Women blame birth control device for medical complications

Originally published 4/24/2014 and updated on 6/12/2014

MINNEAPOLIS - Minnesota women are among thousands nationwide who say they they've suffered serious complications because of a popular birth control device. And a Minnesota expert tells KARE 11 that some women may be having needless hysterectomies as a result.

Jessica Williams says she embraces motherhood. But after her third child, Gabe, she and her husband decided he would be the last addition to their family.

So, she took steps to prevent pregnancy.

In June of 2012, the Maple Grove woman underwent what's billed as a simple 10-minute procedure to provide permanent birth control.

It's called Essure. A video on the company's webpage says "the procedure can be performed in a doctor's office in minutes, without general anesthesia."

Two small coils are inserted into a woman's fallopian tubes. It triggers a tissue build up that blocks sperm.

But soon after the procedure, Williams says she experienced a mysterious pain.

"Basically I couldn't lay on my side. My stomach. My back. It hurt everywhere," she said.

But Williams, 33, isn't alone. KARE 11 talked to other women from Minnesota who say they have experienced similar pain.

Minneapolis resident Andrea Moll, 38, says she experienced "severe pain" and "heavy bleeding."

Tricia Elke, 40, of Dassel, said her pain started immediately after the procedure. "Right away is when I noticed the pain - and it just never stopped," Elke said.

In all, six women agreed to share their stories with KARE 11. During our group interview, we asked them to raise their hands if they experienced severe pain. All hands went up.

The women all say they suffered debilitating side effects.

Some say their pain was so serious, they had hysterectomies. But, at first, the Minnesota women say their doctors downplayed the symptoms. In some cases, telling them the pain could not be because of Essure.

"I lived in pain every day for two years," Carrie Lewis said.

Nicole Michniewicz, 28, of Ham Lake says her pain was constant. "I was calling off of work 2 -3 times per week," Michniewicz said." I was in constant pain for the entire time."

Julie Wimperis of Hugo said she had more side effects "from that simple thing than any other thing in my life. Worse than pregnancies or giving birth."

KARE 11 checked the government website that tracks complaints about medical devices and we found more than 1,500 complaints about Essure. And they've doubled in the past year.

Kim Hudak, of Cleveland, Ohio says she reported similar pain during the clinical trials for Essure. But, just like the women in Minnesota, she says her complaints were ignored.

"They knew about these problems," Hudak said. "They knew about them as far back as the clinical trials."

Bayer, the company that now owns Essure says three-quarters of a million women rely on it. The device is approved by the Food and Drug Administration, and it's been on the market for more than a decade.

READ: Bayer statement to KARE 11 about Essure

From the beginning Essure has warned about a number of rare side effects. But records show the company recently added chronic pain as a long term risk.

For some women, that pain has been so severe they decided to have hysterectomies.

But when we investigated, we discovered there's an expert who says there is another option. It's a simple procedure that could save some women from having needless hysterectomies.

Dr. James Presthus was an early advocate when Essure came on the market. He specializes in gynecology and works at Minnesota Gynecology and Surgery in Edina. He served on the faculty at the University of Minnesota and once sat on a medical advisory board for Essure.

"Essure was kind of the holy grail when it came on the market," Presthus told us. "I've done hundreds of these procedures in my office. I have had generally a very favorable experience. Patients were pleased. They generally tolerated it well."

He says inserting the Essure coils is usually successful but not always. He warns doctors are making a mistake if they don't take side effects seriously.

But some of the women KARE 11 interviewed said that, too often, no one would listen to them. Which promoted us to raise the question: Is there an education gap?

"There is an education gap." Dr. Presthus told us. "A lot of times the message they get is like, well, it's you're fault," he said. "You're just being kind of wimpy about it or something."

He said doctors are making an even bigger mistake if they tell women that hysterectomies are the only answer. He said the coils can be removed during a simply outpatient procedure, not a full hysterectomy.

"I've never had trouble removing the device," he said.

So, are women having needless hysterectomies? Dr. Presthus says he thinks some are. "I do think there are needless hysterectomies being done because of the Essure device."

Without knowing their options, some women may be choosing between hysterectomies and chronic pain.

But there is another strange twist to this story. Because of a loophole in the law, the women have been told they probably can't take the makers of Essure to court.

Turns out, to help encourage medical break-throughs, Congress passed and the courts have upheld a law saying certain medical devices, like Essure, that go through a special government premarket approval process are protected from most law suits.

So, women have been sharing their stories about Essure on a Facebook page.

Activist Erin Brockovich has even gotten involved creating an online petition drive to change the law.

And while the women fight to have their day in court there is relief in realizing they are not alone. Many days, the women said they would sit alone, thinking they were going insane. Now, they laugh about it.

Laughing, they say, is easier because they have each other.

The Minnesota women, call themselves E-sisters, have found a silver lining through pain.


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