 a new permanent
birth control came on the market claiming to work with the body to create a
natural barrier to prevent pregnancy. Now, the device is raising some concerns with
women across the country, and one famous name is getting behind the cause.
Toledo native Evelynn McCulloch
Owens says her family had grown big enough, so she and her husband made the
decision to move forward with Essure-A type of permanent birth control.
Owens was implanted with
the device in January of 2011. Shortly after, her life changed.
"I was getting very
depressed. It was affecting my ability to be a good mom, a good wife," said
For Evelynn it was a
nearly 3 year nightmare, dealing with painful symptoms every day.
"[I had] extreme
pelvic pain, which is the worst of all the symptoms I had," said Owens. "Muscle
pain in my calf to the point I was on muscle relaxer just to go to sleep. Fatigue."
According to the Essure
website, the device is a series of coils placed in the fallopian tubes which
works with the body to create a natural barrier to prevent pregnancy.
"That coil causes a reaction inside the tube,
that the tube closes in… so it's a tubal ligation," said ProMedica
Physician Dr. Terry Gibbs "It's a permanent way to stopping
your ability to have babies."
Dr. Gibbs say he performs
anywhere from 50 to 100 of the procedures a year. He says while his patients
have been pleased, he's aware of the controversy, including what the coils are
"The coil that's
placed in the body is made of titanium and nickel and 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," said
Dr. Gibbs believes Essure
is safe, and says like anything there is always a risk.
"I would tell you that
there is a very low complication rate to it and It's like anything ...Nothing
is 100-percent perfect," said Gibbs
The FDA has acknowledged
some of the complaints. On its website it says there are reports that describe symptoms
"not included in the labeling," such as fatigue, depression and
Some of the symptoms same
described by Owens.
"I couldn't go
through one day without taking a nap," said Owens.
From November 4, 2002
through October 25, 2013 the FDA has received 943 reports of adverse events
related to Essure.
Many of the women affected
are taking their fight online. A Facebook group titled "Essure
problems" has nearly 3,000 members.
"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," said Owens.
Well known consumer
advocate Erin Brockovich is now getting behind the cause. Back in October she
spoke on The Doctors about the hundreds of women who have contacted her.
Bayer, the company who
makes Essure, responded to our request with the following statement.
"We are saddened to
hear of any serious health condition affecting a patient using one of our products.
Regardless of the cause, 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."
On November 8 Owens made
the decision to get the coils removed and undergo a hysterectomy. She says life is now back to normal.
"I've literally gotten
my life back. I feel amazing," said Owens.